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More studies on risks and benefits of COX-2 inhibitors published in Archives of Internal Medicine

CHICAGO -- A group of studies published in the January 24 issue of Archives of Internal Medicine add to the growing body of medical literature about the cardiovascular risks that may be associated with the class of pain-relieving drugs known as COX-2 inhibitors. Archives of Internal Medicine is one of the JAMA/Archives journals.

The Celecoxib Rofecoxib Efficacy and Safety in Comorbodities Evaluation Trial (CRESCENT) evaluated the effects of the COX-2 inhibitors and naproxen on 24-hour blood pressure readings in patients with type 2 diabetes, hypertension, and osteoarthritis. Patients were randomly assigned to receive 200 mg of celecoxib (Celebrex; Pfizer Inc., New York) [n= 136], or 25 mg of rofecoxib once daily (Vioxx, Merck & Co., West Point, Penn.) [n = 138], or 500 mg of naproxen twice daily (Naprosyn; Roche Pharmaceuticals, Basel, Switzerland) [n = 130] for 12 weeks. A total of 65 centers from 7 countries participated in this trial from May 2001 to April 2002. Patient evaluations were conducted at the start of the study and 1, 2, 6, and 12 weeks after randomization.

"Reductions in osteoarthritis symptoms, including pain, mobility, and stiffness, were similar in all treatment groups," the researchers found. "The mean (average) 24-hour systolic [top number in blood pressure reading] blood pressure following 6-weeks of therapy was increased significantly by refecoxib but not by celecoxib or naproxen."

"these results suggest the need for careful monitoring and control of blood pressure when NSAIDS (non-steroidal anti-inflammatory drugs) or COX-2 inhibitors are chosen for osteoarthritis management for patients with hypertension and type 2 diabetes and further suggest need for careful evaluation of currently available as well as future COX-2-specific inhibitors and nonspecific NSAIDs in this population," the authors conclude.

(Arch Intern Med. 2005; 165: 161-168. Available post-embargo at

Contact: Jane Shaskan
860-679-4777
JAMA and Archives Journals
24-Jan-2005


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