Adverse reaction of specific acute kidney injury caused by atorvastatin: an actual study based on the database of the US FDA adverse event reporting system.

Abstract

Introduction: Atorvastatin, one of the most widely used drugs, has attracted controversy regarding its potential adverse reactions to acute kidney injury(AKI). This study aims to provide evidence in support of the safe use of atorvastatin.

Areas covered: Reports with atorvastatin as the primary suspect drug were extracted from the FDA Adverse Event Reporting System (FAERS) and categorized into five groups: general population, acute myocardial infarction (AMI), ischemic stroke (IS), type 2 diabetes mellitus (T2DM), and hyperlipidemia (HLD). We conducted subgroup analyses by gender and age, using four standards-ROR, PRR, BCPNN, and EGBM-to perform disproportionality analysis and assess positive signals. Statistical analysis evaluated differences between the occurrence and non-occurrence of adverse drug reactions (ADRs), as well as differences between high and low induction time groups.

Expert opinion: In the general population, evidence for a positive AKI signal was insufficient. However, subgroup analysis showed risk in males and older individuals in AMI and IS populations, while younger age groups in T2DM showed positive signals. In the HLD population, evidence was insufficient across genders and ages. Atorvastatin is generally safe, but clinical vigilance for AKI is needed in T2DM, AMI, and IS populations, especially in those 65 and older.