Efficacy and safety of prolonged-release versus immediate-release tacrolimus in
Humans
Immunosuppressive agents
Liver transplantation
Prolonged-release tacrolimus
Republic of Korea
Treatment outcome
Journal
Korean journal of transplantation
ISSN: 2671-8790
Titre abrégé: Korean J Transplant
Pays: Korea (South)
ID NLM: 101775609
Informations de publication
Date de publication:
30 Jun 2019
30 Jun 2019
Historique:
received:
27
09
2018
revised:
27
03
2019
accepted:
31
03
2019
entrez:
30
6
2022
pubmed:
30
6
2019
medline:
30
6
2019
Statut:
ppublish
Résumé
Prolonged-release tacrolimus is associated with better long-term graft and patient survival than the immediate-release formulation in liver transplant patients. However, no clinical data are available to assess the efficacy and safety of early conversion from twice-daily, immediate-release tacrolimus to once-daily, prolonged-release tacrolimus in A 24-week, randomized, open-label study was conducted in 36 liver transplant recipients. All patients received immediate- release tacrolimus (0.1-0.2 mg/kg/day, divided into two doses) for 4 weeks after transplantation, at which time 50% of the patients were converted, at a ratio of 1 mg to 1 mg, to prolonged-release tacrolimus (once-daily). The primary efficacy endpoint was the incidence of biopsy-confirmed acute rejection (BCAR) from weeks 4 to 24 after transplantation (per-protocol set). Medication adherence, adverse event profiles, laboratory tests, vital signs, and physical changes were also recorded. BCAR frequency at 24 weeks was similar between the two treatment groups; two cases (mean±standard deviation, 0.14±0.53 cases) of BCAR were reported in one patient treated with prolonged-release tacrolimus (n=14), while no such cases were reported among patients treated with immediate-release tacrolimus (n=12). The tacrolimus blood concentration at weeks 12 and 24, medication adherence, and adverse event profiles were also similar between the formulations, with no unusual laboratory test results, vital signs, or physical changes reported. Early conversion to a simplified, once-daily, prolonged-release tacrolimus regimen may be an effective treatment option for liver transplant recipients in Korea. Larger-scale studies are warranted to confirm non-inferiority to immediate-release tacrolimus formulation in
Sections du résumé
Background
UNASSIGNED
Prolonged-release tacrolimus is associated with better long-term graft and patient survival than the immediate-release formulation in liver transplant patients. However, no clinical data are available to assess the efficacy and safety of early conversion from twice-daily, immediate-release tacrolimus to once-daily, prolonged-release tacrolimus in
Methods
UNASSIGNED
A 24-week, randomized, open-label study was conducted in 36 liver transplant recipients. All patients received immediate- release tacrolimus (0.1-0.2 mg/kg/day, divided into two doses) for 4 weeks after transplantation, at which time 50% of the patients were converted, at a ratio of 1 mg to 1 mg, to prolonged-release tacrolimus (once-daily). The primary efficacy endpoint was the incidence of biopsy-confirmed acute rejection (BCAR) from weeks 4 to 24 after transplantation (per-protocol set). Medication adherence, adverse event profiles, laboratory tests, vital signs, and physical changes were also recorded.
Results
UNASSIGNED
BCAR frequency at 24 weeks was similar between the two treatment groups; two cases (mean±standard deviation, 0.14±0.53 cases) of BCAR were reported in one patient treated with prolonged-release tacrolimus (n=14), while no such cases were reported among patients treated with immediate-release tacrolimus (n=12). The tacrolimus blood concentration at weeks 12 and 24, medication adherence, and adverse event profiles were also similar between the formulations, with no unusual laboratory test results, vital signs, or physical changes reported.
Conclusions
UNASSIGNED
Early conversion to a simplified, once-daily, prolonged-release tacrolimus regimen may be an effective treatment option for liver transplant recipients in Korea. Larger-scale studies are warranted to confirm non-inferiority to immediate-release tacrolimus formulation in
Identifiants
pubmed: 35769149
doi: 10.4285/jkstn.2019.33.2.20
pii: KJT-33-2-020
pmc: PMC9186832
doi:
Types de publication
Journal Article
Langues
eng
Pagination
20-29Informations de copyright
© 2019 The Korean Society for Transplantation.
Déclaration de conflit d'intérêts
CONFLICT OF INTEREST This study was funded by Astellas Pharma Inc. and YJL and HJ are employees of Astellas Pharma Inc. No other potential conflict of interest relevant to this article was reported.
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