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Efficacy of Generic Atorvastatin in a Real-World Setting
Panisa Manasirisuk1, Nanthaphan Chainirun1,2, Somsak Tiamkao2,3
1Department of Pharmacy Service, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Insights
Generic atorvastatin effectively lowers LDL-c and total cholesterol in patients with atherosclerotic cardiovascular disease. This cost-effective option demonstrates comparable efficacy to brand-name atorvastatin over six months.
Area of Science:
- Cardiology
- Pharmacoeconomics
- Clinical Pharmacy
Background:
- Statins, including atorvastatin, are crucial for preventing atherosclerotic cardiovascular diseases by reducing LDL-c.
- Generic atorvastatin offers a cost-saving alternative to brand-name medication.
- Previous short-term studies indicated comparable efficacy between generic and brand-name atorvastatin.
Purpose of the Study:
- To evaluate the real-world efficacy of generic atorvastatin over a six-month period.
- To compare lipid profiles and safety of generic atorvastatin versus brand-name atorvastatin.
Main Methods:
- Retrospective cohort study involving adult patients switching from brand-name to generic atorvastatin.
- Evaluation of lipid and safety profiles at six months post-switch.
- Adjusted analyses considering age, sex, comorbidities, dosage, and indications.
Main Results:
- Significant reductions in total cholesterol, HDL-c, and LDL-c observed after six months.
- LDL-c showed the most significant reduction (9.30 mg/dL; p < 0.001).
- Stratified analyses confirmed similar efficacy across various patient subgroups.
Conclusions:
- Generic atorvastatin achieved significantly lower LDL-c levels compared to brand-name atorvastatin.
- Generic atorvastatin demonstrated a less pronounced increase in HDL-c compared to brand-name.
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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