New Gout Drug Does Well in Trial

The first new drug for gout in 40 years has shown promising results in a large trial. Patients who got febuxostat had lower levels of serum uric acid than those getting allopurinol, the standard medication for the painful condition, according to a report in the Dec. 8 issue of The New England Journal of Medicine.

"What hasn't been established is that the clinical benefits of febuxostat compared to allopurinol after one year were statistically significant," says study author Dr. Michael A.

Becker, a professor of medicine at the University of Chicago Medical Center.

While the trial, which included 762 people with gout, was "the largest study of patients with gout I know of that has ever been done," Becker says, more studies are needed to show it reduces the number of gout flare-ups and other problems associated with the disease.

Gout is a form of arthritis in which crystals of uric acid accumulate in joints, most commonly the joint at the base of the big toe, causing pain and inflammation. Febuxostat, like allopurinol, is designed to prevent those deposits from forming by reducing blood levels of uric acid.

In the trial, participants took either allopurinol or one of two different doses of febuxostat, with the goal being a reduction of uric acid levels to no more than 6 milligrams per deciliter of blood. That goal was achieved by 21 percent of the people taking allopurinol -- 53 percent of those taking 80 milligrams of febuxostat a day, and 62 percent of those taking 120 milligrams a day of the new drug.

"Whether the reduction in uric acid levels in the blood will ultimately be accompanied by reversal of the clinical symptoms of the disease is not clear," Becker says. "Although the trends are there, after one year, there wasn't sufficient evidence of that."

An accompanying editorial by Dr. Larry W. Moreland, a professor of medicine at the University of Alabama at Birmingham, noted that a large number of participants who started the study did not complete it. That high dropout rate and the possibility that it was due to adverse side effects "emphasize the need for more information about the short- and long-term toxicity of febuxostat," Moreland wrote.

Moreland declined a request for an interview through a spokesperson who quoted him as saying his comments were "speculative."

A major difference between the two drugs is that allopurinol is metabolized by the kidney, while febuxostat is metabolized by the liver, Becker notes. That might make the new drug preferable for people with gout who have weak kidney function, he says.

Longer-term studies to determine the effect of febuxostat are underway or planned, and the results should be available "within a year or two," Becker says.

TAP Pharmaceutical Products applied for U.S. Food and Drug Administration approval to market febuxostat a year ago. The agency has not yet acted on the request.

(The HealthDay Web site is at http://www.HealthDay.com.)