Kardiologia polska 2017 05 29() doi 10.5603/KP.a2017.0074
Atorvastatin reduces low-density lipoprotein (LDL) cholesterol levels and the risk of cardiovascular events, but whether the addition of ezetimibe (EZE), a nonstatin drug that reduces intestinal cholesterol absorption, can reduce the rate of cardiovascular events further, and if there any sex differences, is not known.
To evaluate the effects of atorvastatin and EZE combination in acute coronary syndrome (ACS) patients on the incidence of composite end point in short-term follow-up and to assess differences according their gender.
We conducted a 16-week, one-centre, prospective, randomized, and open-label clinical trial, involving 323 patients who had been hospitalized for an ACS within the preceding 14 days. They were received atorvastatin 20 mg during 28 days and after that 292 patients, who had LDL cholesterol levels ≥ 1.81 mmol/L, were randomized to EZE 10 mg/day co-administered with atorvastatin therapy (EZE + Statin) or doubling their current atorvastatin dose. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, unstable angina requiring rehospitalisation, coronary revascularization (≥30 days after randomization), or nonfatal stroke.
The Kaplan-Meier event-free survival rate at 16 weeks were 88 .1 % in the EZE + statin group patients and 77.0 % in the atorvastatin monotherapy group ones (absolute risk reduction, 11.1 percentage points; hazard ratio, 2.099; 95% confidence interval, 1.165 to 3.781; p=0.014). The log rank test indicated that there was not a statistically significant difference between males and females survival rates in both treatment groups (P=0.897).
The results of our study demonstrated that when added to statin therapy, EZE resulted in improved cardiovascular outcomes and the response to atorvastatin and EZE combination was similar for both men and women.