Department of Cardiovascular Medicine, Shinshu University Graduate School of Medicine, Asahi 3-1-1, Matsumoto 390-8621, Japan.
J Cardiol. 2009 Aug;54(1):76-9. doi: 10.1016/j.jjcc.2009.04.008. Epub 2009 May 23.
Statins reduce the incidence of cardiovascular events in patients with acute myocardial infarction (AMI). Although all statins are equally effective in secondary prevention, there might be certain differences in the effects of lipophilic and hydrophilic statins. Therefore, our aim is to compare the effectiveness of lipophilic atorvastatin and hydrophilic pravastatin in secondary prevention after AMI.
This study is a prospective, randomized, open-label, multicenter study of 500 patients with AMI. Patients that have undergone successful percutaneous coronary intervention will be randomly allocated to receive either atorvastatin or pravastatin with the treatment goal of lowering their low-density lipoprotein-cholesterol level below 100 mg/dl for 2 years. The primary endpoint will be death due to any cause, nonfatal MI, nonfatal stroke, unstable angina, or congestive heart failure requiring hospital admission, or any type of coronary revascularization.
This is the first multicenter trial to compare the effects and safety of lipophilic and hydrophilic statin therapy in Japanese patients with AMI. It addresses an important issue and could influence the use of statin treatment in the secondary prevention of coronary artery disease.
他汀类药物可降低急性心肌梗死（AMI）患者心血管事件的发生率。虽然所有他汀类药物在二级预防中均同样有效，但亲脂性和亲水性他汀类药物的作用可能存在一定差异。因此，我们旨在比较亲脂性阿托伐他汀和亲水性普伐他汀在 AMI 后的二级预防中的效果。
这是一项前瞻性、随机、开放标签、多中心研究，共纳入 500 例 AMI 患者。成功行经皮冠状动脉介入治疗的患者将被随机分配接受阿托伐他汀或普伐他汀治疗，治疗目标是将低密度脂蛋白胆固醇水平降低至 100mg/dl 以下，持续 2 年。主要终点为任何原因导致的死亡、非致死性心肌梗死、非致死性卒、不稳定型心绞痛或需要住院治疗的充血性心力衰竭、或任何类型的冠状动脉血运重建。
这是第一项比较亲脂性和亲水性他汀类药物治疗在日本 AMI 患者中的效果和安全性的多中心试验。它解决了一个重要问题，可能会影响他汀类药物在冠状动脉疾病二级预防中的应用。
