Efficacy and safety of atorvastatin compared to pravastatin in patients with hypercholesterolemia
Efficacy and safety of atorvastatin compared to pravastatin in patients with hypercholesterolemia
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DOI：
10.1016/s0021-9150(96)06052-2
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发表时间：
1997-04-01
期刊：
影响因子：
5.3
通讯作者：
Nawrocki, JW
中科院分区：
文献类型：
--
作者：
Bertolini, S;Bon, GB;Nawrocki, JW
血浆胆固醇和其他脂蛋白在动脉粥样硬化和随后的冠心病(CHD)的发展中起着重要作用。这项为期一年的研究旨在证实阿托伐他汀(立普妥)与普伐他汀的有效性和安全性，普伐他汀是一种用于降低高胆固醇血症患者低密度脂蛋白胆固醇(LDL-C)的市售药物。患者是在六个欧洲国家的26个中心招募的。在6周的安慰剂基线阶段后，患者被随机分成两组，每天服用阿托伐他汀10 mg或普伐他汀20 mg。在第16周，如果低密度脂蛋白胆固醇水平继续大于或等于3.4mmo1/L(135mgdl)，剂量可增加一倍。与普伐他汀相比，阿托伐他汀显著降低低密度脂蛋白胆固醇水平35%(P<；0.05)。共有72%的阿托伐他汀患者达到了3.4mmo1/L的低密度脂蛋白胆固醇目标水平，相比之下，普伐他汀患者的这一比例为26%。阿托伐他汀还能显著降低TC、TG和apo B(P<；0.05)。通过记录不良事件和测量临床实验室参数来评估安全性。两个治疗组的不良事件情况相似，而且两种治疗都没有引起临床相关的实验室异常。阿托伐他汀10 mg和20 mg每日1次治疗高胆固醇血症的疗效优于普伐他汀20 mg和40 mg每日1次。(C)1997年爱思唯尔爱尔兰科学有限公司。
Plasma cholesterol and other lipoproteins play a significant role in the development of atherosclerosis and subsequent coronary heart disease (CHD). This 1 year study was designed to confirm the efficacy and safety of atorvastatin (Lipitor) compared to pravastatin, a marketed agent for low density lipoprotein cholesterol (LDL-C) reduction in hypercholesterolemic patients. Patients were recruited at 26 centers in six European countries. After a 6 week placebo baseline phase, patients were randomized to receive atorvastatin 10 mg or pravastatin 20 mg daily. The dose could be doubled at week 16, if LDL-C levels remained greater than or equal to 3.4 mmol/l (135 mg/dl). Atorvastatin significantly lowered LDL-C from baseline by 35% compared with 23% for pravastatin (P < 0.05). A total of 72% of atorvastatin patients attained the LDL-C target level of < 3.4 mmol/l, compared to 26% of pravastatin patients. Atorvastatin also significantly reduced TC, TG and apo B (P < 0.05). Safety was assessed by recording adverse events and measuring clinical laboratory parameters. The adverse event profile was similar for both treatment groups and neither treatment caused clinically relevant laboratory abnormalities. Atorvastatin 10 and 20 mg once daily is superior to pravastatin 20 and 40 mg once daily in treating patients with hypercholesterolemia. (C) 1997 Elsevier Science Ireland Ltd.