Clinical Pharmacology: Advances and Applications (Mar 2021)
Efficacy of Generic Atorvastatin in a Real-World Setting
Abstract
Panisa Manasirisuk,1 Nanthaphan Chainirun,1,2 Somsak Tiamkao,2,3 Sunee Lertsinudom,4 Kutcharin Phunikhom,5 Bundit Sawunyavisuth,6 Kittisak Sawanyawisuth3 1Department of Pharmacy Service, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 2Integrated Epilepsy Research Group, Khon Kaen University, Khon Kaen, Thailand; 3Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 4Division of Pharmaceutical Care, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand; 5Department of Pharmacology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand; 6Department of Marketing, Faculty of Business Administration and Accountancy, Khon Kaen University, Khon Kaen, ThailandCorrespondence: Nanthaphan ChainirunDepartment of Pharmacy Service, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002, ThailandEmail [email protected] SawanyawisuthDepartment of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002, ThailandTel +66-43-363664Fax +66-43-348399Email [email protected]: 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.Keywords: low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, HMG CoA reductase inhibitors