Composite endpoints in clinical trials in type 2 diabetes
Composite endpoints are conventionally used in clinical outcomes studies to increase statistical power and precision. More recent outcomes studies in diabetes have tended to predominantly use a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke (i.e. major adverse cardiovascular events or MACE), with or without the addition of hospitalization for unstable angina. This report argues that inclusion of this additional endpoint may be problematic, specifically with respect to subjective variability in its ascertainment and a lower prognostic relevance compared with the MACE outcomes, and thus the MACE outcomes may be more clinically relevant when evaluating treatment effects. Ultimately, there is no gold standard for a specific endpoint (either single or composite) for cardiovascular outcomes studies.
Composite primary end points in cardiovascular outcomes trials involving type 2 diabetes patients: should unstable angina be included in the primary end point?
Marx N, McGuire DK, Perkovic V et al.