Safety and tolerability of intensive lipid-lowering therapy after acute coronary syndromes: defining the role of ezetimibe in a comprehensive secondary prevention program

Lipid-lowering treatment with atorvastatin 80 mg/d (A80) represents an effective therapeutic option after Acute Coronary Syndromes (ACS). Despite evidence, switching to less intensive statin regimens frequently occurs in practice, either for side effects or for safety concerns. However, the prescription of lower doses may reduce the likelihood of LDL-Cholesterol (LDL-C) target achievement, while increasing residual risk. Actually, the combination of ezetimibe with a low dose statin therapy may favor the achievement of recommended lipid goals and limit the incidence of side effects. Aim of this prospective observational study was to describe the tolerability of statin therapy with A80 in real world practice. Moreover, we tried to outline the potential role of ezetimibe in this specific scenario. A cohort of 863 consecutive ACS patients (586 men, mean age 68±13 years) discharged on A80 in a 2.5 year period was followed for 12 months. All patients were included in a hospital-based secondary prevention program promoting medical and lifestyle components of secondary prevention and offering regular follow-up visits. Within 90 days of discharge: 1. 535 patients (62%) were still on A80, 2. 51 patients (6%) discontinued any statin for major side effects and were started on ezetimibe 10 mg/d (E10), 3. 113 patients (13%) showed minor side effects and were switched to a lower atorvastatin dose of 20-40 mg/d (A20-40), 4. 164 patients (19%) showed minor side effects and were switched to a A20-40 in combination with E10. Increasing age (HR 1.59 per 10-year increase, 95% CI 1.29-1.89, p=0.01), female gender (HR 1.31, 95% CI 1.16-1.43, p=0.02), and presence of kidney dysfunction (HR 2.19 per 10-year increase, 95% CI 1.79-2.93, p=0.001), were associated with a higher probability of side effects during treatment with A80. The table shows LDL-C values on admission and during follow-up according to the different treatments. View this table: Despite inclusion in a comprehensive secondary prevention program, 38% of ACS patients did not tolerate A80 for side effects. The combination of E10 with lower statin doses may represent an effective alternative for lipid control after ACS.