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Journal of Transplantation
Volume 2011, Article ID 535983, 7 pages
http://dx.doi.org/10.1155/2011/535983
Clinical Study

Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial

1Department of Cardiothoracic Surgery, University of Vienna, 1090 Vienna, Austria
2Division of Cardiovascular Surgery, National Taiwan University Hospital, Taipei 100, Taiwan
3Department of Cardiology, Toronto General Hospital, Toronto, ON, Canada M56 2C4
4Divisione di Cardiologia, Azienda Ospedale Niguarda Ca' Granda, 20162 Milano, Italy
5Division of Cardiology, Drexel University College of Medicine, Philadelphia, PA 19102, USA
6Klinik für Thorax-, Herz- und Gefäßchirurgie, Medizinische Hochschule Hannover, 30625 Hannover, Germany
7Department of Cardiac Surgery, Innsbruck Medical University, 6020 Innsbruck, Austria
8Dipartimento di Scienze Cardio-Toraciche e Respiratorie Sezione di Cardiologia Pediatrica, Azienda Ospedaliera Monaldi Cotugno Il Università di Napoli, 80122 Napoli, Italy
9Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936-1016, USA
10Novartis Pharma AG, 4002 Basel, Switzerland
11Heart Lung Transplant Unit, St. Vincent's Hospital, Sydney, NSW 1340, Australia
12Department of Cardiothoracic Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria

Received 6 August 2011; Accepted 29 August 2011

Academic Editor: Diego Cantarovich

Copyright © 2011 Andreas Zuckermann et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. D. O. Taylor, J. Stehlik, L. B. Edwards et al., “Registry of the International Society for Heart and Lung Transplantation: 26th Official Adult Heart Transplant Report,” Journal of Heart and Lung Transplantation, vol. 28, no. 10, pp. 1007–1022, 2009. View at Publisher · View at Google Scholar · View at Scopus
  2. A. Dhaliwal and V. Thohan, “Cardiac allograft vasculopathy: the achilles' heel of long-term survival after cardiac transplantation,” Current Atherosclerosis Reports, vol. 8, no. 2, pp. 119–130, 2006. View at Publisher · View at Google Scholar · View at Scopus
  3. D. Ramzy, V. Rao, J. Brahm, S. Miriuka, D. Delgado, and H. J. Ross, “Cardiac allograft vasculopathy: a review,” Canadian Journal of Surgery, vol. 48, no. 4, pp. 319–327, 2005. View at Google Scholar · View at Scopus
  4. H. J. Eisen, E. M. Tuzcu, R. Dorent et al., “Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients,” New England Journal of Medicine, vol. 349, no. 9, pp. 847–858, 2003. View at Publisher · View at Google Scholar · View at Scopus
  5. M. Viganò, M. Tuzcu, R. Benza et al., “Prevention of acute rejection and allograft vasculopathy by everolimus in cardiac transplants recipients: a 24-month analysis,” Journal of Heart and Lung Transplantation, vol. 26, no. 6, pp. 584–592, 2007. View at Publisher · View at Google Scholar
  6. S. J. Tomlanovich and F. Vincenti, “Sirolimus: defining nephrotoxicity in the renal transplant recipient,” Clinical Journal of the American Society of Nephrology, vol. 2, no. 2, pp. 198–199, 2007. View at Publisher · View at Google Scholar · View at Scopus
  7. D. R. J. Kuypers, “Benefit-risk assessment of sirolimus in renal transplantation,” Drug Safety, vol. 28, no. 2, pp. 153–181, 2005. View at Publisher · View at Google Scholar · View at Scopus
  8. myfortic, Summary of Product Characteristics, Novartis Pharma AG, Basel, Switzerland, 2010.
  9. L. Gullestad, M. Iversen, S. A. Mortensen et al., “Everolimus with reduced calcineurin inhibitor in thoracic transplant recipients with renal dysfunction: a multicenter, randomized trial,” Transplantation, vol. 89, no. 7, pp. 864–872, 2010. View at Publisher · View at Google Scholar · View at Scopus
  10. H. Ross, P. Pflugfelder, H. Haddad et al., “Cyclosporine reduction in the presence of everolimus: 3-month data from a Canadian pilot study of maintenance cardiac allograft recipients,” Journal of Heart and Lung Transplantation, vol. 27, no. 2, pp. 197–202, 2008. View at Publisher · View at Google Scholar · View at Scopus
  11. H. Ross, P. Pflugfelder, H. Haddad et al., “Reduction of cyclosporine following the introduction of everolimus in maintenance heart transplant recipients: a pilot study,” Transplant International, vol. 23, no. 1, pp. 31–37, 2010. View at Publisher · View at Google Scholar · View at Scopus
  12. L. Potena, I. G. Bianchi, G. Magnani et al., “Cyclosporine lowering with everolimus or mycophenolate to preserve renal function in heart recipients: a randomized study,” Transplantation, vol. 89, no. 2, pp. 263–265, 2010. View at Publisher · View at Google Scholar · View at Scopus
  13. M. Schweiger, A. Wasler, G. Prenner et al., “Everolimus and reduced cyclosporine trough levels in maintenance heart transplant patients,” Transplant Immunology, vol. 16, p. 46, 2006. View at Google Scholar
  14. M. Cantarovich, E. Elstein, B. de Varennes, and J. S. Barkun, “Clinical benefit of Neoral dose monitoring with cyclosporine 2-hr post-dose levels compared with trough levels in stable heart transplant patients,” Transplantation, vol. 68, no. 12, pp. 1839–1842, 1999. View at Google Scholar · View at Scopus
  15. A. L. P. Caforio, F. Tona, S. Piaserico et al., “C2 is superior to C0 as predictor of renal toxicity and rejection risk profile in stable heart transplant recipients,” Transplant International, vol. 18, no. 1, pp. 116–124, 2005. View at Publisher · View at Google Scholar · View at Scopus
  16. D. H. Delgado, V. Rao, J. Hamel, S. Miriuka, R. J. Cusimano, and H. J. Ross, “Monitoring of cyclosporine 2-hour post-dose levels in heart transplantation: improvement in clinical outcomes,” Journal of Heart and Lung Transplantation, vol. 24, no. 9, pp. 1343–1346, 2005. View at Publisher · View at Google Scholar · View at Scopus
  17. H. C. Mathias, F. Ozalp, M. B. Will et al., “A randomized, controlled trial of C0- Vs C2-guided therapeutic drug monitoring of cyclosporine in stable heart transplant patients,” Journal of Heart and Lung Transplantation, vol. 24, no. 12, pp. 2137–2143, 2005. View at Publisher · View at Google Scholar · View at Scopus
  18. S. Schubert, H. Abdul-Khaliq, H. B. Lehmkuhl et al., “Advantages of C2 monitoring to avoid acute rejection in pediatric heart transplant recipients,” Journal of Heart and Lung Transplantation, vol. 25, no. 6, pp. 619–625, 2006. View at Publisher · View at Google Scholar · View at Scopus
  19. M. Cantarovich, N. Giannetti, and R. Cecere, “Impact of cyclosporine 2-h level and mycophenolate mofetil dose on clinical outcomes in de novo heart transplant patients receiving anti-thymocyte globulin induction,” Clinical Transplantation, vol. 17, no. 2, pp. 144–150, 2003. View at Publisher · View at Google Scholar · View at Scopus
  20. J. B. Barnard, J. Thekkudan, S. Richardson et al., “Cyclosporine Profiling With C2 and C0 Monitoring Improves Outcomes After Heart Transplantation,” Journal of Heart and Lung Transplantation, vol. 25, no. 5, pp. 564–568, 2006. View at Publisher · View at Google Scholar · View at Scopus
  21. H. B. Lehmkuhl, J. Arizon, M. Viganò et al., “Everolimus with reduced cyclosporine versus MMF with standard cyclosporine in de novo heart transplant recipients,” Transplantation, vol. 88, no. 1, pp. 115–122, 2009. View at Publisher · View at Google Scholar · View at Scopus