Merck's IMPROVE-IT Study: Will Missing Data, Subgroups Hinder Zetia CV Claim?

FDA asks advisory committee to weigh impact of missing follow-up and 'notable differences' in subgroup treatment effects on company's request for broad cardiovascular benefit claim for Zetia and Vytorin.

An FDA advisory committee review of Merck & Co. Inc.’s IMPROVE-IT trial looks to be a debate over the extent to which missing data and subgroup analyses affect the robustness of the overall cardiovascular benefit demonstrated with Zetia (ezetimibe).

How the Endocrinologic and Metabolic Drugs Advisory Committee views these issues at its Dec

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