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) as the dependent variable and the following as independent variables: standard measures of kidney function (indicated by creatinine clearance) and liver function (as assessed by AST, ALT, albumin and alkaline phosphatase); gout duration (years); obesity (BMI >30); age (years); and presence or absence of CV history (eg, myocardial infarction, cardiovascular or cerebrovascular illness). Odds ratios (OR) were reported and compared.
Study Results
The incidence of adverse events among comorbid patients with acute gout flares treated with Colcrys was not affected by any of the independent variables analyzed.
Across the study, a total of 83 patients (approximately 45 percent) experienced an AE; most of these were mild to moderate gastrointestinal AEs (approximately 73 percent). A greater proportion of patients receiving the high-dose colchicine experienced AEs than patients receiving the Colcrys dose or placebo (77 percent vs. 37 percent and 27 percent, respectively). No patients discontinued the study due to AEs.
The authors concluded that these data offer reassurance regarding the safety of colchicine in patients with several comorbid conditions.
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