COX 2 inhibitors, traditional NSAIDs, and the heart

doi:10.1136/bmj.330.7504.1342

BMJ 2005;330:1342-1343 (11 June), doi:10.1136/bmj.330.7504.1342

Editorial

COX 2 inhibitors, traditional NSAIDs, and the heart

Adverse event data from clinical trials must inform decisionmaking

The first 150 words of the full text of this article appear below.

These are trying times for patients with chronic musculoskeletalpain. Worrying data about the drugs they regularly use keepemerging. In September 2004 rofecoxib (Vioxx) was withdrawnby Merck after the adenomatous polyp prevention on Vioxx (APPROVe)¹trial showed an increase in major cardiovascular events in patientswith a history of colorectal adenomas who were randomised toreceive Vioxx, compared with those in the placebo group.^w1 Rofecoxibhad been marketed as the non-steroidal anti-inflammatory drug(NSAID) of choice because selective inhibition of the isoform2 of the cyclooxygenase (COX 2) enzyme made it highly effectivebut free from gastrointestinal toxicity.

More unwelcome data from placebo controlled trials of rofecoxib'scompetitors followed: valdecoxib (Bextra, Pfizer) taken aftercoronary artery bypass grafting was shown to be associated withan increased incidence of cardiovascular events²; and the adenomaprevention with celecoxib (APC) trial³ reported an increasedrisk of cardiovascular events associated . . . [Full text of this article]

Peter Jüni, senior research fellow in clinical epidemiology

Department of Social and Preventive Medicine, University of Berne, Finkenhubelweg 11, 3012 Berne, Switzerland
(juni@ispm.unibe.ch)

Stephan Reichenbach

Department of Rheumatology, University Hospital Berne, 3010 Berne, Switzerland

Matthias Egger, visiting professor of clinical epidemiology

MRC Health Services Research Collaboration, Department of Social Medicine, University of Bristol, Bristol BS8 2PR

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