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Journal of Transplantation
Volume 2011, Article ID 535983, 7 pages
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.


A six-month, multicenter, randomized, open-label study was undertaken to determine whether renal function is improved using reduced-exposure cyclosporine (CsA) versus standard-exposure CsA in 199 de novo heart transplant patients receiving everolimus and steroids ± induction therapy. Mean C2 levels were at the low end of the target range in standard-exposure patients ( ) and exceeded target range in reduced-exposure patients ( ) throughout the study. Mean serum creatinine at Month 6 (the primary endpoint) was mol/L in standard-exposure patients versus mol/L in reduced-exposure patients ( ). The incidence of biopsy-proven acute rejection ≥3A at Month 6 was 21.0% (21/100) in the standard-exposure group and 16.2% (16/99) in the reduced-exposure group (n.s.). Adverse events and infections were similar between treatment groups. Thus, everolimus with reduced-exposure CsA resulted in comparable efficacy compared to standard-exposure CsA. No renal function benefits were demonstrated; that is possibly related to poor adherence to reduced CsA exposure.