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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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Although HDL levels predict cardiovascular risk in the overall population, the increased risk may be caused by other factors, such as accompanying lipid and metabolic abnormalities, rather than the HDL level itself.
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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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Pharmacokinetic studies suggested that after oral administration, Ezetimibe is rapidly absorbed and conjugated to a pharmacologically active phenolic glucuronide known as Ezetimibe-glucuronide.
The committee also struggled with drugmaker Merck's request to apply the results of the IMPROVE-IT trial in acute coronary syndrome patients to the more general population of coronary heart disease patients.
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