SAN ANTONIO, Texas – Researchers said Thursday that a new study indicates that the investigative drug febuxostat reduces serum urate levels better than allopurinol, the longtime standard of care for gout.

Lead author Michael Becker, MD, Professor of Medicine at the Pritzker School of Medicine of the University of Chicago in Illinois, said the new drug also appears to reduce the frequency of flares as well as reduce gouty tophus — uric acid crystals typically deposited in periarticular fibrous soft tissue, in areas such as the big toe. "We saw the greatest reductions in serum urate in patients taking 120 mg of febuxostat," said Dr. Becker in a late-breaking oral session on the closing day of the 68th annual scientific meeting of the American College of Rheumatology.

He reported that 62% of the 250 patients randomized to 120 mg/day of febuxostat were able to reduce their serum urate level to below the goal of 6 mg/dL at their last 3 office visits, compared with 53% of the 255 patients on 80 mg/day of febuxostat and only 21% of the 251 patients on 300 mg/day of allopurinol (P <0.05).

"I think this drug may be very helpful for people with gout," said Roy Fleishmann, MD, Clinical Professor of Medicine at the University of Texas Southwestern Medical School at Dallas, and a member of the CIAOMed editorial board. "We have not had a new drug for gout in many years. Many people cannot tolerate allopurinol."

For the phase III 52-week controlled study, Dr. Becker and colleagues at 120 medical centers recruited 760 patients to test the safety and efficacy of febuxostat — a nonpurine selective inhibitor of xanthine oxidase — compared to allopurinol. The average age of the patients in the study was 52, and more than 95% were men. Gout patients were eligible for participation if they had a serum urate level >e;8 mg/dL.

The overall incidences of adverse events were similar in each of the 3 treatment groups, Dr. Becker said. Most of the adverse events reported were mild to moderate in severity. He said that 4 deaths occurred in the trial, but none were judged to be treatment related. Four percent of patients in the 80 mg febuxostat group, 8% in the 120 mg febuxostat group, and 8% in the 300 mg allopurinol group suffered serious adverse events. However, Dr. Becker said that most of those events were related to cardiac disorders in patients who entered the trial with cardiovascular disease or cardiovascular risk factors.

Reference:

Becker MA, Schumacher HR, Wortmann RL, et al. A phase 3 study comparing the safety and efficacy of oral febuxostat and allopurinol in subjects with hyperuricemia and gout. Presented at: Annual Meeting of the American College of Rheumatology; October 21, 2004; San Antonio, Texas. Abstract L18.