P Deharo1, M Pankert2, J Quilici2, C Grosdidier3, V Verdier4, G Bonnet2, P Morange3, M-C Alessi3, J-L Bonnet2, T Cuisset2. 1. Département de cardiologie, CHU Timone, 13385 Marseille, France; Inserm, UMR1062, « Nutrition, Obesity and Risk of Thrombosis », 13385 Marseille, France; Faculté de médecine, Aix-Marseille université, 13385 Marseille, France. Electronic address: pierre.deharo@ap-hm.fr. 2. Département de cardiologie, CHU Timone, 13385 Marseille, France; Inserm, UMR1062, « Nutrition, Obesity and Risk of Thrombosis », 13385 Marseille, France; Faculté de médecine, Aix-Marseille université, 13385 Marseille, France. 3. Inserm, UMR1062, « Nutrition, Obesity and Risk of Thrombosis », 13385 Marseille, France; Faculté de médecine, Aix-Marseille université, 13385 Marseille, France; Laboratoire d'hématologie, CHU Timone, 13385 Marseille, France. 4. Équipe mobile d'aide à l'investigation (EMAI), Assistance publique-Hôpitaux de Marseille, 13385 Marseille, France.
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. Ezetimibe is a newer lipid-lowering agent, with fewer side effects. AIMS: The present study was designed to compare a commercially available association of ezetimibe and simvastatin (E-S) to high dose Rosuvastatin on cholesterol and muscular enzyme levels and occurrence of muscular pain. METHODS:All consecutive ACS statin-naïve patients with LDL cholesterol (LDL-C)>100mg/dL randomly received either high dose statin (Rosuvastatin 20mg) 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 receivedE-S and 64 Rosuvastatin. In the two groups, the lowering of LDL-C level (Δ=51%) at one month was significant (P<0.01) without any difference in the rate of lowering on LDL-C or HDL-C suggesting that E-S is as effective as high dose Rosuvastatin (P=0.77 and P=0.99). The rate of patients reaching the objective of LDL-C<100mg/dL (45%) and LDL-C<70mg/dL (51%) was not different in the two clusters (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 Rosuvastatin with a lower incidence of muscular pain, which might impact adherence to medication after ACS.
RCT Entities:
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. Ezetimibe is a newer lipid-lowering agent, with fewer side effects. AIMS: The present study was designed to compare a commercially available association of ezetimibe and simvastatin (E-S) to high dose Rosuvastatin on cholesterol and muscular enzyme levels and occurrence of muscular pain. METHODS: All consecutive ACS statin-naïve patients with LDL cholesterol (LDL-C)>100mg/dL randomly received either high dose statin (Rosuvastatin 20mg) 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<0.01) without any difference in the rate of lowering on LDL-C or HDL-C suggesting that E-S is as effective as high dose Rosuvastatin (P=0.77 and P=0.99). The rate of patients reaching the objective of LDL-C<100mg/dL (45%) and LDL-C<70mg/dL (51%) was not different in the two clusters (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 Rosuvastatin with a lower incidence of muscular pain, which might impact adherence to medication after ACS.