Expression of Concern: Bombardier et al., "Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis," N Engl J Med 2000;343:1520-8.
Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D.
Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.
We have recently obtained information regarding inaccuraciesin data in the report of the VIGOR (Vioxx Gastrointestinal OutcomesResearch) study by Bombardier et al.1 that raise concern aboutcertain conclusions in the article.
The VIGOR study was designed primarily to compare gastrointestinalevents in patients with rheumatoid arthritis randomly assignedto treatment with rofecoxib (Vioxx) or naproxen (Naprosyn),but data on cardiovascular events were also monitored. Threemyocardial infarctions, all in the rofecoxib group, were notincluded in the data submitted to the Journal. The editors firstbecame aware of the additional myocardial infarctions in 2001when updated data . . . [Full Text of this Article]
Source Information
This editorial was published on December 8, 2005, at www.nejm.org.
Related Letters:
Response to Expression of Concern Regarding VIGOR Study
Bombardier C., Laine L., Burgos-Vargas R., Davis B., Day R., Ferraz M. B., Hawkey C. J., Hochberg M. C., Kvien T. K., Schnitzer T. J., Weaver A., Reicin A., Shapiro D.
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N Engl J Med 2006;
354:1196-1199, Mar 16, 2006;
published at www.nejm.org on Feb 22, 2006 (10.1056/NEJMc066096).
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