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Data Presented at ACR Meeting Demonstrate Safety of Colcrys® (Colchicine, USP) for Treatment of Gout Flares in Patients with Multiple Co-Morbid Conditions
Date:11/8/2010

) 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.

About Gout and Painful Gout Flares

Gout is a painful form of arthritis that affects an estimated 3 to 5 million Americans, most commonly adult men. It occurs when excess uric acid in the body is deposited as needle-like crystals, or tophi, in the joints or soft tissues, which cause inflammatory arthritis and can lead to gout flares typically lasting three to 10 days.

Gout flares are characterized by intermittent swelling, redness, heat, joint stiffness and pain, which are often excruciating and can be debilitating enough to significantly interfere with work, social activities and daily living. For many people, gout initially affects the joint of the big toe, though it can also affect other joint areas such as the ankles, heels, knees, wrists, fingers and el
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