Randomized clinical trial of tacrolimus- vs cyclosporine-based immunosuppression in pediatric heart transplantation: preliminary results at 15-month follow-up.
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.
Pollock-Barziv
Stacey M
SM
Division of Cardiology, Department of Pediatrics and Immunology, University of Toronto, The Hospital for Sick Children, Toronto, Ontario, Canada.
Dipchand
Anne I
AI
McCrindle
Brian W
BW
Nalli
Nadya
N
West
Lori J
LJ
D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D002311:Cardiomyopathy, Dilated / Q000401:mortality / Q000628:therapy; D002313:Cardiomyopathy, Restrictive / Q000401:mortality / Q000628:therapy; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000517:prevention & control*; D006330:Heart Defects, Congenital / Q000401:mortality / Q000628:therapy; D016027:Heart Transplantation; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011446:Prospective Studies; D016019:Survival Analysis; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*; D014184:Transplantation, Homologous; D016896:Treatment Outcome
D000305:Adrenal Cortex Hormones; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D016559:Tacrolimus