London, Sept 13: A review of studies on pain relievers has found that a widely-used medicine may confer cardiovascular risks as serious as those found with Vioxx, an arthritis medicine that was withdrawn from the market two years ago.
Diclofenac, an older non-steroidal anti-inflammatory drug (NSAID), has been on the market for decades and is one of the most-widely prescribed anti-inflammatories in the world — especially in Europe. At commonly prescribed doses, it was found to increase the risk of cardiovascular events — primarily heart attack and sudden death — by 40%.
The good news from the study is that there are alternatives. "European consumers would be better off switching [from diclofenac] to naproxen," says David Graham, a safety official at the US Food and Drug Administration, who authored an editorial1 accompanying the published review. Naproxen was found to neither increase nor decrease cardiac risk.
The study authors — Patricia McGettigan of the University of Newcastle in New South Wales, Australia, and David Henry of Newcastle Mater Hospital in Waratah, New South Wales — call for a review of the regulatory status of diclofenac, which is marketed as a generic drug and also under the trade names Voltaren, Cataflam, Solaraze and Arthrotec.
The study suggests that Celebrex (celecoxib) is not harmful to the heart at the commonly used dose of 200 mg, but seems to be unsafe at doses of 400 mg or more.
For the future, researchers are aiming to find a class of anti-inflammatories that will both be kind to the stomach and to the heart. Research released by the Proceedings of the National Acadamy of Sciences this week shows promising news of a drug target, found in a mouse model, that slows the development of atherosclerosis. This might help a new class of 'super NSAIDs' not only steer clear of heart disease risk but work to reduce it.
In the meantime, the JAMA study may cause problems for Merck. The company is currently using diclofenac as a comparison drug in a trial of Arcoxia, a next-generation cox-2 inhibitor developed to succeed Vioxx for arthritis patients. They had no immediate comment on the JAMA results, or how this will affect their drug trials. (ANI)