If the IMPROVE-IT Trial Was Positive, as Reported, Why Did the FDA Denied Expanded Approval for Ezetimibe and Simvastatin? An Explanation of the Tipping Point Analysis

In 2015, the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) trial was published in the New England Journal of Medicine and claimed the addition of ezetimibe to simvastatin reduced the risk of cardiovascular events in patients with a previous cardiovascular event. 1 The benefit in the trial was a 2% absolute or 6.4% relative risk reduction in cardiovascular events in the ezetimibe/simvastatin group as compared with simvastatin alone.