Safety and tolerability of simvastatin plus niacin in patients with coronary artery disease and low high-density lipoprotein cholesterol (The HDL Atherosclerosis Treatment Study).
Safety and tolerability of simvastatin plus niacin in patients with coronary artery disease and low high-density lipoprotein cholesterol (The HDL Atherosclerosis Treatment Study).
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辛伐他汀加烟酸治疗冠状动脉疾病和低高密度脂蛋白胆固醇患者的安全性和耐受性（HDL 动脉粥样硬化治疗研究）。
DOI：
10.1016/j.amjcard.2003.10.009
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发表时间：
2004
期刊：
影响因子：
--
通讯作者：
Brown,BGreg
中科院分区：
文献类型：
--
作者：
Zhao,Xue-Qiao;Morse,JoshS;Dowdy,AliceA;Heise,Nancy;DeAngelis,Debbie;Frohlich,Jiri;Chait,Alan;Albers,JohnJ;Brown,BGreg
高密度脂蛋白(HDL)-动脉粥样硬化治疗研究表明，与安慰剂相比，辛伐他汀加烟酸（平均每日剂量分别为13 mg和2.4 g）在3年以上的时间里，可使低HDL的冠状动脉疾病（CAD）患者的血管造影动脉粥样硬化进展停止，主要临床事件减少60%。这种组合的安全性和耐受性如何？160例冠心病患者，包括25例糖尿病患者，平均低密度脂蛋白胆固醇为128 mg/dl，高密度脂蛋白胆固醇≤35 mg/dl（平均31），平均甘油三酯为217 mg/dl，随机分为抗氧化维生素或其安慰剂组和辛伐他汀加烟酸组或其安慰剂组。患者每月或每月检查一次，持续38个月；副作用（胃肠道不适、恶心、厌食、视力、皮肤和精力问题或肌肉疼痛）直接询问并记录。定期监测天冬氨酸转氨酶、肌酸磷酸激酶（CPK）、尿酸、同型半胱氨酸和空腹血糖水平。一名安全监督员审查了所有的副作用，并相应地调整了药物剂量。服用辛伐他汀加烟酸的患者和服用安慰剂的患者出现临床或实验室副作用的频率相似：任何程度的冲洗(30%比23%,p = NS),疲劳的症状,恶心,和/或肌肉疼痛(9%比5%,p = NS)、天冬氨酸转氨酶(血清)≥3倍正常上限(3%比1%,p = NS)、肌酸磷酸激酶≥2倍正常上限(3%比4%,p = NS)、肌酸磷酸激酶≥5次正常上限,新出现尿酸≥7.5 mg / dl(18%比15%,p = NS),和同型半胱氨酸≥15μmol / L(9%比4%,p = NS)。辛伐他汀-烟酸组糖尿病患者的血糖控制轻度下降，但在8个月时恢复到预处理水平，并在其余研究中保持稳定。91%的治疗患者和86%的安慰剂患者反复描述这种联合治疗方案“非常容易”或“相当容易”。因此，辛伐他汀加烟酸方案对有或无糖尿病的患者是有效、安全且耐受性良好的。
The high-density lipoprotein (HDL)-Atherosclerosis Treatment Study showed that simvastatin plus niacin (mean daily dose 13 mg and 2.4 g, respectively) halt angiographic atherosclerosis progression and reduce major clinical events by 60% in patients with coronary artery disease (CAD) who have low HDL, in comparison with placebos, over 3 years. How safe and well-tolerated is this combination? One hundred sixty patients with CAD, including 25 with diabetes mellitus, with mean low-density lipoprotein cholesterol of 128 mg/dl, HDL cholesterol of ≤35 mg/dl (mean 31), and mean triglycerides of 217 mg/dl were randomized to 4 factorial combinations of antioxidant vitamins or their placebos and simvastatin plus niacin or their placebos. Patients were examined monthly or bimonthly for 38 months; side effects (gastrointestinal upset, nausea, anorexia, vision, skin, and energy problems, or muscle aches) were directly queried and recorded. Aspartate aminotransferase, creatine phosphokinase (CPK), uric acid, homocysteine, and fasting glucose levels were regularly monitored. A safety monitor reviewed all side effects and adjusted drug dosages accordingly. Patients who received simvastatin plus niacin and those on placebo had similar frequencies of clinical or laboratory side effects: any degree of flushing (30% vs 23%, p = NS), symptoms of fatigue, nausea, and/or muscle aches (9% vs 5%, p = NS), aspartate aminotransferase (SGOT) ≥3 times upper limit of normal (3% vs 1%, p = NS), CPK ≥2 times upper limit of normal (3% vs 4%, p = NS), CPK ≥5 times upper limit of normal, new onset of uric acid ≥7.5 mg/dl (18% vs 15%, p = NS), and homocysteine ≥15 μmol/L (9% vs 4%, p = NS). Glycemic control among diabetics declined mildly in the simvastatin-niacin group but returned to pretreatment levels at 8 months and remained stable for rest of the study. This combination regimen was repeatedly described by 91% of treated patients and 86% of placebo subjects as “very easy” or “fairly easy” to take. Thus, the simvastatin plus niacin regimen is effective, safe, and well tolerated in patients with or without diabetes mellitus.
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DOI：
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影响因子：
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影响因子：
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