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Efficacy and safety of everolimus with reduced tacrolimus in living-donor liver transplant recipients: 12-month results of a randomized multicenter study

Authors
 Long-Bin Jeng  ;  Sung Gyu Lee  ;  Arvinder Singh Soin  ;  Wei-Chen Lee  ;  Kyung-Suk Suh  ;  Dong Jin Joo  ;  Shinji Uemoto  ;  Jaewon Joh  ;  Tomoharu Yoshizumi  ;  Horng-Ren Yang  ;  Gi-Won Song  ;  Patricia Lopez  ;  Jossy Kochuparampil  ;  Carole Sips  ;  Shuhei Kaneko  ;  Gary Levy 
Citation
 AMERICAN JOURNAL OF TRANSPLANTATION, Vol.18(6) : 1435-1446, 2018 
Journal Title
 AMERICAN JOURNAL OF TRANSPLANTATION 
ISSN
 1600-6135 
Issue Date
2018
Keywords
clinical research/practice ; immunosuppressant - mechanistic target of rapamycin (mTOR) ; immunosuppression/immune modulation ; lung (allograft) function/dysfunction
Abstract
In a multicenter, open-label, study, 284 living-donor liver transplant patients were randomized at 30 ± 5 days posttransplant to start everolimus+reduced tacrolimus (EVR+rTAC) or continue standard tacrolimus (TAC Control). EVR+rTAC was non-inferior to TAC Control for the primary efficacy endpoint of treated BPAR, graft loss or death at 12 months posttransplant: difference -0.7% (90% CI -5.2%, 3.7%); P < .001 for non-inferiority. Treated BPAR occurred in 2.2% and 3.6% of patients, respectively. The key secondary endpoint, change in estimated glomerular filtration rate (eGFR) from randomization to month 12, achieved non-inferiority (P < .001 for non-inferiority), but not superiority and was similar between groups overall (mean -8.0 vs. -12.1 mL/min/1.73 m2 , P = .108), and in patients continuing randomized treatment (-8.0 vs. -13.3 mL/min/1.73 m2 , P = .046). In the EVR+rTAC and TAC control groups, study drug was discontinued in 15.5% and 17.6% of patients, adverse events with suspected relation to study drug occurred in 57.0% and 40.4%, and proteinuria ≥1 g/24 h in 9.3% and 0%, respectively. Everolimus did not negatively affect liver regeneration. At 12 months, hepatocellular recurrence was only seen in the standard TAC-treated patients (5/62; 8.1%). In conclusion, early introduction of EVR+rTAC was non-inferior to standard tacrolimus in terms of efficacy and renal function at 12 months, with hepatocellular carcinoma recurrence only in TAC Control patients. ClinicalTrials.gov Identifier: NCT01888432.
Full Text
https://onlinelibrary.wiley.com/doi/abs/10.1111/ajt.14623
DOI
10.1111/ajt.14623
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Joo, Dong Jin(주동진) ORCID logo https://orcid.org/0000-0001-8405-1531
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/163311
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