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Investigative Febuxostat for Gout: Twice as Effective as Allopurinol in Lowering Uric Acid, Researchers Report: Presented at ACR

By Bruce Sylvester

SAN DIEGO, CA -- November 17, 2005 -- Investigative febuxostat, the first prospective gout treatment in 40 years, appears to be twice as effective for lowering serum uric acid than the standard gout treatment, allopurinol, researchers said here at the American College of Rheumatology Annual Scientific Meeting (ACR).

"This is a breakthrough in our field. Febuxostat at all doses in this trial was much more effective at lowering serum uric acid than standard allopurinol," said lead investigator Robert Wortmann, MD, professor of medicine, University of Oklahoma, Tulsa, Oklahoma, in a press briefing on November 14^th.

The underlying cause of gout is hyperuricemia, or levels of uric acid in the blood greater than 6.8 mg/dL, he said.

Dr. Wortmann and colleagues studied uric acid levels in blood samples obtained from 1067 subjects with hyperuricemia and gout. Most were male (94%) and Caucasian (78%). Mean age was 52 years, and mean disease duration was 11 years.

Over the 28 weeks of the study, patients received daily doses of febuxostat at 80 mg, 120 mg, or 240 mg. They compared this data with that from subjects receiving 100 mg or 300 mg of allopurinol, dosed depending on kidney function, and to data from placebo subjects.

The primary endpoint was uric acid levels < 6 mg/dL at the last 3 monthly visits. Among febuxostat subjects, this target was achieved in 48% of subjects on 80 mg/day, 65% of subjects on 120 mg/day, and 69% of subjects on 240 mg/day. In allopurinol subjects, 22% achieved the target. None of the placebo subjects achieved the target uric acid level.

Data from a single visit at week 28 showed that, among subjects whose uric acid level fell to < 6 mg/dL, 76% were taking febuxostat 80 mg/day, 87% were taking febuxostat 120 mg/day, and 94% were taking 240 mg/day, 41% were allopurinol subjects, and 1% were placebo subjects.

Adverse events included digestive disturbances, headache, and liver abnormalities, with similar rates across the treatment groups. There were 34 serious adverse events among all subjects and groups, and most were cardiac-related in subjects with pre-existing cardiovascular disease.

"Febuxostat appears to be a safe and effective agent for the elimination of hyperuricemia," added Dr. Wortmann, "and it looks like it could become a new and excellent treatment alternative for patients not effectively treated by the older drug."

Gout affects more than 5 million Americans.

This research was supported by TAP Pharmaceuticals.


[Presentation title: Febuxostat Vs. Allopurinol and Placebo in Subjects With Hyperuricemia and Gout: The 28-Week APEX Study. Abstract 1837]

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