Publication details
Čím níže tím lépe – studie IMPROVE-IT potvrzuje význam snižování cholesterolu ezetimibem
| Title in English | The lower the better – the IMPROVE-IT confirmed the importance of lowering cholesterol by ezetimibe |
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| Authors | |
| Year of publication | 2015 |
| Type | Article in Periodical |
| Magazine / Source | Intervenční a akutní kardiologie |
| MU Faculty or unit | |
| Citation | |
| Field | Cardiovascular diseases incl. cardiosurgery |
| Keywords | acute coronary syndrom; LDL cholesterol; combination therapy; ezetimibe |
| 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 placebo 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 patiens with acute coronary syndrome and low cholesterol level. The simvastatin monotherapy arm‘s LDL-C target was <70 mg/dL, tho 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 (MI), 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 MI (STEMI, n = 5.192) or UA/non-ST-segment elevation MI (UA/NSTEMI, n = 12.952) from October 2005 to July 2010. Primary endpoint occured in 2742 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. Deaths from cardiovascular disease were statistically the same in both groups. Patients were followed an average of approximately six years, and some 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). Conclusions: The study has shown a claer benefit from combination treatment with simvastatin and ezetimibe in patients with acute coronary syndrome and low LDL-C. |