https://www.ncbi.nlm.nih.gov/pubmed/31436896 Liver transplant
Clin Transplant. 2019 Aug 22. doi: 10.1111/ctr.13698. [Epub ahead of print]
Efficacy and safety of tacrolimus in de novo pediatric transplant recipients randomized to receive immediate- or prolonged-release tacrolimus.
Vondrak K1, Parisi F2, Dhawan A3, Grenda R4, Webb NJ5, Marks SD6, Debray D7, Holt RC8, Lachaux A9, Kelly D10, Kazeem G11,12, Undre N11.

Abstract

BACKGROUND AND AIMS:
This multicenter trial compared immediate-release tacrolimus (IR-T) versus prolonged-release tacrolimus (PR-T) in de novo kidney-, liver-, and heart-transplant recipients aged <16 years. Each formulation had similar pharmacokinetic (PK) profiles. Follow-up efficacy and safety results are reported herein.

MATERIALS AND METHODS:
Patients, randomized 1:1, received once-daily, PR-T or twice-daily, IR-T within 4 days of surgery. After a 4-week PK assessment, patients continued randomized treatment for 48 additional weeks. At Year 1, efficacy assessments included the number of clinical acute rejections, biopsy-confirmed acute rejection (BCAR) episodes (including severity), patient and graft survival, and efficacy failure (composite of death, graft loss, BCAR, or unknown outcome). Adverse events were assessed throughout.

RESULTS:
The study included 44 children. At Year 1, mean ± standard deviation tacrolimus trough levels were 6.6±2.2 and 5.4±1.6 ng/mL, and there were 2 and 7 acute rejection episodes in the PR-T and IR-T groups, respectively. No cases of graft loss or death were reported during the study. The overall efficacy failure rate was 18.2% (PR-T n=1; IR-T n=7).

CONCLUSIONS:
In pediatric de novo solid organ recipients, the low incidence of BCAR and low efficacy failure rate suggests that PR-T-based immunosuppression is effective and well tolerated to 1-year post transplantation. This article is protected by copyright. All rights reserved.