PROactive: A Sad Tale of Inappropriate Analysis and Unjustified Interpretation

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Abstract
PROactive was a much-anticipated study because it was the first large study to be reported that was designed to determine whether the potential theoretical benefits of peroxisome proliferator-activated receptor-γ (PPAR-γ) agonists (in this case pioglitazone) on endothelial function and cardiovascular risk markers might indeed result in fewer macrovascular disease (atherosclerosis) events in patients with type 2 diabetes. That anticipation was driven by a considerable amount of hype and by the 2004 publication of the study's design and baseline data in Diabetes Care.7 An entire hour was allocated for the PROactive presentation on 12 September 2005 during the annual meeting of the European Association for the Study of Diabetes (EASD) in Athens, Greece, and the presentation was webcast worldwide.8 The publication of the study's results in Lancet occurred < 1 month later.1