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The study assessed the incidence of major CV events, as measured by a composite of CV death, non-fatal MI, non-fatal stroke, re-hospitalization for unstable angina, or coronary revascularization (occurring 30 days or more after the initial event), in patients treated with ezetimibe and simvastatin (VYTORIN) compared with patients treated with simvastatin alone.

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FDA has not received a final study report and at this time it is not clear why the lower levels of LDL cholesterol in the patients who took Vytorin did not lead to lesser amounts of plaque compared to patients treated with simvastatin alone.

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