How does PROactive compare to other cardiovascular and diabetes trials, such as RECORD, VA-HIT, CARDS, HPS, CARE, 4S, TNT, and UKPDS?
Kaplan-Meier estimates indicate that allocation of 1000 patients to pioglitazone would avoid 21 first myocardial infarctions, strokes, or deaths over 3 years. In other words, 48 patients would need to be treated for 3 years to avoid one first major cardiovascular event. Although several intervention trials using antihypertensive agents, lipid-modifying drugs (principally statins), glucose-lowering agents, or multifactorial intervention strategies have looked at macrovascular outcomes in patients with type 2 diabetes, much of the data pertaining to patients with diabetes are post-hoc or, in some instances, predefined subgroup analyses from larger cohorts. This makes direct comparisons difficult and, in most cases, inappropriate. Comparison between the results of PROactive and previous outcomes studies is also complicated by differences in predefined endpoints, study population, study duration, concomitant medication use, and a range of other methodological issues.
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