Efficacy and Safety of de Novo and Early Use of Extended-release Tacrolimus in Heart Transplantation.

Fecha de publicación: 01/01/2018

Autores de IIS La Fe

Luis Almenar Bonet

Autor
Ignacio José Sánchez Lázaro

Autor

Participantes ajenos a IIS La Fe

Gonzalez-Vilchez, F
Lamber, JL
Rangel, D
de la Fuente, JL
Palomo, J
Molina, BD
Lage, E
de Prada, JAV

Grupos

Grupo de Investigación Clínica y Traslacional en Cardiología

Investigador Principal

Esther Roselló Lletí

Abstract

INTRODUCTION AND OBJECTIVES: The extended-release formulation of tacrolimus (ERT) allows once-daily dosage, thus simplifying the immunosuppressive regimen. This study aimed to describe the safety and efficacy of the de novo and early use of ERT in heart transplantation. METHODS: This was an observational, retrospective, multicenter study comparing the safety and efficacy of the de novo use of ERT (ERT group [n=94]), standard-release tacrolimus (SRT group [n=42]) and early conversion (EC) from SRT to ERT (EC group [n=44]). Extended-release tacrolimus was used between 2007 and 2012. One-year incidence rates of acute rejection, infection, and cytomegalovirus infection were analyzed. Safety parameters were also evaluated. RESULTS: There were no significant between-group differences in the daily dose or trough levels of tacrolimus during the first year after transplantation. The rejection incidence rates were 1.05 (95%CI, 0.51-1.54), 1.39 (95%CI, 1.00-1.78), and 1.11 (95%CI, 0.58-1.65) episodes per patient-years in the SRT group, ERT group, and EC group, respectively (P=.48). The infection incidence rates were 0.75 (95%CI, 0.60-0.86), 0.62 (95%CI, 0.52-0.71), and 0.55 (95%CI, 0.40-0.68) in the SRT group, ERT group, and EC group, respectively (P=.46). Cytomegalovirus infection occurred in 23.8%, 20.2%, and 18.2% of the patients, respectively (P=.86). No significant between-group differences were found in laboratory tests or in allograft function. There was 1 death in the SRT group and 2 in the ERT group. CONCLUSIONS: Both de novo and early use of ERT seem to have similar safety and efficacy profiles to conventional SRT-based immunosuppression.

Datos de la publicación

ISSN/ISSNe:: 1885-5857, 1885-5857
Tipo:: Article
Páginas:: 18-25
DOI:: 10.1016/j.rec.2017.03.014
Factor de Impacto:: 0,352 SCImago ℠
Cuartil:: Q3 SCImago ℠

Documentos

No hay documentos

Métricas

Filiaciones

Gonzalez-Vilchez, F:: Hosp Univ Marques de Valdecilla, Serv Cardiol, Unidad Insuficiencia Cardiaca Avanzada & Trasplan, Santander, Cantabria, Spain
Lamber, JL:: Hosp Univ Cent Asturias, Serv Cardiol, Unidad Insuficiencia Cardiaca Avanzada & Trasplan, Oviedo, Asturias, Spain
Rangel, D:: Hosp Univ Virgen del Rocio, Serv Cardiol, Unidad Insuficiencia Cardiaca Avanzada & Trasplan, Seville, Spain
Almenar, L:: Hosp Univ La Fe, Serv Cardiol, Unidad Insuficiencia Cardiaca Avanzada & Trasplan, Valencia, Spain
de la Fuente, JL:: Hosp Univ Clin Valladolid, Serv Cardiol, Unidad Insuficiencia Cardiaca Avanzada & Trasplan, Valladolid, Spain
Palomo, J:: Hosp Univ Gregorio Maranon, Serv Cardiol, Unidad Insuficiencia Cardiaca Avanzada & Trasplan, Madrid, Spain
Molina, BD:: Hosp Univ Cent Asturias, Serv Cardiol, Unidad Insuficiencia Cardiaca Avanzada & Trasplan, Oviedo, Asturias, Spain
Lage, E:: Hosp Univ Virgen del Rocio, Serv Cardiol, Unidad Insuficiencia Cardiaca Avanzada & Trasplan, Seville, Spain
Lazaro, IS:: Hosp Univ La Fe, Serv Cardiol, Unidad Insuficiencia Cardiaca Avanzada & Trasplan, Valencia, Spain
de Prada, JAV:: Hosp Univ Marques de Valdecilla, Serv Cardiol, Unidad Insuficiencia Cardiaca Avanzada & Trasplan, Santander, Cantabria, Spain