Efficacy and safety of everolimus with reduced tacrolimus in living-donor liver transplant recipients: 12-month results of a randomized multicenter study
- Authors
- Jeng, L.-B.[Jeng, L.-B.]; Lee, S.G.[Lee, S.G.]; Soin, A.S.[Soin, A.S.]; Lee, W.-C.[Lee, W.-C.]; Suh, K.-S.[Suh, K.-S.]; Joo, D.J.[Joo, D.J.]; Uemoto, S.[Uemoto, S.]; Joh, J.[Joh, J.]; Yoshizumi, T.[Yoshizumi, T.]; Yang, H.-R.[Yang, H.-R.]; Song, G.-W.[Song, G.-W.]; Lopez, P.[Lopez, P.]; Kochuparampil, J.[Kochuparampil, J.]; Sips, C.[Sips, C.]; Kaneko, S.[Kaneko, S.]; Levy, G.[Levy, G.]
- Issue Date
- Jun-2018
- Publisher
- Blackwell Publishing Ltd
- Keywords
- clinical research/practice; immunosuppressant - mechanistic target of rapamycin (mTOR); immunosuppression/immune modulation; lung (allograft) function/dysfunction
- Citation
- American Journal of Transplantation, v.18, no.6, pp.1435 - 1446
- Indexed
- SCIE
SCOPUS
- Journal Title
- American Journal of Transplantation
- Volume
- 18
- Number
- 6
- Start Page
- 1435
- End Page
- 1446
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/21588
- DOI
- 10.1111/ajt.14623
- ISSN
- 1600-6135
- 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. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons
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