An open-label randomized trial of the safety and efficacy of sirolimus vs. azathioprine in living related renal allograft recipients receiving cyclosporine and prednisone combination

An open-label randomized trial of the safety and efficacy of sirolimus vs. azathioprine in living related renal allograft recipients receiving cyclosporine and prednisone combination

Autor Machado, P. G. Google Scholar
Felipe, C. R. Google Scholar
Hanzawa, N. M. Google Scholar
Park, S. I. Google Scholar
Garcia, R. Google Scholar
Alfieri, F. Google Scholar
Franco, M. Google Scholar
Silva, H. T. Google Scholar
Medina-Pestana, J. O. Google Scholar
Instituição Universidade Federal de São Paulo (UNIFESP)
Labs Wyeth Brasil
Resumo Background: the ability of sirolimus (SRL), in combination with reduced exposure of cyclosporine, was investigated to prevent acute rejection and associated side effects.Methods: Between June 1999 and February 2000, 70 recipients of primary one-haplotype living-related donor renal allografts were randomized to receive SRL (2 mg/d) or azathioprine (AZA) (2 mg/kg/d) combined with cyclosporine and prednisone. the primary end-point was a composite of first occurrence of biopsy-confirmed acute rejection, graft loss, or death during the first 3 months after transplantation.Results: From week 4 to month 12, SRL patients received lower cyclosporine (week 4: 364 mg/d vs. 455 mg/d, p = 0.004; month 12: 195 mg/d vs. 255 mg/d, p = 0.038) doses and showed lower cyclosporine concentrations (week 4: 247 ng/mL vs. 309 ng/mL, p = 0.04; month 12: 143 ng/mL vs. 188 ng/mL, p = 0.045). Compared with AZA, SRL patients showed reduced 3-month primary end point (0% vs. 17.1%, p = 0.025), and reduced incidence of biopsy-confirmed acute rejection at 3 months (0% vs. 14.3%, p = 0.01) but not at 12 months (11.4% vs. 14.3%, NS). Mean creatinine at 12 months were not different (1.8 +/- 0.6 vs. 1.6 +/- 0.6, p = 0.23). Hyperlipidemia was the only adverse event more frequent among SRL patients (49% vs. 17%, p = 0.01). There were no differences in infections and no malignancies in both groups.Conclusions: the combination of 2 mg fixed doses of SRL, reduced cyclosporine exposure and prednisone was associated with a low incidence of acute rejection and did not result in significantly impaired graft function compared with patients receiving AZA, standard doses of cyclosporine and prednisone.
Assunto acute rejection
clinical trial
cyclosporine
kidney transplantation
sirolimus
Idioma Inglês
Data 2004-02-01
Publicado em Clinical Transplantation. Copenhagen: Blackwell Munksgaard, v. 18, n. 1, p. 28-38, 2004.
ISSN 0902-0063 (Sherpa/Romeo, fator de impacto)
Editor Blackwell Munksgaard
Extensão 28-38
Fonte http://dx.doi.org/10.1111/j.1399-0012.2004.00113.x
Direito de acesso Acesso restrito
Tipo Artigo
Web of Science WOS:000188046700005
URI http://repositorio.unifesp.br/handle/11600/27629

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