Publication details
IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (studie IMPROVE-IT)
| Title in English | IMProved Reduction of Outcomes: Vytorin Efficacy International Trial |
|---|---|
| Authors | |
| Year of publication | 2014 |
| Type | Article in Periodical |
| Magazine / Source | Vnitřní lékařství |
| MU Faculty or unit | |
| Citation | |
| Field | Cardiovascular diseases incl. cardiosurgery |
| Keywords | acute coronary syndrome; combination therapy; ezetimibe; LDL-cholesterol |
| Description | Background: The IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) is evaluating the potential benefit for reduction in major cardiovascular (CV) events from the addition of ezetimibe versus pla¬cebo to 40 mg/d of simvastatin therapy in patients who present with acute coronary syndromes and have low-density lipoprotein cholesterol (LDL-C) < 125 mg/dl. Methods: Randomized double blind clinical trial in patients with acute coronary syndrome and low cholesterol level. The simvastatin monotherapy arm's LDL-C target was < 70 mg/dl, the comparison arm was simvastatin + ezetimibe. 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 (Ml), nonfatal stroke, rehospitalization for unstable angina (UA), and coronary revascularization (> 30 days postrandomization). The targeted number of events was 5,250. Results: 18,144 patients were enroled with either ST segment elevation Ml (STEMI, n = 5,192) or UA/non-ST segment elevation Ml (UA/NSTEMI, n = 12,952) from October 2005 to July 2010. Primary endpoint occured 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 coro¬nary heart disease given the drug simvastatin plus a placebo, those given both simvastatin and the non-statin drug, ezetimibe, had a 6.4 % 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 %, and non-fatal stroke by 20 %. Deaths from cardiovascular disease were statistically the same in both groups. |