PHILADELPHIA – New data show that low-dose colchicine (ColcrysTM) rapidly controls acute gout flares.
The results, which were presented at the 2009 Annual Scientific Meeting of the American College of Rheumatology, are drawn from a secondary analysis of the phase III Acute Gout Flare Receiving Colchicine Evaluation (AGREE) trial.
Robert Terkeltaub, MD, with the Veterans Affairs Medical Center in San Diego, presented data in 184 gout patients who were randomized to high-dose colchicine (1.2 mg, then 0.6 mg hourly x 6 hours = 4.8 mg total), low-dose colchichine (1.2 mg, then 0.6 mg in 1 hour = 1.8 mg total, followed by 5 placebo doses hourly), or placebo (2 capsules, then 1 capsule hourly x 6 hours).
Colchicine has been used for centuries for the treatment of gout flares but, until recently, it has not been studied extensively for safety and efficacy in controlled trials.
The results provide the first evidence for the usefulness and tolerability of low-dose colchicine therapy in the treatment of acute gout flares, Dr. Terkeltaub, Chief of the Rheumatology-Allergy Division, said.
Demographic and gout characteristics were similar in the three treatment groups. Most patients were overweight white males roughly 50 years of age with an elevated serum urate concentration and a 10-year history of gout. Less than one-third of patients were receiving concurrent urate-lowering therapy, and 9% had evidence of tophi. Mean baseline pain scores were 6.8 to 6.9.
The efficacy of low-dose colchicine was comparable to that of high-dose colchicine as evidenced by
- a similar percent of patients with at least a two-unit decrease in target joint pain scores at 24 hours (34.6% for the high -dose and 43.2% for the low-dose groups, respectively, p=.3298) and 32 hours (38.5% and 45.9% for the two groups, p=.4033).
- a similar median time to 50% reduction in target joint pain.
- a similar frequency of use of rescue medication.
Both colchicine groups were statistically superior to placebo in terms of median time to 50% reduction in target joint pain, and both groups needed fewer rescue medications than placebo-treated patients and had a longer median time to use of rescue medication.
Despite similar pain relief observe in low-dose and high-dose colchicine groups, the low-dose colchicine safety profile was comparable to placebo.
Colcrys, the only single-agent low-dose colchicine approved for the treatment of acute gout flares and familial Mediterranean fever, was recently approved for the prevention of gout flares.
Presently, more than 5 million U.S. adults are affected by gout. The condition is increasing in prevalence.
Written by Jill Stein
Jill Stein is a Paris-based freelance medical writer.