title: Economic evaluation of everolimus vs. azathioprine at one year after de novo heart transplantation.
abstract: BACKGROUND
  Everolimus decreases acute rejection and cardiac allograft vasculopathy after heart transplantation. We compared within-trial costs and resource use over 1 yr of follow-up in de novo heart transplant patients randomized to everolimus 1.5 mg/d (n = 209), everolimus 3.0 mg/d (n = 211), or azathioprine (n = 214).
  
  
  METHODS
  Resource use data were collected prospectively for 634 patients from 14 countries. We used the nonparametric bootstrap method to test for differences in mean costs and to estimate confidence intervals for cost-effectiveness ratios.
  
  
  RESULTS
  Everolimus patients had lower incidence of efficacy failure compared with azathioprine patients (41.6%, everolimus 1.5 mg; 32.2%, everolimus 3.0 mg; 52.8%, azathioprine). Compared with patients receiving azathioprine, everolimus patients spent more days in the hospital [36.3 d for everolimus 1.5 mg/d (p = 0.21); 38.4 d for everolimus 3.0 mg/d (p = 0.01); 32.2 d for azathioprine]. Mean total costs, excluding the study medications, were not significantly different among treatment groups ($72 065 for everolimus 1.5 mg; $72 631 for everolimus 3.0 mg; $70 815 for azathioprine).
  
  
  CONCLUSIONS
  Over 1 yr of follow-up after heart transplantation, everolimus did not significantly increase treatment costs, excluding the costs of the study medications, while reducing efficacy failure. Longer follow-up and the cost of everolimus are required to fully evaluate the cost-effectiveness of everolimus vs. azathioprine in post-transplant maintenance.
authors.affiliation: Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Durham, NC 27715, USA.
authors.forename: Jasmina I
authors.initials: JI
authors.lastname: Radeva
authors.forename: Shelby D
authors.initials: SD
authors.lastname: Reed
authors.forename: Zoltán
authors.initials: Z
authors.lastname: Kaló
authors.forename: Teresa L
authors.initials: TL
authors.lastname: Kauf
authors.forename: Edward
authors.initials: E
authors.lastname: Cantu
authors.forename: Nathalie
authors.initials: N
authors.lastname: Cretin
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Schulman
mesh_terms: D001379:Azathioprine / Q000191:economics / Q000276:immunology / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000191:economics; D003586:Cytomegalovirus Infections / Q000453:epidemiology / Q000276:immunology; D000068338:Everolimus; D005260:Female; D016027:Heart Transplantation / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007166:Immunosuppressive Agents / Q000191:economics / Q000276:immunology / Q000627:therapeutic use*; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000191:economics / Q000276:immunology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D000068338:Everolimus; D001379:Azathioprine; D020123:Sirolimus