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EWTOPIA 75: Ezetimibe better than standard care for primary prevention of atherosclerotic disease in elderly Japanese patients

Elderly patients treated with the cholesterol-absorption inhibitor ezetimibe had a significantly lower risk of atherosclerotic cardiovascular events over 5 years when compared with patients who received standard care, according to the results of the EWTOPIA 75 trial presented at a Late Breaking Science session at the American Heart Association 2018 Scientific Sessions.

The EWTOPIA 75 trial was a multicenter, prospective, open-label randomized controlled trial in Japan.  It evaluated the effect of lipid-lowering therapy by ezetimibe on the primary prevention of atherosclerotic cardiovascular disease (ASCVD) events in 3,796 old-old patients (75 years or older) with elevated LDL-cholesterol level (≥ 140 mg/dL) and no history of cardiovascular disease. Mean patient age was 80.7 years, and 74% of the population was female.  Patients in the study received dietary counseling with or without a daily dose of ezetimibe 10 mg.

Both groups saw reductions in LDL cholesterol over 5 years, but there was a larger reduction observed in the ezetimibe-treated patients. For those treated with ezetimibe, LDL cholesterol was reduced from 161.3 to 120.1 mg/dL, while patients just counselled on diet reduced their LDL levels from 162.0 to 131.4 mg/dL (< 0.001 for interaction).

Lowering LDL cholesterol by ezetimibe monotherapy significantly prevented ASCVD events (sudden cardiac death, MI, PCI or CABG, and/or stroke, hazard ratio 0.66, p=0.002). 

The study was led by Yasuyoshi Ouchi, M.D., Ph.D., Tokyo Metropolitan Institute of Gerontology, Japan.  Dr. Ouchi reports no relevant conflicts of interest.


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