Changes in the commercial brand of tacrolimus lead to subtherapeutic trough levels and acute rejection in renal transplant recipients

Autor: Guadalupe Ricalde-Ríos, Alfredo Chew-Wong, J. Rafael Villafan-Bernal, Leslie Zuñiga-Macias, José M. Arreola-Guerra, Rafael Reyes-Acevedo, Fabian Haro‐Alcalde, Rodolfo Delgadillo-Castañeda, Dulce Maria Macias, Carmen L. Ramos‐Medellín, Jesus Hernández‐Rosales, Josefina Alberú
Rok vydání: 2019
Předmět:
Zdroj: Clinical Transplantation. 33
ISSN: 1399-0012
0902-0063
DOI: 10.1111/ctr.13749
Popis: BACKGROUND The vigilance of tacrolimus (TAC) trough levels is an essential part of renal transplant follow up. Reduced TAC trough levels and high variability are related to adverse outcomes. The aim of this study was to evaluate the impact of brand changes on tacrolimus (TAC) subtherapeutic (SubT) trough levels, acute rejection (AR), and kidney function. METHODS This is a prospective, observational cohort study of renal transplant recipients, between January 2016 and October 2018. Tacrolimus trough levels and brand used by the patient were both registered at every consult. Tacrolimus values ≤3.5 ng/mL were considered SubT. RESULTS 445 patients were included. The median number of TAC brand changes was 2 (IQR, 1-4). Patients were grouped according to the number of brand changes: Group 1 = 0 (n = 107), Group 2 = 1-4 (n = 236), and Group 3 = ≥5 (n = 102). Patients with the greatest number of brand changes had a greater proportion and number of SubT TAC trough levels (Group 1 = 36.4%, average 0.53; Group 2 = 39.8%, average 0.65, Group 3 = 59.8%, average 1.17, P
Databáze: OpenAIRE