Low-dose oral colchicine is just as effective as high-dose colchicine in reducing pain associated with early acute gout flare, but with a safety profile statistically indistinguishable from placebo, according to a study published in the April issue of Arthritis & Rheumatism, the official journal of the American College of Rheumatology.
Low-dose oral colchicine is just as effective as high-dose colchicine in reducing pain associated with early acute gout flare, but with a safety profile statistically indistinguishable from placebo, according to a study published in the April issue of Arthritis & Rheumatism, the official journal of the American College of Rheumatology.
“High vs. Low-dosing of Oral Colchicine for Early Acute Gout Flare: Twenty-Four Hour Outcome Results of the First Randomized, Placebo-Controlled, Dose Comparison Colchicine Trial” details the AGREE (Acute Gout Flare Receiving Colchicine Evalulation) trial, a placebo-controlled comparison of low-dose and high-dose colchicine in the treatment of acute gouty flares.
“Our AGREE trial was designed to see if a lower dose of colchicine would still be effective, but with a more favorable side-effect profile,” said Matthew W. Davis, MD, RPh, chief medical officer, URL Pharma, which funded this trial.
The multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluated the safety and efficacy of low-dose versus high-dose colchicine in male and postmenopausal female patients aged ≥18 years with a confirmed past diagnosis of gout and ≥2 gout flares within the prior 12 months. A stable regimen of urate-lowering therapy was permitted. A total of 575 patients were randomly assigned into one of three treatment groups: 1) a novel “low-dose” (1.8 mg over 5 hours) abbreviated colchicine regimen group; 2) a “high-dose” (4.8 mg over 6 hours) colchicine regimen group that reflects long-standing medical practice and is still actively taught to physicians; 3) placebo. Of these patients, 185 had an acute gout flare; 184 were included in the efficacy analysis. The primary end point was ≥50% pain reduction at 24 hours without rescue medication.
Both low-dose colchicine and high-dose colchicine were superior to placebo and had equivalent efficacy, according to the study results.“The surprise of the study was that the adverse event profile of the low-dose colchicine was similar to the placebo arm,” Dr Davis said.One out of 5 patients in the high-dose colchicine group had severe intensity adverse events, including severe diarrhea; 1 of 6 in this group also experienced vomiting. None of the patients in the low-dose colchicine group experienced either severe adverse events or vomiting.“In conclusion, the results of the AGREE trial provide the first evidence basis, after centuries of colchicine use, for low-dose colchicine therapy in the treatment of early acute gout flare,” Dr Davis said. “The low-dose colchicine regimen maintained efficacy equivalent to that of high-dose colchicine. It had a side-effect profile significantly better than that of high-dose colchicine and comparable with that of placebo. The results…support an immediate change in clinical practice from a high-dose colchicine regimen to a low-dose colchicine regimen for treatment of early gout flare.”
Prior to AGREE, only one other placebo-controlled study evaluated colchicine for the treatment of acute gout flare, a 43-patient trial by Ahern from 1987. In this trial, all the subjects who were taking colchicine had gastrointestinal toxicity (diarrhea). “The Ahern trial showed that high-dose colchicine was effective, but with a high price in [terms of] side effects,” Dr Davis said.
According to Dr Davis, primary care physicians see approximately 98% of all gout patients; rheumatologists treat approximately 2%.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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