Statins Safety Analysis Based On Adverse Event Reporting Systems

Objective:①To analyze the association between statin use and cognitive decline,diabetes mellitus and cancer through the US Food and Drug Administration (FDA)Adverse Event Reporting System (AERS).②To examine all reports includingrhabdomyolysis with statins and ranolazine from the U.S. AERS to assess if data weresuggestive of an interaction.Methods: Widely used pharmacovigilance tools were adopted for quantitativedetection of signals, i.e. drug-associated adverse events, including the reporting oddsratio (ROR), the Bayesian confidence propagation neural network (BCPNN) and thegamma possion shrinker (GPS). Omega shrinkage method and logistic regressionmethod were used to detect the interaction between stains and ranolazine resulting inrhabdomyolysis.Results: As for the association between statin use and cognitive decline, ROR andBCPNN were indicative of a definite risk, especially for atorvastatin and fluvastatin;as for the association between statin use and diabetes mellitus, ROR, BCPNN andGPS were all indicative of a definite risk, especially for simvastatin, atorvastatin andlovastatin; ROR, BCPNN and GPS all found no convincing evidence for risk ofcancer after statin use. Through logistic regression method and omega shrinkagemehod, the reporting rhabdomyolysis cases in association with statins and ranolazineover time showed that rhabdomyolysis under concomitant use of ranolazine andstatins was reported more often than expected.Conclusions: Data mining of the FDA’s adverse event reporting system, AERS, isuseful for examining statin-associated cognitive decline, diabetes mellitus and cancer.The number of rhabdomyolysis cases associated with statins and ranolzine could beconsidered unexpected on the basis of current data and needs further investigation ontheir true rhabdomyolysis-liability. The data strongly suggest the necessity ofwell-organized clinical studies with respect to statin-associated adverse events.