Abstract

Background: There is limited long term data of generic atorvastatin in terms of clinical efficacy and safety. This study aimed to evaluate the efficacy of generic atorvastatin in a 12-month period.
 Methods: This study was a retrospective cohort study. The inclusion criteria were adult patients who received the original atorvastatin for at least three months and then switched to the generic atorvastatin for 12 months. Lipid profiles and safety profiles were evaluated after 12 months of switching therapy.
 Results: During the study period, there were 297 patients met the study criteria. The mean (SD) age of the patients was 61.05 (11.51) years. Male sex accounted for 46.80% (139 patients). For lipid outcomes, only HDL-c was significantly increased by 2.05 mg/dL (p 0.001). Serum creatinine was increasing by 0.07 mg/dL, while eGFR was decreasing by 2.55 ml/min/1.73m2. Other laboratory outcomes were not significantly changed after one year including ALT, AST, and CK.
 Conclusions: Generic atorvastatin had comparable effect on LDL-c reduction compared with the original atorvastatin. Renal deterioration were found with increasing HDL-c level in this study population with generic atorvastation. Physicians should be aware of declining of renal function in long term use of generic atorvastatin.

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