Journal article
Prevention of Acute Rejection and Allograft Vasculopathy by Everolimus in Cardiac Transplants Recipients: A 24-Month Analysis
The Journal of heart and lung transplantation, v 26(6), pp 584-592
2007
PMID: 17543781
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Everolimus is an immunosuppressive agent that reduces cardiac allograft vasculopathy. This report presents the 24-month results of a multicenter trial of everolimus vs azathioprine in heart transplantation.
A total of 634 patients were randomized to receive 1.5 mg everolimus, 3 mg everolimus or azathioprine, with cyclosporine and steroids. A 12-month, double-blind, double-dummy period was followed by a 12-month open-label period.
At 24 months, the percentage of patients reaching the composite efficacy end-points was significantly lower with everolimus (1.5 mg: 45.9%,
p = 0.016; 3 mg: 36.0%,
p < 0.001) than with azathioprine (57.5%). The change in maximal intimal thickness from baseline to 24 months was significantly smaller with everolimus 1.5 mg (0.07 mm,
p = 0.014) and 3 mg (0.06 mm,
p = 0.004) compared with azathioprine (0.15 mm). The 24-month incidence of vasculopathy was 33.3% with everolimus 1.5 mg, 45.5% with everolimus 3 mg and 58.3% with azathioprine (
p = 0.017 vs everolimus 1.5 mg). Incidence of cytomegalovirus infection was 3-fold lower in patients receiving everolimus compared with azathioprine (7.2% and 7.1% in the 1.5-mg and 3-mg everolimus cohorts, respectively, and 21% in the azathioprine group;
p < 0.0001). Median serum creatinine levels at 24 months were higher with everolimus than with azathioprine, but decreased when cyclosporine exposure was reduced (everolimus 1.5 mg: baseline 167 μmol, after 6 months 157.5 μmol; everolimus 3 mg: baseline 185.6 μmol, after 6 months 160 μmol; azathioprine: baseline 123.3 μmol, after 6 months 127 μmol).
Everolimus significantly reduced acute rejection and limited the progression of allograft vasculopathy at 24 months compared with azathioprine. Although graft and patient survival was comparable at 24 months, everolimus therapy may improve longer-term outcomes after heart transplantation.
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Details
- Title
- Prevention of Acute Rejection and Allograft Vasculopathy by Everolimus in Cardiac Transplants Recipients: A 24-Month Analysis
- Creators
- Mario Viganò - University Hospital FoundationMurat Tuzcu - Cleveland ClinicRaymond Benza - University of Alabama at BirminghamPascale Boissonnat - Hôpital Louis PradelAxel Haverich - Medizinische Hochschule HannoverJames Hill - UF Health Shands HospitalGuenther Laufer - Department of Cardiac Surgery, University Klinik für Chirurge, Innsbruck, AustriaRobert Love - Division of Cardiothoracic Surgery, Clinical Science Center, Madison, WisconsinJayan Parameshwar - Papworth HospitalLuis Alonso Pulpón - Department of Cardiology, Clinica Puerto de Hierro, Madrid, SpainDale Renlund - University of UtahKamal Abeywickrama - Novartis (Switzerland)Nathalie Cretin - Novartis (Switzerland)Randall C. Starling - Cleveland ClinicHoward J. Eisen - Drexel UniversityRAD B253 Study Group
- Publication Details
- The Journal of heart and lung transplantation, v 26(6), pp 584-592
- Publisher
- Elsevier
- Resource Type
- Journal article
- Language
- English
- Web of Science ID
- WOS:000247222200005
- Scopus ID
- 2-s2.0-34249279808
- Other Identifier
- 991019330914904721
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InCites Highlights
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Cardiac & Cardiovascular Systems
- Respiratory System
- Surgery
- Transplantation