title: A prospective randomized study comparing cyclosporine versus tacrolimus combined with daclizumab, mycophenolate mofetil, and steroids in heart transplantation.
abstract: 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.
authors.affiliation: Heart Failure and Transplantation Unit, Cardiology Department, Hospital Universitario La Fe, Valencia, Spain. ignaciosanchezlazaro@gmail.com
authors.forename: Ignacio J
authors.initials: IJ
authors.lastname: Sánchez-Lázaro
authors.forename: Luis
authors.initials: L
authors.lastname: Almenar
authors.forename: Luis
authors.initials: L
authors.lastname: Martínez-Dolz
authors.forename: Francisco
authors.initials: F
authors.lastname: Buendía-Fuentes
authors.forename: Jaime
authors.initials: J
authors.lastname: Agüero
authors.forename: Josep
authors.initials: J
authors.lastname: Navarro-Manchón
authors.forename: José-Luis
authors.initials: JL
authors.lastname: Vicente
authors.forename: Antoinio
authors.initials: A
authors.lastname: Salvador
mesh_terms: 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
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D011282:Pregnenediones; D016572:Cyclosporine; D000077561:Daclizumab; D009173:Mycophenolic Acid; C021988:deflazacort; D016559:Tacrolimus