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

Forskningsoutput: TidskriftsbidragArtikel i vetenskaplig tidskrift

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% 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.

Detaljer

Författare
  • Lars Gullestad
  • Hans Eiskjaer
  • Finn Gustafsson
  • Gerdt C. Riise
  • Kristjan Karason
  • Göran Dellgren
  • Göran Rådegran
  • Lennart Hansson
  • Einar Gude
  • Øystein Bjørtuft
  • Kjell Jansson
  • Hans Henrik Schultz
  • Dag Solbu
  • Martin Iversen
Enheter & grupper
Externa organisationer
  • University of Oslo
  • Aarhus University Hospital
  • Copenhagen University Hospital
  • Sahlgrenska University Hospital
  • Skåne University Hospital
  • Oslo university hospital
  • Linköping University Hospital
  • Novartis Norge AS
Forskningsområden

Ämnesklassifikation (UKÄ) – OBLIGATORISK

  • Kardiologi

Nyckelord

Originalspråkengelska
Sidor (från-till)819-829
TidskriftTransplant International
Volym29
Utgåva nummer7
Tidigt onlinedatum2016 maj 30
StatusPublished - 2016 jul
PublikationskategoriForskning
Peer review utfördJa