medigraphic.com
SPANISH

Revista Mexicana de Trasplantes

ISSN 2007-6800 (Print)
  • Contents
  • View Archive
  • Information
    • General Information        
    • Directory
  • Publish
    • Instructions for authors        
    • Send manuscript
  • Policies
  • medigraphic.com
    • Home
    • Journals index            
    • Register / Login
  • Mi perfil

2019, Number 3

<< Back Next >>

Rev Mex Traspl 2019; 8 (3)

Prospective study in mexican patients for the safety and efficacy assessment of the conversion from mycophenolate mofetil (Cellcept™) to enteric-coated mycophenolate sodium (Myfortic™) in stable renal transplant recipients

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

Language: Spanish
References: 13
Page: 86-89
PDF size: 178.45 Kb.


Key words:

Sodium mycophenolate, ECM MPS, enteric coated, mycophenolate mofetil, kidney transplantation.

ABSTRACT

Introduction: The use of mycophenolate mofetil (MMF) has reduced the incidence of graft rejection when it is combined with calcineurine inhibitors. Gastrointestinal complications lead to stop the drug in 10 to 15% of the cases. Myfortic (ECM MPS) with enteric coat reduce these adverse events. Objective: To present the results comparing MMF to ECM MPS. Material and methods: 20 patients with at least six months receiving MMF were recruited. Cyclosporine and steroids completed the immunosuppression scheme and a signed consent was needed. 2 g/day of MMF were changed to 1440 mg/day of ECM MPS and the patients were evaluated clinically and with laboratory during six months. Adverse events, graft rejection episodes, graft loss, deaths and modifications in ECM MPS dose were registered. Results: 17 patients completed the study and the other three were out of the study: one retired consent and two for protocol violations. Four patients presented bilirrubin elevations and were corrected with dose adjustments. Two cases had diarrhea and one drug gastritis that responded to dose adjustments. There were no graft rejections, graft loss and no deaths. Conclusions: The results demonstrate the safety and efficacy of the ECM MPS compared to MMF with a reduction of gastrointestinal adverse events that is a relevant clinical point.


REFERENCES

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

  2. Calne R, White D, Thiru S et al. Cyclosporine A in patients receiving renal allografts from cadaver donors. Lancet. 1978; 2: 1323-1327.

  3. Yoshimura N, Matsui S, Hamashima T et al. Effect of a new immunosuppressive agent, TAC 506 on human lymphocyte responses in vitro. Transplantation. 1989; 47: 35-59.

  4. The US Multicenter TAC Liver Study Group. A comparison of tacrolimus (TAC) and cyclosporine for immunosuppression in liver transplantation. New Engl J Med. 1994; 331: 1110-1115.

  5. Wiesner R et al. A randomized double-blind comparative study of mycophenolate mofetil and azathioprine in combination with cyclosporine and corticosteroids in primary liver transplant recipients. Liver Transplantation. 2001; 7 (5): 442-450.

  6. Allison AC, Eugui EM. Immunosuppressive and other effects of mycophenolic acid and an ester prodrug, mycophenolate. Immunol Rev. 1994; 136: 5-28.

  7. Behrend M. Adverse gastrointestinal effects of mycophenolate mofetil. Drug Saf. 2001; 24: 645.

  8. Gabardi S, Tran JL, Clarkson MR. Enteric-coated mycophenolate sodium. Ann Pharmacother. 2003; 37: 1685.

  9. Budde K, Curtis J, Knoll G et al. Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients: results of a 1-year study. Am J Transplant. 2004; 4: 237.

  10. Salvadori M, Holzer H, de Mattos A et al. Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients. Am J Transplant. 2004; 4: 231.

  11. Budde K, Glander P, Mai I et al. Mycophenolate mofetil and enteric-coated mycophenolate sodium have similar pharmacokinetic and pharmacodynamic profiles in stable renal allograft recipients. J Am Soc Nephrol. 2002; 13: Abstract 510.

  12. Abbud-Filho M, Girón GE, Hernández E et al. Stable renal transplant recipients can be safely converted from MMF to enteric-coated mycophenolate sodium tablets: interim results from a multicenter Latin American study. Transplant Proc. 2004; 36 (6): 1647-1649.

  13. Keown P et al. A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation. The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group). Transplantation. 1996; 61: 1029-1037.




2020     |     www.medigraphic.com

Mi perfil

C?MO CITAR (Vancouver)

Rev Mex Traspl. 2019;8