PMID- 22936996
OWN - NLM
STAT- MEDLINE
DCOM- 20130425
LR  - 20220321
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 7
IP  - 8
DP  - 2012
TI  - A survey of the FDA's AERS database regarding muscle and tendon adverse events 
      linked to the statin drug class.
PG  - e42866
LID - 10.1371/journal.pone.0042866 [doi]
LID - e42866
AB  - BACKGROUND: Cholesterol management drugs known as statins are widely used and 
      often well tolerated; however, a variety of muscle-related side effects can 
      arise. These adverse events (AEs) can have serious impact, and form a significant 
      barrier to therapy adherence. Surveillance of post-marketing AEs is of vital 
      importance to understand real-world AEs and reporting differences between 
      individual statin drugs. We conducted a review of post-approval muscle and tendon 
      AE reports in association with statin use, to assess differences within the drug 
      class. METHODS: We analyzed all case reports from the FDA AE Reporting System 
      (AERS) database linking muscle-related AEs to statin use (07/01/2005-03/31/2011). 
      Drugs examined were: atorvastatin, simvastatin, lovastatin, pravastatin, 
      rosuvastatin, and fluvastatin. RESULTS: Relative risk rates for rosuvastatin were 
      consistently higher than other statins. Atorvastatin and simvastatin showed 
      intermediate risks, while pravastatin and lovastatin appeared to have the lowest 
      risk rates. Relative risk of muscle-related AEs, therefore, approximately tracked 
      with per milligram LDL-lowering potency, with fluvastatin an apparent exception. 
      Incorporating all muscle categories, rates for atorvastatin, simvastatin, 
      pravastatin, and lovastatin were, respectively, 55%, 26%, 17%, and 7.5% as high, 
      as rosuvastatin, approximately tracking per milligram potency 
      (Rosuvastatin>Atorvastatin>Simvastatin>Pravastatin  approximately  Lovastatin) and comporting 
      with findings of other studies. Relative potency, therefore, appears to be a 
      fundamental predictor of muscle-related AE risk, with fluvastatin, the least 
      potent statin, an apparent exception (risk 74% vs rosuvastatin). INTERPRETATION: 
      AE reporting rates differed strikingly for drugs within the statin class, with 
      relative reporting aligning substantially with potency. The data presented in 
      this report offer important reference points for the selection of statins for 
      cholesterol management in general and, especially, for the rechallenge of 
      patients who have experienced muscle-related AEs (for whom agents of lower 
      expected potency should be preferred).
FAU - Hoffman, Keith B
AU  - Hoffman KB
AD  - AdverseEvents, Inc, Healdsburg, California, United States of America.
FAU - Kraus, Christina
AU  - Kraus C
FAU - Dimbil, Mo
AU  - Dimbil M
FAU - Golomb, Beatrice A
AU  - Golomb BA
LA  - eng
PT  - Journal Article
DEP - 20120822
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Fatty Acids, Monounsaturated)
RN  - 0 (Fluorobenzenes)
RN  - 0 (Heptanoic Acids)
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Indoles)
RN  - 0 (Pyrimidines)
RN  - 0 (Pyrroles)
RN  - 0 (Sulfonamides)
RN  - 4L066368AS (Fluvastatin)
RN  - 83MVU38M7Q (Rosuvastatin Calcium)
RN  - 9LHU78OQFD (Lovastatin)
RN  - A0JWA85V8F (Atorvastatin)
RN  - AGG2FN16EV (Simvastatin)
RN  - KXO2KT9N0G (Pravastatin)
SB  - IM
MH  - Atorvastatin
MH  - Databases, Factual
MH  - Fatty Acids, Monounsaturated/adverse effects
MH  - Fluorobenzenes/adverse effects
MH  - Fluvastatin
MH  - Heptanoic Acids/adverse effects
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*adverse effects
MH  - Indoles/adverse effects
MH  - Lovastatin/adverse effects
MH  - Muscle, Skeletal/*drug effects
MH  - Pravastatin/adverse effects
MH  - Pyrimidines/adverse effects
MH  - Pyrroles/adverse effects
MH  - Risk Factors
MH  - Rosuvastatin Calcium
MH  - Simvastatin/adverse effects
MH  - Sulfonamides/adverse effects
MH  - Tendons/*drug effects
MH  - United States
MH  - United States Food and Drug Administration
PMC - PMC3425581
COIS- Competing Interests: Authors Keith Hoffman, Christina Kraus, and Mo Dimbil work 
      for Adverse Events, Inc. which produced the RxFilter software used in this paper. 
      There is no financial conflict regarding the focus of the paper: That there are 
      adverse event reports for statins within the FDA AERS database is not in dispute; 
      and there is no rationale by which this company affiliation would bias a 
      comparative analysis of agents within a class, such as that presented. Although 
      the software will not be made available, the methods have been elucidated by 
      which the results can be replicated without this software. This does not alter 
      the authors' adherence to all the PLoS ONE policies on sharing data and 
      materials.
EDAT- 2012/09/01 06:00
MHDA- 2013/04/26 06:00
PMCR- 2012/08/22
CRDT- 2012/09/01 06:00
PHST- 2012/03/20 00:00 [received]
PHST- 2012/07/12 00:00 [accepted]
PHST- 2012/09/01 06:00 [entrez]
PHST- 2012/09/01 06:00 [pubmed]
PHST- 2013/04/26 06:00 [medline]
PHST- 2012/08/22 00:00 [pmc-release]
AID - PONE-D-12-09227 [pii]
AID - 10.1371/journal.pone.0042866 [doi]
PST - ppublish
SO  - PLoS One. 2012;7(8):e42866. doi: 10.1371/journal.pone.0042866. Epub 2012 Aug 22.