Pegloticase normalized uric acid levels within 6 hours for participants in phase II trial
WEDNESDAY, Sept. 3 (HealthDay News) -- An experimental gout drug called pegloticase lowered levels of uric acid in the blood to target levels within a few hours in most patients.
That's the conclusion of a study by researchers at Duke University Medical Center and Savient Pharmaceuticals, the company that's developing the drug.
The phase II clinical trial included 41 patients randomly selected to receive either four or eight milligrams of pegloticase every two weeks, or eight or 12 milligrams every four weeks, for a 12- or 14-week period. The treatment is an infusion that takes about two hours.
Pegloticase normalized uric acid levels within six hours for participants in all dosage groups, and those levels were sustained throughout the treatment period in the two groups at the higher dosage levels. The most effective dose was found to be eight milligrams every two weeks, the study found.
During treatment, 88 percent of the patients experienced gout flares and some also experienced mild to moderate side effects, including reactions to the infusion and joint pain.
"The generally accepted goal of therapy is to reduce serum urate concentrations to less than 6 milligrams per deciliter, and we found that pegloticase can do that very, very quickly," study lead author Dr. John Sundy, a rheumatologist at Duke, said in a university news release.
"We were delighted to see this response, because all of the patients in our trial had already tried all the existing treatments for gout, and nothing was helping them," said Sundy, who added that more studies need to be conducted to confirm and expand the findings.
The findings were published online and were to be in the September issue of the journal Arthritis & Rheumatism. Results of a phase III study of pegloticase were expected to be presented in October at the annual meeting of the American College of Rheumatology, in San Francisco.
The American Academy of Family Physicians has more about gout.
-- Robert Preidt
Duke University, news release, Sept. 2, 2008
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