title: Ten-year follow-up of a randomized trial of pravastatin in heart transplant patients.
abstract: BACKGROUND
  Outcomes from this trial's first year data demonstrated significant benefit in heart transplant patients treated with pravastatin in cholesterol levels, survival, rejection with hemodynamic compromise, the development of cardiac allograft vasculopathy, and decreased natural killer cell cytotoxicity. Other heart transplant studies have shown similar benefit. We now report the 10-year follow-up of this study.
  
  
  METHODS
  Ninety-seven heart transplant recipients were randomized to pravastatin (n = 47) or no pravastatin (n = 50) within 2 weeks after surgery both in combination with cyclosporine and corticosteroids. Ten-year outcomes include survival, cholesterol levels, and development of cardiac allograft vasculopathy documented by coronary angiography.
  
  
  RESULTS
  Forty-two percent of the control patients crossed over to pravastatin treatment during the second year of the study, and 81% of the control patients were eventually placed on statin therapy by the 10-year follow-up. The control group had subsequent low and comparable cholesterol levels in Years 2 to 10 of the study compared with the patients originally randomized to pravastatin. Intent-to-treat analysis demonstrated that the pravastatin group compared with control had increased 10-year survival (68% vs 48%, p = 0.026). The 10-year freedom from angiographic cardiac allograft vasculopathy and/or death in the pravastatin group was significantly greater compared with the control group (43% vs 20%, p = 0.009).
  
  
  CONCLUSIONS
  The 10-year follow-up of this study suggests that the use of pravastatin in heart transplant patients maintains survival benefit and appears to reduce the development of cardiac allograft vasculopathy.
authors.affiliation: Division of Cardiology, The David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California 90095, USA. jonk@mednet.ucla.edu
authors.forename: Jon A
authors.initials: JA
authors.lastname: Kobashigawa
authors.forename: Jaime D
authors.initials: JD
authors.lastname: Moriguchi
authors.forename: Hillel
authors.initials: H
authors.lastname: Laks
authors.forename: Liane
authors.initials: L
authors.lastname: Wener
authors.forename: Antoine
authors.initials: A
authors.lastname: Hage
authors.forename: Michele A
authors.initials: MA
authors.lastname: Hamilton
authors.forename: Greg
authors.initials: G
authors.lastname: Cogert
authors.forename: Angela
authors.initials: A
authors.lastname: Marquez
authors.forename: Maria E
authors.initials: ME
authors.lastname: Vassilakis
authors.forename: Jignesh
authors.initials: J
authors.lastname: Patel
authors.forename: Lawrence
authors.initials: L
authors.lastname: Yeatman
mesh_terms: D000328:Adult; D017023:Coronary Angiography; D003327:Coronary Disease / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000517:prevention & control; D006085:Graft Survival / Q000187:drug effects; D016027:Heart Transplantation / Q000401:mortality; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017035:Pravastatin / Q000627:therapeutic use*; D016019:Survival Analysis; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D017035:Pravastatin