Publication details

Postavení ezetimibu v léčbě dyslipidémií – aktuální poznatky

Title in English Status of ezetimibe in the treatment of dyslipidemia - current knowledge
Authors

ŠPINAR Jindřich ŠPINAROVÁ Lenka VÍTOVEC Jiří

Year of publication 2016
Type Article in Periodical
Magazine / Source Medicína po promoci
MU Faculty or unit

Faculty of Medicine

Citation
Field Cardiovascular diseases incl. cardiosurgery
Keywords acute coronary syndrome; LDL cholesterol; combination therapy; ezetimibe; diabetes mellitus
Description Randomized double blind clinical trial the IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) has evaluated the potential benefit for reduction in major cardiovascular events from the addition of ezetimibe versus placebo to 40 mg/d of simvastatin therapy in patients who present with acute coronary syndromes and have low-density lipoprotein cholesterol (LDL-C) LESS-THAN OR EQUAL TO125 mg/dL. Ezetimibe was assumed to further lower LDL-C by 15 mg/dL and produce an estimated ~8% to 9% treatment effect. The primary composite end point was CV death, nonfatal myocardial infarction (MI), nonfatal stroke, rehospitalization for unstable angina (UA), and coronary revascularization (GREATER-THAN OR EQUAL TO 30 days postrandomization). The targeted number of events was 5,250. 18,144 patients with acute myocardial infarction were enrolled. Primary endpoint occurred in 2,742 patients (34.7%) treated with simvastatin in monotherapy and in 2,572 patients (32.7%) (p = 0.016) treated with combination. Compared to patients with coronary heart disease given the drug simvastatin plus a placebo, those given both simvastatin and the non-statin drug, ezetimibe, had a 6.4 percent lower combined risk of subsequent heart attack, stroke, cardiovascular death, rehospitalization for unstable angina, and procedures to restore blood flow to the heart. Heart attacks alone were reduced by 13 percent and non-fatal stroke by 20 percent. The numbers of death from cardiovascular causes were statistically the same in both groups. Patients were followed for approximately six years on average, some for as long as 8.5 years. Approximately 2 patients out of every 100 patients treated for 7 years avoided a heart attack or stroke (number needed to treat [NNT] = 50/7years). Subanalysis in 4,933 (27%) diabetic patients showed that diabetic patients were older, more frequently women, and less frequently smokers. The baseline lipid values did not differ.

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