ULORIC(R) (febuxostat) Demonstrated Efficacy for Management of Hyperuricemia in Patients...(59 mL/min) ULORIC 40 mg resulted in a si...),Health

Documentation of Fewer Gout Flares After Long-Term Urate-Lowering Treatment

Researchers also examined gout flare rates among patients in the CONFIRMS trial and from a subset of 276 patients who had previously participated in the five-year FOCUS or three-year EXCEL trials maintaining sUA <6.0 mg/dL for up to five years while receiving ULORIC 40 mg, 80 mg or 120 mg or allopurinol 300 mg. Patients were randomized by renal function and whether or not patients had already participated in long-term urate-lowering therapy studies. Patients also received gout flare prophylaxis with colchicine or naproxen throughout the six-month study.

Patients who had previously received long-term urate-lowering therapy with ULORIC 40 mg, ULORIC 80 mg or allopurinol achieved goal range sUA (<6.0 mg/dL) more often (57 percent, 77 percent and 52 percent, respectively) than patients who had not received long-term urate-lowering therapy (43 percent, 66 percent and 41 percent, respectively) and had lower rates of acute gout flares (p less than or equal to 0.0001).

Rates of adverse events were similar regardless of prior participation with the most frequent being upper respiratory infection, abnormal liver function tests, musculoskeletal pain and diarrhea.

Overall study results from the CONFIRMS trial demonstrated ULORIC 80 mg was superior in lowering sUA levels compared to ULORIC 40 mg and allopurinol 300 mg (67 percent, 45 percent and 42 percent, respectively).

About Gout and Uric Acid

Gout is the most common inflammatory arthritis in men. According to the National Health and Nutrition Examination Survey III 1988-1994, an estimated 5.1 million Americans suffer from gout. It is a chronic condition associated with hyperuricemia and is characteri
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