title: Risk of hospitalized rhabdomyolysis associated with lipid-lowering drugs in a real-world clinical setting.
abstract: BACKGROUND
  The occurrence of low rates of rhabdomyolysis among patients receiving lipid-lowering drugs (LLDs) in randomized clinical trials may be elucidated with population-based studies.
  
  
  OBJECTIVE
  To determine the risk of hospitalized rhabdomyolysis associated with LLD therapy.
  
  
  METHODS
  This observational study used claims data from 9 million members of five United States health plans to identify patients (≥18 years) who received >2 statin and nonstatin LLDs during July 2000 to December 2004. Inpatient International Classification of Diseases, Ninth Revision, Clinical Modification, codes for rhabdomyolysis (791.3, 728.89, and 728.88) were observed during the follow-up period; cases were confirmed with patients' medical records. Rhabdomyolysis events were reported per 10,000 person-years of LLD exposure; multivariate analysis was conducted.
  
  
  RESULTS
  The study cohort (N = 473,343) received 490,988 and 11,624 person-years of LLD, and combination therapy, respectively. Medical charts were obtained for 104 of 144 eligible patients with rhabdomyolysis claims; 42 cases were confirmed. With atorvastatin as reference, rhabdomyolysis rates (95% confidence interval) were greatest for cerivastatin, 8.4 (2.3-21.7); no difference among available statins was observed. Rates for other LLD monotherapies were: niacin, 2.1 (0.3-7.7), ezetimibe, 2.1 (0.3-7.8), fenofibrate, 0 (0-1.7), and gemfibrozil, 2.0 (0.5-5.2). Multivariate analysis showed only cerivastatin with a significantly greater risk of rhabdomyolysis (odds ratio 4.74, 95% confidence interval 1.1-21.2, P = .041) versus atorvastatin among the statins. Combination therapies had increased rhabdomyolysis risk (OR 7.1, 1.6-31.6, P = .010) versus LLDs alone.
  
  
  CONCLUSIONS
  The risk of habdomyolysis among hospitalized patients receiving statins was low; no difference among the available statins was evident. Further data are needed to establish the risk profile but current findings already offer guidance to physicians.
authors: HealthCore, Inc., 800 Delaware Avenue, Wilmington, DE 19801, USA. mcziraky@healthcore.com
authors: Mark J
authors: MJ
authors: Cziraky
authors: Vincent J
authors: VJ
authors: Willey
authors: James M
authors: JM
authors: McKenney
authors: Siddhesh A
authors: SA
authors: Kamat
authors: Maxine D
authors: MD
authors: Fisher
authors: John R
authors: JR
authors: Guyton
authors: Terry A
authors: TA
authors: Jacobson
authors: Michael H
authors: MH
authors: Davidson
mesh_terms: D000328:Adult; D000368:Aged; D000069059:Atorvastatin; D015331:Cohort Studies; D005260:Female; D011345:Fenofibrate / Q000009:adverse effects / Q000627:therapeutic use; D005500:Follow-Up Studies; D015248:Gemfibrozil / Q000009:adverse effects / Q000627:therapeutic use; D006538:Heptanoic Acids / Q000009:adverse effects / Q000627:therapeutic use; D006760:Hospitalization; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D007003:Hypoglycemia / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009525:Niacin / Q000009:adverse effects / Q000627:therapeutic use; D016017:Odds Ratio; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use; D012206:Rhabdomyolysis / Q000453:epidemiology / Q000209:etiology*; D012307:Risk Factors
chemical_list: D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011725:Pyridines; D011758:Pyrroles; D009525:Niacin; D000069059:Atorvastatin; C086276:cerivastatin; D015248:Gemfibrozil; D011345:Fenofibrate