A prospective randomized study comparing cyclosporine versus tacrolimus combined with daclizumab, mycophenolate mofetil, and steroids in heart transplantation

• Published in: Clinical transplantation 2011-07, Vol.25 (4), p.606-613
• Main Authors: Sánchez-Lázaro, Ignacio J., Almenar, Luis, Martínez-Dolz, Luis, Buendía-Fuentes, Francisco, Agüero, Jaime, Navarro-Manchón, Josep, Vicente, José-Luis, Salvador, Antoinio
• Format: Article
• Language: English
• Subjects: Adult; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antibodies, Monoclonal, Humanized - therapeutic use; Antiviral agents; Biological and medical sciences; Cohort Studies; cyclosporine; Cyclosporine - therapeutic use; Drug Therapy, Combination; Female; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Graft Rejection - drug therapy; Graft Survival; heart transplantation; Heart Transplantation - mortality; Humans; Immunoglobulin G - therapeutic use; Immunosuppression; Immunosuppressive Agents - therapeutic use; Male; Medical sciences; Middle Aged; Mycophenolic Acid - analogs & derivatives; Mycophenolic Acid - therapeutic use; Pharmacology. Drug treatments; Pregnenediones - therapeutic use; Prospective Studies; renal function; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Surgery of the heart; Survival Rate; tacrolimus; Tacrolimus - therapeutic use; Tissue, organ and graft immunology; Treatment Outcome
• ISSN: 0902-0063; 1399-0012
• DOI: 10.1111/j.1399-0012.2010.01309.x

Sánchez‐Lázaro IJ, Almenar L, Martínez‐Dolz L, Buendía‐Fuentes F, Agüero J, Navarro‐Manchón J, Vicente J‐L, Salvador A. A prospective randomized study comparing cyclosporine versus tacrolimus combined with daclizumab, mycophenolate mofetil and steroids in heart transplantation.
Clin Transplant 2011: 25: 606–613. © 2010 John Wiley & Sons A/S. 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.