This is a multicenter, randomized, double blind study designed to test the hypothesis that the combination of ezetimibe and simvastatin improves outcomes compared to simvastatin alone in ACS patients (ST or non ST elevation AMI in the last 10 days).
The study included more than 18000 patients randomized to ezetimibe/simvastatin 10/40 mg vs. simvastatin monotherapy 40 mg. 27% of patients were diabetic and 29% were undergoing ST elevation infarction. LDL levels at the time of randomization were 95 mg/dl in both groups and were reduced to 69.9 mg/dl in the simvastatin monotherapy group and to 53.2 mg/dl in the simvastatin/ezetimibe combination group. This difference was maintained after a 7 day follow up.
Primary end point incidence (combination of death, infarction or stroke) was 20.4% in the simvastatin/ezetimibe group and 22.2% in the simvastatin monotherapy group (p=0.003).
Conclusion
Adding 10 mg ezetimibe to the 40 mg dose of simvastatin will reduce cardiovascular events in ACS patients.
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Christopher P Cannon
2014-11-18
Original title: IMPROVE-IT Trial: A Comparison of Ezetimibe/Simvastatin versus Simvastatin Monotherapy on Cardiovascular Outcomes After Acute Coronary Syndromes.