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Everolimus Initiati...
Everolimus Initiation and Early Calcineurin Inhibitor Withdrawal in Heart Transplant Recipients: A Randomized Trial
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- Andreassen, A. K. (author)
- University of Oslo, Norway
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- Andersson, B. (author)
- Sahlgrens University Hospital, Sweden
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- Gustafsson, F. (author)
- Rigshosp, Denmark
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- Eiskjaer, H. (author)
- Aarhus University Hospital, Denmark
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- Rådegran, Göran (author)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital, Sweden Lund University, Sweden
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- Gude, E. (author)
- University of Oslo, Norway
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- Jansson, Kjell (author)
- Östergötlands Läns Landsting,Linköpings universitet,Avdelningen för kardiovaskulär medicin,Hälsouniversitetet,Kardiologiska kliniken US
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- Solbu, D. (author)
- Novartis Norge AS, Norway
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- Sigurdardottir, V. (author)
- Sahlgrens University Hospital, Sweden
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- Arora, S. (author)
- University of Oslo, Norway
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- Dellgren, G. (author)
- Sahlgrens University Hospital, Sweden
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- Gullestad, L. (author)
- University of Oslo, Norway University of Oslo, Norway University of Oslo, Norway
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(creator_code:org_t)
- Elsevier BV, 2014
- 2014
- English.
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In: American Journal of Transplantation. - : Elsevier BV. - 1600-6135 .- 1600-6143. ; 14:8, s. 1828-1838
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Abstract
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- In a randomized, open-label trial, everolimus was compared to cyclosporine in 115 de novo heart transplant recipients. Patients were assigned within 5 days posttransplant to low-exposure everolimus (3-6 ng/mL) with reduced-exposure cyclosporine (n 56), or standard-exposure cyclosporine (n = 59), with both mycophenolate mofetil and corticosteroids. In the everolimus group, cyclosporine was withdrawn after 7-11 weeks and everolimus exposure increased (6-10 ng/mL). The primary efficacy end point, measured GFR at 12 months posttransplant, was significantly higher with everolimus versus cyclosporine (mean +/- SD: 79.8 +/- 17.7 mL/min/1.73m 2 vs. 61.5 +/- 19.6 mL/min/1.73m 2; p<0.001). Coronary intravascular ultrasound showed that the mean increase in maximal intimal thickness was smaller (0.03 mm [95% CI 0.01, 0.05 mm] vs. 0.08 mm [95% CI 0.05, 0.12 mm], p = 0.03), and the incidence of cardiac allograft vasculopathy (CAV) was lower (50.0% vs. 64.6%, p = 0.003), with everolimus versus cyclosporine at month 12. Biopsy-proven acute rejection after weeks 7-11 was more frequent with everolimus (p = 0.03). Left ventricular function was not inferior with everolimus versus cyclosporine. Cytomegalovirus infection was less common with everolimus (5.4% vs. 30.5%, p<0.001); the incidence of bacterial infection was similar. In conclusion, everolimus-based immunosuppression with early elimination of cyclosporine markedly improved renal function after heart transplantation. Since postoperative safety was not jeopardized and development of CAV was attenuated, this strategy may benefit long-term outcome.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
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- art (subject category)
- ref (subject category)
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- By the author/editor
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Andreassen, A. K ...
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Andersson, B.
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Gustafsson, F.
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Eiskjaer, H.
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Rådegran, Göran
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Gude, E.
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Jansson, Kjell
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Solbu, D.
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Sigurdardottir, ...
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Arora, S.
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Dellgren, G.
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Gullestad, L.
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Surgery
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
- Articles in the publication
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American Journal ...
- By the university
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Lund University
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Linköping University