Efficacy and safety of tacrolimus in de novo pediatric transplant recipients randomized to receive immediate- or prolonged-release tacrolimus.
Adolescent
Child
Child, Preschool
Female
Follow-Up Studies
Graft Rejection
/ drug therapy
Graft Survival
/ drug effects
Humans
Immunosuppressive Agents
/ therapeutic use
Male
Organ Transplantation
/ adverse effects
Postoperative Complications
/ drug therapy
Prognosis
Retrospective Studies
Risk Factors
Survival Rate
Tacrolimus
/ therapeutic use
Transplant Recipients
/ statistics & numerical data
calcineurin inhibitor: tacrolimus
heart (allograft) function/dysfunction
immunosuppressant
kidney transplantation: living donor
liver transplantation: living donor
Journal
Clinical transplantation
ISSN: 1399-0012
Titre abrégé: Clin Transplant
Pays: Denmark
ID NLM: 8710240
Informations de publication
Date de publication:
10 2019
10 2019
Historique:
received:
22
02
2019
revised:
06
08
2019
accepted:
19
08
2019
pubmed:
23
8
2019
medline:
22
9
2020
entrez:
23
8
2019
Statut:
ppublish
Résumé
This multicenter trial compared immediate-release tacrolimus (IR-T) vs 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. 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. 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). In pediatric de novo solid organ recipients, the low incidence of BCAR and low efficacy failure rate suggest that PR-T-based immunosuppression is effective and well tolerated to 1-year post-transplantation.
Sections du résumé
BACKGROUND AND AIMS
This multicenter trial compared immediate-release tacrolimus (IR-T) vs 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 suggest that PR-T-based immunosuppression is effective and well tolerated to 1-year post-transplantation.
Identifiants
pubmed: 31436896
doi: 10.1111/ctr.13698
pmc: PMC6900073
doi:
Substances chimiques
Immunosuppressive Agents
0
Tacrolimus
WM0HAQ4WNM
Types de publication
Clinical Trial, Phase II
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e13698Subventions
Organisme : Department of Health
Pays : United Kingdom
Informations de copyright
© 2019 The Authors. Clinical Transplantation published by John Wiley & Sons Ltd.
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