[How I explore...outcomes in clinical trials: comments about recent studies of cardiovascular prevention].
The comparison of two therapeutic interventions requires the use of endpoints in randomized clinical trials, which supports evidence-based medicine. It is preferable to consider hard endpoints, such as major clinical events and mortality rather than biological or surrogate endpoints. In large cardiovascular prevention trials, it is now well accepted to analyze primary and secondary endpoints as well as to use combined clinical endpoints. Such composite endpoints offer the advantage of increasing the number of events, but have the disadvantage of diluting the therapeutic effect and of exposing to possible bias. We discuss this crucial issue at the light of controversial results from a few recent important cardiovascular prevention trials.
Scheen
A J
AJ
Université de Liège, Service de Diabétologie, Nutrition et Maladies métaboliques, Unité de Pharmacologie clinique, Département de Médicine.
D002318:Cardiovascular Diseases / Q000517:prevention & control*; D002986:Clinical Trials as Topic; D019317:Evidence-Based Medicine; D006801:Humans; D012307:Risk Factors