- This study provides the first evidence that primary prevention of atherosclerotic cardiovascular events is possible with lipid-lowering therapy in eligible patients ≥75 years old.
Why this matters
- A growing population of ≥75-year-olds in many countries dramatically increases the rates of hypercholesterolemia.
- However, there are no randomized controlled trials on the efficacy of LDL-cholesterol (C)-lowering therapy in patients aged ≥75 years of age with elevated LDL-C.
- Prospective, randomized open-label blinded endpoint (PROBE) study on Japanese older adults (≥75) without cardiovascular disease.
- Patients included if they have LDL-C ≥140 and 1 of the following: diabetes mellitus, hypertension, low HDL-cholesterolemia, hypertriglyceridemia, smoking, previous documented history of cerebral infarction, or peripheral artery disease.
- Patients were randomly assigned to dietary counseling only vs dietary counseling and ezetimibe 10 mg/day.
- Primary endpoint was a composite of atherosclerotic cardiovascular events including sudden cardiac death, myocardial infarction, percutaneous coronary intervention/coronary artery bypass grafting, and stroke.
- 3796 patients were included in the final analysis.
- Ezetimibe cohort showed significant decrease of primary endpoint HR (CI 95%): 0.659 (0.504-0.862), P=.002.
- Ezetimibe cohort did not show significant benefits in:
- Cerebrovascular events HR (CI 95%): 0.781 (0.549-1.112), P=.171.
- All-cause mortality HR (CI 95%): 1.087 (0.885-1.337), P=.427.
- PROBE design, so no placebo.
- "[Are the results] generalizable to other non-Japanese populations? . . . There's a possibility that the Japanese may have different biological response to LDL-lowering. There are different NPC1L1 polymorphisms in the Japanese population, which we're inhibiting with ezetimibe. But that would affect efficacy and we do have data from Japanese PRECISE-IVUS of really quite remarkable regression with ezetimibe added to atorvastatin, so it could be some biological effect." — Jennifer Robinson, MD, MPH, Professor, Departments of Epidemiology & Medicine, University of Iowa.