Abstract
Objective: The reports submitted to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from 1997 to 2011 were reviewed to assess the gender effects on muscular adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins). Methods: After the deletion of duplicated submissions and the revision of arbitrary drug names, the reports involving pravastatin, simvastatin, atorvastatin, rosuvastatin, and cerivastatin were analyzed. Data mining algorithms were applied for the quantitative detection of signals, where a signal means a drug-associated adverse event, including the proportional reporting ratio, the reporting odds ratio, the information component, and the empirical Bayes geometric mean. Myopathy, myalgia, myositis, rhabdomyolysis, and an increase in creatine phosphokinase level were focused on as the muscular adverse events. Results: The total number of reports was 3,472,494. The signal scores suggested that all 5 statins were associated with 5 muscular adverse events in both male and female patients. The scores varied among statins, but were more noteworthy for cerivastatin. Conclusion: The data strongly suggested the necessity of well-organized clinical studies on statin-associated muscular adverse events.
Highlights
Cardiovascular disease (CVD) is one of leading causes of death worldwide, and a high level of LDL-cholesterol in blood is an important risk factor for CVD [1,2,3]
The reports submitted to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from 1997 to 2011 were reviewed to assess the gender effects on muscular adverse events induced by the administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors
The signal scores suggested that all 5 statins were associated with 5 muscular adverse events in both male and female patients
Summary
Cardiovascular disease (CVD) is one of leading causes of death worldwide, and a high level of LDL-cholesterol in blood is an important risk factor for CVD [1,2,3]. The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, known as statins, are well-established therapeutic intervention for lowering of LDLcholesterol, and the primary and secondary prevention of CVD [1,2,3]. Adverse events most commonly found in statin users are muscle symptoms, ranging from mild myalgia to life-threatening rhabdomyolysis requiring hospitalization [4,5,6]. Statin-associated muscular symptoms may affect 10% to 15% of users, resulting in autonomously discontinuation [4]. A better understanding of this important issue would improve the management of patients [4,5,6]. In 2002, a guideline for managing statin-related myopathy was issued by clinical advisory of the American
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