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


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??mol/L in standard-exposure patients versus 130.1 ± 53.7??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.

SUBMITTER: Zuckermann A 

PROVIDER: S-EPMC3268050 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature

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

Zuckermann Andreas A   Wang Shoei-Shen SS   Ross Heather H   Frigerio Maria M   Eisen Howard J HJ   Bara Christoph C   Hoefer Daniel D   Cotrufo Maurizio M   Dong Gaohong G   Junge Guido G   Keogh Anne M AM  

Journal of transplantation 20110913


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  ...[more]

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