仿制药阿托伐他汀在现实世界中的疗效。

IF 2.5 Q2 PHARMACOLOGY & PHARMACY
Clinical Pharmacology : Advances and Applications Pub Date : 2021-03-05 eCollection Date: 2021-01-01 DOI:10.2147/CPAA.S285750
Panisa Manasirisuk, Nanthaphan Chainirun, Somsak Tiamkao, Sunee Lertsinudom, Kutcharin Phunikhom, Bundit Sawunyavisuth, Kittisak Sawanyawisuth
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引用次数: 16

摘要

背景:他汀类药物降低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起重要作用。这种治疗往往很昂贵,但使用阿托伐他汀仿制药可使费用减少至多2635美元。此外,之前一项为期8周的研究发现,它的疗效与品牌药物相当。本研究旨在评估仿制药阿托伐他汀在现实环境中更长时间6个月的疗效。方法:这是一项回顾性队列研究,研究对象是接受品牌阿托伐他汀治疗至少3个月,然后改用仿制阿托伐他汀治疗至少6个月的成年患者。脂质和安全性在转换后6个月进行评估。还进行了年龄、性别、合并症、剂量和他汀类药物治疗适应症的调整分析。结果:在研究期间,有488例患者符合研究标准。患者平均(SD)年龄为60.97(12.26)岁,男性占48.36%(236例)。6个月时,平均总胆固醇、HDL-c和LDL-c均较低,分别从174.43 mg/dL降至166.15 mg/dL,从51.64 mg/dL降至49.51 mg/dL,从110.08降至100.78 mg/dL (p < 0.001)。在任何其他实验室测试结果方面没有显着差异。LDL-c在9.30 mg/dL时降低幅度最大。按年龄、性别、合并症、剂量和他汀类药物治疗的适应症进行分层分析,结果显示HDL-c和LDL-c的降低与整个研究人群相似。结论:仿制药阿托伐他汀显著降低LDL-c,但降低HDL-c。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Efficacy of Generic Atorvastatin in a Real-World Setting.

Efficacy of Generic Atorvastatin in a Real-World Setting.

Background: 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.

Methods: 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.

Results: 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.

Conclusion: Generic atorvastatin resulted in significantly lower LDL-c than name-brand atorvastatin but less of an increase in HDL-c.

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来源期刊
CiteScore
4.60
自引率
0.00%
发文量
14
审稿时长
16 weeks
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