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Title: Novel Urate-Lowering Agent, Febuxostat, Shows Better Results in Older Adults With Gout Compared With Allopurinol: Presented at AGS

"Novel Urate-Lowering Agent, Febuxostat, Shows Better Results in Older Adults With Gout Compared With Allopurinol: Presented at AGS"

By Crina Frincu-Mallos, PhD WASHINGTON, DC -- May 8, 2008 -- Febuxostat, a novel, nonpurine, selective inhibitor of xanthine oxidase, is effective for the treatment of gout and hyperuricemia, according to research presented here at the 2008 Annual Scientific Meeting of the American Geriatrics Society (AGS). "This is the first analysis of urate-lowering therapy in subjects 65 years and older suffering from gout and hyperuricemia," said lead author H. Ralph Schumacher Jr., MD, Professor, Rheumatology Division, University of Pennsylvania and VA Medical Center, Philadelphia, Pennsylvania. Febuxostat was tested in a phase 3, double-blind, randomised, active-controlled and placebo-controlled clinical trial of 1,832 subjects with gout and hyperuricemia, of which 295 were aged 65 years and older. In this older adult population, the majority were men (84%). The mean age in this subgroup was 71 years, with a mean duration of disease of 15 years. The study randomised patients to 1 of 3 doses of febuxostat (80, 120, and 240 mg), allopurinol 300 mg, or placebo, administered once daily in subjects with gout and normal renal function, explained Dr. Schumacher in his presentation on May 2. Patients also received 8 weeks of naproxen or colchicines for gout prophylaxis. The investigators sought to determine the benefit of febuxostat treatment, determined as the proportion of subjects having serum urate levels <6 mg/dL after 28 weeks of treatment. At baseline, the mean level of serum urate was 9.62 mg/dL, with 32% of patients having serum urate levels >10.0 mg/dL, noted Dr. Schumacher. Of the 79 patients treated with febuxostat 80 mg, 94% achieved serum urate levels <6.0 mg/dL. In the febuxostat 120-mg arm, 89% of 83 patients had serum urate levels <6.0 mg/dL, while all 28 subjects on febuxostat 240 mg achieved this goal. In the allopurinol arm, 66% of 82 patients had serum urate levels <6.0 mg/dL at the final visit, while none of the subjects in the placebo-controlled arm achieved the goal, noted Dr. Schumacher. A significantly greater proportion of patients with gout and hyperuricemia were successful in reducing their serum urate levels to <6.0 mg/dL compared with allopurinol ([P <= .01) or placebo (P <= .01), concluded Dr. Schumacher.

Adverse events occurred in 74% of patients treated with febuxostat and in 89% of patients treated with allopurinol, said Dr. Schumacher and colleagues. No dose-related adverse effects were observed with febuxostat.

The most frequent adverse events were upper respiratory infections, diarrhoea, musculoskeletal and connective tissue signs and symptoms, pain, and discomfort.

Serious adverse events, assessed by the investigators as unrelated to the study drug, occurred in 28 patients in the study; 18 of these patients continued with treatment.

The most frequently reported serious adverse events were cardiac disorders, occurring in 4% of patients on febuxostat and 5% of patients on allopurinol, said Dr. Schumacher.

Funding for this study was provided by TAP Pharmaceutical Products Inc.

[Presentation title: Febuxostat (FEB) versus Allopurinol (ALLO) in the Treatment of Gout in Subjects >= 65 Years of Age. Abstract C44]

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