title: A survey of the FDA's AERS database regarding muscle and tendon adverse events linked to the statin drug class.
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).
  
  
  CONCLUSIONS
  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.affiliation: AdverseEvents, Inc, Healdsburg, California, United States of America.
authors.forename: Keith B
authors.initials: KB
authors.lastname: Hoffman
authors.forename: Christina
authors.initials: C
authors.lastname: Kraus
authors.forename: Mo
authors.initials: M
authors.lastname: Dimbil
authors.forename: Beatrice A
authors.initials: BA
authors.lastname: Golomb
mesh_terms: D000069059:Atorvastatin; D016208:Databases, Factual; D005229:Fatty Acids, Monounsaturated / Q000009:adverse effects; D005464:Fluorobenzenes / Q000009:adverse effects; D000077340:Fluvastatin; D006538:Heptanoic Acids / Q000009:adverse effects; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D007211:Indoles / Q000009:adverse effects; D008148:Lovastatin / Q000009:adverse effects; D018482:Muscle, Skeletal / Q000187:drug effects*; D017035:Pravastatin / Q000009:adverse effects; D011743:Pyrimidines / Q000009:adverse effects; D011758:Pyrroles / Q000009:adverse effects; D012307:Risk Factors; D000068718:Rosuvastatin Calcium; D019821:Simvastatin / Q000009:adverse effects; D013449:Sulfonamides / Q000009:adverse effects; D013710:Tendons / Q000187:drug effects*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D005229:Fatty Acids, Monounsaturated; D005464:Fluorobenzenes; D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007211:Indoles; D011743:Pyrimidines; D011758:Pyrroles; D013449:Sulfonamides; D000077340:Fluvastatin; D000068718:Rosuvastatin Calcium; D008148:Lovastatin; D000069059:Atorvastatin; D019821:Simvastatin; D017035:Pravastatin