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Volume 360:86-87 January 1, 2009 Number 1
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Analyses of Cancer Data from Three Ezetimibe Trials

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 by Peto, R.
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To the Editor: The article by Peto et al. (Sept. 25 issue),1 which reports cancer incidence and mortality in three clinical trials of ezetimibe, raises disturbing scientific and ethical questions. Premature unblinding of ongoing trials is not a reliable approach to the evaluation of drug safety. In their discussion of one of the trials, the Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), the authors report that the mean exposure to ezetimibe was only 12 months, which is insufficient time for any hazard to emerge. Analysis of short-term trials dilutes any evidence of an excess risk. The most relevant . . . [Full Text of this Article]




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