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Febuxostat Effective Nonpurine Alternative for Treating Gout: Presented at EULAR

By Paula Moyer

BERLIN, GERMANY -- June 15, 2004 -- Febuxostat, a selective nonpurine inhibitor of xanthine oxidase and dehydrogenase, is an effective option to purine-based therapies for the treatment of gout, according to researchers.

Michael A. Becker, MD, professor of medicine in the rheumatology department at the University of Chicago, Illinois, presented study findings here June 10th at the European Congress of Rheumatology. "This treatment will broaden physicians' options for treating gout," he said, noting that that febuxostat is unique as a nonpurine gout therapy. He added that prophylactic concomitant treatment with colchicine may be necessary to prevent recurrence.

Dr. Becker and his coinvestigators undertook a double-blind, placebo-controlled, dose-response study, recruiting 136 men and 17 women with gout and with a baseline serum urate level of 8 mg/dL or more. The subjects ranged in age from 23 to 80 years old. After a 2-week washout period in which patients could use colchicine, the patients were randomized to placebo or to febuxostat, 40 mg, 80 mg, or 120 mg daily, for 4 weeks. The patients also received concomitant colchicines during 2 weeks of double-blind treatment.

By day 28, no placebo patients had the target serum urate level less than 6.0 mg/dL, compared to 56% in the 40 mg group, 76% in the 80 mg group, and 94% in the 120 mg group. The average decreases from baseline in serum urate levels at that time were 2% for placebo, 37% for the 40 mg group, 44% for the 80 mg group, and 59% for the 120 mg group (P <.001 for both end points). Significantly higher rates of febuxostat subjects achieved a serum urate level of less than 5.0 mg/dL (P <.01) or less than 4.0 mg/dL (P <.05 compared to placebo for the 80 mg and 120 mg groups).

When colchicine was coadministered, gout flares occurred in 11% of placebo patients, 8% of both the 40 and 80 mg groups, and 13% of the 120 mg group. Without colchicine, 34% of placebo patients had flares, compared to 30% of 40 mg patients, 40% of 80 mg patients, and 42% of 120 mg patients.

Overall, 95% of the subjects completed the study; 1 placebo patient and 5 of the treatment patients withdrew due to adverse events. The incidence of adverse events for febuxostat subjects, 54%, was similar to the 50% seen in the placebo patients. These were primarily mild and self-limiting, Dr. Becker said. The adverse events reported by patients in the treatment arms included diarrhea, pain, back pain, headache, and arthralgia.


[Presentation title: A Safety and Efficacy Clinical Trial of a Novel Non-Purine Selective Inhibitor of Xanthine Oxidase, Febuxostat, in Subjects With Gout. Abstract OP007]

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