MUNICH — Aspirin at a daily dose of 100 mg was not seen to reduce the long-term risk for cardiovascular (CV) or cerebrovascular events in a trial that randomly assigned more than 12,000 nondiabetic adults with multiple CV risk factors but no history of CV events. Nor was the risk for stroke reduced.
In the study's primary intention-to-treat (ITT) analysis, 4.29% of persons assigned to aspirin and 4.48% of those in the placebo group experienced the primary endpoint of CV death, myocardial infarction (MI), unstable angina, stroke, or transient ischemic attack (TIA) over a mean of 5 years. The adjusted hazard ratio (HR) for aspirin vs placebo was 0.96 (95% confidence interval [CI], 0.81 - 1.13; P = .604).
Aspirin also did not show a significant effect on any of the individual components of the primary endpoint.
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Cleland doesn't seem to buy into the alleged value of a per protocol analysis and sees it as emblematic of a more widespread problem. "The presentation of aspirin data is always biased," he said.
"I think it's fine for them to show the per protocol analysis, but ultimately, their conclusions are correct, that there isn't a benefit of aspirin." Or, Cleland added, "that such benefits, if they exist, are so small that, why don't we move on to something more useful."/.../
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