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25 February 2003

COX-2's, naproxen, and other NSAID's: no effect on MI risk short-term

A large cohort study indicates that neither rofecoxib as normally used, nor naproxen have a significant short-term effect on risk of acute myocardial infarction (MI). The study aimed to provide more evidence following the finding of the VIGOR trial that rofecoxib appeared to be associated with a greater risk of MI than naproxen. A population-based retrospective study, it used five cohorts from Ontario, Canada, and data from the three year period April 1998 to March 2001. The cohorts were people aged >65 years not previously prescribed an NSAID who were started on rofecoxib (n=12,156), celecoxib (n=15,271), naproxen (n=5669), other non-selective NSAID (n=33, 868), and a non-exposed control group (n=100,000). The rate of MI was compared between the groups. The data gave about 75,000 person-years of follow-up, during which time there were 701 hospitalisations for MI. After correction for potential confounding factors, there was no significant difference in rate of MI in the drug groups relative to control or between the different drug groups. Analysis by age, and sex, and exclusion of those with a history of MI, all produced similar results. The authors conclude that the short-term risk of MI is not increased by either COX-2 inhibitor in the doses used, nor was it decreased by naproxen. They comment that other evidence suggests that the risk may differ with high doses of rofecoxib, which may explain the findings in VIGOR. Although they captured data on aspirin use, there were too few events to be able to examine reliably whether use of aspirin with other NSAIDs affected risk.

Arch Intern Med 2003; 163: 481-6 - Archives of Internal Medicine website