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Everolimus with reduced tacrolimus improves renal function in de novo liver transplant recipients: a randomized controlled trial.

Publication ,  Journal Article
De Simone, P; Nevens, F; De Carlis, L; Metselaar, HJ; Beckebaum, S; Saliba, F; Jonas, S; Sudan, D; Fung, J; Fischer, L; Duvoux, C; Chavin, KD ...
Published in: Am J Transplant
November 2012

In a prospective, multicenter, open-label study, de novo liver transplant patients were randomized at day 30±5 to (i) everolimus initiation with tacrolimus elimination (TAC Elimination) (ii) everolimus initiation with reduced-exposure tacrolimus (EVR+Reduced TAC) or (iii) standard-exposure tacrolimus (TAC Control). Randomization to TAC Elimination was terminated prematurely due to a higher rate of treated biopsy-proven acute rejection (tBPAR). EVR+Reduced TAC was noninferior to TAC Control for the primary efficacy endpoint (tBPAR, graft loss or death at 12 months posttransplantation): 6.7% versus 9.7% (-3.0%; 95% CI -8.7, 2.6%; p<0.001 for noninferiority [12% margin]). tBPAR occurred in 2.9% of EVR+Reduced TAC patients versus 7.0% of TAC Controls (p = 0.035). The change in adjusted estimated GFR from randomization to month 12 was superior with EVR+Reduced TAC versus TAC Control (difference 8.50 mL/min/1.73 m(2) , 97.5% CI 3.74, 13.27 mL/min/1.73 m(2) , p<0.001 for superiority). Drug discontinuation for adverse events occurred in 25.7% of EVR+Reduced TAC and 14.1% of TAC Controls (relative risk 1.82, 95% CI 1.25, 2.66). Relative risk of serious infections between the EVR+Reduced TAC group versus TAC Controls was 1.76 (95% CI 1.03, 3.00). Everolimus facilitates early tacrolimus minimization with comparable efficacy and superior renal function, compared to a standard tacrolimus exposure regimen 12 months after liver transplantation.

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Published In

Am J Transplant

DOI

EISSN

1600-6143

Publication Date

November 2012

Volume

12

Issue

11

Start / End Page

3008 / 3020

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Transplantation Immunology
  • Time Factors
  • Tacrolimus
  • Survival Analysis
  • Surgery
  • Sirolimus
  • Risk Assessment
  • Prospective Studies
 

Citation

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De Simone, P., Nevens, F., De Carlis, L., Metselaar, H. J., Beckebaum, S., Saliba, F., … H2304 Study Group. (2012). Everolimus with reduced tacrolimus improves renal function in de novo liver transplant recipients: a randomized controlled trial. Am J Transplant, 12(11), 3008–3020. https://doi.org/10.1111/j.1600-6143.2012.04212.x
De Simone, P., F. Nevens, L. De Carlis, H. J. Metselaar, S. Beckebaum, F. Saliba, S. Jonas, et al. “Everolimus with reduced tacrolimus improves renal function in de novo liver transplant recipients: a randomized controlled trial.Am J Transplant 12, no. 11 (November 2012): 3008–20. https://doi.org/10.1111/j.1600-6143.2012.04212.x.
De Simone P, Nevens F, De Carlis L, Metselaar HJ, Beckebaum S, Saliba F, et al. Everolimus with reduced tacrolimus improves renal function in de novo liver transplant recipients: a randomized controlled trial. Am J Transplant. 2012 Nov;12(11):3008–20.
De Simone, P., et al. “Everolimus with reduced tacrolimus improves renal function in de novo liver transplant recipients: a randomized controlled trial.Am J Transplant, vol. 12, no. 11, Nov. 2012, pp. 3008–20. Pubmed, doi:10.1111/j.1600-6143.2012.04212.x.
De Simone P, Nevens F, De Carlis L, Metselaar HJ, Beckebaum S, Saliba F, Jonas S, Sudan D, Fung J, Fischer L, Duvoux C, Chavin KD, Koneru B, Huang MA, Chapman WC, Foltys D, Witte S, Jiang H, Hexham JM, Junge G, H2304 Study Group. Everolimus with reduced tacrolimus improves renal function in de novo liver transplant recipients: a randomized controlled trial. Am J Transplant. 2012 Nov;12(11):3008–3020.
Journal cover image

Published In

Am J Transplant

DOI

EISSN

1600-6143

Publication Date

November 2012

Volume

12

Issue

11

Start / End Page

3008 / 3020

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Transplantation Immunology
  • Time Factors
  • Tacrolimus
  • Survival Analysis
  • Surgery
  • Sirolimus
  • Risk Assessment
  • Prospective Studies