El-Tamalawy Mona Mohammed, Ibrahim Osama Mohamed, Hassan Timour Mostafa, El-Barbari Ali Ali
Drug and Poison Information Center, College of Pharmacy, Tanta University, Tanta, Egypt.
Clinical Pharmacy Department, College of Pharmacy, Tanta University, Tanta, Egypt.
J Clin Pharmacol. 2018 Jan;58(1):34-41. doi: 10.1002/jcph.976. Epub 2017 Aug 31.
A high level of remnant lipoprotein cholesterol (RLP-C) is a predominant feature in diabetic patients with atherosclerosis. This study aimed to investigate the effect of ezetimibe added to statin therapy compared to doubling standard statin dose. Sixty-five eligible patients were recruited then prospectively randomized to receive ezetimibe 10 mg/day plus their 40 mg daily atorvastatin dose (group 1) or atorvastatin 80 mg/day (group 2) for 3 months. Efficacy was evaluated using plasma levels of RLP-C, apolipoprotein B, non-high-density lipoprotein cholesterol (non-HDL), percentage of brachial artery flow-mediated dilation, and lipid profile. Forty patients completed the study and provided efficacy data. Group 1 showed more reduction in RLP-C (45.7% vs 31.7%, P = .02), apolipoprotein B (28.5% vs 9.5%, P = .01), total cholesterol (34.7% vs 24.6%, P = .003), triglycerides (49% vs 24.4%, P = .000), non-HDL (49.3% vs 33%, P = .002), and low-density lipoprotein cholesterol (49.6% vs 35.2%, P = .02) compared to group 2. Group 1 showed a greater increase in HDL (66% vs 35%, P = .002); and flow-mediated dilation (30% vs 17%, P = .01) compared to group 2. It is concluded that adding ezetimibe 10 mg to atorvastatin 40 mg may be a better choice than doubling atorvastatin dose in improving RLPs, endothelial function, and lipid profile in diabetic cardiovascular patients who could not achieve their therapeutic treatment goals with the standard atorvastatin dose.
残余脂蛋白胆固醇（RLP-C）水平升高是糖尿病动脉粥样硬化患者的一个主要特征。本研究旨在探讨与将他汀类药物标准剂量加倍相比，在他汀类药物治疗基础上加用依折麦布的效果。招募了65名符合条件的患者，然后将其前瞻性随机分为两组，一组接受每日10毫克依折麦布加每日40毫克阿托伐他汀剂量（第1组），另一组接受每日80毫克阿托伐他汀（第2组），为期3个月。使用RLP-C、载脂蛋白B、非高密度脂蛋白胆固醇（non-HDL）、肱动脉血流介导的扩张百分比和血脂谱的血浆水平评估疗效。40名患者完成了研究并提供了疗效数据。与第2组相比，第1组的RLP-C降低幅度更大（45.7%对31.7%，P = 0.02）、载脂蛋白B降低幅度更大（28.5%对9.5%，P = 0.01）、总胆固醇降低幅度更大（34.7%对24.6%，P = 0.003）、甘油三酯降低幅度更大（49%对24.4%，P = 0.000）、non-HDL降低幅度更大（49.3%对33%，P = 0.002）以及低密度脂蛋白胆固醇降低幅度更大（49.6%对35.2%，P = 0.02）。与第2组相比，第1组的高密度脂蛋白升高幅度更大（66%对35%，P = 0.002）；血流介导的扩张增加幅度更大（30%对17%，P = 0.01）。得出的结论是，对于使用标准阿托伐他汀剂量无法达到治疗目标的糖尿病心血管患者，在40毫克阿托伐他汀基础上加用10毫克依折麦布可能比将阿托伐他汀剂量加倍在改善RLP、内皮功能和血脂谱方面是更好的选择。
