Journal article
Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial
Journal of transplantation, v 2011, pp 535983-7
01 Jan 2011
PMID: 22295178
Featured in Collection : UN Sustainable Development Goals @ Drexel
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 C
2
levels were at the low end of the target range in standard-exposure patients (
n
= 100) and exceeded target range in reduced-exposure patients (
n
= 99) throughout the study. Mean serum creatinine at Month 6 (the primary endpoint) was 141.0 ± 53.1
μ
mol/L in standard-exposure patients versus 130.1 ± 53.7
μ
mol/L in reduced-exposure patients (
P
= 0.093). 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.
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Details
- Title
- Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial
- Creators
- Andreas Zuckermann - University of ViennaShoei-Shen Wang - Drexel UniversityHeather Ross - Drexel UniversityMaria Frigerio - 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 M562C4 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, AustriaHoward J. Eisen - Drexel UniversityChristoph Bara - 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 M562C4 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, AustriaDaniel Hoefer - 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 M562C4 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, AustriaMaurizio Cotrufo - 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 M562C4 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, AustriaGaohong Dong - 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 M562C4 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, AustriaGuido Junge - 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 M562C4 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, AustriaAnne M. Keogh - Drexel University
- Publication Details
- Journal of transplantation, v 2011, pp 535983-7
- Publisher
- Hindawi Publishing Corporation
- Resource Type
- Journal article
- Language
- English
- Web of Science ID
- WOS:000215622400027
- Other Identifier
- 991019330915204721
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