Switching Therapy to the Second Brand of Generic Atorvastatin: A 6-Month Retrospective Cohort, Real-World Study.

INTRODUCTION

High levels of low-density lipoprotein-cholesterol (LDL) is a major risk factor for cardiovascular diseases. While treatment with atorvastatin is beneficial, the original atorvastatin may be cost prohibitive to some patients. Currently, a second brand of generic atorvastatin is available on the market. This study aimed to evaluate the effectiveness of the second generic brand of atorvastatin.

METHODS

This was a retrospective cohort study conducted at Khon Kaen University Hospital, Thailand. The inclusion criteria were adult patients who received either Xarator (original atorvastatin; Pfizer Pharmaceuticals, Puerto Rico) or Atorvastatin Sandoz (Lek Pharmaceuticals, Slovenia) for at least 3 months prior to switching therapy to the second brand: Lipostat (Siam Pharmaceutical, Thailand). The study period was between 1 April 2022 and 30 June 2023. The primary outcome of this study was a change in LDL 6 months after switching therapy from either the original (Xarator) or generic atorvastatin (Atorvastatin Sandoz).

RESULTS

There were 683 patients who switched therapy from the original atorvastatin (Xarator), and 1044 patients who switched therapy from generic atorvastatin (Atorvastatin Sandoz), for a total of 1727 patients. Regarding LDL levels, switching therapy from original atorvastatin (Xarator) resulted in a slightly lower but not significant decrease in LDL at 6 months (- 0.96 mg/dL; 95% CI of - 3.20, 1.28), while switching therapy from generic atorvastatin (Atorvastatin Sandoz) led to significantly lower LDL at - 3.30 mg/dL (95% CI of - 5.25, - 1.36). The original (Xarator) and generic atorvastatin (Atorvastatin Sandoz) group also resulted in a significantly lower estimated glomerular filtration rate at - 0.90 and - 1.21 mL/min/1.73 m, respectively, from baseline.

CONCLUSIONS

The second generic atorvastatin (Lipostat) resulted in comparable outcomes on LDL compared with the original (Xarator), but significantly lower LDL levels than another generic atorvastatin (Atorvastatin Sandoz) 6 months after switching therapy. However, renal function should be closely monitored.