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2019, Number 2

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Rev Mex Traspl 2019; 8 (2)

A six month, single centre, open, single arm study to evaluate the efficacy, safety and tolerability of everolimus in combination with neoral and steroids for the prophylaxis of acute rejection after kidney transplantation

Juárez‑de la Cruz FJ, Barrios‑Reyes CY
Full text How to cite this article

Language: Spanish
References: 31
Page: 49-55
PDF size: 222.10 Kb.


Key words:

Kidney transplantation, everolimus, organ transplantation, rejection, acute rejection, everolimus, RAD-SDZ, m-TOR inhibitors.

ABSTRACT

Introduction: Everolimus is an M-TOR inhibitor and help to prevent chronic allograft nephropathy and acute rejection episodes. Material and methods: Open six month study to evaluate the safety and efficacy of everolimus in combination with neoral and steroids in patients with living donor kidney transplant. Total dose of everolimus was 3 mg/day divided in two doses. The evaluations were done at basal, 7, 14 and 28 days through six months and followed to one year. Results: Total of 20 patients (12 women and 8 men) with 39.2 ± 10.2 years of age. The study was completed in 17 patients and three of them were lost: one with leucopenia, one with thrombocytopenia and the other with chronic allograft nephropathy. There was a 10% incidence of acute rejection and there were no deaths. The adverse effects: hypercholesterolemia in 13 patients (65%), hypertriglicerydemia in 10 (50%) and pharyngitis in 5 (25%). There were no surgical wound complications and no lymphoceles. The serum everolimus levels were between 5 and 10 ng/mL. Serum creatinine was maintained in 1.6 mg/dL and was related to cyclosporine trough levels (C0) above 100 ng/mL; after the first six months the C0 level was dropped to 75 ng/ml and the serum creatinine level dropped to 1.2 mg/dL. Conclusion: Everolimus is an effective and potent immunosuppresor agent with no nephrotoxicity and can be used safely in organ transplantation.


REFERENCES

  1. Browne BJ, Kahan BD. Trasplante 1994: el año en revisión. Trasplante Clínico. 1994; 317-340.

  2. Cecka JM. Registro científico UNOS de trasplante renal-diez años de trasplante de riñón. Trasplante clínico. 1997; 1: 14.

  3. Sollinger HW para el Grupo de estudio con Micofenolato Mofetil en trasplantes renales en los Estados Unidos. El micofenolato mofetil para la prevención de los rechazos agudos e en receptores primarios de aloinjerto renal cadavérico. Trasplante. 1995; 53: 225.

  4. Sedrani R, Cottens S, Kallen J, Schuler W. Modificaciones químicas de la rapamicina: el descubrimiento de SDZ RAD. Procedimientos para el Trasplante. 1998; 30: 2192-2194.

  5. Liu J. FK506 y la ciclosporina, pruebas moleculares para estudiar la transducción de señales intracelulares. Inmunología de Hoy. 1993; 14: 290-295.

  6. Schuler W, Sedrani R, Cottens S et al. SDZ RAD, un nuevo derivado de la rapamicina. Trasplante. 1997; 64: 36-42.

  7. Schuurman HJ, Cottens S, Fuchs S et al. SDZ RAD un nuevo derivado de la rapamicina: sinergismo con rapamicina. Comentarios sobre: trasplantes. 1997; 64: 63-42.

  8. Hausen B, Boeke K, Berry GJ et al. Supresión del rechazo agudo en el trasplante allogeneic de pulmón en ratas: un estudio de la eficacia y fármaco cinética del derivado de rapamicina. (SDZ RAD) usado solo o en combinación con una microemulsión de ciclosporina. Trasplante de Corazón y Pulmón 1999a; 18: 150-159.

  9. Hausen B, Boeke K, Berry GJ et al. Coadministración de Neoral y del nuevo análogo de la rapamicina, SDZ RAD, en receptores de aloinjerto de pulmón en rata potencialidad de la eficacia inmunosupresora y mejoramiento de la tolerancia del tratamiento escalonado contra el tratamiento simultáneo. Trasplante. 1999b; 67: 956-962.

  10. Hausen B, Gummert JF, Berry GJ et al. Prevención de los rechazos de aloinjerto agudos en receptores de trasplantes de pulmón de primates no humanos: la inducción con anticuerpos monoclonales de receptores chimeric anti-IL2 mejora la tolerancia e impulsa la actividad inmunosupresora de un régimen utilizando bajas dosis tanto de microemulsión de ciclosporina y el derivado de sirolimus (SDZ-RAD). Trasplante 1999d: en prensa.

  11. Appel-Dingemanse S, Wong R, Dou L et al. Fármaco cinética de dosis múltiple de inmunosupresor SDZ RAD en receptores estables de trasplante renal. Trasplante. 1998; 65: 138.

  12. Dantal J, Lehne G, Winkler M et al. Fármaco cinética de estado estable y tolerancia de RAD y sus influencias sobre la ciclosporina en pacientes estables de trasplante renal. Trasplante. 1999; 67: S160.

  13. Levy GA, Grant D, Guilbault N et al. Perfil de absorción de RAD en pacientes de novo con trasplante de hígado. Trasplante. 1999; 67: S33.

  14. Appel-Dingemanse, Wong R, Dou L et al. Primer estudio fármaco cinético con SDZ RAD en pacientes estables con trasplante de pulmón. Trasplante. 1998; 65: 264.

  15. Doyle R, Wong R, Newmark R et al. Seguridad y tolerancia de dos diferentes dosis únicas de SDZ RAD en pacientes con trasplante de pulmón. Trasplante. 1998; 65: 234.

  16. Kovarik JM, Rordorf C, Hartmann S et al. Estudio de escalada de dosis para evaluar la seguridad, fármaco cinética y la proporcionalidad de las dosis de RAD. Trasplante. 1999; 67: S158.

  17. Kahan B, Wilkie M, Appel-Dingemanse S et al. Seguridad y tolerancia del inmunosupresor SDZ RAD en receptores estables de trasplante renal. Trasplante. 1998; 65: 17.

  18. Andoh TF, Lindsley J, Franceschini N, Bennett WM. Synergistic effects of ciclosporinae and rapamycin in a chronic nephrotoxicity model. Transplantation. 1996; 62: 311-316.

  19. Eris J. Clinical experience with everolimus (Everolimus) in young renal transplant recipients. Transplantation. 2005; 79: S89-S92.

  20. Flechner SM, Goldfarb D, Modlin C et al. Kidney transplantation without calcineurin inhibitor drugs: a prospective, randomized trial of sirolimus versus ciclosporinae. Transplantation. 2002; 74: 1070-1076.

  21. Lorber MI, Ponticelli C, Whelchel J et al. Therapeutic drug monitoring for everolimus in kidney transplantation using 12-month exposure, efficacy, and safety data. Clin Transplant. 2005b; 19: 145-152.

  22. Johnson RWG, Kreis H, Oberbauer R, Brattstrom C, Claesson K, Eris J. Sirolimus allows early ciclosporinae withdrawal in renal transplantation resulting in improved renal function and lower blood pressure. Transplantation. 2001; 72: 777-786.

  23. Jardine AG, Holdaas H, Fellstrom B et al. Fluvastatin prevents cardiac death and myocardial infarction in renal transplant recipients: post-hoc subgroup analyses of the ALERT Study. Am J Transplant. 2004; 4: 988-995.

  24. Keane WF. Proteinuria: its clinical importance and role in progressive renal disease. Am J Kidney Dis. 2000; 35: S97-105.

  25. Bischof G, Rockenschaub S, Berlakovich G et al. Management of lymphoceles after kidney transplantation. Transpl Int. 1998; 11: 277-280.

  26. Flechner SM, Zhou L, Derweesh I et al. The impact of Sirolimus, mycophenolate mofetil, ciclosporinae, azathioprine, and steroids on wound healing in 513 kidney-transplant recipients. Transplantation. 2003; 76: 1729-1734.

  27. Kamar N, Allard J, Ribes D, Durand D, Ader JL, Rostaing L. Assessment of glomerular and tubular functions in renal transplant patients receiving ciclosporinae A in combination with either sirolimus or everolimus. Clin Nephrol. 2005; 63: 80-86.

  28. Kasiske B, Cosio FG, Beto J et al. Clinical practice guidelines for managing dyslipidemias in kidney transplant patients: a report from the Managing Dyslipidemias in Chronic Kidney Disease Work Group of the National Kidney Foundation Kidney Disease Outcomes Quality Initiative. Am J Transplant. 2004; 4 (Suppl 7): 13-53.

  29. Khauli RB, Stoff JS, Lovewell T, Ghavamian R, Baker S. Post-transplant lymphoceles: a critical look into the risk factors, pathophysiology and management. J Urol. 1993; 150: 22-26.

  30. Knight RJ, Villa M, Welsh M et al. Risk factors for impaired wound healing in Sirolimus treated renal transplant recipients. Am J Transplant. 2003; 3 (Suppl 5): 481.

  31. Magee J, Tedesco H, Pascual J et al. Efficacy and safety of 2 doses of Everolimus combined with reduced-dose Neoral in de novo kidney transplant recipients: 12 month analysis. Am J Transplant. 2004; 4 (Suppl 8): 296.




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Rev Mex Traspl. 2019;8