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"apellidos" => "Budar-Fernández" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "affb" ] ] ] 4 => array:3 [ "nombre" => "Benjamín" "apellidos" => "Franco-Ahumada" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "affa" ] ] ] 5 => array:3 [ "nombre" => "Felipe" "apellidos" => "González-Velázquez" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "affc" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Servicio de Trasplantes, IMSS UMAE 189 ARC. Hospital Regional de Alta Especialidad de Veracruz, México, " "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "affa" ] 1 => array:3 [ "entidad" => "Servicio de Trasplantes, IMSS UMAE 189 ARC, Veracruz, México, " "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "affb" ] 2 => array:3 [ "entidad" => "Servicio de Investigación, IMSS UMAE 189 ARC, Veracruz, México, " "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "affc" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Resultados a 5 años de trasplante renal de donante vivo sin inhibidores de calcineurina" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig1" "etiqueta" => "Tab. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "figura" => array:1 [ 0 => array:4 [ "imagen" => "11810_16025_60216_en_t111810.jpg" "Alto" => 818 "Ancho" => 2150 "Tamanyo" => 530166 ] ] "descripcion" => array:1 [ "en" => "Clinical and demographic parameters" ] ] ] "textoCompleto" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">To the Editor,</span></p><p class="elsevierStylePara">Calcineurin inhibitor-based (CNI) immunosuppression regimens have improved the outcomes of renal transplantation. Unfortunately, the use of CNI has been associated with interstitial fibrosis and tubular atrophy, affecting graft function and graft survival<span class="elsevierStyleSup">1</span>. In order to avoid exposure to CNI, agents such as sirolimus (SRL) have emerged as new therapeutic options. Therapeutic strategies with SRL include the minimisation, suspension, elimination and total absence of CNI<span class="elsevierStyleSup">2</span>.</p><p class="elsevierStylePara">Experiences with CNI-free SRL/mycophenolate mofetil (MMF)/ST immunosuppression have not obtained sufficient acute rejection (AR) prophylaxis<span class="elsevierStyleSup">3</span>. The introduction of induction therapy improved AR rates and short-term efficacy (1-3 years) with contradictory results<span class="elsevierStyleSup">4-7</span>. We previously reported excellent and satisfactory results after 1 and 3 years without CNI<span class="elsevierStyleSup">8,9</span> and we now present an observational and retrospective study of efficacy and safety after 5 years of the SRL/MMF/ST regimen compared with cyclosporine (CS)/MMT/ST and selective induction with basiliximab in 41 patients enrolled between May 2004 and January 2005.</p><p class="elsevierStylePara">The study design has previously been reported in detail<span class="elsevierStyleSup">8</span>. In this report, the results were analysed in two populations: the intention-to-treat (ITT) population, which included all patients with a functioning graft, and the population on treatment (OT), which included patients who were maintained on the same original study immunosuppression regimen.</p><p class="elsevierStylePara">The demographic data of patients are displayed in Table 1. Five-year patient survival was 90% in the SRL group and 80.9% in the CS group (<span class="elsevierStyleItalic">p</span>=ns). The causes of death in the SRL group were cardiovascular (n=1) and infectious (n=1), which was similar to the CS group: cardiovascular (n=2), infectious (n=2) and gastrointestinal bleeding (n=1). Five-year graft survival was 80% for SRL and 76.1% for CS (<span class="elsevierStyleItalic">p</span>=ns). The causes of graft loss in the SRL group were: graft thrombosis (n=1), <span class="elsevierStyleItalic">de novo </span><span class="elsevierStyleItalic">glomerulonephritis</span> (n=1), urological complications (n=1) and a lack of adherence to treatment (n=1). In the CS group they were: graft thrombosis (n=1), <span class="elsevierStyleItalic">de novo </span><span class="elsevierStyleItalic">glomerulonephritis</span> (n=1), lupus (n=1), chronic kidney disease (n=1) and death with a functioning graft (n=1).</p><p class="elsevierStylePara">Eight patients (40%) from the SRL group and 3 (14%) from the CS group received basiliximab induction. After 5 years, there was a decrease in the dose of CS (133±29.9mg/day, range 120-200) and of SRL (1.75±0.66mg/day, range 1-3) compared to 12 months after transplantation (205.7±66mg/day and 3.2±1.7mg/day CS and SRL, respectively). The mean dose of MMF was higher in the CS group (1218.75±363g/day, range 500-2000), compared with the SRL group (1093.9±417g/day, range 500-2000) (<span class="elsevierStyleItalic">p</span>=.3). All patients in the study continued to take 5mg/day of oral prednisone. Four patients (25%) in the CS group (<span class="elsevierStyleItalic">p</span>=.039) with a functioning graft changed their regimen to SRL due to interstitial fibrosis and tubular atrophy confirmed by biopsy. We maintained all patients in the SRL group with a functioning graft on the SRL/MMF/ST regimen. After one year of follow-up, 2 patients in the SRL group (11.1%) and 3 in the CS group (17.7%) had episodes of AR (<span class="elsevierStyleItalic">p</span>=ns).</p><p class="elsevierStylePara">Graft function calculated by the glomerular filtration rate estimated using the MDRD (Modification of Diet in Renal Disease) formula<span class="elsevierStyleSup">10 </span>and serum creatinine is displayed in Table 2. We did not find a statistically significant difference between the two groups, independently of whether they were an ITT population or a population OT. Patients in the SRL group had a higher elimination of proteins in 24h urine (<span class="elsevierStyleItalic">p</span>=.039) than patients in the CS group in the ITT population. Serum haemoglobin was similar in both cases. Cholesterol and triglycerides were significantly higher in the SRL group (Table 2).</p><p class="elsevierStylePara">There were a total of 81 adverse effect events, which were mostly infectious (14 in the SRL group and 16 in the CS group). There was a similar incidence in new onset diabetes after transplantation (NODAT) (10% in the SRL group versus 9.5% in the CS group). No patient developed a malignancy during follow-up. Six patients (37.5%) in the SRL group and 31.3% (n=5) in the CS group were taking angiotensin-converting-enzyme inhibitors and/or angiotensin receptor blockers after 5 years (<span class="elsevierStyleItalic">p</span>=.7). Similarly, more patients in the SRL group were taking lipid-lowering drugs than in the CS group (n=7, 43.8%, versus n=6, 37.5%) (<span class="elsevierStyleItalic">p</span>=.2).</p><p class="elsevierStylePara">In summary, despite the fact that our results need to be carefully reviewed due to certain limitations, such as the sample size, retrospective recording and a population of low immunological risk, we concluded that living donor transplantation patients with selective induction on the SRL/MMF/ST regimen have similar graft survival and function 5 years after transplantation to those on the CSA/MMF/ST regimen.</p><p class="elsevierStylePara"> </p><p class="elsevierStylePara"><span class="elsevierStyleBold">Conflict of interest</span></p><p class="elsevierStylePara">The authors declare the following conflicts of interest:</p><p class="elsevierStylePara">-       Dr. Gustavo Martínez Mier receives lecture fees from Pfizer, Roche and Novartis and consultancy fees from Novartis and Sanofi.</p><p class="elsevierStylePara"><a href="grande/11810_16025_60216_en_t111810.jpg" class="elsevierStyleCrossRefs"><img src="11810_16025_60216_en_t111810.jpg" alt="Clinical and demographic parameters"></img></a></p><p class="elsevierStylePara">Table 1. Clinical and demographic parameters</p><p class="elsevierStylePara"><a href="grande/11810_16025_60217_en_t211810.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. Graft function based on the analysis of patients on treatment and those who we intended to treat</p>" "pdfFichero" => "P1-E572-S4665-A11810-EN.pdf" "tienePdf" => true "multimedia" => array:2 [ 0 => array:8 [ "identificador" => "fig1" "etiqueta" => "Tab. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "figura" => array:1 [ 0 => array:4 [ "imagen" => "11810_16025_60216_en_t111810.jpg" "Alto" => 818 "Ancho" => 2150 "Tamanyo" => 530166 ] ] "descripcion" => array:1 [ "en" => "Clinical and demographic parameters" ] ] 1 => array:8 [ "identificador" => "fig2" "etiqueta" => "Tab. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "copyright" => "Elsevier España" "figura" => array:1 [ 0 => array:4 [ "imagen" => "11810_16025_60217_en_t211810.jpg" "Alto" => 1756 "Ancho" => 2157 "Tamanyo" => 853030 ] ] "descripcion" => array:1 [ "en" => "Graft function based on the analysis of patients on treatment and those who we intended to treat" ] ] ] "bibliografia" => array:2 [ "titulo" => "Bibliography" "seccion" => array:1 [ 0 => array:1 [ "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:3 [ "referenciaCompleta" => "Nankivell BJ, Borrows RJ, Fung CL, O´Connel PJ, Allen RD, Chapman JR. 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Year/Month | Html | Total | |
---|---|---|---|
2024 November | 5 | 40 | 45 |
2024 October | 41 | 45 | 86 |
2024 September | 37 | 26 | 63 |
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 |