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with contradictory results<span class="elsevierStyleSup">4-7</span>&#46; We previously reported excellent and satisfactory results after 1 and 3 years without CNI<span class="elsevierStyleSup">8&#44;9</span> and we now present an observational and retrospective study of efficacy and safety after 5 years of the SRL&#47;MMF&#47;ST regimen compared with cyclosporine &#40;CS&#41;&#47;MMT&#47;ST and selective induction with basiliximab in 41 patients enrolled between May 2004 and January 2005&#46;</p><p class="elsevierStylePara">The study design has previously been reported in detail<span class="elsevierStyleSup">8</span>&#46; In this report&#44; the results were analysed in two populations&#58; the intention-to-treat &#40;ITT&#41; population&#44; which included all patients with a functioning graft&#44; and the population on treatment &#40;OT&#41;&#44; which included patients who were maintained on the same original study immunosuppression regimen&#46;</p><p class="elsevierStylePara">The demographic data of patients are displayed in Table 1&#46; 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in the CS group &#40;<span class="elsevierStyleItalic">p</span>&#61;&#46;039&#41; with a functioning graft changed their regimen to SRL due to interstitial fibrosis and tubular atrophy confirmed by biopsy&#46; We maintained all patients in the SRL group with a functioning graft on the SRL&#47;MMF&#47;ST regimen&#46; After one year of follow-up&#44; 2 patients in the SRL group &#40;11&#46;1&#37;&#41; and 3 in the CS group &#40;17&#46;7&#37;&#41; had episodes of AR &#40;<span class="elsevierStyleItalic">p</span>&#61;ns&#41;&#46;</p><p class="elsevierStylePara">Graft function calculated by the glomerular filtration rate estimated using the MDRD &#40;Modification of Diet in Renal Disease&#41; formula<span class="elsevierStyleSup">10 </span>and serum creatinine is displayed in Table 2&#46; We did not find a statistically significant difference between the two groups&#44; independently of whether they were an ITT population or a population OT&#46; Patients in the SRL group had a higher elimination of proteins in 24h urine &#40;<span class="elsevierStyleItalic">p</span>&#61;&#46;039&#41; than patients in the CS group in the ITT population&#46; Serum haemoglobin was similar in both cases&#46; Cholesterol and triglycerides were significantly higher in the SRL group &#40;Table 2&#41;&#46;</p><p class="elsevierStylePara">There were a total of 81 adverse effect events&#44; which were mostly infectious &#40;14 in the SRL group and 16 in the CS group&#41;&#46; There was a similar incidence in new onset diabetes after transplantation &#40;NODAT&#41; &#40;10&#37; in the SRL group versus 9&#46;5&#37; in the CS group&#41;&#46; No patient developed a malignancy during follow-up&#46; Six patients &#40;37&#46;5&#37;&#41; in the SRL group and 31&#46;3&#37; &#40;n&#61;5&#41; in the CS group were taking angiotensin-converting-enzyme inhibitors and&#47;or angiotensin receptor blockers after 5 years &#40;<span class="elsevierStyleItalic">p</span>&#61;&#46;7&#41;&#46; Similarly&#44; more patients in the SRL group were taking lipid-lowering drugs than in the CS group &#40;n&#61;7&#44; 43&#46;8&#37;&#44; versus n&#61;6&#44; 37&#46;5&#37;&#41; &#40;<span class="elsevierStyleItalic">p</span>&#61;&#46;2&#41;&#46;</p><p class="elsevierStylePara">In summary&#44; despite the fact that our results need to be carefully reviewed due to certain limitations&#44; such as the sample size&#44; retrospective recording and a population of low immunological risk&#44; we concluded that living donor transplantation patients with selective induction on the SRL&#47;MMF&#47;ST regimen have similar graft survival and function 5 years after transplantation to those on the CSA&#47;MMF&#47;ST regimen&#46;</p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Conflict of interest</span></p><p class="elsevierStylePara">The authors declare the following conflicts of interest&#58;</p><p class="elsevierStylePara">-&#160;&#160;&#160;&#160;&#160;&#160; Dr&#46; Gustavo Mart&#237;nez Mier receives lecture fees from Pfizer&#44; Roche and Novartis and consultancy fees from Novartis and Sanofi&#46;</p><p class="elsevierStylePara"><a href="grande&#47;11810&#95;16025&#95;60216&#95;en&#95;t111810&#46;jpg" class="elsevierStyleCrossRefs"><img src="11810_16025_60216_en_t111810.jpg" alt="Clinical and demographic parameters"></img></a></p><p class="elsevierStylePara">Table 1&#46; Clinical and demographic parameters</p><p class="elsevierStylePara"><a href="grande&#47;11810&#95;16025&#95;60217&#95;en&#95;t211810&#46;jpg" class="elsevierStyleCrossRefs"><img src="11810_16025_60217_en_t211810.jpg" alt="Graft function based on the analysis of patients on treatment and those who we intended to treat"></img></a></p><p class="elsevierStylePara">Table 2&#46; Graft function based on the analysis of patients on treatment and those who we intended to treat</p>"
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Results 5 years after living donor renal transplantation without calcineurin inhibitors
Resultados a 5 años de trasplante renal de donante vivo sin inhibidores de calcineurina
Gustavo Martínez-Miera, Sandro F. Ávila-Pardoa, Marco T. Méndez-Lópezb, Luis F. Budar-Fernándezb, Benjamín Franco-Ahumadaa, Felipe González-Velázquezc
a Servicio de Trasplantes, IMSS UMAE 189 ARC. Hospital Regional de Alta Especialidad de Veracruz, México,
b Servicio de Trasplantes, IMSS UMAE 189 ARC, Veracruz, México,
c Servicio de Investigación, IMSS UMAE 189 ARC, Veracruz, México,
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    "textoCompleto" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">To the Editor&#44;</span></p><p class="elsevierStylePara">Calcineurin inhibitor-based &#40;CNI&#41; immunosuppression regimens have improved the outcomes of renal transplantation&#46; Unfortunately&#44; the use of CNI has been associated with interstitial fibrosis and tubular atrophy&#44; affecting graft function and graft survival<span class="elsevierStyleSup">1</span>&#46; In order to avoid exposure to CNI&#44; agents such as sirolimus &#40;SRL&#41; have emerged as new therapeutic options&#46; Therapeutic strategies with SRL include the minimisation&#44; suspension&#44; elimination and total absence of CNI<span class="elsevierStyleSup">2</span>&#46;</p><p class="elsevierStylePara">Experiences with CNI-free SRL&#47;mycophenolate mofetil &#40;MMF&#41;&#47;ST immunosuppression have not obtained sufficient acute rejection &#40;AR&#41; prophylaxis<span class="elsevierStyleSup">3</span>&#46; The introduction of induction therapy improved AR rates and short-term efficacy &#40;1-3 years&#41; with contradictory results<span class="elsevierStyleSup">4-7</span>&#46; We previously reported excellent and satisfactory results after 1 and 3 years without CNI<span class="elsevierStyleSup">8&#44;9</span> and we now present an observational and retrospective study of efficacy and safety after 5 years of the SRL&#47;MMF&#47;ST regimen compared with cyclosporine &#40;CS&#41;&#47;MMT&#47;ST and selective induction with basiliximab in 41 patients enrolled between May 2004 and January 2005&#46;</p><p class="elsevierStylePara">The study design has previously been reported in detail<span class="elsevierStyleSup">8</span>&#46; In this report&#44; the results were analysed in two populations&#58; the intention-to-treat &#40;ITT&#41; population&#44; which included all patients with a functioning graft&#44; and the population on treatment &#40;OT&#41;&#44; which included patients who were maintained on the same original study immunosuppression regimen&#46;</p><p class="elsevierStylePara">The demographic data of patients are displayed in Table 1&#46; Five-year patient survival was 90&#37; in the SRL group and 80&#46;9&#37; in the CS group &#40;<span class="elsevierStyleItalic">p</span>&#61;ns&#41;&#46; The causes of death in the SRL group were cardiovascular &#40;n&#61;1&#41; and infectious &#40;n&#61;1&#41;&#44; which was similar to the CS group&#58; cardiovascular &#40;n&#61;2&#41;&#44; infectious &#40;n&#61;2&#41; and gastrointestinal bleeding &#40;n&#61;1&#41;&#46; Five-year graft survival was 80&#37; for SRL and 76&#46;1&#37; for CS &#40;<span class="elsevierStyleItalic">p</span>&#61;ns&#41;&#46; The causes of graft loss in the SRL group were&#58; graft thrombosis &#40;n&#61;1&#41;&#44; <span class="elsevierStyleItalic">de novo </span><span class="elsevierStyleItalic">glomerulonephritis</span> &#40;n&#61;1&#41;&#44; urological complications &#40;n&#61;1&#41; and a lack of adherence to treatment &#40;n&#61;1&#41;&#46; In the CS group they were&#58; graft thrombosis &#40;n&#61;1&#41;&#44; <span class="elsevierStyleItalic">de novo </span><span class="elsevierStyleItalic">glomerulonephritis</span> &#40;n&#61;1&#41;&#44; lupus &#40;n&#61;1&#41;&#44; chronic kidney disease &#40;n&#61;1&#41; and death with a functioning graft &#40;n&#61;1&#41;&#46;</p><p class="elsevierStylePara">Eight patients &#40;40&#37;&#41; from the SRL group and 3 &#40;14&#37;&#41; from the CS group received basiliximab induction&#46; After 5 years&#44; there was a decrease in the dose of CS &#40;133&#177;29&#46;9mg&#47;day&#44; range 120-200&#41; and of SRL &#40;1&#46;75&#177;0&#46;66mg&#47;day&#44; range 1-3&#41; compared to 12 months after transplantation &#40;205&#46;7&#177;66mg&#47;day and 3&#46;2&#177;1&#46;7mg&#47;day CS and SRL&#44; respectively&#41;&#46; The mean dose of MMF was higher in the CS group &#40;1218&#46;75&#177;363g&#47;day&#44; range 500-2000&#41;&#44; compared with the SRL group &#40;1093&#46;9&#177;417g&#47;day&#44; range 500-2000&#41; &#40;<span class="elsevierStyleItalic">p</span>&#61;&#46;3&#41;&#46; All patients in the study continued to take 5mg&#47;day of oral prednisone&#46; Four patients &#40;25&#37;&#41; in the CS group &#40;<span class="elsevierStyleItalic">p</span>&#61;&#46;039&#41; with a functioning graft changed their regimen to SRL due to interstitial fibrosis and tubular atrophy confirmed by biopsy&#46; We maintained all patients in the SRL group with a functioning graft on the SRL&#47;MMF&#47;ST regimen&#46; After one year of follow-up&#44; 2 patients in the SRL group &#40;11&#46;1&#37;&#41; and 3 in the CS group &#40;17&#46;7&#37;&#41; had episodes of AR &#40;<span class="elsevierStyleItalic">p</span>&#61;ns&#41;&#46;</p><p class="elsevierStylePara">Graft function calculated by the glomerular filtration rate estimated using the MDRD &#40;Modification of Diet in Renal Disease&#41; formula<span class="elsevierStyleSup">10 </span>and serum creatinine is displayed in Table 2&#46; We did not find a statistically significant difference between the two groups&#44; independently of whether they were an ITT population or a population OT&#46; Patients in the SRL group had a higher elimination of proteins in 24h urine &#40;<span class="elsevierStyleItalic">p</span>&#61;&#46;039&#41; than patients in the CS group in the ITT population&#46; Serum haemoglobin was similar in both cases&#46; Cholesterol and triglycerides were significantly higher in the SRL group &#40;Table 2&#41;&#46;</p><p class="elsevierStylePara">There were a total of 81 adverse effect events&#44; which were mostly infectious &#40;14 in the SRL group and 16 in the CS group&#41;&#46; There was a similar incidence in new onset diabetes after transplantation &#40;NODAT&#41; &#40;10&#37; in the SRL group versus 9&#46;5&#37; in the CS group&#41;&#46; No patient developed a malignancy during follow-up&#46; Six patients &#40;37&#46;5&#37;&#41; in the SRL group and 31&#46;3&#37; &#40;n&#61;5&#41; in the CS group were taking angiotensin-converting-enzyme inhibitors and&#47;or angiotensin receptor blockers after 5 years &#40;<span class="elsevierStyleItalic">p</span>&#61;&#46;7&#41;&#46; Similarly&#44; more patients in the SRL group were taking lipid-lowering drugs than in the CS group &#40;n&#61;7&#44; 43&#46;8&#37;&#44; versus n&#61;6&#44; 37&#46;5&#37;&#41; &#40;<span class="elsevierStyleItalic">p</span>&#61;&#46;2&#41;&#46;</p><p class="elsevierStylePara">In summary&#44; despite the fact that our results need to be carefully reviewed due to certain limitations&#44; such as the sample size&#44; retrospective recording and a population of low immunological risk&#44; we concluded that living donor transplantation patients with selective induction on the SRL&#47;MMF&#47;ST regimen have similar graft survival and function 5 years after transplantation to those on the CSA&#47;MMF&#47;ST regimen&#46;</p><p class="elsevierStylePara">&#160;</p><p class="elsevierStylePara"><span class="elsevierStyleBold">Conflict of interest</span></p><p class="elsevierStylePara">The authors declare the following conflicts of interest&#58;</p><p class="elsevierStylePara">-&#160;&#160;&#160;&#160;&#160;&#160; Dr&#46; Gustavo Mart&#237;nez Mier receives lecture fees from Pfizer&#44; Roche and Novartis and consultancy fees from Novartis and Sanofi&#46;</p><p class="elsevierStylePara"><a href="grande&#47;11810&#95;16025&#95;60216&#95;en&#95;t111810&#46;jpg" class="elsevierStyleCrossRefs"><img src="11810_16025_60216_en_t111810.jpg" alt="Clinical and demographic parameters"></img></a></p><p class="elsevierStylePara">Table 1&#46; Clinical and demographic parameters</p><p class="elsevierStylePara"><a href="grande&#47;11810&#95;16025&#95;60217&#95;en&#95;t211810&#46;jpg" class="elsevierStyleCrossRefs"><img src="11810_16025_60217_en_t211810.jpg" alt="Graft function based on the analysis of patients on treatment and those who we intended to treat"></img></a></p><p class="elsevierStylePara">Table 2&#46; Graft function based on the analysis of patients on treatment and those who we intended to treat</p>"
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Article information
ISSN: 20132514
Original language: English
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2024 August 57 59 116
2024 July 44 29 73
2024 June 66 33 99
2024 May 58 32 90
2024 April 54 23 77
2024 March 41 18 59
2024 February 52 31 83
2024 January 27 20 47
2023 December 24 27 51
2023 November 39 35 74
2023 October 56 24 80
2023 September 34 29 63
2023 August 35 23 58
2023 July 33 20 53
2023 June 28 19 47
2023 May 42 36 78
2023 April 35 13 48
2023 March 50 18 68
2023 February 34 27 61
2023 January 35 22 57
2022 December 44 38 82
2022 November 53 24 77
2022 October 56 35 91
2022 September 60 29 89
2022 August 37 45 82
2022 July 38 41 79
2022 June 44 33 77
2022 May 32 29 61
2022 April 45 62 107
2022 March 43 47 90
2022 February 34 43 77
2022 January 37 30 67
2021 December 34 38 72
2021 November 50 36 86
2021 October 53 43 96
2021 September 43 40 83
2021 August 48 42 90
2021 July 50 28 78
2021 June 47 33 80
2021 May 65 40 105
2021 April 94 57 151
2021 March 79 49 128
2021 February 65 29 94
2021 January 42 23 65
2020 December 42 19 61
2020 November 32 10 42
2020 October 34 19 53
2020 September 28 12 40
2020 August 47 16 63
2020 July 34 12 46
2020 June 48 13 61
2020 May 37 7 44
2020 April 46 18 64
2020 March 32 10 42
2020 February 55 23 78
2020 January 44 15 59
2019 December 51 20 71
2019 November 50 23 73
2019 October 33 11 44
2019 September 38 15 53
2019 August 30 16 46
2019 July 36 24 60
2019 June 31 16 47
2019 May 34 14 48
2019 April 71 27 98
2019 March 33 19 52
2019 February 24 14 38
2019 January 38 20 58
2018 December 93 52 145
2018 November 92 18 110
2018 October 63 13 76
2018 September 86 14 100
2018 August 54 17 71
2018 July 53 17 70
2018 June 63 23 86
2018 May 58 9 67
2018 April 94 11 105
2018 March 80 5 85
2018 February 44 7 51
2018 January 51 6 57
2017 December 71 5 76
2017 November 65 11 76
2017 October 47 6 53
2017 September 55 12 67
2017 August 61 8 69
2017 July 61 10 71
2017 June 65 13 78
2017 May 64 7 71
2017 April 58 12 70
2017 March 32 2 34
2017 February 32 12 44
2017 January 20 6 26
2016 December 73 8 81
2016 November 78 6 84
2016 October 93 11 104
2016 September 124 4 128
2016 August 188 2 190
2016 July 170 4 174
2016 June 126 0 126
2016 May 132 0 132
2016 April 97 0 97
2016 March 75 0 75
2016 February 106 0 106
2016 January 98 0 98
2015 December 117 0 117
2015 November 79 0 79
2015 October 90 0 90
2015 September 83 0 83
2015 August 71 0 71
2015 July 86 0 86
2015 June 48 0 48
2015 May 53 0 53
2015 April 16 0 16
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