Division of Cardiology, Department of Medicine, University of Washington, Box 358771, 1914 North 34th Street, Suite 204, Seattle, WA 98103, USA.
J Clin Lipidol. 2007 Dec;1(6):620-5. doi: 10.1016/j.jacl.2007.09.001. Epub 2007 Sep 15.
The use of combination therapies is needed to treat dyslipidemia in patients with both elevated low-density lipoprotein cholesterol (LDL-C) and low high-density lipoprotein cholesterol (HDL-C). We conducted a study to assess the efficacy and safety of combination therapy with statin plus extended-release (ER) niacin and colesevelam, aimed at lowering LDL-C and raising HDL-C, in subjects with atherosclerotic disease.
This 1-year study randomized 123 subjects with atherosclerotic disease to atorvastatin alone, double therapy with atorvastatin plus ER niacin, or triple therapy with atorvastatin, plus ER niacin and colesevelam. Target LDL-C was ≤80 mg/dL for single and double therapy, and ≤60 mg/dL for triple therapy. Target HDL-C was an increase of ≥10 mg/dL for double and triple therapy.
Single therapy, with mean atorvastatin dose 30 mg/day, had a 47% reduction in LDL-C (P < 0.001) from 148 ± 29 mg/dL to 77 ± 15 mg/dL. With the addition of ER niacin, the double therapy had a 25% increase in HDL-C, from 42 ± 11 mg/dL to 53 ± 16 mg/dL (P < 0.001). The triple therapy decreased LDL-C by 57%, from 157 ± 29 mg/dL to 66 ± 18 mg/dL (P < 0.001), and increased HDL-C by 29%, from 40 ± 9 mg/dL to 50 ± 14 mg/dL (P < 0.001). Double and triple therapy required a lower atorvastatin dose of 20 mg/day to reach the target LDL-C levels. On average, 75% and 67% of subjects reached the predefined LDL-C and HDL-C treatment targets. No related myopathy or hepatotoxicity required stopping the therapy.
This study demonstrated that combination therapy with atorvastatin plus ER niacin and colesevelam can safely and effectively treat dyslipidemia in subjects with atherosclerotic disease.
对于同时存在低密度脂蛋白胆固醇（LDL-C）升高和高密度脂蛋白胆固醇（HDL-C）降低的血脂异常患者，需要使用联合治疗。我们开展了一项研究，旨在评估他汀类药物联合应用缓释烟酸和考来维仑治疗动脉粥样硬化疾病患者的疗效和安全性，以降低 LDL-C 并升高 HDL-C。
这项为期 1 年的研究将 123 例动脉粥样硬化疾病患者随机分为阿托伐他汀单药治疗组、阿托伐他汀联合缓释烟酸双药治疗组或阿托伐他汀联合缓释烟酸和考来维仑三药治疗组。单药和双药治疗的 LDL-C 目标值为≤80mg/dL，三药治疗的 LDL-C 目标值为≤60mg/dL。双药和三药治疗的 HDL-C 目标值为增加≥10mg/dL。
阿托伐他汀单药治疗组（平均剂量 30mg/天）使 LDL-C 降低 47%（P<0.001），从 148±29mg/dL降至 77±15mg/dL。加用缓释烟酸后，双药治疗组 HDL-C 升高 25%，从 42±11mg/dL升至 53±16mg/dL（P<0.001）。三药治疗使 LDL-C 降低 57%，从 157±29mg/dL降至 66±18mg/dL（P<0.001），HDL-C 升高 29%，从 40±9mg/dL升至 50±14mg/dL（P<0.001）。双药和三药治疗均需要较低剂量的阿托伐他汀（20mg/天）即可达到 LDL-C 目标水平。平均 75%和 67%的患者达到了 LDL-C 和 HDL-C 的预设治疗目标。未发生与治疗相关的肌病或肝毒性而需停药。
这项研究表明，阿托伐他汀联合应用缓释烟酸和考来维仑可安全有效地治疗动脉粥样硬化疾病患者的血脂异常。
