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Cardiovascular Outcome Trials (CVOTs)

Meaning

Cardiovascular Outcome Trials, or CVOTs, are large-scale, long-duration clinical studies specifically designed to assess the effect of a therapeutic agent on major adverse cardiovascular events (MACE) in high-risk patient populations. These trials are critical in endocrinology and diabetology to ensure that novel agents, particularly those for glucose or lipid management, do not increase cardiovascular risk. Primary endpoints typically include non-fatal myocardial infarction, non-fatal stroke, and cardiovascular-related death. Regulatory bodies often mandate these trials before granting approval for new pharmacological compounds.