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Long-term outcomes of thoracic transplant recipients following conversion to everolimus with reduced calcineurin inhibitor in a multicenter, open-label, randomized trial

Gullestad, Lars; Eiskjaer, Hans; Gustafsson, Finn; Riise, Gerdt C.; Karason, Kristjan; Dellgren, Göran; Rådegran, Göran LU ; Hansson, Lennart LU ; Gude, Einar and Bjørtuft, Øystein, et al. (2016) In Transplant International 29(7). p.29-819
Abstract

The NOCTET study randomized 282 patients ≥1 year after heart or lung transplantation to continue conventional calcineurin inhibitor (CNI) therapy or to start everolimus with reduced-exposure CNI. Last follow-up, at ≥5 years postrandomization (mean: 5.6 years) was attended by 72/140 everolimus patients (51.4%) and 91/142 controls (64.1%). Mean measured GFR remained stable in the everolimus group from randomization (51.3 ml/min) to last visit (51.4 ml/min) but decreased in controls (from 50.5 ml/min to 45.3 ml/min) and was significantly higher with everolimus at last follow-up (P = 0.004). The least squares mean (SE) change from randomization was -1.5 (1.7)ml/min with everolimus versus -7.2 (1.7)ml/min for controls (difference: 5.7 [95%... (More)

The NOCTET study randomized 282 patients ≥1 year after heart or lung transplantation to continue conventional calcineurin inhibitor (CNI) therapy or to start everolimus with reduced-exposure CNI. Last follow-up, at ≥5 years postrandomization (mean: 5.6 years) was attended by 72/140 everolimus patients (51.4%) and 91/142 controls (64.1%). Mean measured GFR remained stable in the everolimus group from randomization (51.3 ml/min) to last visit (51.4 ml/min) but decreased in controls (from 50.5 ml/min to 45.3 ml/min) and was significantly higher with everolimus at last follow-up (P = 0.004). The least squares mean (SE) change from randomization was -1.5 (1.7)ml/min with everolimus versus -7.2 (1.7)ml/min for controls (difference: 5.7 [95% CI 1.7; 9.6]ml/min; P = 0.006). The difference was accounted for by heart transplant patients (difference: 6.9 [95% 2.3; 11.5]ml/min; P = 0.004). Lung transplant patients showed no between-group difference at last follow-up. Rates of rejection, death, and major cardiac events were similar between groups, as was graft function. Pneumonia was more frequent with everolimus (18.3% vs. 6.4%). In conclusion, introducing everolimus in maintenance heart transplant patients, with reduced CNI, achieves a significant improvement in renal function which is maintained for at least 5 years, but an early renal benefit in lung transplant patients was lost. Long-term immunosuppressive efficacy was maintained.

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published
subject
keywords
Calcineurin inhibitor, Certican, Cyclosporine, Everolimus, Heart, Lung, Randomized, Renal impairment, Tacrolimus, Transplantation
in
Transplant International
volume
29
issue
7
pages
29 - 819
publisher
Springer
external identifiers
  • Scopus:84973875483
ISSN
0934-0874
DOI
10.1111/tri.12783
language
English
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yes
id
4fe88f4c-ce34-4377-a116-b6cfff87ffca
date added to LUP
2016-07-12 15:39:54
date last changed
2016-11-17 12:18:54
@misc{4fe88f4c-ce34-4377-a116-b6cfff87ffca,
  abstract     = {<p>The NOCTET study randomized 282 patients ≥1 year after heart or lung transplantation to continue conventional calcineurin inhibitor (CNI) therapy or to start everolimus with reduced-exposure CNI. Last follow-up, at ≥5 years postrandomization (mean: 5.6 years) was attended by 72/140 everolimus patients (51.4%) and 91/142 controls (64.1%). Mean measured GFR remained stable in the everolimus group from randomization (51.3 ml/min) to last visit (51.4 ml/min) but decreased in controls (from 50.5 ml/min to 45.3 ml/min) and was significantly higher with everolimus at last follow-up (P = 0.004). The least squares mean (SE) change from randomization was -1.5 (1.7)ml/min with everolimus versus -7.2 (1.7)ml/min for controls (difference: 5.7 [95% CI 1.7; 9.6]ml/min; P = 0.006). The difference was accounted for by heart transplant patients (difference: 6.9 [95% 2.3; 11.5]ml/min; P = 0.004). Lung transplant patients showed no between-group difference at last follow-up. Rates of rejection, death, and major cardiac events were similar between groups, as was graft function. Pneumonia was more frequent with everolimus (18.3% vs. 6.4%). In conclusion, introducing everolimus in maintenance heart transplant patients, with reduced CNI, achieves a significant improvement in renal function which is maintained for at least 5 years, but an early renal benefit in lung transplant patients was lost. Long-term immunosuppressive efficacy was maintained.</p>},
  author       = {Gullestad, Lars and Eiskjaer, Hans and Gustafsson, Finn and Riise, Gerdt C. and Karason, Kristjan and Dellgren, Göran and Rådegran, Göran and Hansson, Lennart and Gude, Einar and Bjørtuft, Øystein and Jansson, Kjell and Schultz, Hans Henrik and Solbu, Dag and Iversen, Martin},
  issn         = {0934-0874},
  keyword      = {Calcineurin inhibitor,Certican,Cyclosporine,Everolimus,Heart,Lung,Randomized,Renal impairment,Tacrolimus,Transplantation},
  language     = {eng},
  month        = {05},
  number       = {7},
  pages        = {29--819},
  publisher    = {ARRAY(0xb5f3538)},
  series       = {Transplant International},
  title        = {Long-term outcomes of thoracic transplant recipients following conversion to everolimus with reduced calcineurin inhibitor in a multicenter, open-label, randomized trial},
  url          = {http://dx.doi.org/10.1111/tri.12783},
  volume       = {29},
  year         = {2016},
}