Healthy Skepticism Library item: 4447

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Mansfield PR.
Safety Query.
Australian Doctor Weekly 2004 Nov 17

Full text:

EDITOR The so-called experts are wrong to claim that there is no evidence of cardiovascular risk with celecoxib (‘Consensus emerges on switch to celecoxib’, ‘Vioxx withdrawal: where now?’, 15 October). Celecoxib has not been studied adequately to prove or disprove cardiovascular risk beyond doubt.

However, the European Agency for the Evaluation of Medicinal Products has found “a trend towards a higher MI risk associated with the use of celecoxib compared to naproxen and diclofenac”.1

As well, a New England Journal of Medicine editorial states: “In the CLASS trial, celecoxib was compared with ibuprofen or diclofenac. In the original report,2 celecoxib appeared to have a more favourable gastrointestinal-side-effect profile, and no increase in cardiovascular risk was revealed.

“However, this report contained only half the data (from only six months of a one-year study): when the full data set became available, it was clear that celecoxib did not differ from the traditional NSAIDs in its effect on the predefined gastrointestinal end points. Indeed, the most powerful evidence supporting claims of celecoxib’s superiority over traditional NSAIDs in terms of gastrointestinal effects rests on a post hoc analysis of the CLASS data for patients who did not use aspirin. However, a similar retrospective approach to the data also reveals signs of increased cardiovascular risk.”3

There may be a place for celecoxib for people who have a higher risk of dying from their disease or GI ulcers than from heart attacks and strokes, but there is no good evidence about this and no proven way to identify these people. Celecoxib is not more effective than older NSAIDs and has not be been proven to be safer overall, but it is more expensive. I believe osteoarthritis is better treated with adequate doses of paracetamol and ibuprofen if needed.

Dr Peter R Mansfield

Director

Healthy Skepticism Inc

1. Overall summary of the scientific evaluation of medicinal products containing celecoxib, etoricoxib, parecoxib, rofecoxib and valdecoxib. Celecoxib. Annex II. European Agency for the Evaluation of Medicinal Products, 30 April 2004. www.emea.eu.int/pdfs/human/referral/celecoxib/EN%20Celecoxib.pdf

2. Silverstein FE, et al. Gastrointestinal toxicity with celecoxib versus nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study. Journal of the American Medical Association 2000; 284(10):1247-55.

3. Fitzgerald GA. Coxibs and cardiovascular disease. NEJM 2004; 351:1709-11. http://content.nejm.org/cgi/reprint/NEJMp048288v1.pdf