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Revista Española de Cardiología (English Edition) Revista Española de Cardiología (English Edition)
Rev Esp Cardiol. 2018;71:18-25 - Vol. 71 Num.01 DOI: 10.1016/j.rec.2017.03.014

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

Francisco González-Vílchez a,, José Luis Lambert b, Diego Rangel c, Luis Almenar d, José Luis de la Fuente e, Jesús Palomo f, Beatriz Díaz Molina b, Ernesto Lage c, Ignacio Sánchez Lázaro d, José A. Vázquez de Prada a

a Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain
b Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
c Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitario Virgen del Rocío, Sevilla, Spain
d Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitario La Fe, Valencia, Spain
e Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitario Clínico de Valladolid, Valladolid, Spain
f Unidad de Insuficiencia Cardiaca Avanzada y Trasplante Cardiaco, Servicio de Cardiología, Hospital Universitario Gregorio Marañón, Madrid, Spain

Keywords

Tacrolimus. Heart transplantation. Rejection. Infection.

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.

1885-5857/© 2018 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved