Effect of Early Everolimus-Facilitated Reduction of Tacrolimus on Efficacy and Renal Function in De Novo Liver Transplant Recipients: 24-Month Results for the North American Subpopulation.
Transplantation
; 101(2): 341-349, 2017 Feb.
Article
en En
| MEDLINE
| ID: mdl-28121741
ABSTRACT
BACKGROUND:
A recent randomized phase III study of 719 de novo liver transplant recipients showed that early everolimus plus reduced-dose tacrolimus (EVR + rTAC) led to significantly better kidney function than standard TAC (TAC-C), without compromising efficacy. In that study, patients from North America (n = 211) had increased risk factors for posttransplant renal insufficiency at study start, relative to patients from Europe and rest of world (eg, worse renal function, more diabetes, older age).METHODS:
A post hoc analysis was performed to assess whether these regional disparities affected study outcomes in North American patients.RESULTS:
In this subpopulation, estimated glomerular filtration rates at randomization were higher in TAC-C over EVR + rTAC (76.4 vs 69.3 mL/min per 1.73 m). Mean changes in estimated glomerular filtration rate values (mL/min per 1.73 m) favored EVR + rTAC over TAC-C at months 12 (+3.7 vs -4.5; P = 0.032), 24 (+2.7 vs -6.6; P = 0.042), and 36 (+4.3 vs -8.1; P = 0.059). The composite efficacy endpoint of treated biopsy-proven acute rejection, graft loss, or death was 10.9%, 14.1%, and 14.1% for EVR + rTAC and 13.1%, 17.2%, and 19.3% for TAC-C at months 12, 24, and 36, respectively.CONCLUSIONS:
Although the North American cohort had more comorbidities, results were consistent with the overall population for efficacy and renal function.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Trasplante de Hígado
/
Tacrolimus
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Inhibidores de la Calcineurina
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Everolimus
/
Rechazo de Injerto
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Supervivencia de Injerto
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Inmunosupresores
/
Riñón
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Aspecto:
Equity_inequality
/
Patient_preference
Límite:
Adult
/
Female
/
Humans
/
Male
/
Middle aged
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Transplantation
Año:
2017
Tipo del documento:
Article