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Cardiovascular Outcomes Trials

Meaning

Cardiovascular Outcomes Trials (CVOTs) are large-scale, long-term, randomized controlled clinical trials specifically designed to assess the effect of a new pharmaceutical agent, typically a non-cardiovascular drug, on major cardiovascular events. These trials are often mandated by regulatory bodies like the FDA to ensure that treatments for conditions such as type 2 diabetes or obesity do not pose an unacceptable cardiovascular risk. The primary endpoints usually focus on a composite of events, including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.