Deharo P, Pankert M, Quilici J, Grosdidier C, Verdier V, Bonnet G, Morange P, Alessi M-C, Bonnet J-L, Cuisset T
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.
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.
Ann Cardiol Angeiol (Paris). 2014 Sep;63(4):222-7. doi: 10.1016/j.ancard.2014.04.018. Epub 2014 May 2.
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.
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.
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.
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).
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.
他汀类药物治疗是急性冠脉综合征（ACS）后二级预防的基石疗法。然而，这些药物的使用可能会受到副作用的限制，主要是肌肉疼痛。依折麦布是一种新型降脂药物，副作用较少。
本研究旨在比较市售的依折麦布与辛伐他汀组合制剂（E-S）和高剂量瑞舒伐他汀对胆固醇和肌肉酶水平以及肌肉疼痛发生率的影响。
所有连续的初治ACS且低密度脂蛋白胆固醇（LDL-C）>100mg/dL的患者随机接受高剂量他汀类药物（瑞舒伐他汀20mg）或E-S 10/40mg。所有患者均接受为期1个月的随访，包括生物学检测和临床检查。我们比较了两组的生物学疗效和肌肉疼痛发生率。
128例患者被随机分组；64例接受E-S，64例接受瑞舒伐他汀。两组在1个月时LDL-C水平的降低（Δ=51%）均显著（P<0.01），LDL-C或HDL-C的降低率无差异，表明E-S与高剂量瑞舒伐他汀效果相当（P=0.77和P=0.99）。两组达到LDL-C<100mg/dL（45%）和LDL-C<70mg/dL（51%）目标的患者比例无差异（P=0.65）。瑞舒伐他汀治疗的患者肌肉疼痛发生率高15%（P=0.01），肌酸磷酸激酶（CPK）水平无差异（P=0.6）。
使用E-S组合制剂是高剂量瑞舒伐他汀的有效替代策略，肌肉疼痛发生率较低，这可能会影响ACS后患者的用药依从性。
