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

Machado, Paula Goulart Pinheiro; Felipe, Cláudia Rosso; Hanzawa, N.M; Park, Sung I; Garcia, Ricardo M; Alfieri, Fernando; Franco, M.; Silva, Hélio T.; Medina-Pestana, J.O.

doi:10.1111/j.1399-0012.2004.00113.x

Cited by 28 publications

(18 citation statements)

References 19 publications

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“…35 For recipients of organs from both living and deceased donors, the findings were consistent with the overall results for the outcomes of any cancer, non-melanoma skin cancer, and other cancer ( fig F in appendix 2). For the outcome of death, sirolimus use was associated with an increased risk of death in recipients from deceased donors (adjusted hazard ratio 1.52, 95% confidence interval 1.21 to 1.91), but there was a null effect in recipients with living donors (1.00, 0.56 to 1.78) (fig F in appendix 2).…”

Section: Subgroup Analysessupporting

confidence: 80%

“…[20][21][22][23] This in turn could have contributed to increased infection related mortality. Sirolimus is known to have side effects that are associated with an increased risk of cardiovascular disease, including anemia, [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] proteinuria, [37][38][39][40][41][42][43] hyperglycemia, 37 44 and hyperlipidemia.…”

Section: Principal Findingsmentioning

confidence: 99%

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Effect of sirolimus on malignancy and survival after kidney transplantation: systematic review and meta-analysis of individual patient data

Knoll

Kokolo

Mallick

et al. 2014

BMJ

264

182

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Objective To examine risk of malignancy and death in patients with kidney transplant who receive the immunosuppressive drug sirolimus.Design Systematic review and meta-analysis of individual patient data.Data sources Medline, Embase, and the Cochrane Central Register of Controlled Trials from inception to March 2013.Eligibility Randomized controlled trials comparing immunosuppressive regimens with and without sirolimus in recipients of kidney or combined pancreatic and renal transplant for which the author was willing to provide individual patient level data. Two reviewers independently screened titles/abstracts and full text reports of potentially eligible trials to identify studies for inclusion. All eligible trials reported data on malignancy or survival. Results The search yielded 2365 unique citations. Patient level data were available from 5876 patients from 21 randomized trials. Sirolimus was associated with a 40% reduction in the risk of malignancy (adjusted hazard ratio 0.60, 95% confidence interval 0.39 to 0.93) and a 56% reduction in the risk of non-melanoma skin cancer (0.44, 0.30 to 0.63) compared with controls. The most pronounced effect was seen in patients who converted to sirolimus from an established immunosuppressive regimen, resulting in a reduction in risk of malignancy (0.34, 0.28 to 0.41), non-melanoma skin cancer (0.32, 0.24 to 0.42), and other cancers (0.52, 0.38 to 0.69). Sirolimus was associated with an increased risk of death (1.43, 1.21 to 1.71) compared with controls.Conclusions Sirolimus was associated with a reduction in the risk of malignancy and non-melanoma skin cancer in transplant recipients. The benefit was most pronounced in patients who converted from an established immunosuppressive regimen to sirolimus. Given the risk of mortality, however, the use of this drug does not seem warranted for most patients with kidney transplant. Further research is needed to determine if different populations, such as those at high risk of cancer, might benefit from sirolimus.

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Section: Subgroup Analysessupporting

confidence: 80%

Section: Principal Findingsmentioning

confidence: 99%

Effect of sirolimus on malignancy and survival after kidney transplantation: systematic review and meta-analysis of individual patient data

Knoll

Kokolo

Mallick

et al. 2014

BMJ

264

182

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“…These studies are important to identify better immunosuppressive regimens for our patients, taking into account the unique demography of our transplant population, which is quite different from that reported in the US or Europe. We have been participants in of the majority of international clinical trials and have also performed local research with immunosuppressive drugs including new combi- nations of cyclosporine (19,20); reduced doses of OKT3 (21), tacrolimus (22), sirolimus (23), everolimus (24), mycophenolate mofetil (25), and mycophenolate sodium (26); and FTY720 (27,28). To implement our research program, we have developed techniques to measure blood levels of sirolimus and mycophenolic acid (16,17).…”

Section: Researchmentioning

confidence: 99%

Organization of a High-Volume Kidney Transplant Program???The ???Assembly Line??? Approach

Medina-Pestana

2006

Transplantation

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This report describes the organization of a high-volume Brazilian kidney transplant program. With use of an "assembly line" approach, 2,461 kidney transplantations were performed between 1999 and 2004, fulfilling government expectations without compromising the care of the patients. The annual number of kidney transplants increased from 428 to 656 per year. In our Organ Procurement Organization (with 7 million inhabitants), brain death notifications increased from 196 to 461, but less than 25% became actual donors. There are 3,200 patients on the waiting list and recipient selection is based of human leukocyte antigen matching (25 new listings per week). More than 700 first appointments for living donation occur every year. A significant number of recipients are of black race and have been receiving dialysis for long periods of time. The majority of patients are followed locally (100-120 appointments per day). Transplant outcomes among living-donor recipients are comparable to those of large registries, but inferior outcomes have been observed among recipients of deceased-donor organs. However, consistent improvement has been seen in more recent years. The present report also discusses issues related to local regulations and solutions to improve efficiency and outcomes.

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“…Nesse estudo, a incidência de rejeição aguda (11,4% versus 14,3%, p > 0,05) e a função renal (creatinina média 1,8 ± 0,6 versus 1,6 ± 0,6 mg/dL, p = 0,23) foi similar àquelas observadas nos pacientes que receberam azatioprina e doses-padrão de CSA ao final do primeiro ano de transplante. 8 Outras estratégias efetivas incluem a redução significativa da concentração-alvo ou a suspensão da CSA 3 meses após o transplante renal. Em um estudo multicêntrico nacional, essas duas estratégias foram eficazes na preservação da função renal após 1 ano de transplante (ritmo de filtração glomerular calculado: 49,5 versus 51,6 mL/min, p = 0,603), sem que houvesse incremento estatisticamente significativo na incidência de rejeição aguda após a suspensão da CSA (14,3% versus 22,5%, p = 0,152).…”

Section: Introductionunclassified

Eficácia, tolerabilidade e segurança do uso do sirolimo após o transplante renal

Oliveira¹,

Harada²,

Spinelli³

et al. 2009

J. Bras. Nefrol.

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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

Abstract: 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.

Cited by 28 publications

References 19 publications

Effect of sirolimus on malignancy and survival after kidney transplantation: systematic review and meta-analysis of individual patient data

Effect of sirolimus on malignancy and survival after kidney transplantation: systematic review and meta-analysis of individual patient data

Organization of a High-Volume Kidney Transplant Program???The ???Assembly Line??? Approach

Eficácia, tolerabilidade e segurança do uso do sirolimo após o transplante renal

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