Statin-Associated Muscular and Renal Adverse Events: Data Mining of the Public Version of the FDA Adverse Event Reporting System
Open Access
- 20 December 2011
- journal article
- research article
- Published by Public Library of Science (PLoS) in PLOS ONE
- Vol. 6 (12), e28124
- https://doi.org/10.1371/journal.pone.0028124
Abstract
Adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA) were reviewed to assess the muscular and renal adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) and to attempt to determine the rank-order of the association. After a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving pravastatin, simvastatin, atorvastatin, or rosuvastatin were analyzed. Authorized pharmacovigilance tools were used for quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean. Myalgia, rhabdomyolysis and an increase in creatine phosphokinase level were focused on as the muscular adverse events, and acute renal failure, non-acute renal failure, and an increase in blood creatinine level as the renal adverse events. Based on 1,644,220 AERs from 2004 to 2009, signals were detected for 4 statins with respect to myalgia, rhabdomyolysis, and an increase in creatine phosphokinase level, but these signals were stronger for rosuvastatin than pravastatin and atorvastatin. Signals were also detected for acute renal failure, though in the case of atorvastatin, the association was marginal, and furthermore, a signal was not detected for non-acute renal failure or for an increase in blood creatinine level. Data mining of the FDA's adverse event reporting system, AERS, is useful for examining statin-associated muscular and renal adverse events. The data strongly suggest the necessity of well-organized clinical studies with respect to statin-associated adverse events.Keywords
This publication has 38 references indexed in Scilit:
- Statin myopathy: A common dilemma not reflected in clinical trialsCleveland Clinic Journal of Medicine, 2011
- Effects of Statins on Skeletal Muscle: A Perspective for Physical TherapistsPTJ: Physical Therapy & Rehabilitation Journal, 2010
- Benefits of statin therapy and compliance in high risk cardiovascular patientsVascular Health and Risk Management, 2010
- Drug Treatment of HyperlipidaemiaDrugs, 2010
- Meta-analysis of Comparative Efficacy of Increasing Dose of Atorvastatin Versus Rosuvastatin Versus Simvastatin on Lowering Levels of Atherogenic Lipids (from VOYAGER)The American Journal of Cardiology, 2010
- A systematic review and meta-analysis on the therapeutic equivalence of statinsJournal of Clinical Pharmacy & Therapeutics, 2009
- Quantitative signal detection using spontaneous ADR reportingPharmacoepidemiology and Drug Safety, 2009
- Dangers of rosuvastatin identified before and after FDA approvalThe Lancet, 2004
- The statin warsThe Lancet, 2003
- Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reportsPharmacoepidemiology and Drug Safety, 2001