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Treatment For Gout And The Condition's Protective Effect

The goal in treating patients with gout is to reduce acute attacks by lowering serum urate levels, which are usually high in this disease. At the same time, high serum urate levels have been shown to lower the risk of developing Parkinson's disease (PD). A new study compared the safety and efficacy of febuxostat, a new drug being developed for gout that was recently approved for use in Europe, and a commonly used drug that has been around for years. Another study examined the link between gout and PD in individuals 65 years and older. The studies were published in the November issue of Arthritis Care & Research (http://www3.interscience.wiley.com/journal/77005015/home).

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.

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."

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.

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

Discovery Of New Genes Linked To 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.

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.----------------------------

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