Analysis of Pivotal AGREE Trial Finds No Correlation Between Incidence of Adverse Events and Age, Disease Duration or Gout-Related Comorbidities
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).
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.
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 elbows.
Important Safety Information
COLCRYS (colchicine, USP) tablets are indicated for the prophylaxis and treatment of gout flares. COLCRYS is contraindicated in patients with renal or hepatic impairment who are concurrently prescribed P-gp inhibitors or strong inhibitors of CYP3A4 as life-threatening or fatal toxicity has been reported. Dose adjustments of COLCRYS may be required when co-administered with P-gp or CYP3A4 inhibitors. The most common adverse events in clinical trials for the prophylaxis and treatment of gout were diarrhea and pharyngolaryngeal pain. Rarely, myelosuppression, thrombocytopenia, and leukopenia have been reported in patients taking colchicine. Rhabdomyolysis has been occasionally observed, especially when colchicine is prescribed in combination with other drugs known to cause this effect. Monitoring is recommended for patients with a history of blood dyscrasias or rhabdomyolysis.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
You may also report negative side effects to the manufacturer of COLCRYS by calling 1.888.351.3786.
For full Prescribing Information, please visit: http://www.colcrys.com/assets/pdf/COLCRYS_Full_Prescribing_Information.pdf
About URL Pharma
URL Pharma, Inc., headquartered in Philadelphia, PA, is a leading specialty pharmaceutical company with fully integrated technology development, product development, manufacturing, and commercialization capabilities. After a long history of generic pharmaceutical research, development, and manufacturing, the Company has successfully transitioned to a technology-driven, specialty pharmaceutical business. The Company seeks to develop and commercialize scientifically and medically innovative products that address unmet medical needs for improvements in safety and efficacy. For additional information about the company, please visit www.urlpharma.com. For further information, please call 215-697-1900 or [email protected].
SOURCE URL Pharma, Inc.