Chung N, Cho S Y, Choi D H, Zhu J R, Lee K, Lee P Y, Lee S H, Lee S, Wang J J, Yin W H, Young M S, Koh K K, Son J W, Sangwatanaroj S, Panchavinnin P, Phankingthongkum R, Cai N S, Fan W F
Cardiology Division, Yonsei University College of Medicine, Seoul, Korea.
Clin Ther. 2001 Jun;23(6):858-70. doi: 10.1016/s0149-2918(01)80074-6.
Most published studies on the use of lipid-lowering agents to treat hypercholesterolemia have focused on Western populations, with few data on Asian populations.
The Simvastatin Treats Asians to Target (STATT) study used a titrate-to-goal protocol to evaluate the efficacy and tolerability of simvastatin 20 to 80 mg/d in the treatment of Asian patients with coronary heart disease.
This was a multicenter, open-label, uncontrolled, 14-week study in patients with coronary heart disease and serum low-density lipoprotein cholesterol (LDL-C) levels of 115-180 mg/dL and triglyceride levels of < or = 400 mg/dL. The dose of simvastatin was titrated from 20 to 80 mg/d to achieve the National Cholesterol Education Program (NCEP) LDL-C target of < or = 100 mg/dL. The primary efficacy measure was the percentage of patients achieving the NCEP target. Among secondary measures were the percentage of patients achieving European Society of Cardiology/European Atherosclerosis Society/European Society of Hypertension target LDL-C levels of < or = 115 mg/dL and the percentage change from baseline in lipid parameters. Tolerability was assessed in terms of the overall incidence of adverse experiences and the incidences of the most commonly reported adverse experiences.
The intent-to-treat analysis included 133 Asian patients (93 men, 40 women; mean age, 59.5 years), of whom 125 completed 14 weeks of therapy. Their mean blood pressure was 130.2/79.4 mm Hg. Overall, 104 (78.2%) patients treated with simvastatin achieved LDL-C levels < or = 100 mg/dL at week 14, and 125 (94.0%) achieved this target at some point during the study. Similarly, 122 (91.7%) patients achieved an LDL-C level < or = 115 mg/dL at week 14, and 130 (97.7%) achieved this target at some point during the study. Treatment with simvastatin had favorable effects on the lipid profile, producing significant percentage changes from baseline in all parameters (P < 0.001). Simvastatin was well tolerated across the dose range. Overall, 40 patients (30.1%) had > or = 1 clinical adverse experience. Only 14 (10.5%) had adverse experiences that were possibly, probably, or definitely related to study drug; none of these experiences were considered serious. The most common adverse experiences (> or = 3% incidence) were abdominal pain (6%); chest pain (5%); dizziness (4%); and asthenia/fatigue, fibromyalgia, headache, insomnia, and upper respiratory tract infection (3% each). No new or unexpected adverse experiences were seen at the higher doses.
Simvastatin was effective and well tolerated at doses of 20, 40, and 80 mg/d in Asian patients with coronary heart disease. Titration enabled the majority to achieve target LDL-C levels of < or = 100 mg/dL.
大多数已发表的关于使用降脂药物治疗高胆固醇血症的研究都集中在西方人群，关于亚洲人群的数据很少。
辛伐他汀治疗亚洲人以达目标（STATT）研究采用滴定至目标方案，评估20至80mg/d辛伐他汀治疗亚洲冠心病患者的疗效和耐受性。
这是一项针对冠心病患者且血清低密度脂蛋白胆固醇（LDL-C）水平为115 - 180mg/dL、甘油三酯水平≤400mg/dL的多中心、开放标签、非对照、为期14周的研究。辛伐他汀剂量从20mg/d滴定至80mg/d，以达到美国国家胆固醇教育计划（NCEP）LDL-C目标值≤100mg/dL。主要疗效指标是达到NCEP目标的患者百分比。次要指标包括达到欧洲心脏病学会/欧洲动脉粥样硬化学会/欧洲高血压学会目标LDL-C水平≤115mg/dL的患者百分比以及血脂参数相对于基线的变化百分比。根据不良事件的总体发生率以及最常报告的不良事件发生率评估耐受性。
意向性分析纳入了133名亚洲患者（93名男性，40名女性；平均年龄59.5岁），其中125名完成了14周治疗。他们的平均血压为130.2/79.4mmHg。总体而言，104名（78.2%）接受辛伐他汀治疗的患者在第14周时LDL-C水平≤100mg/dL，125名（94.0%）患者在研究期间的某个时间点达到了该目标。同样，122名（91.7%）患者在第14周时LDL-C水平≤115mg/dL，130名（97.7%）患者在研究期间的某个时间点达到了该目标。辛伐他汀治疗对血脂谱有良好影响，所有参数相对于基线均产生了显著的百分比变化（P < 0.001）。辛伐他汀在整个剂量范围内耐受性良好。总体而言，40名患者（30.1%）发生了≥1次临床不良事件。只有14名（10.5%）患者的不良事件可能、很可能或肯定与研究药物有关；这些事件均不被认为严重。最常见的不良事件（发生率≥3%）是腹痛（6%）；胸痛（5%）；头晕（4%）；以及乏力/疲劳、纤维肌痛、头痛、失眠和上呼吸道感染（各3%）。在较高剂量时未发现新的或意外的不良事件。
对于亚洲冠心病患者，20mg/d、40mg/d和80mg/d剂量的辛伐他汀有效且耐受性良好。滴定使大多数患者达到了≤100mg/dL的目标LDL-C水平。
