Manasirisuk Panisa, Chainirun Nanthaphan, Tiamkao Somsak, Lertsinudom Sunee, Phunikhom Kutcharin, Sawunyavisuth Bundit, Sawanyawisuth Kittisak
Department of Pharmacy Service, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Integrated Epilepsy Research Group, Khon Kaen University, Khon Kaen, Thailand.
Clin Pharmacol. 2021 Mar 5;13:45-51. doi: 10.2147/CPAA.S285750. eCollection 2021.
The ability of statins to reduce LDL-c plays an important role in both primary and secondary prevention of atherosclerotic cardiovascular diseases. Such treatment can often be costly, but using generic atorvastatin may reduce cost by up to US$2635. In addition, a previous 8-week study found that it exhibited comparable efficacy to the brand-name medication. This study aimed to evaluate the efficacy of generic atorvastatin over a longer period of six months in a real-world setting.
This was a retrospective cohort study in adult patients who had received brand-name atorvastatin for at least three months and then had switched to generic atorvastatin for at least six months. Lipid and safety profiles were evaluated at six months after switching. Adjusted analyses for age, sex, co-morbid disease, dosage, and indications for statin therapy were also performed.
During the study period, there were 488 patients who met the study criteria. The mean (SD) age of the patients was 60.97 (12.26) years, and 48.36% were male (236 patients). At six months, average total cholesterol, HDL-c, and LDL-c were all lower, from 174.43 to 166.15 mg/dL, from 51.64 to 49.51 mg/dL, and from 110.08 to 100.78 mg/dL (p < 0.001), respectively. There were no significant differences in terms of any other laboratory test results. LDL-c exhibited the highest significant reduction at 9.30 mg/dL. Stratified analyses by age, sex, co-morbid disease, dose, and indications for statin therapy revealed similar decreases in HDL-c and LDL-c as in the study population as a whole.
Generic atorvastatin resulted in significantly lower LDL-c than name-brand atorvastatin but less of an increase in HDL-c.
他汀类药物降低低密度脂蛋白胆固醇（LDL-c）的能力在动脉粥样硬化性心血管疾病的一级和二级预防中均发挥着重要作用。此类治疗通常成本高昂，但使用阿托伐他汀仿制药可能会使成本降低多达2635美元。此外，此前一项为期8周的研究发现，其疗效与品牌药物相当。本研究旨在评估在真实世界环境中，阿托伐他汀仿制药在长达6个月的较长时间内的疗效。
这是一项回顾性队列研究，研究对象为成年患者，这些患者接受品牌阿托伐他汀至少3个月，之后改用阿托伐他汀仿制药至少6个月。在换药6个月后评估血脂和安全性指标。还对年龄、性别、合并疾病、剂量以及他汀类药物治疗指征进行了校正分析。
在研究期间，有488名患者符合研究标准。患者的平均（标准差）年龄为60.97（12.26）岁，男性占48.36%（236例患者）。6个月时，平均总胆固醇、高密度脂蛋白胆固醇（HDL-c）和低密度脂蛋白胆固醇均降低，分别从174.43降至166.15mg/dL、从51.64降至49.51mg/dL、从110.08降至100.78mg/dL（p<0.001）。其他任何实验室检查结果均无显著差异。LDL-c的显著降幅最大，为9.30mg/dL。按年龄、性别、合并疾病、剂量以及他汀类药物治疗指征进行的分层分析显示，HDL-c和LDL-c的降幅与整个研究人群相似。
阿托伐他汀仿制药导致LDL-c水平显著低于品牌阿托伐他汀，但HDL-c的升高幅度较小。
