Ezetimibe: Clinical and Scientific Meaning of the IMPROVE-IT Study

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

“…The denial of the approval hinged on the small magnitude of event reduction with the ezetimibe/simvastatin combination, causing the results to be viewed as clinically insignificant by some experts. 2 And, though some analyses of the trial argue that IMPROVE-IT's design and methodology resulted in a high degree of confidence in the results, due to low risk of bias and adequate statistical power, 3 the FDA noted IMPROVE-IT had two key flaws: there was a large volume of missing data, and the researchers likely underestimated the rate of cardiovascular events when making assumptions about that missing data.…”