Document Detail

Statin safety: an appraisal from the adverse event reporting system.
MedLine Citation:
PMID:  16581327     Owner:  NLM     Status:  MEDLINE    
The adverse event (AE) profiles of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) agents are of great interest, in particular the most recently approved statin, rosuvastatin. The forwarding of reports of AEs has been shown to be influenced by several reporting biases, including secular trend, the new drug reporting effect, product withdrawals, and publicity. Comparative assessments that use AE reporting rates are difficult to interpret under these circumstances, because such effects can themselves lead to marked increases in AE reporting. Consequently, many comparative reporting rate analyses are best carried out in conjunction with other metrics that put reporting burden into context, such as report proportion. All-AE reporting rates showed a temporal profile that resembled those of other statins when marketing cycle and secular trend were taken into account. A before-and-after cerivastatin withdrawal comparison showed a substantial increase in the reporting of AEs of interest for the statin class overall. Report proportion analyses indicated that the burden of rosuvastatin-associated AEs was similar to that for other statin agents. Analyses of monthly reporting rates showed that the reporting of rosuvastatin-associated rhabdomyolysis and renal failure have increased following AE-specific mass media publicity. Postrosuvastatin AE reporting patterns were comparable to those seen with other statins and did not resemble cerivastatin.
Michael H Davidson; John A Clark; Lucas M Glass; Anju Kanumalla
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Publication Detail:
Type:  Journal Article     Date:  2006-02-03
Journal Detail:
Title:  The American journal of cardiology     Volume:  97     ISSN:  0002-9149     ISO Abbreviation:  Am. J. Cardiol.     Publication Date:  2006 Apr 
Date Detail:
Created Date:  2006-04-03     Completed Date:  2006-06-06     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0207277     Medline TA:  Am J Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  32C-43C     Citation Subset:  AIM; IM    
Rush University Medical Center, Chicago, Illinois, USA.
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MeSH Terms
Adverse Drug Reaction Reporting Systems / statistics & numerical data*
Databases, Factual
Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage,  adverse effects*
Kidney Failure / chemically induced
Liver Failure / chemically induced
Muscular Diseases / chemically induced
Peripheral Nervous System Diseases / chemically induced
Product Surveillance, Postmarketing
United States
United States Food and Drug Administration
Reg. No./Substance:
0/Hydroxymethylglutaryl-CoA Reductase Inhibitors

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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