Tags

Type your tag names separated by a space and hit enter

A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the statin drug class.
PLoS One. 2012; 7(8):e42866.Plos

Abstract

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 ≈ 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).

Authors+Show Affiliations

AdverseEvents, Inc, Healdsburg, California, United States of America.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22936996

Citation

Hoffman, Keith B., et al. "A Survey of the FDA's AERS Database Regarding Muscle and Tendon Adverse Events Linked to the Statin Drug Class." PloS One, vol. 7, no. 8, 2012, pp. e42866.
Hoffman KB, Kraus C, Dimbil M, et al. A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the statin drug class. PLoS ONE. 2012;7(8):e42866.
Hoffman, K. B., Kraus, C., Dimbil, M., & Golomb, B. A. (2012). A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the statin drug class. PloS One, 7(8), e42866. https://doi.org/10.1371/journal.pone.0042866
Hoffman KB, et al. A Survey of the FDA's AERS Database Regarding Muscle and Tendon Adverse Events Linked to the Statin Drug Class. PLoS ONE. 2012;7(8):e42866. PubMed PMID: 22936996.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the statin drug class. AU - Hoffman,Keith B, AU - Kraus,Christina, AU - Dimbil,Mo, AU - Golomb,Beatrice A, Y1 - 2012/08/22/ PY - 2012/03/20/received PY - 2012/07/12/accepted PY - 2012/9/1/entrez PY - 2012/9/1/pubmed PY - 2013/4/26/medline SP - e42866 EP - e42866 JF - PloS one JO - PLoS ONE VL - 7 IS - 8 N2 - 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 ≈ 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). SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/22936996/A_survey_of_the_FDA's_AERS_database_regarding_muscle_and_tendon_adverse_events_linked_to_the_statin_drug_class_ L2 - http://dx.plos.org/10.1371/journal.pone.0042866 DB - PRIME DP - Unbound Medicine ER -