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COX 2 inhibitors, traditional NSAIDs, and the heart

BMJ 2005; 330 doi: (Published 09 June 2005) Cite this as: BMJ 2005;330:1342
  1. Peter Jüni, senior research fellow in clinical epidemiology (,
  2. Stephan Reichenbach,
  3. Matthias Egger, visiting professor of clinical epidemiology
  1. Department of Social and Preventive Medicine, University of Berne, Finkenhubelweg 11, 3012 Berne, Switzerland
  2. Department of Rheumatology, University Hospital Berne, 3010 Berne, Switzerland
  3. MRC Health Services Research Collaboration, Department of Social Medicine, University of Bristol, Bristol BS8 2PR

Adverse event data from clinical trials must inform decision making

These are trying times for patients with chronic musculoskeletal pain. Worrying data about the drugs they regularly use keep emerging. In September 2004 rofecoxib (Vioxx) was withdrawn by Merck after the adenomatous polyp prevention on Vioxx (APPROVe)1 trial showed an increase in major cardiovascular events in patients with a history of colorectal adenomas who were randomised to receive Vioxx, compared with those in the placebo group.w1Rofecoxib had been marketed as the non-steroidal anti-inflammatory drug (NSAID) of choice because selective inhibition of the isoform 2 of the cyclooxygenase (COX 2) enzyme made it highly effective but free from gastrointestinal toxicity.

More unwelcome data from placebo controlled trials of rofecoxib's competitors followed: valdecoxib (Bextra, Pfizer) taken after coronary artery bypass grafting was shown to be associated with an increased incidence of cardiovascular events2; and the adenoma prevention with celecoxib (APC) trial3 reported an increased risk of cardiovascular events associated with use of celecoxib (Celebrex, Pfizer), a drug known to be less selective …

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