Why the study?
Does rofecoxib increase the risk of death or cardiovascular thromboembolic events compared to placebo?
Population
20,152 subjects from 30 randomized, placebo-controlled trials of rofecoxib
Comparison
Rofecoxib for 4 weeks to 4 years vs Placebo
Design
Meta-analysis, randomized, placebo-controlled
Follow-up
4 weeks to 4 years
Authors
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Supports earlier rofecoxib withdrawal; confirms value of cumulative meta-analyses for proactive postmarket safety surveillance.
Does rofecoxib increase the risk of death or cardiovascular thromboembolic events compared to placebo?
A cumulative pooled analysis demonstrated that the increased cardiovascular risk associated with rofecoxib was evident years before its voluntary market withdrawal, highlighting the need for proactive postmarket safety surveillance.
Joseph S. Ross (2009) studied this question.
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