JRSM > Volume 99, Number 7 > Pp. 336

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Letters

Celecoxib

Raymond Cheung   Simon Lowry

Worldwide Medical Team, Pfizer Inc, New York, NY 10017, USA

raymond.y.cheung{at}pfizer.com

Caldwell et al. (March 2006, JRSM¹) concluded that there was an increased risk of myocardial infarction with celecoxib. However, their meta-analysis was limited to preexisting data from six studies and no new information.

Other meta-analyses of case-controlled/cohort observational studies² and clinical trials³ did not show increased risk of cardiovascular thromboembolic events with celecoxib compared with nonselective NSAIDs.

Based on their inclusion criteria, the authors could have included additional studies in their meta-analysis. Synopses of more than 50 celecoxib clinical studies including serious adverse events (SAE) and fatalities are available at the website [http://www.clinicalstudyresults.org].

The authors also queried differences in the reporting of cardiovascular events from the CLASS trial in a Food and Drug Administration briefing document⁴ and in a published paper.⁵ This is due to differences in analytical criteria. In the briefing documents, if the time of last dose of study medication was unavailable, time of last visit or laboratory test was utilized as a proxy. This analysis gave 13 cardiovascular deaths (celecoxib: 5, comparator NSAIDs: 8) occurring within 28 days ending treatment⁴. White et al. reported all cardiovascular deaths within 30 days of the end of treatment. Where the time that treatment was stopped was not available, it was assumed death occurred on study medication. This gave a total of 20 (celecoxib: 10, comparator NSAIDs: 10).⁵

The USA Food and Drug Administration and the European Medicines Agency, Europe, have conducted reviews of celecoxib safety, including data from all trials utilized by Caldwell et al. and concluded that celecoxib could continue to be marketed with appropriate warnings on cardiovascular risk. Only a properly powered, prospective clinical study can definitively assess the relative safety of nonselective NSAIDs and the COX-2 selective inhibitors. PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen), a large clinical study meeting these requirements is currently in final stages of preparation.

Footnotes

Competing interests The authors are employees of Pfizer Inc.

REFERENCES

1. Caldwell B, Aldington S, Weatherall M, Shirtcliffe P, Beasley R. Risk of cardiovascular events and celecoxib: a systematic review and meta-analysis. J R Soc Med2006; 99:132 -40[Abstract/Free Full Text]

2. Hernandez-Diaz S, Varas-Lorenzo C, Garcia Rodriguez LA. Non-steroidal anti-inflammatory drugs and the risk of acute myocardial infarction. Basic Clin Pharmacol Toxicol2006; 98:266 -74[CrossRef][Medline]

3. Simon L, White W, MacDonald T, Pan S, Rosenstein R, Gaffney M. Cardiovascular safety of CELEBREX: a meta-analysis of 41 clinical studies in 44,308 patients. American College of Rheumatology (ACR) annual scientific meeting 12-17 November 2005. Atlanta: ACR,2006

4. US Food and Drugs Administration CLASS Advisory Committee Briefing Document. [http://www.fda.gov/ohrms/dockets/ac/01/briefing/3677b1_01_searle.pdf] Accessed 15 May 2006

5. White WB, Faich G, Whelton A, et al. Comparison of thromboembolic events in patients treated with celecoxib, a cyclooxygenase-2 specific inhibitor, versus ibuprofen or diclofenac. Am J Cardiol 2002;89:425 -30[CrossRef][Medline]

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This Article Full Text (PDF) Send a Quick Comment Alert me when this article is cited Alert me when Quick Comments are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Cheung, R. Articles by Lowry, S. Search for Related Content PubMed PubMed Citation Social Bookmarking                      What's this?