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Treatment For Gout And The Condition's Protective Effect

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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.

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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).

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"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.

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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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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.

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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.

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