ATLANTA, Nov. 8, 2010 /PRNewswire/ — Patients who experience
gout flares can be treated safely with Colcrys® (colchicine,
USP), even in the presence of co-morbid conditions that often
present physicians with treatment challenges, according to a new
analysis presented here at the 74th Annual Scientific Meeting of
the American College of Rheumatology (ACR).
“Many patients with gout have other serious health conditions to
consider, including cardiovascular and metabolic disorders,
hypertension and kidney disease, which can make gout treatment
complex,” said Matthew W. Davis, M.D., R.Ph., Chief Medical
Officer, URL Pharma. “This analysis demonstrates that patients with
these comorbidities did not have an increased likelihood of adverse
events from the use of Colcrys.”
Data were collected as part of a post-hoc analysis of The Acute
Gout Flare Receiving Colchicine Evaluation (AGREE) trial, a pivotal
Phase 3 study of Colcrys in the treatment of gout flares. AGREE
results were presented at the 2009 ACR annual meeting, and were
published in Arthritis & Rheumatism in March 2010.
Colcrys is the only single-ingredient colchicine product
approved by the U.S. Food and Drug Administration (FDA) for the
prevention and treatment of gout flares, and for the treatment of
Familial Mediterranean Fever (FMF).
Study Design
This Phase 3, randomized, double-blind, placebo-controlled
parallel group study represents a regression analysis of the
previously presented AGREE trial. A total of 185 patients meeting
ACR criteria for acute gout flares were randomized to receive,
within 12 hours of symptom onset, either high-dose colchicine (1.2
mg, then 0.6 mg hourly x 6 hours = 4.8 mg total); Colcrys (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).
Logistics regression was undertaken using presence or absence of
adverse events (AEs
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