Long-term outcomes of thoracic transplant recipients following conversion to everolimus with reduced calcineurin inhibitor in a multicenter, open-label, randomized trial
2016 (English)In: Transplant International, ISSN 0934-0874, E-ISSN 1432-2277, Vol. 29, no 7, 819-829 p.Article in journal (Refereed) Published
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.
Place, publisher, year, edition, pages
Wiley-Blackwell Publishing Inc., 2016. Vol. 29, no 7, 819-829 p.
calcineurin inhibitor, certican, cyclosporine, everolimus, heart, lung, randomized, renal impairment, tacrolimus, transplantation
IdentifiersURN: urn:nbn:se:liu:diva-130205DOI: 10.1111/tri.12783ISI: 000379691200009PubMedID: 27067532OAI: oai:DiVA.org:liu-130205DiVA: diva2:948976
Funding agencies: Novartis Scandinavia2016-07-142016-07-142016-08-15Bibliographically approved