Superior Prevention of Acute Rejection by Tacrolimus vs. Cyclosporine in Heart Transplant Recipients—A Large European Trial
2006; Elsevier BV; Volume: 6; Issue: 6 Linguagem: Inglês
10.1111/j.1600-6143.2006.01300.x
ISSN1600-6143
AutoresMichael Grimm, Mauro Rinaldi, Nizar Yonan, Giorgio Arpesella, José María Arizón del Prado, L. Alonso Pulpón, J. P. Villemot, Maria Frigerio, José Luis Lambert, María G. Crespo‐Leiro, Luís Almenar, D Duveau, Antonio Ordóñez, J Gandjbakhch, Massimo Maccherini, Günther Laufer,
Tópico(s)Viral Infections and Immunology Research
ResumoWe compared efficacy and safety of tacrolimus (Tac)-based vs. cyclosporine (CyA) microemulsion-based immunosuppression in combination with azathioprine (Aza) and corticosteroids in heart transplant recipients. During antibody induction, patients were randomized (1:1) to oral treatment with Tac or CyA. Episodes of acute rejection were assessed by protocol biopsies, which underwent local and blinded central evaluation. The full analysis set comprised 157 patients per group. Patient/graft survival was 92.9% for Tac and 89.8% for CyA at 18 months. The primary end point, incidence of first biopsy proven acute rejection (BPAR) of grade >/= 1B at month 6, was 54.0% for Tac vs. 66.4% for CyA (p = 0.029) according to central assessment. Also, incidence of first BPAR of grade >/= 3A at month 6 was significantly lower for Tac vs. CyA; 28.0% vs. 42.0%, respectively (p = 0.013). Significant differences (p < 0.05) emerged between groups for these clinically relevant adverse events: new-onset diabetes mellitus (20.3% vs. 10.5%); post-transplant arterial hypertension (65.6% vs. 77.7%); and dyslipidemia (28.7% vs. 40.1%) for Tac vs. CyA, respectively. Incidence and pattern of infections over 18 months were comparable between groups, as was renal function. Primary use of Tac during antibody induction resulted in superior prevention of acute rejection without an associated increase in infections.
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