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




Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial - Download this document for free, or read online. Document in PDF available to download.

Journal of TransplantationVolume 2011 2011, Article ID 535983, 7 pages

Clinical Study

Department of Cardiothoracic Surgery, University of Vienna, 1090 Vienna, Austria

Division of Cardiovascular Surgery, National Taiwan University Hospital, Taipei 100, Taiwan

Department of Cardiology, Toronto General Hospital, Toronto, ON, Canada M56 2C4

Divisione di Cardiologia, Azienda Ospedale Niguarda Ca- Granda, 20162 Milano, Italy

Division of Cardiology, Drexel University College of Medicine, Philadelphia, PA 19102, USA

Klinik für Thorax-, Herz- und Gefäßchirurgie, Medizinische Hochschule Hannover, 30625 Hannover, Germany

Department of Cardiac Surgery, Innsbruck Medical University, 6020 Innsbruck, Austria

Dipartimento di Scienze Cardio-Toraciche e Respiratorie Sezione di Cardiologia Pediatrica, Azienda Ospedaliera Monaldi Cotugno Il Università di Napoli, 80122 Napoli, Italy

Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936-1016, USA

Novartis Pharma AG, 4002 Basel, Switzerland

Heart Lung Transplant Unit, St. Vincent-s Hospital, Sydney, NSW 1340, Australia

Department 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.

Abstract

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.





Author: Andreas Zuckermann, Shoei-Shen Wang, Heather Ross, Maria Frigerio, Howard J. Eisen, Christoph Bara, Daniel Hoefer, Maurizio

Source: https://www.hindawi.com/



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