McKenney J M, McCormick L S, Weiss S, Koren M, Kafonek S, Black D M
Virginia Commonwealth University, Richmond, USA.
Am J Med. 1998 Feb;104(2):137-43. doi: 10.1016/s0002-9343(97)00311-2.
To assess the lipid-lowering effects and safety of atorvastatin and niacin in patients with combined hyperlipidemia or isolated hypertriglyceridemia.
We performed a randomized, open-label, parallel-design, active-controlled, study in eight centers in the United States. We enrolled 108 patients with total cholesterol (TC) of > or =200 mg/dL, serum triglycerides (TG) > or =200 and < or =800 mg/dL, and apolipoprotein B (apo B) > or =110 mg/dL. Patients were randomly assigned to receive atorvastatin 10 mg once daily (n=55) or immediate-release niacin 1 g three times daily for 12 weeks (n=53). Patients were stratified based on low-density lipoprotein cholesterol (LDL-C): Patients with LDL-C > or =135 mg/dL were considered to have combined hyperlipidemia and patients with LDL-C <135 mg/dL were considered to have isolated hypertriglyceridemia. The primary outcome measure was percent change from baseline in LDL-C. Other lipid levels were evaluated as secondary parameters.
Atorvastatin reduced LDL-C 30% and TC 26% from baseline, and increased high-density lipoprotein cholesterol (HDL-C) 4%. Total TG were reduced 17%. Niacin reduced LDL-C 2%, TC 7%, increased HDL-C 25%, and reduced total TG 29% from baseline. There was a significant difference in LDL-C reduction, the primary efficacy parameter, between the two treatment groups (P <0.05, favoring atorvastatin), as well as a significant difference in the improvement in HDL-C (P <0.05, favoring niacin). The effect of atorvastatin was relatively consistent between patients with combined hyperlipidemia and isolated hypertriglyceridemia, whereas there was more variability between these strata in the niacin treatment group. Atorvastatin was better tolerated than niacin.
Atorvastatin may allow patients with combined hyperlipidemia to be treated with monotherapy and offers an efficacious and well-tolerated alternative to niacin for the treatment of patients with isolated hypertriglyceridemia.
评估阿托伐他汀和烟酸对混合性高脂血症或单纯高甘油三酯血症患者的降脂效果及安全性。
我们在美国的八个中心进行了一项随机、开放标签、平行设计、活性对照研究。我们纳入了108例总胆固醇（TC）≥200mg/dL、血清甘油三酯（TG）≥200且≤800mg/dL、载脂蛋白B（apo B）≥110mg/dL的患者。患者被随机分配接受每日一次10mg阿托伐他汀（n = 55）或每日三次1g速释烟酸，共12周（n = 53）。患者根据低密度脂蛋白胆固醇（LDL-C）进行分层：LDL-C≥135mg/dL的患者被认为患有混合性高脂血症，LDL-C<135mg/dL的患者被认为患有单纯高甘油三酯血症。主要结局指标是LDL-C相对于基线的变化百分比。其他血脂水平作为次要参数进行评估。
阿托伐他汀使LDL-C较基线降低30%，TC降低26%，高密度脂蛋白胆固醇（HDL-C）升高4%。总TG降低17%。烟酸使LDL-C降低2%，TC降低7%，HDL-C升高25%，总TG较基线降低29%。两个治疗组在主要疗效参数LDL-C降低方面存在显著差异（P<0.05，阿托伐他汀更优），在HDL-C改善方面也存在显著差异（P<0.05，烟酸更优）。阿托伐他汀在混合性高脂血症患者和单纯高甘油三酯血症患者中的效果相对一致，而烟酸治疗组在这些分层之间的变异性更大。阿托伐他汀的耐受性优于烟酸。
阿托伐他汀可使混合性高脂血症患者接受单一疗法治疗，并为单纯高甘油三酯血症患者提供了一种有效且耐受性良好的烟酸替代疗法。
