Eficácia e segurança do Sirolimus associado a tacrolimus em baixas doses em paciente idoso transplantado renal
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Data
2016-03-04
Autores
Kojima, Christiane Akemi [UNESP]
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Universidade Estadual Paulista (Unesp)
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Introdução: O transplante renal é considerado uma opção de terapia renal substitutiva segura para pacientes acima de 60 anos, entretanto, não há consenso sobre o melhor esquema imunossupressor para o paciente transplantado renal idoso. Objetivo: Avaliar a eficácia e segurança da combinação de tacrolimus e sirolimus em doses reduzidas comparada com a associação tacrolimus e micofenolato. Métodos: Estudo prospectivo randomizado de centro único comparando a combinação de tacrolimus e sirolimus em dose reduzida (grupo sirolimus) contra tacrolimus e micofenolato (grupo micofenolato). Foram incluídos todos os pacientes transplantados renais maiores de 60 anos. Foram avaliadas a sobrevida do paciente e enxerto, taxas de rejeição, função renal e incidência de infecção por citomegalovírus (CMV) em 12 meses de seguimento. Resultados: Foram randomizados 46 pacientes e analisados 44 casos (dois casos excluídos por não terem sido transplantados). As características basais dos grupos foram semelhantes sendo todos os casos transplantados com doador falecido e a maioria induzida com basiliximabe. O grupo micofenolato (n=23) e o grupo sirolimus (n=21) apresentaram sobrevida do paciente e enxerto censurado óbito respectivamente de 95,7% e 100% para o micofenolato e 79,6% e 90,5% para o sirolimus sem diferenças estatísticas. A incidência de rejeição e função renal ao longo de 12 meses foi semelhante entre os grupos. A infecção de ferida operatória, retardo de função do enxerto e proteinúria foram semelhantes entre os grupos. O colesterol total e HDL colesterol foram maiores no grupo sirolimus. A infecção por CMV ocorreu em 60,9% no grupo micofenolato e 16,7% no grupo sirolimus apresentando um risco relativo 3,54 [1,2 – 10,3] vezes maior no grupo micofenolato, p=0,004. Conclusão: No grupo de transplantados renais idosos a combinação de tacrolimus e sirolimus em doses reduzidas foi segura mantendo taxas semelhantes de função renal em 12 meses, rejeição e sobrevida do enxerto e paciente. As principais complicações associadas ao sirolimus foram semelhantes com exceção de maiores taxas de colesterol total. A incidência de CMV foi significativamente menor no grupo sirolimus.
Introduction: Renal transplantation is considered safe for patients over 60 years, however, there is no consensus on the best immunosuppressive regimen in elderly. Objective: To evaluate the combination of tacrolimus and sirolimus in reduced dose in renal function comparing the combination tacrolimus and mycophenolate. Methods: A single-center prospective randomized study comparing the combination of tacrolimus and sirolimus in reduced dose (sirolimus group) against tacrolimus and mycophenolate (mycophenolate group). We included all kidney transplant patients over 60 years of age. We evaluated patient survival, biopsy prove acute rejection, renal function and incidence of cytomegalovirus (CMV) at 12 months of follow-up. Results: 46 patients were randomized and we analyzed 44 cases (two cases excluded because they were not transplanted). Baseline characteristics were similar between groups, all patients were transplanted with deceased donor, and the majority were induced with basiliximab. Mycophenolate group (n = 23) and sirolimus group (n = 21) had patient survival, and death censored graft survival respectively 95.7% and 100% for mycophenolate and 79.6% and 90.5% for the sirolimus without statistical differences. The incidence of acute rejection and kidney function over 12 months was similar between the groups. Infection of the surgical wound, delayed graft function and proteinuria were similar between groups. The total cholesterol and HDL cholesterol were higher in the sirolimus group. CMV infection occurred in 60.9% and 16.7% in mycophenolate and sirolimus group respectively. The relative risk of CMV were 3.54 [1, 2 - 10.3] times greater in mycophenolate group, p=0.004. Conclusion: In the sample of elderly kidney transplant combining tacrolimus and sirolimus in low doses was safe keeping similar rates of renal function at 12 months, rejection and graft survival. The main complications associated with sirolimus were similar except for a higher total cholesterol rates. The incidence of CMV was significantly lower in the sirolimus group.
Introduction: Renal transplantation is considered safe for patients over 60 years, however, there is no consensus on the best immunosuppressive regimen in elderly. Objective: To evaluate the combination of tacrolimus and sirolimus in reduced dose in renal function comparing the combination tacrolimus and mycophenolate. Methods: A single-center prospective randomized study comparing the combination of tacrolimus and sirolimus in reduced dose (sirolimus group) against tacrolimus and mycophenolate (mycophenolate group). We included all kidney transplant patients over 60 years of age. We evaluated patient survival, biopsy prove acute rejection, renal function and incidence of cytomegalovirus (CMV) at 12 months of follow-up. Results: 46 patients were randomized and we analyzed 44 cases (two cases excluded because they were not transplanted). Baseline characteristics were similar between groups, all patients were transplanted with deceased donor, and the majority were induced with basiliximab. Mycophenolate group (n = 23) and sirolimus group (n = 21) had patient survival, and death censored graft survival respectively 95.7% and 100% for mycophenolate and 79.6% and 90.5% for the sirolimus without statistical differences. The incidence of acute rejection and kidney function over 12 months was similar between the groups. Infection of the surgical wound, delayed graft function and proteinuria were similar between groups. The total cholesterol and HDL cholesterol were higher in the sirolimus group. CMV infection occurred in 60.9% and 16.7% in mycophenolate and sirolimus group respectively. The relative risk of CMV were 3.54 [1, 2 - 10.3] times greater in mycophenolate group, p=0.004. Conclusion: In the sample of elderly kidney transplant combining tacrolimus and sirolimus in low doses was safe keeping similar rates of renal function at 12 months, rejection and graft survival. The main complications associated with sirolimus were similar except for a higher total cholesterol rates. The incidence of CMV was significantly lower in the sirolimus group.
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Palavras-chave
Transplante renal, Inibidores da m-TOR, Sirolimus, Citomegalovírus, Idoso, Kidney transplantation, Cytomegalovirus, Aged, Elderly