By Jill Stein
PHILADELPHIA -- October 23, 2009 -- Low-dose colchicine (Colcrys) provides a prompt improvement in the joint pain triggered by an acute gout flare, according to data released on October 19 at the 2009 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).
The new results are derived from a secondary analysis of the phase 3 Acute Gout Flare Receiving Colchicine Evaluation (AGREE) trial.
Robert Terkeltaub, MD, Veterans Affairs Medical Center, San Diego, California, and associates randomised 184 patients with gout to high-dose colchicine (1.2 mg, then 0.6 mg hourly x 6 hr = 4.8 mg total), low-dose colchichine (1.2 mg, then 0.6 mg in 1 hr = 1.8 mg total, followed by 5 placebo doses hourly), or placebo (2 capsules, then 1 capsule hourly x 6 hr).
"The results provide the first evidence for the utility and tolerability of low-dose colchicine therapy in the treatment of acute gout flares," Dr. Terkeltaub said.
The efficacy of low-dose (LD) colchicine (n = 74) was comparable to that of high-dose (HD) colchicine (n = 52) as evidenced by the following:
· A similar percent of patients achieved at least a 2-unit decrease in target joint pain scores at 24 (HD group, 34.6%; LD group, 43.2%; P = .3298) and 32 hours (HD group, 38.5%; LD group, 45.9%; P = .4033).
· A similar median time to 50% reduction in target joint pain (HD, 24.5 hr; LD, 24 hr).
· 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 required fewer rescue medications.
The side effect profile with low-dose colchicine was superior to high-dose colchicine and comparable to placebo.
Colcrys, the only single-agent low-dose colchicine approved by the US Food and Drug Administration for the treatment of acute gout flares and familial Mediterranean fever, was recently approved for the prevention of gout flares.
[Presentation title: Colchicine Efficacy Assessed by Time to 50% Reduction of Pain Is Comparable in Low-Dose and High-Dose Regimens: Secondary Analyses of the AGREE Trial. Abstract Number 1103]
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