Safety Comparison of Risk of Liver Dysfunction between Generic and Brand Statin Drugs Marketed in Japan: A Cohort Study Using MID-NET®.

ABSTRACT: To verify safety profiles of generic statins in a real-world setting, the risk of liver dysfunction as a common adverse event was compared between generic and brand drugs. A new user cohort design was employed in which patients prescribed one of six statins (atorvastatin, simvastatin, pitavastatin, pravastatin, fluvastatin, or rosuvastatin) in Japan between January 1, 2014 and March 31, 2022 were identified in the MID-NET^® database. Adjusted hazard ratios (aHRs) for generic drugs compared with their corresponding brand drug for the occurrence of first liver dysfunction were estimated using high-dimensional propensity score-weighted Cox models. Among the six statins, no increased trends in aHRs were observed in the primary analysis, except for atorvastatin. The primary analysis s

SUBMITTER: Maruyama H 

PROVIDER: S-EPMC12945947 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature