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Rofecoxib Cardiovascular Risk Apparent in Late 2000

Company research shows evidence of risk more than three years before drug's withdrawal

MONDAY, Nov. 23 (HealthDay News) -- Dozens of studies on rofecoxib revealed its association with an increased risk of cardiovascular events nearly three and a half years before it was voluntarily withdrawn by maker Merck and Company, according to a study in the Nov. 23 issue of the Archives of Internal Medicine.

Joseph S. Ross, M.D., of the Mount Sinai School of Medicine in New York City, and colleagues analyzed pooled subject-level data from 30 randomized and placebo-controlled trials of rofecoxib (Vioxx), comprising a total of 20,152 subjects, that were conducted by the manufacturer before September 2004. The outcome of interest was incidence of death from any cause or cardiovascular thromboembolic (CVT) adverse event.

The researchers found that, by December 2000, 21 of the 30 trials had been completed, revealing an increased risk of CVT adverse event or death among study subjects taking rofecoxib compared to placebo (rate ratio, 2.18), which should have raised safety concerns. Analyzing subsequent data collected through June 2001, the researchers found rofecoxib was associated with a 35 percent increased risk of a CVT adverse event or death. Using data through April 2002, they calculated a 39 percent increased risk, and through September 2004, a 43 percent increased risk.

"Cumulative pooled analysis of all randomized, placebo-controlled trials demonstrates a trend toward increased cardiovascular risk associated with rofecoxib compared with placebo as early as December 2000, the comparison reaching a P value of .05 by June 2001, nearly three and a half years before the manufacturer's voluntary market withdrawal," the authors write.

The study authors have all been, or are currently, consultants for plaintiffs in lawsuits against the maker of rofecoxib, Merck & Company Inc. Several study authors have also been consultants for or served on advisory boards for pharmaceutical companies.

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