Garmendia F, Brown A S, Reiber I, Adams P C
Universidada Nacional Mayor De San Marcos, Lima, Peru.
Curr Med Res Opin. 2000;16(3):208-19.
The effectiveness and safety of simvastatin in reducing low-density lipoprotein cholesterol (LDL-C) to target levels in patients with coronary heart disease (CHD) were evaluated in the GOALLS (Getting to Appropriate LDL-C Levels with Simvastatin) study. This multinational, multicentre, prospective, open-label, study consisted of a six-week diet washout period followed by a 14-week titrate-to-goal treatment period with simvastatin. One hundred and ninety-eight men and women with documented CHD and a fasting LDL-C level between 115 mg/dl (3.0 mmol/l) and 180 mg/dl (4.7 mmol/l) and triglycerides (TGs) < or = 400 mg/dl (4.5 mmol/l) were enrolled. The patients were started on 20 mg simvastatin with dose titration up to 80 mg if the LDL-C remained above 100 mg/dl at weeks 6 and 10. The key efficacy parameters were the percentage of patients achieving US and European LDL-C goals [< or = 100 mg/dl (2.6 mmol/l) and < or = 115 mg/dl (3.0 mmol/l), respectively]. Safety was evaluated by monitoring laboratory tests and recording adverse events. After 14 weeks of simvastatin (20-80 mg) treatment, approximately 90% of the patients achieved LDL-C goals according to US (87%) and European (94%) guidelines. Most patients (72-93%) achieved target LDL-C levels on 20 mg simvastatin. An estimated 14% of the patients required titration to the 80 mg dose. Treatment with simvastatin (20-80 mg) produced statistically significant improvements in all measured lipid variables by the end of the study. The mean reductions in total cholesterol and LDL-C, and the median reduction in TG, were 28%, 41% and 16%, respectively. The increase in high-density lipoprotein cholesterol and apolipoprotein A-1 were 5% and 4%, respectively. Simvastatin was well tolerated across the dosage range. In conclusion, simvastatin, 20-80 mg/day, was safe and highly effective at reducing LDL-C levels. The recommended US and European LDL-C treatment goals were achieved in approximately 90% of the patients. These goals were similarly achieved for a variety of high-risk sub-groups (hypertensives, diabetics and elderly patients).
在GOALLS（使用辛伐他汀达到适当的低密度脂蛋白胆固醇水平）研究中，评估了辛伐他汀在将冠心病（CHD）患者的低密度脂蛋白胆固醇（LDL-C）降低至目标水平方面的有效性和安全性。这项跨国、多中心、前瞻性、开放标签的研究包括为期六周的饮食洗脱期，随后是为期14周的辛伐他汀滴定至目标治疗期。招募了198名有CHD记录且空腹LDL-C水平在115mg/dl（3.0mmol/l）至180mg/dl（4.7mmol/l）之间且甘油三酯（TGs）≤400mg/dl（4.5mmol/l）的男性和女性。患者开始服用20mg辛伐他汀，若在第6周和第10周时LDL-C仍高于100mg/dl，则剂量滴定至80mg。关键疗效参数是达到美国和欧洲LDL-C目标的患者百分比[分别为≤100mg/dl（2.6mmol/l）和≤115mg/dl（3.0mmol/l）]。通过监测实验室检查和记录不良事件来评估安全性。经过14周的辛伐他汀（20 - 80mg）治疗后，根据美国（87%）和欧洲（94%）指南，约90%的患者达到了LDL-C目标。大多数患者（72 - 93%）在服用20mg辛伐他汀时达到了目标LDL-C水平。估计14%的患者需要滴定至80mg剂量。到研究结束时，辛伐他汀（20 - 80mg）治疗在所有测量的血脂变量方面产生了具有统计学意义的改善。总胆固醇和LDL-C的平均降低幅度以及TG的中位数降低幅度分别为28%、41%和16%。高密度脂蛋白胆固醇和载脂蛋白A-1的增加幅度分别为5%和4%。辛伐他汀在整个剂量范围内耐受性良好。总之，每天20 - 80mg的辛伐他汀在降低LDL-C水平方面安全且高效。约90%的患者达到了推荐的美国和欧洲LDL-C治疗目标。对于各种高危亚组（高血压患者、糖尿病患者和老年患者）也同样实现了这些目标。
