title: Long-term safety and effectiveness of statins for heart transplant recipients in routine clinical practice.
abstract: BACKGROUND
  Whereas the efficacy of statins after heart transplantation (HT) in controlled study settings has been clearly demonstrated, more extensive data are required on the safety and effectiveness of long-term treatment in routine clinical practice.
  
  
  METHODS
  We analyzed the risks and benefits in clinical practice of treatment with statins in all patients who survived HT for at least a month from December 1985 through 2001.
  
  
  RESULTS
  During a mean follow-up of 4.8+/-3.8 years, 186 patients were treated with statins (for a median duration [25th to 75th percentile] of 29 [12 to 54] months), while 48 received dietary therapy alone. Patients treated with statins (pravastatin, 48%; atorvastatin, 37%; simvastatin, 14%) presented linearized rates of rhabdomyolisis, myositis, and significant transaminase elevation of 0.37%, 0.74%, and 0.37% per year of treatment, respectively (no fatal event occurred). Low-density lipoprotein decreased after statins by 19% (P<.001). At multivariate analysis, treatment with statins was independently associated with reduced risk of cardiac allograft vasculopathy and overall mortality (P<.001).
  
  
  CONCLUSIONS
  Our data provide necessary confirmation of the safety and effectiveness in routine clinical practice of appropriately monitored long-term administration of statins (particularly atorvastatin, pravastatin, and simvastatin) in the chronic post-HT phase. Strict follow-up is needed for HT recipients receiving high doses of statins with/without other medications potentially exacerbating the risk of adverse effects.
authors.affiliation: Institute of Cardiology, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy. francesco.grigioni@unibo.it
authors.forename: F
authors.initials: F
authors.lastname: Grigioni
authors.forename: S
authors.initials: S
authors.lastname: Carigi
authors.forename: L
authors.initials: L
authors.lastname: Potena
authors.forename: F
authors.initials: F
authors.lastname: Fabbri
authors.forename: A
authors.initials: A
authors.lastname: Russo
authors.forename: A C
authors.initials: AC
authors.lastname: Musuraca
authors.forename: F
authors.initials: F
authors.lastname: Coccolo
authors.forename: G
authors.initials: G
authors.lastname: Magnani
authors.forename: P
authors.initials: P
authors.lastname: Ortolani
authors.forename: O
authors.initials: O
authors.lastname: Leone
authors.forename: G
authors.initials: G
authors.lastname: Arpesella
authors.forename: C
authors.initials: C
authors.lastname: Magelli
authors.forename: A
authors.initials: A
authors.lastname: Branzi
mesh_terms: D000328:Adult; D005260:Female; D006331:Heart Diseases / Q000145:classification / Q000601:surgery; D016027:Heart Transplantation / Q000401:mortality / Q000502:physiology*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012449:Safety; D016019:Survival Analysis; D017741:Survivors; D016896:Treatment Outcome
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors