The Effect of Everolimus Versus Calcineurin Inhibitors on Quality of Life 10–12 Years After Heart Transplantation : The Results of a Randomized Controlled Trial (SCHEDULE Trial)
(2024) In Clinical Transplantation 38(11).- Abstract
Background: Calcineurin inhibitors (CNIs) are associated with long-term complications after heart transplantation (HTx). Everolimus (EVR)-based immunosuppression allows for CNI withdrawal. We used data from The Scandinavian heart transplant everolimus de novo study with early CNI avoidance (SCHEDULE) trial to assess whether health-related quality of life (HRQoL) differed between patients on long-term treatment with EVR versus a CNI-based regimen. Methods: In SCHEDULE, we randomized 115 patients (mean age 51 ± 13 years, 27% women) to cyclosporine (CNI group; n = 59), or early introduction of EVR and cyclosporine withdrawal within 11 weeks of HTx (EVR group; n = 56). The primary endpoint was the glomerular filtration rate. We used the... (More)
Background: Calcineurin inhibitors (CNIs) are associated with long-term complications after heart transplantation (HTx). Everolimus (EVR)-based immunosuppression allows for CNI withdrawal. We used data from The Scandinavian heart transplant everolimus de novo study with early CNI avoidance (SCHEDULE) trial to assess whether health-related quality of life (HRQoL) differed between patients on long-term treatment with EVR versus a CNI-based regimen. Methods: In SCHEDULE, we randomized 115 patients (mean age 51 ± 13 years, 27% women) to cyclosporine (CNI group; n = 59), or early introduction of EVR and cyclosporine withdrawal within 11 weeks of HTx (EVR group; n = 56). The primary endpoint was the glomerular filtration rate. We used the Short Form-36 (SF-36v2), the EuroQoL visual analogue scale (EQ VAS), and the Beck Depression Inventory (BDI) to assess HRQoL. We re-evaluated the participants after 10–12 years. Results: Seventy-eight patients attended follow-up at a median of 11 years after HTx. The SF-36 physical component summary score increased from 32 ± 10 pre-HTx to 44 ± 12 11 years after HTx (p < 0.01) in the EVR group and from 33 ± 9 to 44 ± 11 (p < 0.01) with CNI. The mental component summary score increased from 46 ± 12 to 53 ± 13 (EVR); p = 0.04 and from 38 ± 13 to 49 ± 13 (CNI); p < 0.01. Similar improvements were observed regarding EQ-VAS and the BDI. There were no significant between-group differences for either measure of HRQoL. Conclusions: In heart transplant recipients, an EVR-based immunosuppressive strategy resulted in similar long-term improvements in HRQoL as treatment with a CNI-based regimen.
(Less)
- author
- author collaboration
- organization
- publishing date
- 2024-11
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- calcineurin inhibitors, cyclosporine, everolimus, health-related quality of life, heart transplantation, immunosuppression, quality of life
- in
- Clinical Transplantation
- volume
- 38
- issue
- 11
- article number
- e70028
- publisher
- Wiley-Blackwell
- external identifiers
-
- scopus:85210088382
- pmid:39575520
- ISSN
- 0902-0063
- DOI
- 10.1111/ctr.70028
- language
- English
- LU publication?
- yes
- id
- 49c73e05-c6eb-4710-8434-3c90ecf45767
- date added to LUP
- 2025-01-15 10:44:16
- date last changed
- 2025-07-17 01:44:15
@article{49c73e05-c6eb-4710-8434-3c90ecf45767,
abstract = {{<p>Background: Calcineurin inhibitors (CNIs) are associated with long-term complications after heart transplantation (HTx). Everolimus (EVR)-based immunosuppression allows for CNI withdrawal. We used data from The Scandinavian heart transplant everolimus de novo study with early CNI avoidance (SCHEDULE) trial to assess whether health-related quality of life (HRQoL) differed between patients on long-term treatment with EVR versus a CNI-based regimen. Methods: In SCHEDULE, we randomized 115 patients (mean age 51 ± 13 years, 27% women) to cyclosporine (CNI group; n = 59), or early introduction of EVR and cyclosporine withdrawal within 11 weeks of HTx (EVR group; n = 56). The primary endpoint was the glomerular filtration rate. We used the Short Form-36 (SF-36v2), the EuroQoL visual analogue scale (EQ VAS), and the Beck Depression Inventory (BDI) to assess HRQoL. We re-evaluated the participants after 10–12 years. Results: Seventy-eight patients attended follow-up at a median of 11 years after HTx. The SF-36 physical component summary score increased from 32 ± 10 pre-HTx to 44 ± 12 11 years after HTx (p < 0.01) in the EVR group and from 33 ± 9 to 44 ± 11 (p < 0.01) with CNI. The mental component summary score increased from 46 ± 12 to 53 ± 13 (EVR); p = 0.04 and from 38 ± 13 to 49 ± 13 (CNI); p < 0.01. Similar improvements were observed regarding EQ-VAS and the BDI. There were no significant between-group differences for either measure of HRQoL. Conclusions: In heart transplant recipients, an EVR-based immunosuppressive strategy resulted in similar long-term improvements in HRQoL as treatment with a CNI-based regimen.</p>}},
author = {{Grov, Ingelin and Authen, Anne Relbo and Arora, Satish and Bergh, Niklas and Rolid, Katrine and Gustafsson, Finn and Eiskjær, Hans and Rådegran, Göran and Gude, Einar and Andreassen, Arne K. and Halden, Thea and Broch, Kaspar and Gullestad, Lars}},
issn = {{0902-0063}},
keywords = {{calcineurin inhibitors; cyclosporine; everolimus; health-related quality of life; heart transplantation; immunosuppression; quality of life}},
language = {{eng}},
number = {{11}},
publisher = {{Wiley-Blackwell}},
series = {{Clinical Transplantation}},
title = {{The Effect of Everolimus Versus Calcineurin Inhibitors on Quality of Life 10–12 Years After Heart Transplantation : The Results of a Randomized Controlled Trial (SCHEDULE Trial)}},
url = {{http://dx.doi.org/10.1111/ctr.70028}},
doi = {{10.1111/ctr.70028}},
volume = {{38}},
year = {{2024}},
}