A prospective randomized study comparing cyclosporine versus tacrolimus combined with daclizumab, mycophenolate mofetil, and steroids in heart transplantation.
BACKGROUND
Cyclosporine (CsA) and tacrolimus (Tac) in heart transplantation (HTx) have been compared but with certain drawbacks. We compared both drugs in a prospective analysis with medium-term follow-up.


METHODS
Hundred and six patients were randomized to receive CsA or Tac (53 per group). Target levels of CsA were 200-300 ng/mL in the first six months and 100-200 ng/mL thereafter. Tac levels were 10-15 and 5-10 ng/mL, respectively. We also used daclizumab as induction and mycophenolate mofetil (MMF) and steroids as maintenance therapy.


RESULTS
Baseline characteristics were similar. Survival (CsA 88.7% vs. Tac 81.1%; p = 0.493) was similar. There was a tendency for longer time to first rejection with CsA (93 ± 110 vs. 55 ± 81 d; p = 0.122). There were more rejection-free patients with Tac (39 vs. 28%; p = 0.233). CsA patients suffered more viral infections (0.41 ± 0.58 vs. 0.11 ± 0.31; p = 0.003). CsA patients developed hypertension often (64 vs. 43%; p = 0.032). Tac patients suffered more gastrointestinal complications (16 vs. 6%; p = 0.042). Renal function and the development of diabetes, dyslipidemia, or neurological complications was similar.


CONCLUSIONS
Tac patients showed a tendency for longer time to first rejection, and there were more rejection-free patients with Tac and suffered fewer viral infections. Tac patients developed less hypertension and needed less drugs for its control. Renal function was similar in both groups.
Sánchez-Lázaro
Ignacio J
IJ
Heart Failure and Transplantation Unit, Cardiology Department, Hospital Universitario La Fe, Valencia, Spain. ignaciosanchezlazaro@gmail.com
Almenar
Luis
L
Martínez-Dolz
Luis
L
Buendía-Fuentes
Francisco
F
Agüero
Jaime
J
Navarro-Manchón
Josep
J
Vicente
José-Luis
JL
Salvador
Antoinio
A
D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D015331:Cohort Studies; D016572:Cyclosporine / Q000627:therapeutic use*; D000077561:Daclizumab; D004359:Drug Therapy, Combination; D005260:Female; D006084:Graft Rejection / Q000188:drug therapy*; D006085:Graft Survival; D016027:Heart Transplantation / Q000401:mortality; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011282:Pregnenediones / Q000627:therapeutic use*; D011446:Prospective Studies; D015996:Survival Rate; D016559:Tacrolimus / Q000627:therapeutic use*; D016896:Treatment Outcome
D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D011282:Pregnenediones; D016572:Cyclosporine; D000077561:Daclizumab; D009173:Mycophenolic Acid; C021988:deflazacort; D016559:Tacrolimus