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Effect of everolimus vs calcineurin inhibitors on quality of life in heart transplant recipients during a 3‐year follow‐up: Results of a randomized controlled trial ( SCHEDULE )
Author(s) -
Relbo Authen Anne,
Grov Ingelin,
Karason Kristjan,
Gustafsson Finn,
Eiskjær Hans,
Rådegran Göran,
Gude Einar,
Jansson Kjell,
Dellgren Göran,
Solbu Dag,
Arora Satish,
Andreassen Arne K.,
Gullestad Lars
Publication year - 2017
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.13038
Subject(s) - medicine , everolimus , randomized controlled trial , immunosuppression , quality of life (healthcare) , urology , calcineurin , coronary artery disease , transplantation , surgery , gastroenterology , nursing
The Sc andinavian he art transplant everolimus d e novo st u dy with ear l y calcineurin inhibitors avoidanc e ( SCHEDULE ) trial was a 12 month, randomized, open‐label, parallel‐group trial that compared everolimus ( EVR ; n=56) to conventional CsA (n=59) immunosuppression. Previously, we reported that EVR outperformed CsA in improving renal function and coronary artery vasculopathy, despite a higher rejection rate with EVR . This study aimed to compare the effects of these treatments on quality of life (QoL). Within five post‐operative days, patients (mean age 50±13 years, 27% women) were randomized to EVR or a standard CsA dosage (CsA group). This study assessed quality of life (QoL), based on the Short Form‐36, EuroQol‐5D, and Beck Depression Inventory ( BDI ). Assessments were performed pre‐ HT x and 12 and 36 months post‐ HT x. At 12 and 36 months, the groups showed similar improvements in Short Form‐36 measures (at pre‐ HT x, 12 and 36 months the values were as follows: Physical component summary: EVR : 31.5±110.9, 49.1±9.7, and 47.9±10.6; P <.01; CsA: 32.5±8.2, 48.4±8.5, and 46.5±11.5; P <.01; mental component summary: EVR : 46.0±12.0, 51.7±11.9, and 52.1±13.0; P <.01; CsA: 38.2±12.5, 53.4±7.1, and 54.3±13.0; P <.01); similar decrease in mean BDI ( EVR : 10.9±10.2, 5.4±4.7, and 8.1±9.0; P <.01; CsA: 11.8±7.1, 6.3±5.4, and 6.2±6.5; P <.01); and similar Euro Qol‐improvements. Thus, in this small‐sized study, EVR ‐based and conventional CsA immunosuppressive strategies produced similar QoL improvements.