Latest Gout News from around the World

Enriched Milk can help Gout

The groundbreaking study is the first clinical trial to study dietary intervention in gout, and was conducted by Dr Nicola Dalbeth from the University of Auckland Bone and Joint Research Group in conjunction with scientists from the Fonterra Research Centre and the University Department of Medicine.

Dr Dalbeth says the results are likely to come as welcome news to the millions worldwide who suffer from gout - the most common form of inflammatory arthritis and a disease associated with extreme joint pain.

"While gout is largely seen as a nutritional disease, until now there have been no clinical trials to show the positive impact of dietary intervention," she says.

"If developed further, this discovery has the potential to give patients more control over their condition, and could become a very useful tool in the ongoing management of gout," said Dr Dalbeth.

Global prevalence of gout appears to be on the increase with recent estimates suggesting that the New Zealand prevalence of gout is around 2.9 per cent of the population, while a rate of 1.4 per cent is reported in Australia. Up to 8.3 million Americans (4 per cent) now suffer from gout and a prevalence of 1.4 per cent has been reported in the UK and Germany, while a comparative study in China showed an increase in prevalence from 0.36 per cent in 2000, to more than 1 per cent in 2006.

The research has been driven by Fonterra's Premium Ingredients division, which has patented the use of the two ingredients in relation to gout and is currently investigating opportunities to bring this new solution to gout sufferers globally.

Fonterra Premium Ingredients Group Director of Marketing, Innovation and Ventures, Joanna Mobley says the company is excited by the study's finding and its potential to provide gout sufferers with a dietary intervention.

"When you look at the statistics, a prevalence level of more than 1 per cent in China sounds small, but it actually equates to over 15 million sufferers in one country alone.

"We know that incidence of gout is growing in adult populations all over the world, so we expect this discovery to play an important part in our innovation strategy to support healthy ageing through advanced nutrition," said Ms Mobley.

A sample group of 120 gout sufferers were enrolled into the three month study, which analysed the frequency and intensity of gout flare ups. The results showed that those taking the enriched skimmed milk had significantly greater reduction in gout flares compared with two control groups, and experienced greater improvements regarding pain intensity.

The research was originally funded by LactoPharma; a joint venture between Fonterra and The University of Auckland, which is funded by Fonterra and the Foundation for Research, Science and Technology.

Gout-fighting drug recalled from shelves

The Health Department said a black substance had been found on some of the tablets, which are used to treat hyperuricaemia and gout.

Tests later revealed that the substance was Hydrocarbon oil used for equipment involved in production of the tablets.

Almost 23-thousand boxes of the affected batch were imported from Hungary to Hong Kong.

A Health Department spokesman said so far they had not received any reports of adverse affects in connection with the product.

Effective Gout Remedies

Gout, a kind of arthritis has become a common disorder in aging men and post menopausal women. It occurs when uric acid builds up in the blood. Gout causes joint inflammation and the condition can get extremely painful. Apart from following diet, there are home remedies to treat gout which we will be discussing in detail. Take a look.

Excessive alcohol consumption and unhealthy food can cause the joint pain. The fire and burning sensation in joints, sweating are the common symptoms of this arthritis pain.

Gout Home Remedies

1. Apples work like a blessing for gout. Eating a apple everyday will be a good gout pain relief treatment. A juice extract of Cherries contains anthocyanins (antioxidant) that reduce the joint inflammation and slowly bring cure.

2. Lemon is the best detox. Drinking lemon juice for at least three times daily will be the best home remedy for gout. Even sweet lime is the best remedy for the disorder.

3. Fresh vegetable juices like carrot, beetroot, ash gourd and cucumber cam purify blood and gradually reduce pain.

4. Soaking the swollen foot in warm water mixed with rock salt or charcoal powder can relieve pain.

5. Massaging ginger turmeric paste around the region which effectively eradicates uric acid and treats it instantly.

6. Herbs like mustard, willow bark are also good home remedies for gout.

Dr. Oz: Three Warning Signs from Your Feet for Gout

Dr. Oz explains that three warning signs from your feet play an important diagnostic role in indicating whether someone may be at risk of a serious health condition. In The Dr. Oz Show, Dr. Oz presents to his viewers three life-saving clues that act as warning signs from your feet that you are in need of treatment by a physician before your condition develops into a serious medical problem.

Warning Sign #1: Hairless toes and feet are a sign of cardiovascular diseaseOne of the life-saving clues Dr. Oz discusses has to do with how well the circulatory system brings oxygenated blood from the heart via arteries that travel within and outside the bones of the legs to the feet.

One test is to observe whether or not you have hair or “peach fuzz” on the tops of your toes. When a person is healthy and his or her circulatory system is not clogged by arterial sclerosis and plaque formation, then blood is able to travel easily to the feet and provide nourishment that supports the growth of hair on the toes. However, if the arteries are clogged, then the blood perfuses poorly the long distance to the feet. According to Dr. Oz, the first sign of this is loss of hair on the toes because they are deprived of the oxygen and nutrients needed to support their growth.

“If you are a smoker,” says Dr. Oz, “one of the first things you will notice is that you’ll have less hair on your feet because those plaques are clogging the arteries…the good news is that all of this is reversible.” He explains that eating ½ a glove of garlic a day mixed in with your food will improve the condition of your arteries and can increase the blood flow to your feet.

Warning Sign #2: A big red swollen toe is a sign of gout“The big toe is frequently where we see the second big warning sign of the body—which is gout,” says Dr. Oz. as he explains that gout typically occurs in the big toe, but can manifest in other toes as well. Gout is a type of arthritis caused by a buildup of uric acid crystals around the joints in the toe. The uric acid crystals eventually buildup and develop into shards that pierce the surrounding tissue like tiny spears, which leads to the characteristic inflammation and swelling seen with gout.

He explains that gout typically occurs in women following menopause, but can also result from eating certain kinds of foods such as wine and red meat. Dr. Oz advises his viewers that if they have gout, that by reducing their intake of red meat and avoiding alcoholic drinks—especially beer, because beer actually aids the formation of the uric acid crystals—that they can lessen the symptoms of gout.The good news according to Dr. Oz is that there are things you can do to prevent gout. “If you have four cups of coffee a day, you can reduce the chances of developing gout by 40 percent,” says Dr. Oz.

Warning Sign #3: Foot cramps are signs of mineral deficiencies“The third warning sign that your feet can give you is foot cramps,” says Dr. Oz as he explains that foot cramps are often caused by an electrolyte imbalance from a deficiency of certain minerals. A mineral deficiency can cause the muscles in the feet to become very rigid and tense, which leads to the cramping pain people feel in their feet. He advises his viewers to bring their electrolytes back in balance by eating a banana for its potassium and to take 400 and 600 milligram supplements of magnesium and calcium respectively; or, to eat deep green lettuces such as romaine and arugula. “They [in comparison to iceberg lettuce] actually have a lot more magnesium in them,” says Dr. Oz.

Natural Remedies for Gout, Part 2: The Anti-Inflammatory Diet

This is not a diet in the typical sense of the word – it is not intended as a weight-loss plan, though some people do lose weight on it. Instead, it is a way of selecting and preparing foods based on scientific research of how they can help your body be healthy while reducing inflammation and the risks of having gout flares. It will provide your body with steady energy and plenty of vitamins, minerals, fiber, essential fatty acids, and protective phyto-nutrients. Adapting some of your favorite recipes to be friendlier to your condition is possible, so do a bit of research and follow these anti-inflammatory principles to keep your flares to a minimum

General Tips

Aim for variety. Eat an abundance of fruits and vegetables. Include as much fresh food as possible. Minimize your consumption of processed foods and fast foods.

Calorie Intake

Most adults need to consume 2000 to 3000 calories daily; smaller and less active people need fewer calories, while larger and more active people need more. Your diet should be divided as follows: 40 percent carbohydrates, 30 percent fat, and 30 percent protein. Try to have some of each of these at each meal.

Carbs

On 2000 calories daily, adult women should eat about 180 grams of carbs each day, whereas adult men should eat about 270 grams of carbs each day. Most of your carb choices should be in the form of unprocessed, unrefined foods that have a low glycemic load. Eat less wheat flour and sugars. Especially avoid bread and processed snack foods like chips, pretzels, cakes, etc. Eat more whole grains like brown rice and bulgur wheat, in which the grain is intact. Eat more beans, winter squashes, and sweet potatoes. Cook pasta al dente (firm to the bite) but not hard, and consume it in moderation. Avoid all foods that contain high fructose corn syrup.

Fat

Daily intake should be about 600 calories – about 67 grams –from fats. Reduce intake of fatty meats, unskinned chicken and turkey, and products that contain palm kernel oil. Use extra virgin olive oil for cooking. If you want oil with a more neutral taste, use expeller-pressed canola, sunflower, or safflower oil. Avoid corn oil, cottonseed oil, mixed vegetable oil, margarine, shortening, and all products that contain them. Eat more avocados, walnuts, cashews, almonds, and nut butters made from them. Eat foods high in omega-3 fatty acids, like salmon (preferably fresh or frozen wild or canned sockeye), tuna, herring, black cod (butterfish), omega-3 fortified eggs, hemp seed, and flax seed, or take a fish oil supplement (store in the freezer to avoid the fishy burps and aftertaste).

Protein

Daily intake should be about 100 grams. Eat less if you have liver or kidney disorders, allergies, or an autoimmune disease. Reduce intake of animal protein, except from fish, natural cheese, and yogurt. Eat more vegetable proteins, especially beans.

Fiber

Daily intake should be forty grams. Eat more fruit (especially berries), vegetables, and whole grains. If you choose ready-made cereals, read the label to be sure that what you choose has at least five grams of bran per one ounce serving.

Phyto-nutrients

To maximize your natural protection against gout and other age-related diseases (like cardiovascular disease, cancers, and neuro-degenerative disease) and environmental toxicity, eat a variety of fruits and vegetables. Choose fruit and veggies from all over the world and from across the color spectrum. Make most of your choices from the various berries (especially strawberries and cherries), tomatoes, yellow and orange fruit, and dark green leafy vegetables. Make organic produce purchases whenever you can. Learn which conventionally grown produce is most likely to carry residue from chemical fertilizers and pesticides and avoid them. Eat members of the cabbage family (like Brussel sprouts, broccoli, etc.) regularly. Include soy products from time to time. Drink tea instead of coffee, especially green, white and oolong teas. If you drink alcohol, do so in moderation and choose red wine over white wine, mixed drinks, or hard liquor. Enjoy plain, dark chocolate with a minimum cocoa content of 70 percent, but do so in moderation.

In closing, let me just remind you that before making any changes to your regular diet and supplement regime you should always consult your doctor or health care provider.

©2011 Off the Grid News

Doctors Seeing Rise Of Gout In Younger People

It’s described as sudden excruciating pain that often strikes at night. Gout is a painful form of arthritis. Now, increasing numbers of younger people are suffering with gout, and doctors want to get the word out.

At 40, Bob Fratto thought he sprained his foot.

“It started out as a small pain in my big toe. It progressed into my ankle, making it impossible to walk at times. I even used a crutch for a week,” said Bob.

Doctors finally diagnosed gout, a painful problem for a growing number of younger people. Experts aren’t sure why.

“I’m seeing a fair amount of gout in people who are 30’s, 40’s and 50’s. I’d say over the last three to four years, [rather] than for example, when I was training most of the gout was in 60’s, 70’s, 80 year old patients,” said Dr. Fotious Koupouras, an Arthritis Specialist.

With gout, something called uric acid builds up in the joints and forms crystals. These cause pain and swelling, typically in the big toe.

“Gout is one of the most painful arthritis conditions known. Individuals who get multiple attacks of gout lose work. These people have difficulty ambulating. We think diet plays a large role for why younger patients are getting gout,” said Dr. Koupouras.

“Some of the things you shouldn’t be doing when you have a gout inflammation, I was still doing, like having red meat, and having alcohol,” said Bob.Other risk factors for gout include high cholesterol, blood pressure and having diabetes.

Fortunately gout is treatable, mainly with medications.

“I went on a prescription pill, and it lowered my uric acid. It took a couple months for my active attack to subside, but now I’m in good shape,” said Bob.

Gout usually strikes men. Women are at an increased risk after menopause. Doctors also say it tends to run in families.

For more info on gout, visit: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001459/ and http://www.nlm.nih.gov/medlineplus/gout.html

The Majority of Gout Patients on Uric Acid Lowering Therapy Fail to Achieve Control of Serum Urate Levels

Allopurinol remains the predominant first-line UAL agent of choice among PCPs and rheumatologists, although Uloric/Adenuric (febuxostat) is making inroads, particularly in the more severe gout patients. The 300mg dose of allopurinol is still the most commonly prescribed strength in both markets and many physicians are reluctant to escalate allopurinol doses due to concerns regarding the patient's renal function and tolerability. Doses of Uloric in the U.S. were significantly higher compared to the same period last year and, among rheumatologists, doses of Adenuric in the EU are significantly higher than those in the U.S. for both moderate and severe patients.

In the U.S. audit, patient profiles revealed that Uloric and Krystexxa patients tend to have greater disease severity with polyarticular tophi, greater likelihood of kidney damage, and a greater frequency of acute gout flares, emergency room visits and hospitalizations compared to allopurinol patients. In the EU, where Krystexxa is not yet commercially available, significant differences exist between patients being treated with allopurinol and those being treated with Adenuric in terms of disease severity, flare frequency and severity, underlying co-morbidities and concomitant steroid use. EU physicians report that more than one-third of their severe gout patients have a suboptimal response to current UAL agents, highlighting a large opportunity for new products.

There is a significant difference in the use of colchicine to prevent paradoxical gout flares during UAL initiation between the U.S. and the EU among rheumatologists. Generic colchicine has been removed from the U.S. market in favor of the branded version, Colcrys, marketed by URL Pharma. Compared to one year ago in the U.S., the use of colchicine/Colcrys as prophylaxis is down sharply in prevalence among rheumatologists, but treatment duration is slightly higher than the prior year. Comparatively in the EU market, the percent of rheumatologists' patients receiving prophylactic treatment with colchicine was more common.

ChartTrends®: Gout is an annual, quantitative publication based on patient and laboratory data collected from over 1,200 gout patient charts in each market. It is designed to compare what physicians self-report about disease management to what actually occurs at the patient level. The reports provide insight into the factors that drive decisions to treat, brand selection of UAL therapies, patient characterizations, and dosing trends among primary care physicians and rheumatologists. Through an in-depth review of specific patient charts, details such as product initiation, switching, concomitant medications, acute gout flare management, and patient demographic variables help define patient types and identify therapy drivers. Patient profiles for the marketed UALs as well as products in late stage clinical development for gout (Regeneron's Arcalyst, Ardea's RDEA594, Biocryst's BCX4208) are characterized.

ChartTrends®: Gout U.S. 2011 report captures information from 1245 patient charts provided by 124 PCPs and 125 rheumatologists in October 2011. All patients are on a UAL therapy at the time of the audit with all UAL brands (Allopurinol, Uloric, Krystexxa) represented.

ChartTrends®: Gout Europe 2011 is a parallel report covering the European market (EU5) and captures information from 1260 patient charts provided by 126 general practitioners and 126 rheumatologists in August 2011. All patients are on a UAL therapy at the time of the audit with all UAL brands (Allopurinol, Adenuric, Probenecid, Sulfinpyrazone, Benzbromarone) represented.

About BioTrends Research Group, LLC

BioTrends Research Group, LLC provides syndicated and custom market research to pharmaceutical manufacturers competing in clinically evolving, specialty pharmaceutical markets. For information on BioTrends publications and research capabilities, please contact us at (610) 363-3872 or www.bio-trends.com.

The Potential Role Of Krystexxa The Treatment Of Gout

Over time, these deposits (larger and more noticeable deposits are known as tophi) can become quite large, unsightly and interfere with the functioning of joints. In over 50% of cases, the first joint affected is the big toe and the popular image of the gout sufferer is an obese person with his foot propped up and bandaged. Gout flares up at unpredictable times and these flares can be painful and debilitating. If not controlled, over several years gout can progress and cause joint deformities that debilitate the patient and put patients at risk for developing kidney stones, kidney damage and heart disease.

Diet related factors account for an estimated 12% of gout cases and genetic factors around 60%. It is often associated with metabolic syndrome and can be triggered by physical trauma and surgery.

Drugs Used to Treat Gout

Earlier and milder stages of gout can be treated with diet and exercise. As gout progresses, it is treated with two types of drugs. Pain relievers like the non-steroidal anti-inflammatory drug are used to treat the pain associated with acute flares. Colchicine may also be used to break down the urate crystals and keep them from forming deposits. In more severe cases of pain and inflammation, steroids may be used.

Another class of drugs is used chronically to reduce the amount of uric acid in the blood with the goal of getting blood levels to 6.0 mg/dl or less. Remember that at levels greater than 6.8 mg/dl, uric acid precipitates out of the blood and forms crystals. The mainstay and gold standard of chronic drug therapy is allopurinol. It inhibits the enzyme xanthine oxidase that is necessary for the body to produce uric acid. Physicians may also use a drug like probenecid that works through a different mechanism of action and causes the kidneys to excrete more uric acid. Alone or in combination, these drugs reduce the concentration of uric acid.

For over 40 years, there was no innovation in chronic gout therapy and allopurinol and to a much lesser extent probenecid were routinely prescribed by physicians. The pharmaceutical industry has rediscovered gout and there is frenetic development activity. About three years ago, the FDA approved Uloric (febuxostat). You may have seen the commercials on television that feature a man carrying a green jar that symbolizes uric acid. Uloric is a xanthine oxidase inhibitor like allopurinol.

The efficacy of allopurinol and Uloric is comparable and the major differentiation is that febuxostat is primarily excreted from the body through the feces and allopurinol through urine. There are a small, but meaningful percentage of patients that have impaired kidney function and for whom Uloric offers a crucial advantage. Uloric is priced at about 40 times the price level of generic allopurinol and has been able to capture only 5% of the market since its February 2009 approval. There are two other uric acid lowering agents that are nearing phase III development and are being closely watched by investors

Ardea’s (RDEA) lesinurad is a once a day oral drug that inhibits the URAT1 transporter in the kidney that regulates uric acid excretion from the body. Lesinurad increases renal excretion of uric acid by moderating URAT1. It is not a xanthine oxidase inhibitor like allopurinol and febuxostat and could potentially be used in combination with them. It is poised to begin phase III trials and if all goes smoothly, it could be approved in the US in late 2014 or 2015. Because lesinurad affects kidney function, any side effects related to the kidney will be closely scrutinized by the regulatory agencies.

BioCryst’s (BCRX) BCX4208 is a novel enzyme inhibitor that works upstream of xanthine oxidase. It is an oral drug with potentially once a day dosing. It should be synergistic with allopurinol and febuxostat and used in combination with them. It is nearing the end of phase II development and could enter phase III in 2012. If all goes well, it could be approved in the U.S. in 2015 or 2016.

Beyond 2017 there is the potential that these three drugs when combined with the current gold standard drug allopurinol could change the natural history for gout patients, reducing the number entering the refractory state and limiting the market potential for Krystexxa. However, none of these drugs promise to have the efficacy of Krystexxa and chronic refractory gout takes many years to reverse. Also, lesinurad and BCX4028 won’t be on the market until 2014, 2015 or 2016 and their clinical profile has yet to be defined in phase III trials. If this is a concern for Krystexxa, it is for the 2017 and beyond time frame.

Krystexxa Is a Breakthrough for Chronic, Refractory Gout

Krystexxa was approved for patients who have the most severe cases of gout and have failed to respond to allopurinol. These patients have high levels of uncontrolled uric acid and usually present with a number of disfiguring tophi.

The type of patient that Krystexxa is effective for was described at the Krystexxa FDA advisory committee by a physician. He said Mr. L, a 46-year-old engineer, came to him with the most severe case of gout that he had ever seen. Due to knee involvement, Mr. L had not walked in more than four years and got about in a motorized scooter. Mr. L sought out the doctor when he learned that he was participating in the phase III clinical trial of Krystexxa. Unfortunately, he was randomized to placebo and endured six months of ineffective therapy and pain without any results. However, he was eligible at the end of the trial to switch over to the open label phase of the program in which he could receive Krystexxa. After a few months on therapy, Mr. L walked for the first time in four years and made great progress toward becoming fully ambulatory. Striking, draining, crusted tophi on his hands resolved over a nine-month period.

The experts on the FDA advisory committee were also convinced of the efficacy of Krystexxa in refractory gout. One was a rheumatologist with a large gout patient population. He said that this was the first drug he had seen that could dissolve tophi. Another said that this was the most exciting data that he had ever seen in terms of resolving chronic gout. Of the 15 members of the committee, all were convinced that Krystexxa is uniquely effective in treating refractory gout. Only one member voted not to approve Krystexxa and this was due to concerns about safety.

Krystexxa Has Administration and Side Effect Issues

The efficacy of Krystexxa in some patients is extraordinary. However, its efficacy must be weighed against other issues. The development of Krystexxa was based on a novel biological observation by scientists at Duke University that mammals with the exception of humans and great apes have an enzyme called urate oxidase that is produced by the body to break down uric acid. Humans and great apes over the course of evolution have lost the ability to produce urate oxidase and rely on excreting uric acid in urine to maintain balance in the blood.

Krystexxa is a recombinantly produced version of pig urate oxidase that is pegylated to allow for longer circulation time in the body and to reduce the immune response. Because it is essentially a foreign (pig) protein, the body can create antibodies against it. These antibodies can lead to troubling side effects and can also inactivate the product. This sounds daunting, but bear in mind that for decades diabetics were treated effectively with pig and cow insulin.

The disadvantages of Krystexxa are its side effect profile and its administration requirements. Drug administration requires a two hour infusion every two weeks until uric acid levels reach targeted levels and in the clinical trials this could take 6 to 18 months. About 80% of patients experience a gout flare when starting on the drug; this is common for all uric acid lowering therapies. Infusion related side effects require prophylaxis with the antihistamine fexofenadine and a steroid to reduce inflammatory reactions. Krystexxa carries a black box warning on its label alerting physicians about the risk of anaphylaxis. In phase III clinical trials, 157 of 212 patients (on intent to treat basis) or 74% of patients completed therapy despite the administration and side effect issues.

Disclosure: I am long SVNT.

Gout drug reduces incidence of irregular heartbeat after surgery

Study Highlights:

The drug colchicine reduced the incidence of post-pericardiotomy syndrome and post-surgery atrial fibrillation by nearly half in a placebo-controlled, randomized study. Heart surgery patients who received colchicine also had shorter hospital stays than those who received a placebo. Colchicine therapy could become a safe and inexpensive way to prevent post-surgery atrial fibrillation.

ORLANDO, FLA., Nov. 16, 2011 — Colchicine, often used to treat gout, greatly reduced the incidence of atrial fibrillation after heart surgery, according to late-breaking research presented at the American Heart Association’s Scientific Sessions 2011.

The Italian study is also published in Circulation: Journal of the American Heart Association.

Atrial fibrillation (AF) occurs when the upper heart chambers beat too rapidly and erratically to effectively pump blood. If untreated, AF can lead to a stroke, clots obstructing blood flow in other parts of the body and/or heart failure.

“This is the first time that colchicine has been shown to prevent atrial fibrillation,” said Massimo Imazio, M.D., lead author of the study and a cardiologist at Maria Vittoria Hospital in Turin, Italy. “The findings are clinically significant and provide evidence that colchicine may represent a cheap, safe option for the prevention of the post-pericardiotomy syndrome and post-operative AF.”

AF is the most frequent complication after heart procedures such as coronary artery bypass grafting, valve surgery or combined bypass/valve surgery. It may affect more than 50 percent of patients after cardiac surgery. Inflammation of the tissues surrounding the heart — post-pericardiotomy syndrome — is a potential cause of the condition, and colchicine may reduce incidence of this syndrome as well as postoperative AF by half, Imazio said.

One month after heart surgery, colchicine had cut the incidence of AF nearly in half — 12 percent of those taking colchicine had AF compared to 22 percent of patients given a placebo.

Furthermore, colchicine patients were hospitalized three fewer days — 21 versus 24 — than those who received a placebo.

The study included 336 heart surgery patients from six centers in northern Italy. Their average age was 66 and 69 percent were men.

Study participants received either colchicine or placebo, beginning three days after heart surgery and continuing for one month. Neither patients nor investigators knew who received active drug or placebo.

Side effects were minimal and similar between the two groups. But colchicine patients were slightly more likely to experience gastrointestinal intolerance, the most common side effect.

The study had a relatively small sample size and scientists started the medicine three days post-surgery. So, before changing recommendations, future large-scale studies should initiate colchicine treatment earlier, ideally before surgery, since postoperative AF often occurs in the early days after surgical intervention.

“In that way, you might also be able to prevent atrial fibrillation in the first few days after the cardiac operation,” Imazio said.

Colchicine is a plant-derived substance from the drug class of alkaloids, which also includes morphine and caffeine. It is not currently approved in North America or Europe for pericarditis, post-pericardiotomy syndrome or for atrial fibrillation prevention.

Co-authors are Antonio Brucato, M.D.; Paolo Ferrazzi, M.D.; Maria Elena Rovere, M.D.; Anna Gandino, M.D.; Roberto Cemin, M.D.; Stefania Ferrua, M.D.; Riccardo Belli, M.D.; Silvia Maestroni, M.D.; Caterina Simon, M.D.; Edoardo Zingarelli, M.D.; Alberto Barosi, M.D.; Fabrizio Sansone, M.D.; Davide Patrini, M.D.; Ettore Vitali, M.D.; Rita Trinchero, M.D.; David H. Spodick, M.D.; and Yehuda Adler, M.D.

Disclosures are here: http://newsroom.heart.org/pr/aha/document/Disclosures_for_LBCT.xlsx.The Maria Vittoria Hospital, ASLTO2, in Torino, Italy, funded the study for the Italian National Healthcare System.###Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.heart.org/corporatefunding. External link

CONTACT:AHA News Media in Dallas: (214) 706-1396AHA News Media Office, Nov. 12–16, at theOrange County Convention Center: (407) 685-5410For public inquiries: (800) AHA-USA1 (242-8721)

CT scans identify gout patients where standard tests fail

Over the past couple decades, advances in technology have made it easier to detect all sorts of conditions, including gout. But some tests do not always work. One type of X-ray can spot gout where other tests miss it.

Computed tomography (CT) scans can verify if someone has gout (a form of arthritis), even if other tests did not detect the painful condition. CT scans are also useful for diagnosing gout in patients who cannot undergo the traditional test of drawing fluid from joints.A CT scan can help diagnose gout in difficult cases.

Gout occurs when crystals of uric acid build up around joints, causing pain and inflammation. Normally, doctors check for gout by drawing fluid from affected joints and looking for uric acid crystals. Tim Bongartz, M.D., a rheumatologist at Mayo Clinic, and colleagues set out to see if CT scans could spot these crystals.

It was only recently that CT scans - or more specifically dual-energy CT scans - were reworked to spot crystals of uric acid. So, the researchers wanted to test the limits of this new method. Instead of only testing the technology on patients with highly developed gout, they also took images of those who were within a few days of their first flare-up of gout.

According to Dr. Bongartz, the scans were "very accurate" in spotting patients with gout. However, he points out that CT scans come with a much higher price tag that the traditional test for diagnosing gout.

Dr. Bongartz also mentions one large drawback to the CT scan method: it was not highly accurate in spotting cases of acute gout. During the study, CT scans did not identify 30 percent of the patients with acute gout.

Rather than using CT scans to diagnose every case of gout, it appears they are most useful when fluid cannot be drawn from the joints or when the fluid test comes back negative even though it is highly likely a patient is suffering from gout, says Dr. Bongartz.

Dr. Bongartz presented his study at the annual meeting of the American College of Rheumatology in Chicago. As such, his team's findings still need to go through the peer-review process.

Preventing Gout Flare Ups In Patients With Renal Impairment - Dosing Guidance

The study "Colchicine Dosing Guidance for Gout Patients with Varying Degrees of Renal Impairment Based on Pharmacokinetic Data," is part of URL Pharma's ongoing clinical research program for colchicine. Colcrys® (colchicine, USP), the only single-ingredient colchicine product approved by the U.S. Food and Drug Administration (FDA) is held by AR Holdings, a URL Pharma company. Colcrys® is designed as a prophylaxis and treatment of gout flares and for the treatment of Familial Mediterranean Fever (FMF).

Jim Belushi & Gout

Gout? The so-called "disease of kings" that plagued aristocrats in the days of King Henry VIII? The condition that was a source of painfully funny comedy in "Laurel & Hardy" shorts more than 70 years ago?

For the actor and comedian who grew up in Wheaton, it was no laughing matter. It was personal. Gout runs in his family. His father and late aunt had it. His sister has it. It is a testament to how seriously Belushi takes gout that on a recent Monday morning he was in Chicago conducting interviews and raising awareness instead of being in Philadelphia to watch the Bears game that night.

Belushi, in association with Savient Pharmaceuticals, is helping to launch Check Out Your Gout, an education campaign about gout and a severe form of the condition known as refractory chronic gout. He has recorded a public service announcement, the first of his career.

Initially, for several years, Belushi did not seek medical treatment for his condition. "My ego said I could stomach it," he laughed. Then came Reno, Nev., where he and Dan Aykroyd were performing as the Blues Brothers. He suffered an excruciating attack that left him immobile onstage, standing on the back heel of his foot.

"I did the whole show in that one position while Danny was dancing around," Belushi said. "I can take the pain at home but what was tortuous to me was that I compromised the show. I went to a rheumatologist and she put me on allopurinol (a generic drug that blocks uric acid production). I've been attack-free for 12 years."

Gout affects an estimated 8 million people in the U.S. It's the most common inflammatory arthritis, said James Grober, rheumatologist at North Shore University Health System. He is not connected with the Check Out Your Gout campaign, which he called "long overdue."

"In younger age groups, it predominantly affects men," he said. "But with women after menopause, it starts to approach the incidences of what we see in men."

Gout is caused by a buildup of uric acid in the bloodstream that crystallizes in the joints and surrounding tissue. The big toe is the joint most commonly associated with the condition, but the disease also can inflame knee, ankle, wrist, hand and elbow joints.

The National Institutes of Health says that gout most often affects one joint, typically in the big toe, ankle or knee.

The pain is as advertised. "You can't even rub a Kleenex across it," Belushi said. "It's the worst."

Refractory chronic gout — which affects about 120,000 people, Belushi's aunt among them — is especially severe. This condition is marked by the frequency of episodes, recurrent pain and disfigurement. Savient has developed Krystexxa, an FDA-approved drug that the company says has lowered uric acid levels and reduced deposits of uric acid crystals in joints and soft tissue in cases that do not respond to standard medications.

Far from the "disease of kings" –– called so because of its past association with a high-meat and alcohol diet –– gout is getting more common than ever, Grober said. "It tends not to attract a lot of attention because when (sufferers) have an active gout attack it's very painful and in the moment, but after the attack subsides they feel like out of sight, out of mind. But that is most definitely not the case. The underlying uric acid excess problem is smoldering beneath the surface, poised to cause recurring gout attacks and potential joint damage."

The nation's rising body mass index can only make things worse. "If you're overweight, it increases your risk of gout," Grober said. "Losing weight will make a difference. Beer is the greatest offender of elevated uric acid. Switching to red wine could be healthful. Increasing dairy intake could also be beneficial. Studies have shown, through lifestyle and dietary changes, you can lower uric acid levels by two points."

The good news, Belushi said, is that gout is treatable. "My message to guys is, don't be an idiot like me and suffer through it. The pain humbled me, so I took action."

For more information, visit checkoutyourgout.com.

Copyright © 2011, Chicago Tribune

Poor Footwear Choices Common in Gout Patients With Foot Pain

The finding is particularly noteworthy considering that gout now affects 8.3 million individuals in the United States. Research has shown that chronic gout-related pain and swelling contributes to changes in patients’ gait, which likely impairs foot function (Clin Biomech [Bristol, Avon]. 2011;26:90-94).

In the current study (Arthritis Care Res. doi 10.1002/acr.20582), researchers recruited 50 patients with a history of gout from local rheumatology clinics in New Zealand. The investigators assessed clinical disease characteristics, overall function, foot impairment and disability, and the type and age of footwear patients chose to wear.

The investigators found more than 50% of study participants wore shoes that were more than 12 months old “and demonstrated excessive wear patterns.” Approximately 56% of patients made good footwear choices by opting for walking shoes, athletic sneakers or oxfords. Of the remaining patients, 42% made poor footwear choices, including sandals, flip-flops, slippers or moccasins; this group reported higher foot-related impairment and disability. Only 2% wore boots, which were considered average choices, and none wore high-heeled shoes.

Characteristics of poor footwear included improper cushioning, lack of support and inadequate stability and motion control. Participants identified comfort (98%), fit (90%), support (79%) and cost (60%) as important factors for selecting footwear.

“We found that gout patients in our study often wore improper footwear and experienced moderate to severe foot pain, impairment and disability,” said Keith Rome, MD, professor in podiatry from Auckland University of Technology in Auckland, New Zealand, in a press statement. “Many patients’ shoes also showed excessive wear and we suggest that proper footwear selection be discussed with gout patients to reduce foot pain and impairment.”

—PMN Staff

CT scans can detect gout cases

The type of CT scan, known as dual-energy computed tomography, is also valuable for diagnosing people who cannot be tested with the typical method of drawing fluid from joints, researchers found.Dual-energy CT scans were recently modified to detect the crystals, and the study found the scans "very accurate" in identifying patients with gout, said Tim Bongartz, rheumatologist at Mayo Clinic in Rochester, Minnesota, who led the study.

"We wanted to really challenge the new method by including patients who were only a few days into their first flare of gout," Bongartz was quoted as saying in a Mayo statement.

Gout, the build-up of uric acid crystals in and around joints, causing inflammation and painful, potentially disabling flare-ups, has historically been portrayed as a disease of the wealthy but it afflicts people from all walks of life.

Men are likelier to develop gout, but women's risk rises after menopause, when their uric acid levels approach those of men. Treatment usually involves medication and dietary changes.

Physicians traditionally check for gout by using a needle to draw fluid from affected joints and examining the fluid for uric acid crystals.

Bongartz noted that CT scans are significantly more expensive than the standard test for diagnosing gout. He also cautioned that, while highly accurate overall, in one subgroup of patients studied -- those with very acute gout -- the CT scan failed to identify 30 percent of cases.

The new tool is most helpful when joint fluid cannot be obtained or the fluid analysis comes back negative even when gout is strongly suspected, he said.

The study was presented at the American College of Rheumatology annual scientific meeting in Chicago.

Chiselling off a bone can end the torture of gout

Around a million Britons have gout, but few realise it can cause abnormal bone spurs around the joints, triggering agonising nerve damage.

Chris Knight, 67, a retired international lawyer from Somerset, had an operation to remove them.

THE PATIENTChris Knight was struck down by gout 11 years ago but has now had surgery to cure the done spurs it can create around joints

Chris Knight was struck down by gout 11 years ago but has now had surgery to cure the done spurs it can create around joints

Gout first struck me 11 years ago. I was sitting in my office when my left ankle suddenly started throbbing unbearably.

Within two hours, it became so painful that I couldn’t put any weight on it — I rang my wife Maggie, who is a nurse, and struggled onto the train home.

She picked me up at the station and drove me to hospital, where they did blood tests and diagnosed gout. They explained it’s caused when uric acid, which is normally passed out in urine, builds up in the body and forms crystals around the joints.

The crystals cause the joints to be inflamed, which is why I was feeling so much pain.

I was sent home with colchicine, an anti-inflammatory drug, which I took whenever I felt the pain coming on, perhaps once a year. I was told that substances in food and drink such as beer and seafood called purines can turn into uric acid, but I’d always had a healthy diet and enjoyed beer and wine in moderation.

Still, I thought it was a good idea to avoid these foods.

However, after visiting our daughter in Australia in 2006, I started having pains in my knees and all down my left leg. My knees and legs ached, as though I’d walked miles. We couldn’t figure out what was causing it — blood tests showed my uric acid levels were normal, so we couldn’t see a connection to the gout.

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Over the next five years, I tried everything — I saw a rheumatologist and a neurologist who ran tests but couldn’t find a cause for the pain. My GP told me I’d just have to manage with painkillers.Gout is caused by a build up of uric acid that form crystals in the joints, most commonly in the toes and feet

Gout is caused by a build up of uric acid that form crystals in the joints, most commonly in the toes and feet

But I wanted a second opinion, so we scoured the internet and found an orthopaedic surgeon called John Hardy — I saw him privately at Spire Hospital Bristol in July this year. I had X-rays and other scans.

Mr Hardy diagnosed a bone spur — an abnormal growth of bone caused by the gout. He explained that when the soft tissue around a joint becomes inflamed, it can prompt the lining of the bone to start growing.

He said that the nerve running down my left leg was wrapped over this bony spur, which was pressing on the nerve causing the pain running down my leg. There was a bone spur on the right leg, too, but it wasn’t stretching the nerve so wasn’t painful.

Mr Hardy said he could operate to move the nerve carefully aside and remove the bony spur by chiselling it off, without damaging the nerve so it wouldn’t cause any more problems. He also put me on allopurinol to reduce the levels of uric acid in my blood.

In early September, I had the operation under general anaesthetic, and woke with my knee in plaster — once it was removed, I went home that afternoon. Maggie made me stay in bed for three days with my leg elevated, but the following week I was as active as ever — without pain.Since I have to go on taking allopurinol for life to keep the condition under control, and am keeping up with the lifestyle changes, I hope I’ll have no more of that agonising pain.

THE SURGEONJohn Hardy is an orthopaedic surgeon at Spire Hospital Bristol, Bupa Cromwell Hospital and the Chelsea Outpatient Centre in London. He says:

Gout is the most common form of arthritis in Britain, affecting 1.4  per cent of the population.

While we don’t know exactly what causes it, we know gout can run in families, peaks between the ages of 30 and 50 because it is linked to the hormone testosterone and, for the same reason, is much more common in men.

It causes cycles of pain which can be excruciating. Typically, it comes on suddenly and the agonising pain increases over a few hours to the point where the limb is too painful to move.

Gout is an inflammation of soft tissue triggered when uric acid crystals carried in the blood are deposited in joints and soft tissues, most commonly in the toes and ankles.

Uric acid is produced when the body breaks down purines which are substances found in food — gout used to be called the disease of kings because of its association with lots of rich food.

This inflammation of the joint can also stimulate the lining of the bone next to the joint to grow — causing bone spurs, or protrusions of bone or cartilage.

This can happen in any joint, but spurs grow biggest and do most harm in the elbow or knee. In patients with untreated gout 70 per cent will end up with them.

The spurs can be up to 5cm long, and when a nerve is stretched over the protrusion it can cause pain and numbness. Eventually, it can even destroy the joint through secondary osteoarthritis, because it wears away the surface of the joint.

Unfortunately, there isn’t enough awareness of the danger of these bone spurs, so they often go undiagnosed.

Doctors can treat gout by keeping blood acid levels below a critical level and advising patients to lose weight gradually, which can lower uric acid levels, drink less beer and wine, drink more water to dilute the uric acid, and avoid trigger foods.

We can also offer medication such as colchicine, which is an anti-inflammatory to prevent attacks and steroids to damp down attacks when they occur.

When patients have chronic gout, allopurinol is used — this inhibits an enzyme our bodies produce that breaks down purines into uric acid, so can prevent further attacks.

For patients with nerve injury from bone spurs, there is a simple operation with a good success rate — it also helps to prevent even worse nerve damage which could lead to a useless limb.

We identify the nerve affected by the spur, move it carefully aside then remove the spur. Patients then take allopurinol so the bone growth doesn’t come back, and the nerve can recover.

The operation, which is widely available on the NHS, takes around 45 minutes, under general anaesthetic. I mark the route of the nerve down the leg, and put a tourniquet round the thigh. Then I make a 5 cm curved, S-shape incision to find the nerve, and follow it carefully to where it is being trapped by the spur.

Then I gently move the nerve off the bone and whittle down the bone spur using an osteotome, a surgical chisel and hammer. Once the nerve is free of the bone spur, I wrap fat from the surrounding area around the nerve to protect it. Then I close the incision with an invisible stitch and dress the wound.

Because the anaesthetic is so light, the patient is up and about immediately and can go home an hour or so after surgery.

For patients like Chris, who is now getting back to his normal lifestyle, this is a fantastic operation and could help thousands more.

Read more: http://www.dailymail.co.uk/health/article-2058833/Chiselling-bone-end-torture-gout.html#ixzz1d7HgLXNY

Foodily Announces Condition-Specific Online Recipe Search

Today, people using the Foodily app for Facebook or visiting Foodily can simply type in one of three specific health concerns – “Diabetes,” “Gout” and “Gastroesophageal Reflux Disease” (or “GERD”) – to easily browse recipes that meet their dietary needs from diverse online resources that range from independent food blogs to major mainstream cooking sites. Then, people using the Foodily app can easily share recipes that meet their dietary restrictions, and follow others with similar medical issues to discover their favorite dish recommendations without ever having to leave Facebook.

“It’s tough enough dealing with a health issue as complicated as Diabetes or GERD on a daily basis, but why should that mean that you can’t have a range of healthy recipe options at your fingertips? All of us at Foodily are dedicated to encouraging people to be both healthy and happy with the food on their table,” said Andrea Cutright, CEO of Foodily. “Moreover, the ability to be social and share recipes on Facebook lets our users tap into their friends and family – as well as others with comparable diet restrictions – for cooking ideas and emotional reinforcement.”

Driving healthy, condition-tailored recipes directly to targeted communities, Foodily has also extended their ongoing partnership with the leading health website Healthline (www.healthline.com). While continuing to power the site’s recipe search, Foodily is additionally providing Healthline with an exclusive drop-down menu for condition recipe searches that is currently being featured on both Healthline’s homepage and related sections of the site.

“We create a rich, condition-focused experience for consumers who are looking for tangible ways to learn about and improve their health,” said David Kopp, SVP of Consumer Media for Healthline Networks. “Our healthy recipe search, powered by Foodily, has received a great response from people seeking diet-specific information. We’re excited to expand this capability to include their new condition-sensitive search that addresses the unique dietary considerations of diabetes, gout and GERD, and connect caregivers and people with conditions to better health.”

This new search advance builds upon Foodily’s proprietary nutrition feature which launched a few months ago, to let visitors have more control over their recipe choices. Searching by keywords such as “low-salt” or “high-protein,” people can compare content beyond calorie count to look at everything from sugar to saturated fat content, and browse healthy eating search results influenced by their friends. Nutritional content of each recipe across the index is based on USDA standards, weights and measures, creating an equitable method for comparing nutritional values within recipes from varied online sources.

About Foodily:

Foodily makes sharing recipes a social experience and empowers people to make more informed decisions about the foods they eat. Through its comprehensive recipe network, influenced by friends, people can find and share the food they love online. Based in San Mateo, CA, the award-winning Foodily is driven by a team of seasoned, food-passionate search, linguistic and consumer product experts. The company is backed by leading venture capital firm Index Ventures. Visit www.foodily.com and get cooking!

About Healthline:

Healthline Networks is the fastest growing provider of intelligent health information services, enabling 100 million consumers a month to make more confident, informed healthcare decisions. The company’s proprietary consumer healthcare taxonomy, the largest of its kind, powers a suite of intelligent health search, content and advertising services. Combining advanced search technology with deep medical expertise, Healthline partners with a network of more than 50 trusted destination sites that include publishers, portals, search engines, employers and health plans. Headquartered in San Francisco and ranked #54 in Deloitte’s 2010 Technology Fast 500, Healthline is backed by Aetna, GE/NBC Peacock Fund, Investor Growth Capital, Kaiser Permanente, Reed Elsevier, U.S. News & World Report, and VantagePoint Venture Partners. For more information, visit http://www.healthline.com.

SOURCE Foodily

Ultrasound Study of detecting Early Stages of Gout

Two trained ultrasonographers assessed 10 joints per patient (metatarsophalangeal [MTP] joints one-two, knees, metacarpophalangeal [MCP] joints two-three) to determine the prevalence of the double-contour (DC) sign and tophi in each site.

The researchers studied 150 joints from 15 patients (median age 56.9 years [interquartile range 31.7] years; 14 males). Interobserver agreement was good to excellent for all articular sites and the median number of acute attacks per patient was 2.0 [0.7].

“The prevalence of the DC sign in the knees and MTP joints was 46.7% and 40% respectively, whereas that of tophi was 26.7% for both sites,” the researchers wrote in the study abstract. “No urate deposits were found in MCP joints. The DC sign and tophi were found in at least one articular site in 60% and 46.7% of patients, respectively. All patients with urate levels > 600 μM (10 mg/dl) had a DC sign in at least one assessed joint. Urate levels were positively correlated with presence of the DC sign in knees (p=0.005) and MTP joints (p=0.03) but not presence of tophi.”

The Impact of Acute Gout Flares on Foot Pain and DisabilityAcute gout flares can result in severe foot pain, impairment, and disability in patients, data that supports improved management of gout to prevent the consequences of poorly controlled disease, according to a new study.

The research, which was conducted by clinicians at the Health and Rehabilitation Research Institute at AUT University in Auckland, New Zealand, was published in Arthritis Care and Research.

The prospective observational study recruited 20 patients with acute gout flares from emergency departments, hospital wards, and rheumatology outpatient clinics. Patients were recruited at the time of the flare, which was the baseline visit, and then reassessed at a follow-up visit six to eight weeks after the initial assessment once the acute flare had resolved.

“The foot was affected by acute gout in 14 patients (70%). Objective measures of joint inflammation including swollen and tender joint counts and C-reactive protein significantly improved at the follow-up visit, compared with the baseline visit,” the researchers wrote in the study abstract.

“At baseline, high levels of foot pain, impairment, and disability were reported. All patient-reported outcome measures of general and foot-specific musculoskeletal function improved at the follow-up visit compared with the baseline visit. However, pain, impairment, and disability scores did not entirely normalize after resolution of the acute gout flare.”

SourcesAn Exploratory Ultrasound Study of Early Gout [Clinical and Experimental Rheumatology]Foot Pain, Impairment and Disability in Patients with Acute Gout Flares: A Prospective Observational Study [Arthritis Care and Research]

Big Mountain Drugs Helps Victims of Shocking Gout Drug Price Hike

Under this initiative, the consumer protection agency ordered pharmaceutical companies manufacturing unapproved drugs to either undergo rigorous and expensive clinical trials to obtain approval for the drugs, or to remove them from the market. In return, those companies winning approval would be given exclusive market rights for a time period, to allow them to recoup their investment.

Among the many older commonly prescribed drugs that have never gone through the formal FDA review and approval process are morphine, phenobarbital, nitroglycerine, and the gout medication colchicine. Colchicine has been widely used in many countries since the 1930's, and won FDA approval in combination with a second gout medication, probenicid, in the early 1980's, but has never been approved as a single ingredient medication.

One of over twenty US pharmaceutical companies manufacturing generic colchicine, URL Pharma, successfully underwent the rigorous approval process and received exclusive rights to market its brand name colchicine, Colcrys, in 2009. The FDA awarded URL Pharma exclusive rights to market colchicine for gout for three years, and for familial Mediterranean fever for seven years. In 2010, all other American pharmaceutical companies were ordered to stop manufacturing the gout drug within 45 days, and to stop shipping it within 90 days.

The price of one colchicine tablet soared from 9 cents to almost $5, a move that is projected to increase state Medicaid costs for the gout drug from $1 million to $50 million. The response was a public outcry, including pointed queries to URL Pharma from a number of Members of Congress. URL Pharma has expanded its patient assistance and co-pay programs to allow price breaks for those in need of the gout medication who were hardest hit by the immense price hike, but still faces a great deal of public criticism.

The American College of Rheumatology (ACR) was one of the organizations that protested the steep increase as unjustified. The ACR encouraged other pharmaceutical companies to enter the market with their own branded version of colchicine, and announced in 2010 that at least one other manufacturer would be seeking FDA approval.

In the meantime, generic colchicine continues to be manufactured and sold cheaply and legally across the border in Canada. Online Canadian pharmacies are rushing to persuade American customers to buy colchicine from Canada, stepping up advertising and educational efforts, discounting prices, and offering pharmacy savings coupons.

For example, the Canadian pharmacy Big Mountain Drugs is offering 100 .5 mg generic colchicine tablets for $29 US, along with a 5% Pharmacy Rewards Program and a $5 pharmacy savings coupon on a partner site, onlinepharmacycoupons.com. American gout patients can obtain a three-month supply of colchicine for gout through an online Canadian pharmacy with a current valid prescription.

Consumers are advised to ensure they are dealing with a reputable online Canada pharmacy by ensuring it does not offer drugs without a prescription, does not sell controlled substances such as narcotics, has clear contact information including a physical address, has a licensed pharmacist available to answer questions, and is accredited by the Canadian International Pharmacy Association.

For more information, please visit http://www.bigmountaindrugs.com or http://www.bigmountaindrugs.com/blog/

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Study identifies genetic basis of human metabolic individuality leading to Gout Detection and Gout treatments

Disturbances in metabolism are at the root of a variety of human afflictions and complex diseases. Although many of the genes that contribute to these conditions have been identified since the completion of the Human Genome Project in 2003, it is still not known how metabolic disorders related to these genetic aberrations disrupt cellular processes.

One hundred years ago, Archibald Garrod, one of the fathers of modern biochemistry, realized that inborn errors in human metabolism are "merely extreme examples of variations of chemical behavior which are probably everywhere present in minor degrees" and that this "chemical individuality [confers] predisposition to and immunities from the various mishaps which are spoken of as diseases." Ever since, identification of the genetic basis of human chemical individuality has been elusive.

Now researchers addressed this challenge by using a new technology, called metabolomics. They measured the levels of more than 250 biochemical compounds in over 60 metabolic pathways, including lipids, sugars, vitamins, amino acids and others in blood from over 2,800 individuals. They then combined this dataset with information on more than 600,000 genetic variants (SNPs) that were detected in the genes of each of the study participants. Most of the SNPs were located in genes known to encode proteins involved in the relevant metabolic pathways. Fifteen of the SNPs had previously been associated with metabolism-related conditions, such as cardiovascular disease, kidney disease, gout, diabetes, gastrointestinal diseases, cancer and adverse drug reactions. But the new findings also uncovered a wealth of new associations that link the genetic makeup of a person to his or her biochemical capacities. This data is publicly available in an online database, accessible at http://www.gwas.eu.

Given the exceptional size of the dataset, the researchers prioritized the data to focus on 37 SNPs that were most strongly associated with metabolic traits, 23 of which had never been described before. The 37 SNPs had very large effects on the individuals' metabolite levels and can be considered to constitute what the authors call the "genetic basis of human metabolic individuality."

First author Dr. Karsten Suhre, professor of physiology and biophysics and director of the Bioinformatics Core at Weill Cornell Medical College–Qatar, says, "These findings will enable researchers to identify new and potentially relevant metabolic processes and pathways. Two highly sophisticated biochemical measurement methods -- genetics and metabolomics -- applied to only two drops of blood can reveal deep insights into the genetic make up of our metabolic capacities. In addition to providing functional insights into the genetic basis of metabolic traits and complex diseases, this information is a way to understand an individual's uniqueness so as to develop highly targeted, personalized therapies and enable novel types of treatments or prevent adverse drug reactions."

Provided by New York- Presbyterian Hospital (news : web)

Treatment For Gout And The Condition's Protective Effect

Gout News

For many years, the most common drug used to treat gout was allopurinol, which is generally safe and effective, but has been known to cause life-threatening rashes in rare cases. Its dosage often has to be reduced in patients with impaired kidney function, but previous clinical trials have shown that febuxostat is effective at lowering urate levels and that its dosage may not need to be adjusted.

A Phase III, randomized, double-blind multi-center trial, known as the APEX (Allopurinol- and Placebo-Controlled, Efficacy Study of Febuxostat) trial, was conducted to compare the safety and efficacy of febuxostat with allopurinal and a placebo in patients with high urate levels (uricemia) and gout, some of whom had impaired renal function. It was the largest randomized controlled clinical trial to date comparing the two drugs. Led by H. Ralph Schumacher of the University of Pennsylvania, the 28-week trial involved 1,072 patients at 167 sites in the U.S. who had serum urate levels of at least 8 mg/dl and gout, with normal or impaired renal function. Patients were randomized to receive one of three dosage levels of febuxostat once daily; allopurinol; or a placebo. The allopurinol dose given was based on kidney function; those with normal function received half the normal dose.

GOUT NEWS:

The results showed that a significantly greater proportion of patients receiving febuxostat at any dose achieved serum urate levels below 6 mg/dl for the last three months in which they participated in the trial. In those with impaired kidney function, about half in the febuxostat groups reached this level, while none of the patients with renal impairment who received the lower dose of allopurinol reached it. During the first eight weeks, more patients receiving febuxostat needed treatment for flares compared with the other groups. This may have been due to a more abrupt lowering of urate levels that caused crystal mobilization. Adverse events, mostly mild to moderate, occurred with similar frequency across the treatment groups.

The authors conclude that febuxostat's effects at these dosage levels "are significantly greater than those produced by the commonly used doses of up to 300 mg of allupurinol or by placebo," adding that "The efficacy of febuxostat in subjects with renal impairment is promising and warrants further study."

GOUT NEWS:

In another study published in the same issue, researchers led by Hyon Choi of the Arthritis Research Centre of Canada in Vancouver, identified 11,258 patients aged 65 or older with gout and 56,199 age and sex matched controls. They divided the gout patients according to those who were being treated with at least one prescription (72 percent) and those who did not receive any prescriptions for anti-gout medication during the study period, which was 1991 to 2004. They also included data on other medical conditions and medication use, such as diuretics and nonsteroidal anti-inflammatory drugs (NSAIDs) known to be associated with gout or PD risk.

During the follow-up period, which averaged about eight years, they identified 1,182 new cases of PD. They found a 30 percent reduction in the risk of PD among those with a history of gout, independent of age, sex, prior medical conditions and use of diuretics and NSAIDs.

"These findings lend further support to the purported protective role of uric acid against PD," the authors state, adding a potential caution that lowering urate levels too much too long might also have harmful neurodegenerative consequences such as PD.

Gout News----------------------------Article adapted by Medical News Today from original press release.---------------------------- GOUT NEWS

Discovery Of New Genes Linked To Gout

A newly-published clinical study demonstrates that Colcrys® (colchicine, USP), a low-dose oral colchicine, is just as effective as high-dose colchicine in reducing pain associated with early acute gout flare, but with a safety profile statistically indistinguishable from placebo.

The study, "High vs. Low-dosing of Oral Colchicine for Early Acute Gout Flare: Twenty-Four Hour Outcome Results of the First Randomized, Placebo-Controlled, Dose Comparison Colchicine Trial," details the AGREE (Acute Gout Flare Receiving Colchicine Evaluation) trial, the first placebo-controlled comparison of low-dose and high-dose colchicine in the treatment of acute gout flares. The study was published in the April issue of Arthritis & Rheumatism, the official journal of the American College of Rheumatology. AGREE formed the basis for URL Pharma's New Drug Application (NDA) submission for Colcrys to the U.S. Food and Drug Administration (FDA).

GOUT NEWS:

"For centuries, colchicine for the indication of acute gouty arthritis has been dosed at levels higher than clinically necessary," said Robert A. Terkeltaub, M.D., Section Chief, Rheumatology-Allergy, VA Medical Center San Diego, and Professor of Medicine and Rheumatology Training Program Director, University of California San Diego. "This study is the first to demonstrate that a low-dose colchicine regimen is just as effective as a high-dose regimen in the treatment of early gout flare, defined as within 12 hours of symptom onset. The low dose colchicine regimen of only a total 3 tablets of 0.6 mg given over only one hour avoids the significant toxicities traditionally associated with high doses repeated over many hours, in this case a total of 8 tablets of 0.6 mg colchicine given over 6 hours." Dr. Terkeltaub was the primary investigator and lead author for the AGREE trial.

Gout News

Colcrys received approval from the FDA on July 30, 2009 for the treatment of acute gout flares at the first sign of a flare, and for the prevention of gout flares on October 19, 2009. Colcrys is the first and only single-ingredient colchicine to receive FDA approval. Other single-ingredient colchicine products currently on the market have never received regulatory review or approval, and have been traditionally used at doses that cause severe toxicities in nearly all patients.

"The approval of Colcrys was based on strong science that included the AGREE trial and 16 additional clinical studies conducted by URL Pharma that determined, for the first time, the appropriate dose and toxicity profile of colchicine for the treatment of gout," said Richard H. Roberts, M.D., Ph.D., President, CEO and Chairman, URL Pharma. "These studies uncovered serious, potentially life-threatening interactions with commonly used treatments such as hypertension drugs and antibiotics. Our research represents a major therapeutic step forward for patients, and provides important new guidance for physicians on the safe and appropriate use of colchicine." The FDA has reported on 169 deaths associated with unapproved colchicine.

GOUT NEWS:Study Details

The multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluated the safety and efficacy of low- vs. high-dose colchicine in male and postmenopausal female patients aged greater than or equal to 18 years with a confirmed past diagnosis of gout and greater than or equal to 2 gout flares within the prior 12 months. A stable regimen of urate-lowering therapy was permitted. A total of 575 patients were randomized into one of three treatment groups: 1) a novel "low-dose" abbreviated colchicine regimen (Colcrys) group; 2) a "high-dose" colchicine regimen group that reflects long-standing medical practice and is still actively taught to physicians; 3) placebo. The primary endpoint was greater than or equal to 50% pain reduction at 24 hours without rescue medication.

Among 184 patients in the intent-to-treat population, results at 24 hours demonstrated superior safety of Colcrys, without loss of efficacy, relative to high-dose colchicine for early acute gout flares when self-administered within 12 hours of flare onset. The percent of patients responding to treatment was proportionally greater in the Colcrys group compared to the high-dose and placebo arms across the entire pain improvement range. The overall adverse events (AEs) profile for Colcrys was statistically similar to placebo (36.5% versus 27.1%, respectively). The high dose associated with unapproved colchicine resulted in significantly more adverse events when compared to Colcrys and placebo, including diarrhea (76.9%, 23.0% and 13.6% respectively), nausea (17.3%, 4.1% and 5.1% respectively) and vomiting (17.3% versus 0% for both Colcrys and placebo). All AEs in the low-dose group were mild to moderate in intensity while 19.2% of the high-dose group had AEs of severe intensity, all of which were diarrhea.

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Clinical Trial LogisticsAustralia's premier provider of clinical trial logistics serviceswww.cryosite.comAbout Gout and Painful Gout Flares

GOUT NEWS:Gout is a painful form of arthritis that affects an estimated 3 to 5 million Americans, most commonly adult men. It occurs when excess uric acid in the body is deposited as needle-like crystals, or tophi, in the joints or soft tissues, which cause inflammatory arthritis and can lead to gout flares typically lasting three to 10 days.

Gout flares are characterized by intermittent swelling, redness, heat, joint stiffness and pain, which are often excruciating and can be debilitating enough to significantly interfere with work, social activities and daily living. For many people, gout initially affects the joint of the big toe, though it can also affect other joint areas such as the ankles, heels, knees, wrists, fingers and elbows.

GOUT NEWS :Important Safety Information

COLCRYS® (colchicine, USP) tablets are indicated for prophylaxis and the treatment of gout flares.

COLCRYS is contraindicated in patients with renal or hepatic impairment who are concurrently prescribed P-gp inhibitors or strong inhibitors of CYP3A4 as life-threatening or fatal toxicity has been reported. Dose adjustments of COLCRYS may be required when co-administered with P-gp or CYP3A4 inhibitors. The most common adverse events in clinical trials for the prophylaxis and treatment of gout were diarrhea and pharyngolaryngeal pain. Rarely, myelosuppression, thrombo-cytopenia, and leukopenia have been reported in patients taking colchicine. Rhabdomyolysis has been occasionally observed, especially when colchicine is prescribed in combination with other drugs known to cause this effect. Monitoring is recommended for patients with a history of blood dyscrasias or rhabdomyolysis.

Gout NewsAbout URL Pharma

URL Pharma, Inc., headquartered in Philadelphia, PA, is a leading specialty pharmaceutical company with fully integrated technology development, product development, manufacturing, and commercialization capabilities. After a long history of generic pharmaceutical research, development, and manufacturing, the Company has successfully transitioned to a technology-driven, specialty pharmaceutical business. The Company seeks to develop and commercialize scientifically and medically innovative products that address unmet medical needs for improvements in safety and efficacy. The Company's profits are derived predominantly from its exclusive products and technologies.

Source: URL Pharma, Inc

Gout News:

Researchers have identified two new genes - and confirmed the role of a third gene - associated with increased risk of higher levels of uric acid in the blood, which can lead to gout, a common, painful form of arthritis. Combined, the three genetic variations were associated with up to a 40-fold increased risk in developing gout. The findings suggest that genetic testing could one day be used to identify individuals at risk for gout before symptoms develop, as well as determine who might benefit from medications to prevent the development of gout.

"Association of three Genetic Loci with Uric Acid Levels and Gout Risk," is published online in The Lancet September 30. The study was supported by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) and the Netherlands organization for scientific research (NWO). Additional support from the NIH's National Center for Research Resources and through the NIH Roadmap for Medical Research was provided.

The genes were identified using data from two large genome-wide association studies - genetic variations of nearly 7,700 participants from NHLBI's Framingham Heart Study SHARe (SNP Health Association Resource) and more than 4,100 participants in NWO's Rotterdam Study. Researchers then replicated their finding using data from nearly 14,900 participants in NHLBI's Atherosclerosis Risk in Communities Study (ARIC).

Caroline S. Fox, M.D MPH, NHLBI is project officer and one of the senior authors of the study, and Christopher J. O'Donnell, M.D., MPH, is scientific director of SHARe and senior advisor to the NHLBI director for genetics and genomics.

Gout News:

Nearly 3 million adults in the United States are estimated to have gout. Gout can develop when excess amounts of uric acid build up in the blood and form crystals, which accumulate in the joints causing swelling and pain. Left untreated over time, gout can permanently damage affected joints and, possibly, the kidneys.

The findings are the first published results of analyses of data from Framingham SHARe since the extensive Web-based dataset of genetic and clinical data was made freely available to researchers worldwide in October 2007. Framingham SHARe includes data on more than 9,300 participants spanning three generations. The Framingham Heart Study is funded by NHLBI in collaboration with Boston University School of Medicine (BUSM) and Boston University School of Public Health.

----------------------------Article adapted by Medical News Today from original press release.---------------------------- gout news

Nuon Therapeutics, Inc., a privately held, clinical stage biopharmaceutical company, announced that the company is advancing its lead program, NU1618, into phase 2b development for the treatment of chronic hyperuricemia in patients with gout. Nuon anticipates releasing topline data from a completed proof-of-principle, phase 2a study of NU1618 in the second quarter of 2010.

A proprietary combination of the drugs tranilast and allopurinol, NU1618 decreases uric acid in the body through two mechanisms: by increasing its excretion by the kidney (via the uricosuric action of tranilast) and by decreasing its production (through inhibition of the enzyme xanthine oxidase, the mechanism of allopurinol). In addition, data demonstrate that tranilast is also an immune system modulator, potentially allowing NU1618 to address the chronic inflammatory component of gout. To the company's knowledge, no other drug in development or on the market possesses these three mechanisms for treating patients with gout.

"The tranilast component of NU1618 inhibits uric acid transport by both URAT1 and GLUT9, transporters in the kidney that regulate uric acid excretion from the body," said Tito Serafini, PhD, Nuon's Chief Scientific Officer. "Tranilast is also an anti-inflammatory, immune system modulator. We believe that NU1618 has the potential therefore to provide an improved therapy for gout both by lowering uric acid through two complementary mechanisms, and by addressing the chronic inflammation induced by the disease."

Nuon Therapeutics is also investigating tranilast as a monotherapy for rheumatoid arthritis.

Although new to the United States and Europe, tranilast has been marketed in Japan as a treatment for asthma, atopic dermatitis and other conditions for nearly three decades. Allopurinol is also well understood and was first introduced as a treatment for gout in 1966.

About Hyperuricemia and Gout Gout News:

Gout is a chronic, progressive rheumatic disease, caused by an inflammatory response to uric acid crystals deposited in joints and soft tissues as a result of an excess of uric acid in the blood ("hyperuricemia"). The most common form of inflammatory arthritis, gout affects approximately 6-10 million people in the United States and Europe. The disease is characterized by acute episodes, or flares, in which uric acid crystals trigger an immune response in the body and produce painful and debilitating inflammation. Gout patients also have a chronic, systemic inflammation as a result of their disease and underlying uric acid crystal burden. This chronic, systemic inflammation associated with gout, as in other rheumatic diseases, has been identified as a risk factor for cardiovascular disease. Effective treatment of hyperuricemia in gout patients requires lifelong therapy to decrease uric acid in the body.

Gout NewsSourceNuon Therapeutics, Inc.

New Gout Drugs Krystexxa & BCX4208

Savient won US approval in September 2010 to sell Krystexxa and some analysts predicted the drug would eventually exceed $1 billion in annual sales.

Krystexxa is a potential option for gout sufferers who cannot take conventional gout treatments. It works by breaking down uric acid and is effective for patients who cannot take irate lowering drugs due to certain circumstances.Krystexxa has to be taken intravenously every 2 weeks, and so far has shown positive effects on Gout Tophi deposits, and reduction of both gout attacks and gout inflammation.

There are a few known side effects so far such as gout flareups and infusion reactions which may need patients to be monitored for any adverse effects.

The next potential Gout Cure is BCX4208.

BioCryst Pharmaceuticals.Inc has been developing BCX4208, which is the next generation purine uncleeoside phosphorylase inhibitor ( PNP). BCX4208 has broad applications to inflammatory and autoimmune diseases. Combined with allopurinol seems to provide significant serum uric acid (sUA) reduction.

The experimental gout drug is called BCX4208. The compound is already in mid-stage clinical trials, but BioCryst is directing part of that $5 million investment for further studies of the compound in patients who do not respond to allopurinol, a drug used to reduce the levels of uric acid produced by the body in patients who have gout. This larger study of 250 patients is enrolling patients now and will evaluate the drug in patients over the course of three months. An earlier trial studied the drug over just three weeks.BioCryst wants to find out if the immune system remains strong enough to produce antibodies after being on the treatment. BioCryst will also be looking for possible drug interactions because gout patients can be on heart or diabetes medications. The company believes BCX4208 won’t have interactions. With the study, they’ll have that data back up the claim. They’ll also have data to help BCX4208 stand out from other drugs.

Regeneron's Arcalyst Treatment Shown to Help Prevent Gout Flares in Study

Regeneron Pharmaceuticals Inc. said its only marketed product, Arcalyst, helped prevent gout flares in a late-stage study of patients starting therapy to lower uric acid levels.

Those taking an injection of 80 or 160 milligrams a week of Arcalyst over four months had a decrease of 72 percent in gout flares compared with placebo, Tarrytown, New York-based Regeneron said today in a statement. The data, from the third and final stage of testing generally required for approval, will support an application with U.S. regulators by mid-2011, the company said.

About 750,000 gout patients start taking uric acid-lowering therapy such as allopurinol each year, Mark Monane, an analyst with Needham & Co. in New York, wrote in a Feb. 17 research note. During the first few months of therapy, the breakup of uric acid crystals can cause flares of joint pain, which Arcalyst aims to prevent. If successful, the medicine may generate up to $500 million in annual revenue, Monane estimated.

Arcalyst “may have significant potential as a co-treatment in allopurinol initiation for chronic gout,” Monane said in his note. “We were impressed by the drastic reduction in the mean number of gout flares” in an earlier study, he said.

The medicine was generally well-tolerated, and the incidence of severe adverse events was similar in both arms of the study reported today, Regeneron said. Mild injection-site reactions were more common in the Arcalyst arm, the company said.

Arcalyst was approved in February 2008 for the treatment of rare, inherited autoinflammatory diseases known as Cryopyrin- Associated Periodic Syndromes. The drug had $25.3 million in revenue last year, according to a Feb. 17 Regeneron statement.

Regeneron fell 73 cents, or 2 percent, to $36.27 at 4 p.m. New York time in Nasdaq Stock Market trading. The shares gained 48 percent in the past 12 months.

To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net.

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.

Novel Drug Effective for Refractory Gout

* Explain that an investigational uricosuric agent, lesinurad, in combination with allopurinol, significantly lowered serum urate in patients with refractory gout.

* Note that lesinurad appeared well-tolerated.

LONDON -- Patients with refractory gout had rapid and sustained lowering of serum urate after a month of treatment with the investigational agent lesinurad along with allopurinol, a researcher said here.

A total of 87% of patients receiving 600 mg per day of lesinurad, which works by increasing the urinary excretion of uric acid, reached the therapeutic target of serum urate below 6 mg/dL, compared with 28% of patients on allopurinol alone (P<0.001), according to Fernando Perez-Ruiz, MD, PhD, of Hospital de Cruces in Vizcaya, Spain, and colleagues.

In addition, 76% of patients receiving 400 mg and 71% of those on a 200-mg dose also reached the target (P<0.001 for both), Perez-Ruiz reported here at the annual meeting of the European League Against Rheumatism (EULAR).

"Gout is increasing in incidence and severity, and is linked to hypertension, chronic kidney disease, and cardiovascular events -- yet more than 50% of people with gout in the European Union are not treated for the condition," he said during a press briefing.

Lesinurad is an oral inhibitor of the uric acid transporter URAT1. In pilot studies, given in combination with the xanthine oxidase inhibitor allopurinol, it was more effective at lowering serum urate than allopurinol alone.

Perez-Ruiz and colleagues therefore conducted a phase IIB randomized trial that included 208 patients who were on stable doses of 200 mg to 600 mg of allopurinol, yet had persisting levels of serum urate of 6 mg/dL on at least two occasions.

The study included a two-week run-in phase, when patients remained on allopurinol and initiated colchicine in doses of 0.5 to 0.6 mg per day as prophylaxis for flare.

At baseline, mean serum urate levels ranged from 6.4 mg/dL to 7.3 mg/dL.

After four weeks of treatment, patients receiving 600, 400, or 200 mg had reductions in serum urate of 30%, 22%, and 16%, respectively, the investigator reported.

Responses were not affected by renal function or doses of allopurinol, he noted.

Adverse events included dyspepsia, dizziness, hematuria, and diarrhea, all occurring in 0.7% of patients on combination therapy and in 1.4% to 2.8% of those on allopurinol.

Three patients in the placebo group withdrew because of an adverse event, as did two in the combination group.

Perez-Ruiz concluded that the response to lesinurad was "highly statistically significant" and that the drug was well-tolerated.

He explained that most patients would benefit from using the lowest dose, at least once crystals that are already present have dissolved.

And the target should be individualized, preferably as low as 4 mg/dL or 3 mg/dL in patients who have had severe disease and tophi, he said.

The session moderator, Maxime Dougados, MD, of René Descartes University in Paris, observed that the "first big revolution" in gout occurred in the 1950s, with the introduction of allopurinol.

At that time, patients with tophi typically underwent surgery to remove them.

"Then the first pill arrived on the market, but the surgeons didn't trust doctors to make the nodules disappear. Now, they disappear most of the time but we still need more options for patients with gout," said Dougados, who is the incoming president of EULAR.

Several of the investigators are consultants or on speakers' bureaus for companies including Ardea Biosciences, Menarini, Novartis, Savient, Roche, and Takeda.

Six authors are employees of Ardea Biosciences.

Primary source: European League Against RheumatismSource reference:Perez-Ruiz F, et al "Efficacy and safety of lesinurad (RDEA594), a novel uricosuric agent, given in combination with allopurinol-refractory gout patients: randomized, double-blind, placebo-controlled, phase 2B study" EULAR 2011; Abstract OOP0111.

Gout drug success for Novartis

By Dr Ananya Mandal, MD

Novartis AG's new gout therapy drug gives patients better pain relief and significantly cuts the risk of new attacks say two late stage studies. The studies show that more than 450 patients taking Ilaris, or ACZ885, had less pain and the risk of new attacks were reduced by up to 68 percent compared to those taking an injectable steroid to treat gouty arthritis attacks, which can last for a week or more.

Gout is severely debilitating disease that affects 1-4 percent of adults. It is a form of arthritis that is characterized by red, hot, inflamed joints. It is the most common form of inflammatory arthritis in adults and can cause chronic disability and joint destruction. Approximately 90% of patients with gout have another co-existing disease, making them ineligible for many of existing gout treatments.

The first study found that ACZ885 reduced pain by an additional 29% on a visual analog scale when compared to TA, and nearly double the number of patients who received TA doses experienced a second gout attack within three months.

The second study expressed similar results, with ACZ885 reducing pain by an additional 31%, with nearly thee times as many patients in the TA group experiencing a second attack within three months.

Novartis had applied for approval of Ilaris in gouty arthritis patients with limited treatment options in the EU last year and in the United States, Canada and Switzerland in the first quarter of this year. The drug is already approved in several countries to treat a rare, inflammatory disorder known as Cryopyrin-Associated Periodic Syndromes (CAPS). The drug maker is also studying Ilaris in other diseases in which IL-1 beta plays a role in causing inflammation, such as cardiovascular disease and diabetes.

This drug, say the developers targets interleukin-1 beta that is the root cause of pain in gouty arthritis. The results of the study will be presented at this year's European League Against Rheumatism (EULAR) Congress in London.

Tweet Share this on LinkedIn Print This Post 5.26.11 | Frank Vinluan Drug partnering as strategy: How BioCryst plans to move its pipeline

Stonehouse is presenting at the Annual European Congress of Rheumatology where he will discuss Durham, North Carolina-based BioCryst’s (NASDAQ:BCRX) gout treatment BCX4208. What he probably won’t touch on with this crowd is how that compound fits into BioCryst’s overall strategy of drug partnering. The drug candidate is still in mid-stage clinical trials. But the compound is now included in a $5 million pipeline infusion for the company to conduct additional research. A closer look at BioCryst’s pipeline gives insight into the company’s strategy that determines which drugs it plans to develop in-house and those it will instead choose to develop with a partner.

COMS 2011AdvertisementBCX4208 is a partner candidate. Most gout patients are treated with allopurinol. Available in the United States since 1964, the drug works by reducing the production of uric acid that leads to inflammation and joint pain characteristic of the disease. But only 40 percent of patients respond to allopurinol. BioCryst’s clinical data show that when BCX4208 is combined with allopurinol, the response rate doubles to 80 percent.

“If most patients on this 50-year-old drug don’t get to goal, and you add BCX4208 and you double the number of patients, that’s a big impact,” Stonehouse said in an interview before his London trip.

New data gleaned from additional studies will better prepare the compound for an evaluation by the U.S. Food and Drug Administration, while also making a stronger case to present to potential partners. Gout affects 8.3 million U.S. patients. Gout is also a chronic condition, so BCX4208 could give a pharma company a drug with recurring revenue.

BioCryst will also seek a partner for BCX5191, a preclinical compound being developed to treat hepatitis C. The disease affects an estimated 170 million people worldwide. The large number of patients means the drug will require a large clinical trial. Stonehouse said it makes more sense for BioCryst to partner with a large pharmaceutical company that has the resources to finance those studies on BCX5191.

But another preclinical candidate is likely to remain in-house. BCX4161 is being developed to treat hereditary angioedema, a rare genetic condition that results in swelling in the face and airways that can lead to suffocation. Just 6,000 U.S. patients have the disease and BCX4161 is a candidate to be an orphan drug. Stonehouse said that because of the small patient population, trials on BCX4161 would be smaller and more affordable for BioCryst.

Meanwhile, Stonehouse notes that BioCryst’s in-house drug discovery efforts are continuing. Those efforts produced BCX5191 and are expected to yield a slate of candidates to follow the compounds that have moved along the pipeline. In that sense, BioCryst is avoiding the decline in discovery and R&D efforts characteristic of many of the large pharmaceutical companies. It’s their empty drug pipelines that give BioCryst and many other smaller pharmaceutical companies opportunities to test and commercialize new drugs.

The first commercialized BioCryst drug we’re likely to see is peramivir, the company’s experimental flu treatment that was available briefly when the FDA granted temporary authorization during the 2009 H1N1 pandemic. Peramivir is in phase 3 clinical trials that are being funded by an additional $55 million awarded to BioCryst from the Biomedical Advanced Research and Development Authority, part of the Department of Health and Human Services. BioCryst can’t turn to federal contracts to finance clinical studies on all of its compounds. If BioCryst’s strategy plays out according to Stonehouse’s plan, it won’t have to.

Congress Probes Pricing of URL Pharma’s Gout Medication

KV-Pharma’s ill-advised pricing of its FDA-approved synthetic progesterone has caused Congress to scrutinize the pricing of other newly-approved versions of old drugs. In an effort to bring such legacy medications into compliance with modern requirements for drug safety and efficacy, FDA offers incentives in the form of patent protection to companies that run older drugs through the appropriate clinical trials and seek FDA approval. URL Pharma markets an FDA-approved gout medication called Colcrys, the active ingredient of which is colchicine, a medication so old that it predated the FDA’s drug safety laws. URL Pharma won approval for their drug in July 2009 and set the price at almost $5 a pill compared with pennies a pill for unapproved versions of colchicine, which FDA ordered be removed from the market once the approved drug became available. URL Pharma vigorously defended their patent after approval and also defended their pricing, saying that it was in line with other approved gout medications and that running the clinical trials provided important safety and dosage information.

On May 23, 2011, Sen. Herb Kohl (D-Wis.), and Reps. Henry Waxman (D-Calif.), Frank Pallone (D- N.J.), and Diana DeGette (D-Colo.) co-authored a letter (available here) to Richard Roberts, President and CEO of URL Pharma, requesting detailed information on costs and revenues associated with the drug, including the cost of clinical trials, manufacturing, and marketing the drug, and projected revenues. The company was given a deadline of June 10 to reply. In the letter, the lawmakers state: “High prices lead to tough choices for patients. Further, the higher price of this treatment will be borne by private health plans and the federal government, and will contribute to the continued overall growth in health spending.”

At the same time, these lawmakers sent a letter with similar requests for information on pricing to Keith Katkin, president and CEO of Avanir Pharmaceuticals. Like URL, Avanir markets an approved version of a legacy drug, in this case a combination of quinidine and dextromethorphane for treatment of pseudobulbar affect (involuntary emotional outbursts) under the trade name Nuedexta. In the case of Nuedexta, the price jumped from $20 for non-approved versions, to $600 for the approved version. In their letter, the lawmakers state: “Although we recognize that we all benefit when FDA approves a new, safe and effective formulation, it is not clear that the significantly higher prices charged for this drug are justified given that it is merely a combination of long-used and inexpensive generic medications.”

The lawmakers’ desire for clarity around drug pricing is admirable. However, cost-of-goods is only a small part of the formula used to determine pricing. A large part of the formula is what the market will bear. In this case, there is value associated with buying FDA-approved, GMP-manufactured products, but companies that venture into the marketing of legacy drugs are still feeling their way around what that value might be.

Gout Drug Linked to Death

My brother was diagnosed with gout and given allopurinol. Within two weeks, he had a horrific reaction and was hospitalized in a burn unit. He developed toxic epidermal necrolysis (TEN) and lost all of his skin. The drug also burned all of his internal organs. After eight weeks of devastating treatments and agony, he passed away at age 63.

The SJS Foundation website (www.sjsupport.org) describes this problem. People should be warned about this possible reaction.

A. We are so sorry to learn of your brother’s tragic death. Drug-induced skin complications like SJS or TEN are rare but can be life-threatening. The prescribing information cautions: “ALLOPURINOL SHOULD BE DISCONTINUED AT THE FIRST APPEARANCE OF SKIN RASH.” Immediately stopping the drug is the first step in treating this condition in which the skin and mucous membranes blister and slough off, leaving the person vulnerable to infection.

Other medications that can trigger serious skin reactions include antibiotics such as co-trimoxazole (TMP-SMZ), antiseizure drugs such as carbamazepine, phenytoin, phenobarbital, valproic acid and lamotrigine, as well as pain relievers like ibuprofen and naproxen.

Q. I’ve been taking Ambien off and on for years to help me sleep. It always worked like a charm. The past few weeks, I have had trouble falling asleep, though. This morning at 4 a.m., I was still wide awake and realized that my prescription had been switched to generic zolpidem. This generic is NOT working. I always thought generics were just as good as brands, but now I have second thoughts. Ambien will cost me more than $200 for 30 pills. What can I do?

A. We have heard from hundreds of visitors to our website about concerns with a variety of generic drugs.

We are sending you our Guide to Saving Money on Medicines with generic-drug pros and cons plus advice on using these drugs safely. Anyone who would like a copy, please send $3 in check or money order with a long (No. 10), stamped (64 cents), self-addressed envelope to: Graedons’ People’s Pharmacy, No. CA-99, P.O. Box 52027, Durham, NC 27717-2027. It also can be downloaded for $2 from our website: www. peoplespharmacy.com.

Certain generic products do work properly. We would stick with the manufacturer of zolpidem that works for you.

Q. I have a friend who was told she probably got her kidney stones from taking vitamin C and calcium supplements. There isn’t a daily vitamin supplement out there that doesn’t contain one or the other, if not both. What’s the story on this?

A. The story is complicated, because the studies have given contradictory results. Calcium supplements appear to increase the risk of kidney stones (American Journal of Clinical Nutrition, July 2011).

Some people make more kidney-stone-forming oxalate after large doses (2,000 mg) of vitamin C (Journal of Nutrition, July 1, 2005). The amount you would get from a multivitamin, however, is not likely to cause problems.

NASCAR Mixes Chase, Charity and Gout Awareness at Charlotte

This weekend marks the midway point of NASCAR’s closest yet Chase for the championship, with just eight drivers within 20 points of the top of the leader board. Yet in the midst of the Chase, charity has also been a major theme at Charlotte Motor Speedway for the race weekend.

goutpitstop.comThe major charitable focus, as expected in the month of October, has been for breast cancer awareness. Almost all of the race cars have been adorned with some sort of pink accents, from the recognizable pink ribbon logos, to pink lanyards and gloves worn by the NASCAR officials.

“Breast cancer awareness month is one of those unique opportunities in which the NASCAR industry and NASCAR fans rally together for such a special and important cause,” Sandy Marshall, executive director of The NASCAR Foundation, said. “Each year the program gets bigger.”

Other charities featured in the Chase race weekend at Charlotte include the USO on Clint Bowyer’s No. 33 Richard Childress Racing Chevy, as well as the No. 16 machine of Greg Biffle sporting a paint scheme for the 3M/Give Kids a Smile effort.

The most unique charitable initiative, however, is one led by Kevin ‘Bono’ Manion, crew chief for the No. 1 Bass Pro Shop/Arctic Cat Chevrolet driven by Jamie McMurray. Manion has been leading the charge for a new gout awareness campaign in conjunction with the Men’s Health Network and Takeda.

Manion suffers from gout, a form of arthritis that affects over 8.3 million people in the United States. It is often misunderstood as a disease afflicting those who are rich who indulge in too much food and alcohol.

“It’s an educational campaign to bring awareness to anyone suffering from gout,” Manion said. “I’ve had it for about ten years and for awhile I didn’t know what it was.”

“I suffered a lot until the pain got so unbearable that you couldn’t sleep because the sheets couldn’t touch your foot,” Manion continued. “I’ve heard of gout before but always thought of somebody that drank a lot or that it was a rich man’s disease.”

“I’m basically trying to get the word out there and to let others know that they are not alone.”

Manion has partnered in the awareness campaign with Men’s Health Network and Takeda. His participation as a spokesperson has not only helped to educate himself about the disease but also to reach others who may be suffering.

One of the biggest issues related to gout is the shock of receiving the diagnosis, particularly due to the stigma and stereotyping of the illness.

“When I got my diagnosis, I was surprised for sure,” Manion said. “I’m not a heavy drinker and don’t do those things that they say trigger a flare up.”

“When I went to the doctor finally, I thought I had a broken foot or a broken toe,” Manion continued. “I went to get X-rayed and they told me that I had gout instead.”

“It was surprising but you wouldn’t believe the people that I’ve met who are suffering too.”

Manion has learned many lessons after being diagnosed with gout. Other than having some occasional pain climbing up the ladder to the top of the pit box or running around on race weekend, he has been able to manage his symptoms.

“What I’ve learned is that you have to take care of yourself,” Manion said. “Like your race car, you’ve got to take care of your body”.

“As we get older, things change and for me I hopefully have not done any damage by not taking care of myself,” Manion continued. “Everyone’s different.”

“There’s surely ways to manage through medication, exercise and watching your diet,” Manion said. “But it’s basically being cautious of what’s going on.”

This weekend, Manion has spent time in the Fan Zone sharing his experience and educating race fans on this illness.

“A lot of people I’ve met haven’t been to the doctor so encouraging people to see their health care provider to get checked out,” Manion said. “We have information at the ‘Gout Pit Stop’ booth and people can also visit the website www.goutpitstop.com for more information as well.”

While Manion and many of the other drivers and teams in the sport focus on charitable endeavors throughout the race weekend, they have just one other goal in common. All want to chase the win in the Bank of America 500.

“Our goal is to win the race,” Manion said simply. “We have a great record and Jamie loves this place. We have a win here so with a 500 mile race, we hope to have a good car for the long hau

Wrong Shoes Make Gout Pain Worse

Sandals may look comfortable, but they can actually worsen the pain of people with gout.

Researchers in New Zealand say people with gout commonly wear the wrong type of shoes, leading to increased pain, impairment, and disability.

A group of scientists led by Keith Rome, PhD, of the University of Auckland in New Zealand, signed up 50 gout patients from rheumatology clinics, and assessed their footwear choices.Careful Footwear Selection Needed

The study showed that many gout patients wore shoes with "poor footwear characteristics that included poor cushioning, lack of support, lack of stability, and motion control," Rome says in an email.

About 56% of the participants made good footwear choices, such as athletic sneakers, walking shoes, or oxfords.

But 42% of the gout sufferers wore footwear that can aggravate pain, such as sandals, flip-flops, slippers, or moccasins. None of those in the study wore high-heeled shoes and 2% said they wore boots.Old Shoes Pose Problems

Rome tells WebMD that more than 50% of the shoes worn by these patients were a year or more old, and demonstrated excessive wear patterns.

Still, when they do get around to buying new shoes, the "patients reported comfort, fit, support, and cost as important factors in choosingtheir own footwear," Rome says.

Specifically, 98% of the participants identified comfort as an important factor in selecting footwear, 90% said fit, 79% support, and 60% cost.Cheaper Shoes for Gout Patients Might Help

Further research needs to be done that will allow doctors and patients to better recognize the best shoes available for comfort that also are economically priced, the researchers write. Gout patients need shoes that are wide enough, have ample cushioning, and allow motion control.

More than half of those in the study mentioned cost as a factor in shoe selection, suggesting that cost may influence gout patients to purchase improper footwear.

Obesity may also be a factor in pain related to the footwear of gout patients, the researchers write.

Rome and his colleagues suggest that proper footwear selection be discussed with gout patients to reduce foot pain and impairment.

Previous research has shown that gout is on the increase around the world and is the most common form of inflammatory arthritis affecting men.

The study is published in Arthritis Care & Research, a journal of the American College of Rheumatology.

Text FDA approval of ancient remedy sends price soaring

By Jonathan LaPook

SILVER SPRING, Md. - Scott McGrath, 24, suffers from a painfully inflamed lining of the heart. Four months ago, the price of his medication suddenly went through the ceiling.

Sixty tablets of Colchicine used to cost him $34.83, and cost his insurance company nothing.

CBS News medical correspondent Dr. Jon LaPook reports the medication is now called Colcrys, and costs McGrath $62.16. "Almost doubled the amount I paid, and it cost my insurance company $244.74," McGrath said.

"The drug is no longer being sold by anyone but a single company, and that explains the price increase," McGrath said.

Colchicine has been used to treat gout and other inflammatory conditions for thousands of years. How could one company gain a monopoly?

There are about 1,000 medications on the market that predate the existence of the Food and Drug Administration and therefore were never approved. FDA official Deborah Autor spoke to CBS News as head of the office of unapproved drugs. "Well, for me, unapproved drugs present current risks," Autor said. "We don't know what's in them. We don't know if they're going to work properly. We don't know how they're made and that's a real concern."

Hundreds of thousands of people take Colchicine each year. The FDA said over the past 40 years, 169 deaths have been linked to the medication. A company called URL Pharma decided it would take the ancient drug, sold for 10 cents a pill, and test it as part of an FDA program to either approve these drugs or get them off the market.

"One company chose to seek FDA approval and they spent tens of millions of dollars in order to present data necessary for that approval and in the process, there were some important things that came out of the approval process," Autor said. "We discovered a lot of people were being excessively dosed with Colchicine."

Unlike companies that develop drugs from scratch and study thousands of patients for years, URL Pharma started with a pre-existing drug. Its research did clarify safety and dosing information. In return for the studies, the FDA granted URL exclusive rights to sell the medication.

"The reward that they got seems far out of proportion to the work that they did," said Dr. Edward Fundman, a rheumatologist who's been prescribing Colchicine for 30 years.

Fundman said the conversations among his colleagues was, "Just outrage that a company could take advantage of this FDA process and basically appropriate the drug for its own purpose. Even if a patient's not paying the full price out of pocket, their insurance company's paying it. Medicaid and Medicare have to pay for it. We're all paying for it."

How much are we paying? URL declined to speak about its sales so we went to a drug benefits manager called Prime Therapeutics. It told us the cost of an average 23-day prescription - including pharmacy charges - has risen from under $6.72 to $185.53.

IMS Health gave CBS News the number of Colchicine prescriptions nationwide. Add it all up and the cost of URL's price hike - over just one year - could exceed half a billion dollars.

With the higher price, URL has started a program to assist patients who can't pay. So far, 60,000 have asked for help. URL declined a request for an interview, but in a statement said its research "dramatically reduced adverse reactions" from Colchicine.

"Did you anticipate that the pricing was going to go up 50 times?" LaPook asked Autor.

"I think that companies have control over the pricing and we certainly hope that they would take into account the interest of consumers and not price them unreasonably."

So was the hike unexpected at the FDA?

"I think that is their decision," Autor replied. "I think we were surprised that they set the price that high."

Scott McGrath tried over-the-counter medications for his heart condition. But they didn't work as well as Colchicine.

"It's scary, it's a scary position to be in, to find myself in," McGrath said. "But ultimately I had to pay because I needed the drug."

URL's exclusive right to Colchicine for the most common indication - gout - expires next July. There are about 1,000 other unapproved medications currently on the market. Since the FDA does not control drug pricing, there's little to stop similar price hikes from happening again.

Statement from URL Pharma:

For 2000 years, people have been getting sick and dying from colchicine unnecessarily. But this wasn't known until URL Pharma conducted its ground-breaking research that dramatically reduced adverse reactions,identified many critically important drug-drug interactions, and showed how to minimize the risks of these adverse reactions. FDA issued press releases, a video, and a White Paper confirming the importance of these discoveries. The American College of Rheumatology (ACR) published our research papers in its journal. Congress established financial incentives for drug companies to make discoveries that benefit the public. Even with the financial incentives that Congress established through the Waxman Hatch Amendment, URL Pharma is the only drug company that answered FDA's request, conducted this novel research, and invested and risked the costs in money, time, and intellectual resources to bring these improvements in patient safety to the public, and thus deserves to receive the Congressionally-mandated reward for our contributions.

Through our patient assistance initiatives, we have assured that virtually every patient should be able to get FDA-approved Colcrys without any financial barrier. This is evidenced by the ratio of people who we help, versus those who register a concern about price, being over 12,000 to 1. The price of Colcrys is consistent with other innovator products for pain and chronic conditions, and should not be compared to the cost of illegal, unapproved versions of colchicine that did nothing to advance medical science for patient safety.

Illumina unveil Risk of Gout, Serum Uric Acid Levels affecting variants

Iceland-based deCODE Genetics and Illumina along with academic collaborators have discovered two low frequency variants in the human genome which are linked to risk and serum uric acid levels.

The researchers at deCODE sequenced the entire genomes of 457 Icelanders, and identified 16 million single nucleotide polymorphisms (SNPs), using the sequencing technology by Illumina.

During the course of the study, it was observed that the effect on risk of gout, for the two loci is higher among men than women, but the effect on serum uric acid levels is the same in both sexes.

deCODE CEO Kari Stefansson said the study underscores the importance of whole genome sequencing of well-phenotyped populations.

The study is published in the online edition of Nature Genetics.

Bone destruction by RANKL-expressing T cells in chronic gouty arthritis

Methods: Fourteen fixed, paraffin-embedded, uninfected tophus samples were analyzed immunohistochemically. Peripheral blood mononuclear cells (PBMCs) were cultured in vitro with MSU crystals, and gene expression was assessed by reverse transcription-polymerase chain reaction.

In vitro osteoclastogenesis was performed using PBMCs and synovial fluid mononuclear cells (SFMCs).

Results: CD4+ T cells, CD8+ T cells, CD20+ B cells, and mast cells infiltrated tophus tissues. Tartrate-resistant acid phosphatase (TRAP)+ osteoclasts were present around tophi and in osteolytic lesions.

Interleukin (IL)-1, IL-6 and tumor necrosis factor (TNF)-alpha were produced from infiltrated mononuclear cells, whereas receptor activator of nuclear factor kappaB ligand (RANKL) was strongly expressed in T cells. However, osteoprotegerin (OPG) was not or weakly expressed in tophus tissues.

MSU crystals induced the expressions of IL-1, IL-6, TNF-alpha and RANKL in PBMCs, but inhibited OPG expression. In addition, the pro-resorptive cytokines were highly expressed in SFMCs of gouty arthritis patients.

Furthermore, in vitro osteoclastogenesis was enhanced in SFMC cultures, but inhibited in T cell-depleted SFMC cultures.

Conclusions: Our study demonstrates that RANKL-expressing T cells and TRAP+ osteoclasts are present within gouty tophus tissues, and that infiltrating cells express pro-resorptive cytokines. Furthermore, our data show that MSU crystals have the potential to induce pro-resorptive cytokines, and T cells are involved in osteoclastogenesis in chronic gout.

Author: Sung-Ji LeeKwang-Il NamHye-Mi JinYoung-Nan ChoSong-Eun LeeTae-Jong KimShin-Seok LeeSeung-Jung KeeKeun-Bae LeeNacksung KimYong-Wook ParkCredits/Source: Arthritis Research &Therapy 2011, 13:R164

11 Things you Need to Know About Gout

1) The reason you hear so much about it, is that the prevalence of gout has increased greatly over the past 30 years.

2) There is more gout for 3 main reasons: a) we live longer b) there is more high blood pressure c) common medications like aspirin and diuretics increase risk of gout.

3) Increased consumption of carbs, proteins and drinks containing fructose contribute to gout.

4) You can presume you have gout if you have: development of severe pain, swelling and tenderness in a joint that reaches its maximum within 6-12 hours especially with redness and often in the big toe, knee or ankle.

5) Gout is a problem of too much uric acid in the blood stream leading to crystal formation of monosodium urate crystals which deposit in the joints.

6) Just decreasing intake of shellfish, beer and red meat can lower the uric acid in your blood stream.

7) 60% of patients who have an attack of gout, will get another one in a year, 78% in two years and 84% in 3 years.

8) Men develop gout more often than women, though women are at risk for gout after menopause.

9) The most important things other than gout to "rule out" are an infected joint, pseudo gout and rheumatoid arthritis.

10) A common mistake patients make is that symptoms of gout MUST RESOLVE before you start on allopurinol or febuxostat, which are for prevention of your next attack.

11) Only 37% of patients taking medicines for gout are compliant with their meds.

Those of you with gout, jump in.

- Dr O.

How to guard against gout

Cases of gout, a painful form of arthritis that often begins in the big toe joint, have climbed steadily in recent decades - and discomfort can be severe. "I've seen patients who can't walk or even stand," says Dr. Kimberly Smith, a family practice physician in Newport News, Va. To avoid flare-ups:

Maintain a healthy weight. Obesity is a risk factor for gout, which is caused by a build-up of a chemical called uric acid around joints. So is high blood pressure, a frequent complication of obesity. But avoid fasting or rapid weight loss plans; both can trigger an attack.

Eat less meat. Animal proteins are high in purine, a substance that the body converts into uric acid. Limit intake of meat, poultry or seafood to between 4 and 6 oz. a day - roughly the width of your fist - to lower gout risk.

Avoid very high-purine foods. Offenders include organ meats such as liver and kidney, sardines, anchovies, mussels, veal, bacon, salmon, asparagus and mushrooms. Talk to your doctor or a nutritionist.

Drink wisely. More than one or two daily alcoholic beverages, particularly beer, interfere with elimination of uric acid from the body. Water, on the other hand, helps flush it out.

Follow a low-fat diet. The usual advice applies: eat lots of fresh fruits and vegetables, whole grains and low-fat or fat-free dairy products.

Know your risk factors. Gout is more common in men than women and typically strikes adults rather than children. A family history also raises risk.

Seek medical attention. If you develop unexplained joint pain or hot, red or swollen joints, see a doctor. A number of medications can prevent flare-ups and control pain, while untreated gout can become chronic and lead to severe joint damage.

Read more: http://www.sunherald.com/2011/10/14/3507094/how-to-guard-against-gout.html#ixzz1b4zZSY5a

Studies Show Gout is Rapidly Spreading in the West

Have you ever heard the phrase “an ounce of prevention is worth a pound of cure”? This is especially true with preventing gout, because reversing the effects of gout can take a long time depending on the severity of the disease.

The most important steps to take in preventing gout are to have a healthy diet and get plenty of rest each night. A good diet is primarily one that eats a lot of vegetables, fruits and whole grains. Most of the foods in the “do not eat” list are meats, fish, sugar, salt, and white breads and pastas.

The reason for these diet choices is because gout is caused by excess uric acid in the blood. Certain food will increase the amount of uric acid, and those are the “bad” foods mentioned.

If you eat a lot of these types of foods and are concerned about the disease, look for some of the main symptoms of gout. The first stage of the disease only has one symptom- higher uric acid concentration in the blood. This can only be discovered through a blood test from your doctor.

The second, third and fourth stages are categorized by painful flare-ups of the gout. Usually this takes place in the foot, and you will experience very sharp, sudden pain. If these symptoms are occurring, see your doctor to find out if you have developed gout.

If it turns out that you have already developed the disease, there are some gout foods to avoid. These foods are very likely to trigger a flare-up, which is intense and painful. The main foods to stay away from are anything with artificial sweeteners, soda, cigarettes, white wheat flour, chocolate, brown sugar, sugar, beer, pasta, table salt, white rice, and breads.

These are basically the foods that make your body more acidic.

Even though there are a lot of foods listed here, consider that there are a number of other things you can eat to help prevent and cure gout. There are a number of simple gout diet recipes you can try which have been proven to lower your uric acid concentration and prevent flare-ups.

TheGoutRemedies.com has several listed on their website, but generally anything without the above foods will do. The most important thing is to have a lot of fruits and vegetables to alkalize the blood.

If you would like to learn more about how to cure or prevent gout, please visit this resource for more information. Due to the very acidic American diet, the next few years is likely to see a major increase of gout cases.

Contact Information:Vareck WattsVareck WattsTel: (656) 492-1426Email us

New Help for Stubborn Gout

About 6 million Americans have gout, and that number has increased by about 50 percent in the last 20 years. Gout is caused by a gradual accumulation of uric acid, which can form tiny crystals that deposit in the lining of joints and other tissues. These crystals can cause inflammation, swelling and pain. There are medications for the condition, but for some, these drugs are either ineffective or cause unwanted side effects.

In two clinical trials, pegloticase lowered high levels of uric acid and kept them normal for six months or more in 42 percent of patients. The patients received the injections every two weeks.

"This represents the first effective therapy for a group of patients who previously had no options at all," Michael A. Becker, M.D., professor of medicine at the University of Chicago, was quoted as saying. "This is for patients with severe gout, including major disabilities and high levels of pain. Many of these people had dramatic responses within months, some with complete resolution of tophi (swollen joint nodules), as well as reduced levels of pain and disability. The rapidity of these outcomes is unheard of."

About 40 percent of patients had complete resolution of at least one of the painful swollen joint nodules that are a hallmark of severe gout. When pegloticase is injected into patients with severe gout, their uric acid levels return to normal within 24 hours.

"People are dramatically helped by the drug," rheumatologist John S. Sundy, M.D., Ph.D., director of the Duke Clinical Research Unit and lead author of the study, was quoted as saying.However, there were some negative effects. For some patients, the drug lost its beneficial effect. Also, nine out of 10 patients had at least one adverse event. The most common was gout flares, which are brief, treatable attacks of pain and inflammation. These attacks slowed after the first three months of treatment. Twenty-six percent of treated patients also developed an immune response to the injection.

SOURCE: The Journal of the American Medical Association, August 20, 2011

More cases of Gout in younger men: Diet could be linked

It's something that used to be found mostly in middle aged men, but it seems more men are being diagnosed with gout at a younger age. Some doctors believe what people eat could be partly to blame.

Forty-one year old BrianTurpin has suffered from gout since he was 19, but he wasn't diagnosed until 10 years ago. "I used to play a lot of sports which I can no longer do," Turpin said.

That's because Turpin's gout causes severe pain. "The way I explain it to people is take some marbles and just crush them up and put them in your joints," Turpin said. "And try walking around with that."

Gout is a form of arthritis that occurs when uric acid accumulates in joints and forms crystals, causing swelling and pain. Turpin's case is so severe it's left nodules on his big toe and on the joints in his wrists.

LewisGale Regional Health System Rheumatologist Dr. Garry Bayliss treats Turpin. He said Turpin's gout is likely genetic, but he says he's seeing more cases of gout in younger men, and it could be connected to diet and obesity.

"That high use of sweeteners and changes in our diet where high fructose corn syrup is a huge component of the diet where it used to not be one. That's leading to more and more gout in younger people over time," according to Dr. Bayliss.

For now Turpin is being treated with drugs that may eventually get rid of the nodules in his joints. Doctor Bayliss hopes to get the word out, while it won't prevent all cases of gout, people can help to reduce their risk by watching what they eat.

"A lot of attention to a healthy diet is important," Dr. Bayliss said. "Going back to foods without so many simple sugars, without the sweeteners introduced to them is likely to counteract this tendency toward obesity and these other problems that we see and that includes gout." Dr. Bayliss said.

Gout drug may help some with few treatment options

The research was designed and funded by the pharmaceutical company Savient, which markets the drug, called Krystexxa, or pegloticase.

Patients taking the drug had fewer gout symptoms a few months after starting treatment than those who got a sham treatment -- but they were also more likely to have a serious reaction to the injections.

The researchers say most gout patients don't have very severe disease and should not be using the drug.

"The progression in these individuals is extreme," study author Dr. Michael Becker, from the University of Chicago, told Reuters Health. The patients in the study had "gone on to have really severe -- on average disabling -- (gout), poor quality of life (and) lots of pain."

"This is not a medication to be undertaken in a much larger group of patients," he added.

Of 5 or 6 million people in the U.S. with gout, about three percent do not get better with typical gout drugs, such as Lopurin and Zyloprim, or they can't take the medication for another reason, Becker and colleagues note in the Journal of the American Medical Association. Last year, the U.S. Food and Drug Administration approved Krystexxa -- given by injection every other week -- for use in those patients.

Gout is a form of arthritis that occurs when uric acid -- generally passed out of the body in the urine -- accumulates in joints and forms crystals, causing swelling and pain. Krystexxa works by breaking that uric acid down into a form that's more easily passed through the body.

The current report combines data from two drug trials involving 212 patients with chronic gout. Study participants who got the drug injection every two weeks for six months were compared to a group that received injections once a month and a group that got only drug-free placebo injections.

The majority of patients were men -- in their fifties, on average.

Krystexxa caused uric acid levels to fall quickly -- but that response didn't always last. Forty-two percent of patients in the biweekly group and 35 percent in the monthly group still had lowered uric acid six months after starting treatment.

On average, patients who received the drug had a bigger improvement in their general physical function and quality of life compared to those who only got the drug-free injections. And those who got the most frequent drug injections also reported the least pain.

However, more than nine out of ten patients reported at least one "adverse event" -- including painful gout flare-ups or reactions to the injections, including a few cases of breathing problems. Those reactions were more common in patients taking Krystexxa.

Some patients also reported headaches and nausea.

Becker said doctors could test which patients had stopped responding to the drug and halt treatment to avoid unnecessary risks in people whose gout isn't getting any better.

Krystexxa costs about $5,000 per month. Becker said patients whose symptoms improved with the injections could probably go back on cheaper medications -- but it's not clear yet how long most patients would have to get the injections first.

Most patients in the study also had heart conditions, or at least the risk factors for heart disease. Gout often occurs together with obesity and high blood pressure.

Becker said patients who don't respond to Lopurin and Zyloprim have a couple of other medication options (including Uloric, approved by the FDA in 2009), but gout drugs can take up to several years to really kick in -- and some patients with severe disease can't wait that long. For a number of those patients, Krystexxa may be worth the risks and cost.

"When you have seriously ill people who have no options, 40 percent (of patients getting better) is pretty good," he said. "Gout can be a really serious and disabling disease. With this and other (drugs) that are coming into line for treatment, we can do a good job in virtually all these people, including the sickest."

SOURCE: http://bit.ly/hwxtTL Journal of the American Medical Association, online August 16, 2011.

New Gout Research Explodes Myths About Gout Food Diets and Reveals Advanced Nanotechnology Benefits of Concept Laboratories' Topical Timed-Release Gout Treatment

Chicago, Illinois (PRWEB) August 25, 2011

The risks of high uric acid levels in the blood, gout foods diets, and advanced topical gout treatments are hot research topics today. In late 2010 at the American College of Rheumatology Annual Scientific Meeting in Atlanta, researchers from around the world gathered to compare gout research data on gout arthritis, gout foods and uric acid blood levels. Harvard Medical School reports that those who consumed milk one or more times per day had lower blood uric acid levels than those who did not drink milk at all.

Gout occurs when high levels of uric acid build up in the blood and crystallizes in the joints, causing intense pain and swelling. The number of people requiring gout treatment and gout foods diets more than doubled between the 1960s and 1990s.

What is uric acid and how do foods impact gout treatment? Because Gout is caused by uric acid build up, it is helpful to reduce your intake of foods that cause uric acid levels to rise. Proper Management of uric acid levels requires pro and con knowledge about gout foods. The list of recommended gout foods just got a lot friendlier and easier to manage for the average person. Now, the do and don't list for gout foods is less rigid and based more on moderation and wise choices within food groups.

Check out Concept Laboratories list of beneficial Gout foods and the foods to avoid list. For information on uric acid and gout food lists, visit UricAcid.Ultimizer.com.

A research team of in-house chemists at Concept Laboratories discovered that topical pain relievers can be vastly improved with timed-release nanotechnology. The Concept Laboratories team developed the world's first timed-release topical pain relief products. The new brand, MyOmega Plus, features FDA-approved pain relief ingredients such as Menthol, Camphor and Capsaicin in an omega oil base. To review of the best new topical gout treatment products, visit MyOmega topical pain relief. A topical application of capsaicin for pain relief is more effective than a gout foods diet or oral medication. Not only does capsaicin from chili peppers reduce pain and inflammation, it also aids in the repair of damage in joints.

ADVANCED TIMED-RELEASE GOUT TREATMENT TOPICAL.MyOmega 3 is the leading edge treatment for gout, acute pain flares and chronic pain conditions. The MyOmega timed-release nanotechnology breakthrough offers three pain relief products for deep penetrating topical pain relief.1. Penetrating Heat Therapy is a Capsaicin-based topical cream treatment for gout arthritis and deep muscle pain. Capsaicin has been scientifically and clinically shown to gradually deplete the chemical in the body that creates the sensation of localized pain. Unlike oral pain relievers, which often lead to treatment intolerance, Capsaicin actually works better over time and contributes to long-term healing of Gout Arthritis.2. Concept Labs also offers a Menthol and Camphor-based formula with two different application methods: a Triple Strength Pain Relief Rub and a Targeted Relief Spray. A nano-encapsulated menthol spray is convenient for those who are unable to comfortably reach painful areas such as their feet and back. Proprietary MyOmega formulas include Omegas 3, 6 and 9, derived from the Brazilian Açai berry to provide a high level of antioxidants. MyOmega products can be reviewed at MyOmegaPlus.com.

How does it work? Each nanosphere within the IcePearls system has a designed-in release time. Some nanospheres are activated immediately, releasing a complex of pain relief ingredients immediately when MyOmega is applied to a target pain area. Other nanospheres are encapsulated within microspheres which have individualized release barriers of varying thicknesses. When the time-based barriers dissolve, a new pain relief complex is released to the target pain area. The process is continual and fully effective for up to 6 hours.

Find out how to order advanced nanotechnology pain relief products direct from the manufacturer with free shipping anywhere in the continental USA.

For information on bulk purchases, executive interviews, b2b laboratory services and private label opportunities, please call Mike Fleming at 866.312.7744

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For the original version on PRWeb visit: www.prweb.com/releases/prweb2011/8/prweb8742140.htm

Read more: http://www.sfgate.com/cgi-bin/article.cgi?f=/g/a/2011/08/25/prweb8742140.DTL#ixzz1b50xwKgJ

Collard Greens and Gout

Collard greens may be worth considering for health additions to your diet. These dark-green leafy vegetables provide iron, vitamin K, folate, calcium and the antioxidants lutein and zeaxanthin. They may even help you prevent gout or reduce your symptoms when you eat collard greens in moderation as part of a healthy diet.Gout Background

Gout, or gouty arthritis, is a painful form of arthritis that results from the buildup of uric acid in your joints. Some unmodifiable risk factors for gout include older age, male gender and family history of gout. Some ways to lower your risk for gout are to limit your alcohol consumption to a maximum of one drink per day for women and two drinks for men, to limit sugar and to stay hydrated. Saturated fat raises your risk for gout, so avoid cooking your collard greens in solid fats such as butter or bacon fat.Natural Health Products 20% Off Free shipping Australia 1000 natural health products naturalhealthdirect.com.auSponsored LinksLow-Purine Diet

Uric acid is a product that your body makes as part of the process of breaking down purines from food. Your risk for gout may decrease when you choose vegetarian protein sources and limit your intake of animal proteins, which are high-purine foods. Instead of meat, fish, shellfish or poultry, you could eat your collard greens with high-protein plant-based foods such as black-eyed peas or soy-based meat substitutes.Weight Control

Losing extra weight or maintaining a healthy weight lowers your risk for developing gout. Collard greens can be part of a calorie-controlled diet because each cup has only 49 calories. You can use greens and other low-calorie vegetables as side dishes or add them to soups, stews, casseroles or other recipes to make your meals bigger, and more filling, without adding many calories. Raw, steamed or boiled collard greens are low in calories, but the calories will be higher if you cook your greens in fat, such as butter or oil.Other Nutrients

A potential benefit of collard greens for gout is their 5.3 g dietary fiber per cup, since dietary fiber lowers levels of cholesterol in your blood. High cholesterol is a risk factor for gout. You may also be at risk for gout when your blood pressure is high. Collard greens cooked without salt have only 30 mg sodium per cup, and they provide 220 mg potassium, which is necessary for regulating blood pressure. They have 35 mg, or 58 percent of the daily value, of vitamin C, which may lower your risk for gout, according to the Linus Pauling Institute Micronutrient Information Center.10 Diet Pills That Work Buy 2011's 10 Best Diet Pills. How Fast Can You Lose Weight? DietPillUniverse.com/Best-Diet-PillTop Rankings on Places Publicity Monster Guarantee Results From $6 a week. 1300 448 305 www.publicitymonster.com.au55/YO Mum Looks 35 Mum Reveals Shocking Trick for Erasing Wrinkles! Doctors Hate Her www.CollagenRenew.net/Anti_WrinklesGout Foods What Food Should You Avoid? Gout Food Listed Here Peeplo.com/Foods+To+Avoid+With+GoutSponsored LinksReferences

Mayo Clinic; Gout Diet; March 2010 U.S. Department of Agriculture: Vegetables and Vegetable Products U.S. Department of Health and Human Services; Dietary Guidelines for Americans, 2010; January 2010 Mayo Clinic; Gout; May 2009 Linus Pauling Institute Micronutrient Information Center; Vitamin C; November 2009

Article reviewed by Marie Slade Last updated on: Aug 20, 2011

Read more: http://www.livestrong.com/article/521926-collard-greens-and-gout/#ixzz1b519dpZ4

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