Novel cholesterol lowering drugs: Can phase 2/3 clinical trial safety assessments predict cardiovascular event outcome trial efficacy?

Key Points

Prediction of cardiovascular event outcomes may benefit from data gathered in phase 2/3 clinical trials, enhancing the understanding of treatment effects.
Among the limitations considered are the drugs studied and variability in major adverse cardiovascular events (MACE) definitions.

Structured PICO

Can phase 2/3 clinical trial safety assessments of novel cholesterol lowering drugs predict cardiovascular event outcome trial efficacy?

Intervention

Phase 2/3 clinical trial safety assessments of novel cholesterol lowering drugs

Outcome

Cardiovascular event outcome trial (CVOT) efficacy (MACE)composite

Results from non-cardiovascular outcome trials (non-CVOTs) for novel cholesterol-lowering drugs have predictive value for actual CVOT outcomes.

Abstract

Within the limitations of the drugs studied and the variability in MACE definitions, there is value in the results of non-CVOTs to predict the CVOT outcome.

Novel cholesterol lowering drugs: Can phase 2/3 clinical trial safety assessments predict cardiovascular event outcome trial efficacy?

Key Points

Structured PICO

Abstract

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