Rofecoxib (Vioxx) was lately withdr...

Rofecoxib (Vioxx) was lately withdrawn from the market because of increased cardiovascular results in participants taking this unsalable article as part of a trial of prevention of colorectal polyp An earlier inquiry the Vioxx Gastrointestinal Outcomes Research trial, showed a fivefold increase in myocardial infarction and included comparisons with naproxen (Aleve). This and other similar reports were attributed to a cardioprotective efficiency of naproxen rather than a cardiotoxic efficiency of rofecoxib. Because an estimated 80 million patients have taken rofecoxib, Juni and colleagues reviewed all randomized controll trials (RCTs) to establish the magnitude of the risk.

Searches of electronic databases, citation indexes, colloquy proceedings, and information from experienced persons and U.S. Food and mix with drugs Administration panels were used to identify all RCT comparing rofecoxib with other nonsteroidal anti-inflammatory medicines (NSAIDs) or placebo for chronic musculoskeletal conditions in adults. All studies were reviewed for quality according to two independent reviewers and data were registered into the meta-analysis.

From the 383 reports originally identified, 63 (including 18 RCTs) were included in the subject of attention Of the 18 RCTs, which included 25273 patients, 12 were belong toed with osteoarthritis, five with rheumatoid arthritis, and the same with low back pain. The duration of the trials ranged from four weeks to longer than single year. A placebo group was used in 14 trials. Because five trials were continueed to report on patients after reallocation of treatment, 22 comparisons were available for the analysis. All of the RCT were sponsored by the agency of the drug manufacturer. The median incidence of myocardial infarction in direct groups was 1.45 per 1000 patient-years. Twelve myocardial infarcts occurr in the govern group, compared with 52 in patients taking rofecoxib. The relative risk varied from 104 to 293 depending onward the agent being used for comparison, yet it was not significantly altered by way of the dose of rofecoxib or the duration of the trial (see accompanying table). The relative risk of serious cardiovascular consequence was 1.55. Relative risk of calamity was 1.02.

The authors infer that rofecoxib is associated with an increased risk of myocardial infarction in short- and long-term trials. They challenge statements that no exces risk occurr until after 18 month of therapy, and that the risk is dose unable to exist without They also found no evidence of a significant cardioprotective validity of naproxen. The authors emphasize that scarcely any trials included patients with significant history of cardiovascular disease, which is not consistent with patients combated in normal clinical practice. The relative risk of rofecoxib could be significantly higher in of that kind patients.

ANNE D WALLING, MD

Juni P et al. Risk of cardiovascular marked occurrences and rofecoxib: cumulative meta-analysis. Lancet December 4 2004;364:2021-9

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