Abstract
Background:
While Tacrolimus (Tac) and Cyclosporine (Cya) immunosuppression are used after cardiac transplantation (tx), few studies have evaluated their use in pediatric patients.
Methods:
We randomized 26 heart transplant recipients (pts) in a prospective, open-label trial to Tac (n = 14) or Cya (n = 12) to compare their efficacy and side-effects. Mean age at tx was 4.2 years for Tac and 5.8 years for Cya. Mean follow-up was 26 months (range: 11-39 months) for Tac and 24 months for Cya (range: 33-13 months).
Results:
Our data suggest that both regimens are efficacious in the pediatric population. Conversion from Cya to Tac was useful for dealing with persistent rejection, although this sample did not suggest lower incidence of acute cellular rejection in the Tac group.
Conclusions:
Further studies are required to establish pharmacokinetic parameters to enhance therapeutic monitoring of these patients to minimize side effects and enhance outcomes.
Publication types
-
Comparative Study
-
Randomized Controlled Trial
-
Research Support, Non-U.S. Gov't
MeSH terms
-
Adolescent
-
Adrenal Cortex Hormones / adverse effects
-
Adrenal Cortex Hormones / therapeutic use
-
Adult
-
Cardiomyopathy, Dilated / mortality
-
Cardiomyopathy, Dilated / therapy
-
Cardiomyopathy, Restrictive / mortality
-
Cardiomyopathy, Restrictive / therapy
-
Child
-
Child, Preschool
-
Cross-Over Studies
-
Cyclosporine / adverse effects
-
Cyclosporine / therapeutic use*
-
Female
-
Follow-Up Studies
-
Graft Rejection / prevention & control*
-
Heart Defects, Congenital / mortality
-
Heart Defects, Congenital / therapy
-
Heart Transplantation*
-
Humans
-
Immunosuppressive Agents / adverse effects
-
Immunosuppressive Agents / therapeutic use*
-
Incidence
-
Infant
-
Infant, Newborn
-
Male
-
Prospective Studies
-
Survival Analysis
-
Tacrolimus / adverse effects
-
Tacrolimus / therapeutic use*
-
Transplantation, Homologous
-
Treatment Outcome
Substances
-
Adrenal Cortex Hormones
-
Immunosuppressive Agents
-
Cyclosporine
-
Tacrolimus