Economic evaluation of everolimus vs. azathioprine at one year after de novo heart transplantation.

Journal Article (Clinical Trial;Clinical Trial, Phase III;Journal Article;Multicenter Study)

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). PATIENTS AND 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.

Full Text

Duke Authors

Cited Authors

  • Radeva, JI; Reed, SD; Kaló, Z; Kauf, TL; Cantu, E; Cretin, N; Schulman, KA

Published Date

  • February 2005

Published In

Volume / Issue

  • 19 / 1

Start / End Page

  • 122 - 129

PubMed ID

  • 15659145

International Standard Serial Number (ISSN)

  • 0902-0063

Digital Object Identifier (DOI)

  • 10.1111/j.1399-0012.2004.00312.x


  • eng

Conference Location

  • Denmark