BACKGROUND There has been no report about outcome of pitavastatin versus atorvastatin therapy in high-risk patients with hypercholesterolemia. METHODS Hypercholesterolemic patients with one or more risk factors for atherosclerotic diseases (n = 664, age = 65, male = 54%, diabetes = 76%, primary prevention = 74%) were randomized to receive pitavastatin 2 mg/day (n = 332) or atorvastatin 10 mg/day (n = 332). Follow-up period was 240 weeks. The primary end point was a composite of cardiovascular death, sudden death of unknown origin, nonfatal myocardial infarction, nonfatal stroke, transient ischemic attack, or heart failure requiring hospitalization. The secondary end point was a composite of the primary end point plus clinically indicated coronary revascularization for stable angina. RESULTS The mean low-density lipoprotein cholesterol (LDL-C) level at baseline was 149 mg/dL. The mean LDL-C levels at 1 year were 95 mg/dL in the pitavastatin group and 94 mg/dL in the atorvastatin group. There were no differences in LDL-C levels between both groups, however, pitavastatin significantly reduced the risk of the primary end point, compared to atorvastatin (pitavastatin = 2.9% and atorvastatin = 8.1%, HR, 0.366; 95% CI 0.170-0.787; P = 0.01 by multivariate Cox regression) as well as the risk of the secondary end point (pitavastatin = 4.5% and atorvastatin = 12.9%, HR = 0.350; 95%CI = 0.189-0.645, P = 0.001). The results for the primary and secondary end points were consistent across several prespecified subgroups. There were no differences in incidence of adverse events between the statins. CONCLUSION Pitavastatin therapy compared with atorvastatin more may prevent cardiovascular events in hypercholesterolemic patients with one or more risk factors for atherosclerotic diseases despite similar effects on LDL-C levels.

中文翻译：

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匹伐他汀与阿托伐他汀治疗在动脉粥样硬化性心血管疾病高风险高胆固醇血症患者中的结果。

背景在高胆固醇血症高危患者中，没有关于匹伐他汀与阿托伐他汀治疗结果的报道。方法 具有一种或多种动脉粥样硬化疾病危险因素的高胆固醇血症患者（n = 664，年龄 = 65，男性 = 54%，糖尿病 = 76%，一级预防 = 74%）随机接受匹伐他汀 2 mg/天（n = 332 ) 或阿托伐他汀 10 毫克/天 (n = 332)。随访期为240周。主要终点是心血管死亡、不明原因猝死、非致死性心肌梗死、非致死性卒中、短暂性脑缺血发作或需要住院治疗的心力衰竭的复合终点。次要终点是主要终点加上有临床指征的冠状动脉血运重建治疗稳定型心绞痛的复合终点。结果 基线时的平均低密度脂蛋白胆固醇 (LDL-C) 水平为 149 mg/dL。匹伐他汀组 1 年的平均 LDL-C 水平为 95 mg/dL，阿托伐他汀组为 94 mg/dL。两组之间的 LDL-C 水平没有差异，但与阿托伐他汀相比，匹伐他汀显着降低了主要终点的风险（匹伐他汀 = 2.9% 和阿托伐他汀 = 8.1%，HR，0.366；95% CI 0.170-0.787 ; P = 0.01，多元 Cox 回归）以及次要终点的风险（匹伐他汀 = 4.5% 和阿托伐他汀 = 12.9%，HR = 0.350；95%CI = 0.189-0.645，P = 0.001）。在几个预先设定的亚组中，主要和次要终点的结果是一致的。他汀类药物的不良事件发生率没有差异。