Abstract
ObjectiveAdverse 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.MethodsAfter 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.ResultsBased 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.ConclusionsData 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.
Highlights
Cardiovascular disease (CVD) involves a wide range of disorders, such as ischemic heart disease, heart attack and stroke, and a high level of LDL-cholesterol (LDL-C) in blood is a risk factor for CVD [1,2,3,4,5]
Continuous operation of the Adverse Event Reporting System (AERS) thereafter has resulted in an enormous database, and in this study, about 2 million adverse event reports (AERs) submitted to the AERS from 2004 to 2009 were reviewed to assess the muscular and renal adverse events induced by the administration of statins and to attempt to determine their rank-order of the association
The signals for myalgia, rhabdomyolysis, and an increase in creatine phosphokinase level were detected for pravastatin, simvastatin, atorvastatin, and rosuvastatin
Summary
Cardiovascular disease (CVD) involves a wide range of disorders, such as ischemic heart disease, heart attack and stroke, and a high level of LDL-cholesterol (LDL-C) in blood is a risk factor for CVD [1,2,3,4,5]. In 2005 and 2006, two post-marketing analyses were published [17,18], in which the safety of statins was assessed using adverse event reports (AERs) submitted to the US Food and Drug Administration (FDA). This database relies on reports of spontaneous adverse events to the FDA generated by health professionals, consumers, and manufacturers, and the system is referred to as the Adverse Event Reporting System (AERS). Continuous operation of the AERS thereafter has resulted in an enormous database, and in this study, about 2 million AERs submitted to the AERS from 2004 to 2009 were reviewed to assess the muscular and renal adverse events induced by the administration of statins and to attempt to determine their rank-order of the association. The AERs with pravastatin, fluvastatin, lovastatin, simvastatin, atorvastatin, and rosuvastatin were analyzed, and 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
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