Sex-differences in reporting of statin-associated diabetes mellitus to the US Food and Drug Administration.

ABSTRACT:

Introduction

Diabetes mellitus (DM) is increasingly recognized as a possible consequence of statin therapy. Secondary analysis of randomized clinical trials and limited observational cohort analyses have suggested that women may be more likely than men to experience statin-associated DM. No analyses of real-world drug safety data addressing this question have been published.

Research design and methods

This was a retrospective pharmacovigilance analysis of spontaneously reported adverse drug events (ADEs) submitted to the Food and Drug Administration Adverse Event Reporting System between January 1997 through December 2023. We analyzed cases that mentioned atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin in aggregate as well as c

SUBMITTER: Kao DP 

PROVIDER: S-EPMC11624814 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature