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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)

Relbo Authen, Anne; Grov, Ingelin; Karason, Kristjan; Gustafsson, Finn; Eiskjær, Hans; Rådegran, Göran LU ; Gude, Einar; Jansson, Kjell; Dellgren, Göran and Solbu, Dag, et al. (2017) In Clinical Transplantation
Abstract

The Scandinavian heart transplant everolimus de novo study with early calcineurin inhibitors avoidance (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... (More)

The Scandinavian heart transplant everolimus de novo study with early calcineurin inhibitors avoidance (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-HTx and 12 and 36 months post-HTx. At 12 and 36 months, the groups showed similar improvements in Short Form-36 measures (at pre-HTx, 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.

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Heart transplantation, Immunosuppression, Quality of life
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Clinical Transplantation
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Wiley-Blackwell
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  • scopus:85025098668
ISSN
0902-0063
DOI
10.1111/ctr.13038
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English
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yes
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afe0c122-cb37-433f-8620-f43c4d2fec2c
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2017-08-24 10:01:57
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2017-08-25 03:00:08
@article{afe0c122-cb37-433f-8620-f43c4d2fec2c,
  abstract     = {<p>The Scandinavian heart transplant everolimus de novo study with early calcineurin inhibitors avoidance (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-HTx and 12 and 36 months post-HTx. At 12 and 36 months, the groups showed similar improvements in Short Form-36 measures (at pre-HTx, 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&lt;.01; CsA: 32.5±8.2, 48.4±8.5, and 46.5±11.5; P&lt;.01; mental component summary: EVR: 46.0±12.0, 51.7±11.9, and 52.1±13.0; P&lt;.01; CsA: 38.2±12.5, 53.4±7.1, and 54.3±13.0; P&lt;.01); similar decrease in mean BDI (EVR: 10.9±10.2, 5.4±4.7, and 8.1±9.0; P&lt;.01; CsA: 11.8±7.1, 6.3±5.4, and 6.2±6.5; P&lt;.01); and similar Euro Qol-improvements. Thus, in this small-sized study, EVR-based and conventional CsA immunosuppressive strategies produced similar QoL improvements.</p>},
  author       = {Relbo Authen, Anne and Grov, Ingelin and Karason, Kristjan and Gustafsson, Finn and Eiskjær, Hans and Rådegran, Göran and Gude, Einar and Jansson, Kjell and Dellgren, Göran and Solbu, Dag and Arora, Satish and Andreassen, Arne K. and Gullestad, Lars},
  issn         = {0902-0063},
  keyword      = {Heart transplantation,Immunosuppression,Quality of life},
  language     = {eng},
  publisher    = {Wiley-Blackwell},
  series       = {Clinical Transplantation},
  title        = {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)},
  url          = {http://dx.doi.org/10.1111/ctr.13038},
  year         = {2017},
}