Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients : A Multicentre, Randomized Trial
Joint Authors
Dong, Gaohong
Zuckermann, Andreas
Cotrufo, Maurizio
Keogh, Anne M.
Wang, Shoei-Shen
Eisen, Howard J.
Ross, Heather
Hoefer, Daniel
Junge, Guido
Frigerio, Maria
Bara, Christoph
Source
Issue
Vol. 2011, Issue 2011 (31 Dec. 2011), pp.1-7, 7 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2011-11-16
Country of Publication
Egypt
No. of Pages
7
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Zuckermann, Andreas& Wang, Shoei-Shen& Ross, Heather& Frigerio, Maria& Eisen, Howard J.& Bara, Christoph…[et al.]. 2011. Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients : A Multicentre, Randomized Trial. Journal of Transplantation،Vol. 2011, no. 2011, pp.1-7.
https://search.emarefa.net/detail/BIM-479476
Modern Language Association (MLA)
Zuckermann, Andreas…[et al.]. Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients : A Multicentre, Randomized Trial. Journal of Transplantation No. 2011 (2011), pp.1-7.
https://search.emarefa.net/detail/BIM-479476
American Medical Association (AMA)
Zuckermann, Andreas& Wang, Shoei-Shen& Ross, Heather& Frigerio, Maria& Eisen, Howard J.& Bara, Christoph…[et al.]. Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients : A Multicentre, Randomized Trial. Journal of Transplantation. 2011. Vol. 2011, no. 2011, pp.1-7.
https://search.emarefa.net/detail/BIM-479476
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-479476