Safety and effectiveness of the association ezetimibe-statin (E-S) versus high dose rosuvastatin after acute coronary syndrome: the SAFE-ES study.

Abstract Background Statin therapy is a cornerstone therapy for secondary prevention after acute coronary syndrome (ACS). However, the use of these drugs can be limited by side effects, mainly muscular pain. Ezetimibeis a newer lipid-lowering agent, with fewer side effects. Aims The present study was designed to compare a commercially available association of ezetimibeand simvastatin (E-S) to high dose Rosuvastatinon cholesterol and muscular enzyme levels and occurrence of muscular pain. Methods All consecutive ACS statin-naive patients with LDL cholesterol (LDL-C) > 100 mg/dL randomly received either high dose statin ( Rosuvastatin20 mg) or E-S 10/40-mg. All patients had one-month follow-up with biological testing and clinical examination. We compared the two groups on the biological efficiency and incidence of muscular pain. Results One hundred and twenty-eight patients were randomized; 64 received E-S and 64 Rosuvastatin. In the two groups, the lowering of LDL-C level (Δ = 51%) at one month was significant ( P P = 0.77 and P = 0.99). The rate of patients reaching the objective of LDL-C P = 0.65). Incidence of muscular pain was 15% higher in patients treated with Rosuvastatin( P = 0.01) without any difference on CPK level ( P = 0.6). Conclusion Using an association of E-S in an effective alternative strategy to high dose Rosuvastatinwith a lower incidence of muscular pain, which might impact adherence to medication after ACS.