TITLE:
Gender Effects on Statin-Associated Muscular Adverse Events: An Analysis of the FDA AERS Database
AUTHORS:
Hiroyuki Murakami, Toshiyuki Sakaeda, Kaori Kadoyama, Yasushi Okuno
KEYWORDS:
Adverse Event; FAERS; Statin; Data Mining; Pharmacovigilance
JOURNAL NAME:
Pharmacology & Pharmacy,
Vol.4 No.3,
June
20,
2013
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.