Everolimus with reduced tacrolimus improves renal function in de novo liver transplant recipients: a randomized controlled trial. De Simone, P., Nevens, F., De Carlis, L., Metselaar, H. J., Beckebaum, S., Saliba, F., Jonas, S., Sudan, D., Fung, J., Fischer, L., Duvoux, C., Chavin, K. D., Koneru, B., Huang, M. A., Chapman, W. C., Foltys, D., Witte, S., Jiang, H., Hexham, J. M., & Junge, G. Am J Transplant, 12(11):3008–20, November, 2012.
abstract   bibtex   
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\textless0.001 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\textless0.001 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.
@article{de_simone_everolimus_2012,
	title = {Everolimus with reduced tacrolimus improves renal function in de novo liver transplant recipients: a randomized controlled trial},
	volume = {12},
	issn = {1600-6143 (ELECTRONIC); 1600-6135 (LINKING)},
	shorttitle = {Everolimus with reduced tacrolimus improves renal function in de novo liver transplant recipients: a randomized controlled trial},
	abstract = {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{\textless}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{\textless}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.},
	number = {11},
	journal = {Am J Transplant},
	author = {De Simone, P. and Nevens, F. and De Carlis, L. and Metselaar, H. J. and Beckebaum, S. and Saliba, F. and Jonas, S. and Sudan, D. and Fung, J. and Fischer, L. and Duvoux, C. and Chavin, K. D. and Koneru, B. and Huang, M. A. and Chapman, W. C. and Foltys, D. and Witte, S. and Jiang, H. and Hexham, J. M. and Junge, G.},
	month = nov,
	year = {2012},
	keywords = {Adolescent Adult Aged Confidence Intervals Cross-Over Studies Dose-Response Relationship},
	pages = {3008--20}
}

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