Thiery J, Basten A, Sommerburg C, Seidel D
Institut für Klinische Chemie, Klinikum Grosshadern, Universität München.
Dtsch Med Wochenschr. 1991 Jun 7;116(23):887-94. doi: 10.1055/s-2008-1063693.
In the course of an open multicentre clinical trial 786 patients (512 men, 274 women; mean age 52.4 +/- 11 years) with primary hypercholesterolaemia (total cholesterol 328 +/- 72 mg/dl, triglycerides 174 +/- 87 mg/dl, LDL cholesterol 246 +/- 73 mg/dl, and HDL cholesterol 50 +/- 18 mg/dl) received 20-80 mg lovastatin daily for 12 weeks, after a four-week placebo period. On this regimen the concentration of total cholesterol fell by 27% to 238 +/- 52 mg/dl (P less than 0.001) of triglycerides by 13% to 140 +/- 69 mg/dl (P less than 0.001), that of LDL cholesterol by 36% to 157 +/- 53 mg/dl (P less than 0.001). But HDL cholesterol rose by an average of 12% to 54 +/- 17 mg/dl (P less than 0.001). Lovastatin was tolerated very well by 79% of patients, well by 19%, and poorly by 2%. Mild undesirable side effects of the drug (in particular meteorism, constipation, diarrhoea and nausea) were reported by fewer than 10% of patients. These data indicate that lovastatin is effective and well tolerated also when broadly applied in clinical practice.
在一项开放性多中心临床试验过程中，786例原发性高胆固醇血症患者（512例男性，274例女性；平均年龄52.4±11岁），其总胆固醇为328±72mg/dl，甘油三酯为174±87mg/dl，低密度脂蛋白胆固醇为246±73mg/dl，高密度脂蛋白胆固醇为50±18mg/dl，在经过四周的安慰剂期后，每天接受20 - 80mg洛伐他汀治疗，为期12周。在此治疗方案下，总胆固醇浓度下降了27%，至238±52mg/dl（P＜0.001）；甘油三酯下降了13%，至140±69mg/dl（P＜0.001）；低密度脂蛋白胆固醇下降了36%，至157±53mg/dl（P＜0.001）。但高密度脂蛋白胆固醇平均升高了12%，至54±17mg/dl（P＜0.001）。79%的患者对洛伐他汀耐受性良好，19%的患者耐受性较好，2%的患者耐受性较差。不到10%的患者报告了该药物的轻度不良副作用（尤其是肠胃胀气、便秘、腹泻和恶心）。这些数据表明，洛伐他汀在临床实践中广泛应用时也是有效且耐受性良好的。
