Ong L M, Punithavathi N, Lena Y L L, Mahanim O, Leekha S
Penang Hospital.
Med J Malaysia. 2011 Aug;66(3):214-9.
A multicentre study was conducted to assess the long term efficacy and safety of a generic atorvastatin in the treatment of primary hypercholesterolaemia. Eighty five patients who received 10mg or 20 mg of atorvastatin for 8 weeks depending on target cholesterol goal were followed up by their own physicians and had final evaluation at 52 weeks. Reduction in mean low density Lipoprotein (LDL-C) was 36.5%, 37.9% and 32.2% at weeks 4, 8 and 52 respectively. LDL-C target was maintained in 81% and 69% of patients at week 8 and 52 respectively without drug related serious adverse events. Generic atorvastatin is safe and effective in usual clinical care setting.
开展了一项多中心研究,以评估一种阿托伐他汀仿制药治疗原发性高胆固醇血症的长期疗效和安全性。85例根据目标胆固醇水平接受10毫克或20毫克阿托伐他汀治疗8周的患者由其各自的医生进行随访,并在52周时进行最终评估。在第4周、第8周和第52周时,平均低密度脂蛋白(LDL-C)分别降低了36.5%、37.9%和32.2%。在第8周和第52周时,分别有81%和69%的患者维持了LDL-C目标水平,且无药物相关严重不良事件。阿托伐他汀仿制药在常规临床治疗环境中是安全有效的。