CardioExchange Archive

Update on IMPROVE-IT: IMPROVE-IT is the much anticipated and highly controversial ongoing study evaluating ezetimibe. In response to the controversy over the drug (see, for example, here and here), and to address the questions that “have been raised about whether the trial will be completed,” the trial investigators have written an editorial that has now been published online in the American Heart Journal.


Califf and colleagues now estimate that the last of the 18,000 subjects will be enrolled in June 2010. Because of the “trial’s prolonged duration” there is a greater number of patients than originally anticipated who have stopped taking the study drug, and this will “cause the estimated treatment effect to be diminished.” Despite the numerous concerns that have been raised in the last few years, the authors report that both the Lipid Monitoring Committee and the Data and Safety Monitoring Board “have consistently recommended that the study continue without design alteration.” The investigators now predict that the trial will be completed in June 2013, which is when their model predicts they will achieve 5,250 primary endpoint events with at least 2.5 years of follow-up for all subjects.

Olympic Hearts: The long-term effects on the heart of intensive athletic training have never been conclusively determined. Italian, U.S., and Japanese investigators, led by Barry Maron, studied 114 Olympic athletes “who experienced particularly intensive and uninterrupted training” over 4 to 17 years. They report in the April 13 issue of the Journal of the American College of Cardiology that they found no significant changes or deterioration in LV function or morphology and no evidence of cardiovascular symptoms or events. “Our findings support the benign nature of physiologic heart remodeling in trained athletes and the safety of long-term and intense sports participation, even at the highest competitive level,” they conclude.