Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial
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...
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| Format: | Article |
| Language: | English |
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Wiley
2011-01-01
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| Series: | Journal of Transplantation |
| Online Access: | http://dx.doi.org/10.1155/2011/535983 |
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| author | Andreas Zuckermann Shoei-Shen Wang Heather Ross Maria Frigerio Howard J. Eisen Christoph Bara Daniel Hoefer Maurizio Cotrufo Gaohong Dong Guido Junge Anne M. Keogh |
| author_facet | Andreas Zuckermann Shoei-Shen Wang Heather Ross Maria Frigerio Howard J. Eisen Christoph Bara Daniel Hoefer Maurizio Cotrufo Gaohong Dong Guido Junge Anne M. Keogh |
| author_sort | Andreas Zuckermann |
| collection | DOAJ |
| description | 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 (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 μmol/L in standard-exposure patients versus 130.1±53.7 μmol/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. |
| format | Article |
| id | doaj-art-ef456c1709a946a8807459f769923cbd |
| institution | Kabale University |
| issn | 2090-0007 2090-0015 |
| language | English |
| publishDate | 2011-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Transplantation |
| spelling | doaj-art-ef456c1709a946a8807459f769923cbd2025-02-03T06:06:09ZengWileyJournal of Transplantation2090-00072090-00152011-01-01201110.1155/2011/535983535983Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized TrialAndreas Zuckermann0Shoei-Shen Wang1Heather Ross2Maria Frigerio3Howard J. Eisen4Christoph Bara5Daniel Hoefer6Maurizio Cotrufo7Gaohong Dong8Guido Junge9Anne M. Keogh10Department of Cardiothoracic Surgery, University of Vienna, 1090 Vienna, AustriaDepartment of Cardiology, Toronto General Hospital, Toronto, ON, M56 2C4, CanadaDivisione di Cardiologia, Azienda Ospedale Niguarda Ca’ Granda, 20162 Milano, ItalyDivision of Cardiology, Drexel University College of Medicine, Philadelphia, PA 19102, USAKlinik für Thorax-, Herz- und Gefäßchirurgie, Medizinische Hochschule Hannover, 30625 Hannover, GermanyDepartment of Cardiac Surgery, Innsbruck Medical University, 6020 Innsbruck, AustriaDipartimento di Scienze Cardio-Toraciche e Respiratorie Sezione di Cardiologia Pediatrica, Azienda Ospedaliera Monaldi Cotugno Il Università di Napoli, 80122 Napoli, ItalyNovartis Pharmaceuticals Corporation, East Hanover, NJ 07936-1016, USANovartis Pharma AG, 4002 Basel, SwitzerlandHeart Lung Transplant Unit, St. Vincent’s Hospital, Sydney, NSW 1340, AustraliaDepartment of Cardiothoracic Surgery, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, AustriaA 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 (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 μmol/L in standard-exposure patients versus 130.1±53.7 μmol/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.http://dx.doi.org/10.1155/2011/535983 |
| spellingShingle | Andreas Zuckermann Shoei-Shen Wang Heather Ross Maria Frigerio Howard J. Eisen Christoph Bara Daniel Hoefer Maurizio Cotrufo Gaohong Dong Guido Junge Anne M. Keogh Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial Journal of Transplantation |
| title | Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial |
| title_full | Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial |
| title_fullStr | Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial |
| title_full_unstemmed | Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial |
| title_short | Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial |
| title_sort | efficacy and safety of low dose cyclosporine with everolimus and steroids in de novo heart transplant patients a multicentre randomized trial |
| url | http://dx.doi.org/10.1155/2011/535983 |
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