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Reduced Incidence of Cytomegalovirus Infection in Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses

Tedesco‐ Silva, H. ; Felipe, C. ; Ferreira, A. ; Cristelli, M. ; Oliveira, N. ; Sandes‐Freitas, T. ; Aguiar, W. ; Campos, E. ; Gerbase‐DeLima, M. ; Franco, M. ; Medina‐Pestana, J.

American journal of transplantation, 2015-10, Vol.15 (10), p.2655-2664 [Periódico revisado por pares]

United States: Wiley Subscription Services, Inc

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Título:
Reduced Incidence of Cytomegalovirus Infection in Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses
Autor: Tedesco‐ Silva, H. ; Felipe, C. ; Ferreira, A. ; Cristelli, M. ; Oliveira, N. ; Sandes‐Freitas, T. ; Aguiar, W. ; Campos, E. ; Gerbase‐DeLima, M. ; Franco, M. ; Medina‐Pestana, J.
Assuntos: Adult ; Antibodies, Monoclonal - therapeutic use ; Antilymphocyte serum ; Antilymphocyte Serum - therapeutic use ; Basiliximab ; Cytomegalovirus ; Cytomegalovirus Infections - epidemiology ; Cytomegalovirus Infections - immunology ; Cytomegalovirus Infections - prevention & control ; Dose-Response Relationship, Drug ; Drug Therapy, Combination ; Everolimus - administration & dosage ; Everolimus - therapeutic use ; Female ; Globulins ; Glomerular filtration rate ; Graft rejection ; Graft Rejection - prevention & control ; Humans ; Immune modulation ; immunosuppression ; Immunosuppressive Agents - administration & dosage ; Immunosuppressive Agents - therapeutic use ; Incidence ; Infections ; Inhibitor drugs ; Kidney Transplantation ; Kidney transplants ; Male ; Middle Aged ; Monoclonal antibodies ; Motivation ; Mycophenolic acid ; Mycophenolic Acid - therapeutic use ; nephrology ; Postoperative Complications - epidemiology ; Postoperative Complications - immunology ; Postoperative Complications - prevention & control ; Prednisone ; Prednisone - therapeutic use ; Prophylaxis ; Prospective Studies ; Proteinuria ; Recombinant Fusion Proteins - therapeutic use ; Sirolimus - therapeutic use ; Tacrolimus ; Tacrolimus - administration & dosage ; Tacrolimus - therapeutic use ; Thymocytes ; Treatment Outcome ; Wound healing
É parte de: American journal of transplantation, 2015-10, Vol.15 (10), p.2655-2664
Descrição: This study compared the incidence of CMV infection/disease in de novo kidney transplant recipients receiving everolimus or mycophenolate and no CMV pharmacological prophylaxis. We randomized 288 patients to receive a single 3 mg/kg dose of antithymocyte globulin, tacrolimus, everolimus, and prednisone (r‐ATG/EVR, n = 85); basiliximab, tacrolimus, everolimus, and prednisone (BAS/EVR, n = 102); or basiliximab, tacrolimus, mycophenolate, and prednisone (BAS/MPS, n = 101). The primary end‐point was the incidence of first CMV infection/disease in the intention‐to‐treat population at 12 months. Patients treated with r‐ATG/EVR showed a 90% proportional reduction (4.7% vs. 37.6%, HR 0.10, 95% CI 0.037–0.29; p < 0.001), while those treated with BAS/EVR showed a 75% proportional reduction (10.8% vs. 37.6%, HR 0.25, 95% CI 0.13–0.48; p < 0.001) in the incidence of CMV infection/disease compared to BAS/MPS. There were no differences in the incidence of acute rejection (9.4 vs. 18.6 vs. 15.8%, p = 0.403), wound‐healing complications, delayed graft function, and proteinuria. Mean estimated glomerular filtration rate was lower in BAS/EVR (65.7 ± 21.8 vs. 60.6 ± 20.9 vs. 69.5 ± 21.5 ml/min, p = 0.021). In de novo kidney transplant recipients receiving no pharmacological CMV prophylaxis, reduced‐dose tacrolimus and everolimus was associated with a significant reduction in the incidence of CMV infection/disease compared to standard tacrolimus dose and mycophenolate (ClinicalTrials.gov NCT01354301). This study shows that in de novo kidney transplant recipients receiving no CMV pharmacological prophylaxis, the use of everolimus and low‐dose tacrolimus is associated with lower incidence of CMV infection/disease compared to a standard tacrolimus and mycophenolate combination.
Editor: United States: Wiley Subscription Services, Inc
Idioma: Inglês

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Reduced Incidence of Cytomegalovirus Infection in Kidney Transplant Recipients Receiving Everolimus and Reduced Tacrolimus Doses

Tedesco‐ Silva, H. ; Felipe, C. ; Ferreira, A. ; Cristelli, M. ; Oliveira, N. ; Sandes‐Freitas, T. ; Aguiar, W. ; Campos, E. ; Gerbase‐DeLima, M. ; Franco, M. ; Medina‐Pestana, J.

United States: Wiley Subscription Services, Inc

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