The Comparative Effectiveness between Branded Generic Atorvastatin (Lipostat®) and Authorized Generic Atorvastatin (Xarator®): A Prospective Cohort Study

Abstract

Background: An authorized generic drug has identical ingredients as the brand-name drug but marketed as a generic version by the innovator company with a lower cost. A branded generic drug is an imitation of the brand-name medication whose patent has expired. The active elements of a branded generic medicine are the same as those of the original drug, however the inactive ingredients may differ. Objective: To assess the effectiveness of the branded generic atorvastatin (Lipostat®), compared to the authorized generic atorvastatin (Xarator®) in decreasing low density lipoprotein cholesterol (LDL-C) levels. Materials and Methods: The present study was a prospective cohort study that included patients who had been taking the authorized generic atorvastatin (Xarator®) 40 mg once daily for at least three months. The authorized generic atorvastatin (Xarator®) was switched to branded generic atorvastatin (Lipostat®) 40 mg once daily for the next three months. Blood chemistry including lipid profile were evaluated before and three months after the transition from Xarator® to Lipostat®. Results: Of the 61 patients, mean age was 67.0±9.9 years, and 45 (73.7%) were male. The two most common comorbidities included coronary artery disease in 80.3% and hypertension in 60.7%. At three months after switching to branded generic atorvastatin, the mean total cholesterol changed from 133.6±28.8 to 130.0±25.8 mg/dL, the triglyceride changed from 123.3±78.3 to 115.6±70.1 mg/dL, and the LDL-C changed from 68.8±24.1 to 65.5±20.3 mg/dL, thus, they were not significantly different compared to the baseline. There were also no significant differences in adverse events between Lipostat® and Xarator®. Conclusion: Branded generic atorvastatin (Lipostat®) is as effective as the authorized generic atorvastatin (Xarator®) in lowering LDL-C levels. Keywords: Atorvastatin; Authorized generic drug; Branded generic atorvastatin; Low-density lipoprotein cholesterol; High-density lipoprotein cholesterol; Statin