New Drug Cleared For Gout Patients

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Data show superiority of febuxostat over allopurinol.

A new oral medication that reduces serum uric acid levels has received FDA approval for treating hyperuricemia in patients with gout.

The drug, febuxostat (ULORIC, Takeda Pharmaceuticals), is the first new treatment option for this patient population in 40 years. The approved doses are 40 mg and 80 mg. The drug is not recommended for managing asymptomatic hyperuricemia.

Febuxostat is contraindicated in patients taking azathioprine, mercaptopurine, theophylline.

The drug lowers serum uric acid levels by blocking xanthine oxidase, an enzyme that breaks down hypoxanthine, a purine base, to xanthine and then to uric acid.

In a large phase 3 clinical trial, patients with hyperuricemia and gout received febuxostat 40 mg, febuxostat 80 mg, or allopurinol 200 or 300 mg once daily for six months. Sixty-seven percent of patients who received febuxostat 80 mg had a reduction in serum uric acid to below 6 mg/dL, the primary study end point, compared with 45% of patients in the 40 mg febuxostat group and 42% of allupurinol recipients.

In a different study, researchers found that febuxostat was superior to allopurinol in patients with hyperuricemia and gout, including those with mild to moderately impaired renal function, according to a report in Arthritis & Rheumatism (2008;59:1540-1548).

In that study, 1,072 patients with hyperuricemia and gout (serum uric acid levels of 8 mg/dL or higher) were randomized to receive febuxostat (80 mg, 120 mg, or 240 mg), allopurinol (100 or 300 mg, depending on renal function), or placebo for 28 weeks.

The primary end point was a serum uric acid level below 6 mg/dL for the last three monthly measurements. In the 80, 120, and 240 mg febuxostat groups, 48%, 65%, and 69% of patients achieved the primary end point compared with 22% of allopurinol-treated subjects and 0% of placebo recipients.

Among patients with impaired renal function (serum creatinine of 2 mg/dL or less but higher than 1.5 mg/dL), 44%, 45%, and 60% of the 80, 120, and 240 mg febuxostat groups achieved the primary end point compared with 0% of those treated with allopurinol 100 mg.

Gout afflicts an estimated 5.1 million Americans, according to the National Health and Nutrition Examination Survey III 1988-1994. It is the most common inflammatory arthritis in men older than 40 years.

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