By Ed Susman

PHILADELPHIA, PA – Treatment with low dose colchicines (Colcrys) appears to rapidly lessen pain caused by flares of gout – and the therapy appears effective with lower risk of adverse gastrointestinal side effects.

“Gout is not a joke,” said Robert Terkeltaub, MD, chief of rheumatology-allergy at the Veterans Affairs Medical Center, San Diego, and professor of medicine at the University of California, San Diego. “It can be a very disabling, painful condition.”

In a secondary analysis of the Acute Gout Flare Receiving Colchicine Evaluation (AGREE) study at the annual meeting of the American College of Rheumatology here, Dr. Terkeltaub found that colchicines – either in the high dose or low dose formulations – was effective in reducing pain in the first 24 hours after patients took the medicine, but the side effect profile favored the low dose formula.

“Overall the adverse event rates were similar for low-dose colchicine, about 36.5%, and placebo, about 27.1%, while this rate was higher for the high dose group, about 76.9%” said Dr. Terkeltaub.

He and colleagues also scrutinized the time to a 50% reduction in pain among 185 patients included in the analysis. “We found that within 24 hours we could reduce pain from a level that was excruciating to a level that was bearable,” he said. “That mean a person can go from being in pain and being bedridden to being able to get out of bed, go to the bathroom and even go to work.”

Dr. Terkeltaub said about 34.6% of the 52 patients on high-dose colchicine evaluated in the secondary analysis were able to achieve a 50% reduction in pain within 24 hours. He said about 43.2% of the 74 patients on low-dose colchicines achieved the 50% reduction in pain in 24 hours. 

Only 17.2% of the 58 patients on placebo achieved that pain reduction. The differences were statistically significant for the low dose (p=0.0015) and high dose (P=0.0368) when compared with placebo, he said.

Tuhina Neogi, MD, PhD, assistant professor of medicine at the Boston University School of Medicine, noted, “Colchicine has been typically used in clinical practice for gout attacks and also for prophylaxis of gout attacks. In the past there has been a lot of high dosing of colchicines used, probably unnecessarily. A 50% reduction in pain after 24 hours is meaningful to patients.”

Low-dose colchicines received a Food and Drug Administration for gout prophylaxis October 16. The drug was previously approved for the treatment of acute gout flares.

The AGREE trial was funded by URL Pharma, based in Philadelphia.

–10-20-2009