Noseda G, Darioli R, Keller U, Mordasini R, Shokry A, Schaffhauser B, Riesen W
Ospedale Regionale della Beata Vergine, Mendrisio.
Schweiz Med Wochenschr. 2000 Jun 10;130(23):889-95.
Elevated levels of serum lipids and lipoproteins are known to play a major role in the development of atherosclerosis and subsequent coronary heart disease (CHD). In controlled clinical studies, atorvastatin (Sortis), a new 3-hydroxy-3-methyl-glutaryl-coenzyme-A (HMG-CoA)-reductase inhibitor, proved to be a very effective and safe lipid-lowering agent. The aim of this open-label, multicentre study (without a control group) was to confirm the efficacy and safety of atorvastatin in a private practice group, including 181 Swiss cardiologists, internists, and general practitioners. A total of 877 hyperlipidaemic patients requiring treatment participated in this study. To evaluate the effectiveness of the treatment with atorvastatin over a period of 12 weeks, total plasma cholesterol (TC), HDL cholesterol, LDL cholesterol and triglycerides (TG) were determined every 4 weeks. The initial atorvastatin dose was 10 mg in 78% of patients and 20 mg in 22%. The dose was doubled every 4 weeks until the target values of TC < or = 5.2 mmol/l and TC/HDL < or = 5 were reached. After 12 weeks of treatment with atorvastatin the mean reduction in TC, TC/HDL, LDL and TG compared to baseline levels was 33, 37, 42, and 25% respectively. At the same time the HDL concentration was increased by 9%. These results were evidenced in patients with existing coronary heart disease, in high risk patients without manifest coronary heart disease and in patients with significantly elevated lipid levels (TC > 7.8 mmol/l, TC/HDL > 6.5). After treatment with atorvastatin for 12 weeks, 59% of patients had reached the therapeutic target of TC < or = 5.2 mmol/l. The target of TC/HDL < or = 5 was reached by 79%. Atorvastatin was almost without exception well tolerated, the most frequently reported side effects being nausea, myalgia, and headache. In this open-label multicentre study atorvastatin was found to be effective and well tolerated. The observed reduction in the lipid and lipoprotein concentration is in accordance with the results of published controlled studies. The lipid and lipoprotein concentrations were decreased significantly in patients with slight to moderate elevation of lipid levels as well as in those with significantly raised values.
血清脂质和脂蛋白水平升高在动脉粥样硬化及随后的冠心病（CHD）发展过程中起着主要作用。在对照临床研究中，新型3-羟基-3-甲基戊二酰辅酶A（HMG-CoA）还原酶抑制剂阿托伐他汀（Sortis）被证明是一种非常有效且安全的降脂药物。这项开放标签、多中心研究（无对照组）的目的是在一个由181名瑞士心脏病专家、内科医生和全科医生组成的私人执业医生群体中，确认阿托伐他汀的疗效和安全性。共有877名需要治疗的高脂血症患者参与了本研究。为评估阿托伐他汀治疗12周期间的有效性，每4周测定一次总血浆胆固醇（TC）、高密度脂蛋白胆固醇（HDL胆固醇）、低密度脂蛋白胆固醇（LDL胆固醇）和甘油三酯（TG）。78%的患者初始阿托伐他汀剂量为10mg，22%的患者为20mg。每4周剂量加倍，直至达到TC≤5.2mmol/l和TC/HDL≤5的目标值。阿托伐他汀治疗12周后，与基线水平相比，TC、TC/HDL、LDL和TG的平均降低幅度分别为33%、37%、42%和25%。同时，HDL浓度升高了9%。这些结果在患有冠心病的患者、无明显冠心病的高危患者以及脂质水平显著升高（TC>7.8mmol/l，TC/HDL>6.5）的患者中均得到证实。阿托伐他汀治疗12周后，59%的患者达到了TC≤5.2mmol/l的治疗目标。79%的患者达到了TC/HDL≤5的目标。阿托伐他汀几乎无一例外地耐受性良好，最常报告的副作用是恶心、肌痛和头痛。在这项开放标签多中心研究中，阿托伐他汀被发现有效且耐受性良好。观察到的脂质和脂蛋白浓度降低与已发表的对照研究结果一致。脂质水平轻度至中度升高以及显著升高的患者，其脂质和脂蛋白浓度均显著降低。
