Detection and Management of Signals Associated with Adverse Drug Reactions from Atorvastatin and Rosuvastatin: An Observational Study

Abstract

Background: Statins are the mainstay of dyslipidaemia treatment, but individual agents display variable adverse drug reaction (ADR) profiles. Pharmacovigilance signal detection facilitates early identification of safety concerns and guides risk minimization.

Objective: To identify and compare ADR signals associated with atorvastatin and rosuvastatin and to evaluate management strategies in real-world settings.

Methods: Patients receiving atorvastatin or rosuvastatin at Teerthanker Mahaveer University were monitored for suspected ADRs. Causality was determined using WHO–UMC criteria, and seriousness per ICH E2A definitions. Signal detection employed disproportionality methods Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR).

Results: Signal detection analysis for system organ class was done by using frequentist disproportionality analysis (cluster-based disproportionality) method for the following organ classes like musculoskeletal disorder, gastrointestinal disorders and general disorders.

Conclusion: Comparative signal detection highlights distinct safety profiles for atorvastatin and rosuvastatin, underscoring the role of structured pharmacovigilance and individualized clinical management.