Efficacy and Safety of Morning Versus Evening Dose of Controlled-Release Simvastatin Tablets in Patients With Hyperlipidemia: A Randomized, Double-Blind, Multicenter Phase III Trial
Efficacy and Safety of Morning Versus Evening Dose of Controlled-Release Simvastatin Tablets in Patients With Hyperlipidemia: A Randomized, Double-Blind, Multicenter Phase III Trial
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DOI：
10.1016/j.clinthera.2013.06.020
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发表时间：
2013-09-01
影响因子：
3.2
通讯作者：
Park, Seong Hoon
中科院分区：
文献类型：
--
作者：
Kim, Sang-Hyun;Kim, Min-Kyung;Park, Seong Hoon
背景：他汀类药物推荐给药时间的灵活性可能会改善患者的依从性。目的：这项研究旨在比较早晚剂量的控释辛伐他汀对患有血脂异常的韩国成年人的疗效和耐受性。要求获得韩国监管机构的授权才能销售该产品。方法：在这项前瞻性、随机、双盲、多中心、安慰剂对照的III期研究中，我们将132名高胆固醇血症患者随机分配到晨服组或晚服组。早服辛伐他汀20 mg，晚服安慰剂；晚服辛伐他汀20 mg，早服安慰剂。结果：治疗8周后，早服与晚服的低密度脂蛋白胆固醇平均变化差异为-2.78%(95%可信区间为-7.65~2.10)。治疗后总胆固醇、甘油三酯、高密度脂蛋白胆固醇、载脂蛋白A1、载脂蛋白B和脂蛋白(A)的变化在组间无差异。此外，韩国血脂和动脉粥样硬化学会的血脂异常治疗指南建议的目标低密度脂蛋白胆固醇目标的达标率也没有不同。两组均未观察到严重不良事件。两组的轻、中度不良反应相似。结论：尽管控释辛伐他汀显著降低韩国成人血脂异常患者的低密度脂蛋白胆固醇水平，且耐受性良好，但给药时间并不影响其疗效。(C)2013 Elsevier HS Journal，Inc.保留所有权利。
Background: Flexibility in the recommended dosing time for a statin may improve patient compliance.Objective: This study was designed to compare the efficacy and tolerability of morning and evening doses of controlled-release simvastatin in Korean adults with dyslipidemia. It was carried out as a requirement to obtain authorization from the Korean regulatory agency to market the product.Methods: In this prospective, randomized, double-blind, multicenter, placebo-controlled Phase III study, we randomly assigned 132 patients with hypercholesterolemia to a morning-dose group or an evening-dose group. Patients in the morning-dose group received 20 mg controlled-release simvastatin in the morning and a placebo in the evening, and those in the evening-dose group received a placebo in the morning and 20 mg controlled-release simvastatin in the evening.Results: After 8 weeks of the treatment, the difference in the mean change of LDL-C between the morning-dose and evening-dose groups was -2.78% (95% confidence interval, -7.65 to 2.10). The changes in total cholesterol, triglycerides, HDL-C, apolipoprotein A1, apolipoprotein B, and lipoprotein (a) after treatment did not differ between groups. Also, the achievement rates of the target LDL-C goal suggested by the dyslipidemia treatment guideline of the Korean Society of Lipidology and Atherosclerosis were not different. No serious adverse event was observed in either group. Mild and moderate adverse events were observed similarly in both groups.Conclusions: Although controlled-release simvastatin significantly reduces LDL-C levels with good tolerability in Korean adults with dyslipidemia, the time of administration does not affect its efficacy. (C) 2013 Elsevier HS Journals, Inc. All rights reserved.