title: 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 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.
authors.affiliation: Department of Cardiothoracic Surgery, University of Vienna, 1090 Vienna, Austria.
authors.forename: Andreas
authors.initials: A
authors.lastname: Zuckermann
authors.forename: Shoei-Shen
authors.initials: SS
authors.lastname: Wang
authors.forename: Heather
authors.initials: H
authors.lastname: Ross
authors.forename: Maria
authors.initials: M
authors.lastname: Frigerio
authors.forename: Howard J
authors.initials: HJ
authors.lastname: Eisen
authors.forename: Christoph
authors.initials: C
authors.lastname: Bara
authors.forename: Daniel
authors.initials: D
authors.lastname: Hoefer
authors.forename: Maurizio
authors.initials: M
authors.lastname: Cotrufo
authors.forename: Gaohong
authors.initials: G
authors.lastname: Dong
authors.forename: Guido
authors.initials: G
authors.lastname: Junge
authors.forename: Anne M
authors.initials: AM
authors.lastname: Keogh