BMJ  2005;331:E371 (13 August), doi:10.1136/bmj.331.7513.E371

BMJ USA: Letter

RAPID RESPONSE FROM BMJ.COM

Following is an edited excerpt from one of the Rapid Responses generated by this article, all of which can be read in their entirety at http://bmj.bmjjournals.com/cgi/eletters/330/7504/1370.—Editor

...In an observational study, a crucial question concerns the appropriateness of the control group. In this study the reference group received celecoxib (unknown prescribed dose) and this is inadequate to know the real risk profile. Furthermore the paper does not have information about some relevant outcome measures [such as] why patients died. An outcome of all cause death includes fatal myocardial infarction, which is probably the main cardiovascular adverse drug reaction of COX-2 inhibitors. We must remember that in the APC trial¹ frequency of non-fatal myocardial infarction and non-fatal heart failure was higher in the celecoxib—400 mg twice daily—group than in the placebo group (1.3% v 0.4% and 0.6% v 0.3%, respectively).

Rofecoxib was withdrawn from the market after the APPROVe trial reported a higher incidence of cardiovascular events in the treatment group.² Cardiovascular adverse effects have been reported for other COX-2 inhibitors such as celecoxib¹ and valdecoxib.³ The findings of this study support some evidence of differences among COX-2 inhibitors, but this does not mean celecoxib could be safer. In addition, when risk of recurrent congestive heart failure was assessed separately, NSAIDs and celecoxib did not differ significantly (hazard ratio = 1.21; C I95% = 0.92-1.60).

Nevertheless, the pharmaceutical industry now can use the published paper for celecoxib promotional activities, presenting the drug as a good alternative for elderly patients.

Pharmacology Unit, Biomedical Center Central University of Ecuador PO Box 17-11-6120, Quito, Ecuador.

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Competing interests: None declared.

References

1. Solomon SD, McMurray JJV, Pfeffer MA, et al, for the Adenoma Prevention with Celecoxib (APC) Study Investigators. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 2005;352: 1071-1080.[Abstract/Free Full Text]
2. Bresalier RS, Sandler RS, Quan H, et al, for the Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005;352: 1092-1102.[Abstract/Free Full Text]
3. Nussmeier NA, Whelton AA, Brown MT, et al. Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. N Engl J Med 2005;352: 1081-1091.[Abstract/Free Full Text]

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