2016
DOI: 10.5935/abc.20160033
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Ezetimibe: Clinical and Scientific Meaning of the IMPROVE-IT Study

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“…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.…”
mentioning
confidence: 99%
“…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.…”
mentioning
confidence: 99%