Journal of Transplantation / 2013 / Article / Tab 1

Review Article

Everolimus in Heart Transplantation: An Update

Table 1

Clinical studies of everolimus versus azathioprine or mycophenolate mofetil (MMF) in de novo heart transplant recipients.

Study DesignPrimary endpointEverolimusComparatorCsA target range (ng/mL) by monthInduction therapySteroids

B253 [2] 24-month Multicenter Randomized Double-blind for months 0–12, open-label for months 12–24Composite efficacy failure at 6 months Fixed-dosea 1.5 mg/day
3.0 mg/day ( )
Azathioprinea 1–3 mg/kg/day All 3 groups:
1: 250–400
2–6: 200–350
7–24: 100–300
In individual centers only:
ATG or muromonab-CD3
Prednisolone, initiated at 0.5–1.0 mg/kg/day, tapered to achieve 0.3–0.5 mg/kg/day by day 21 and ≥0.1 mg/kg/day by month 6

Lehmkuhl et al. 2007 [10]12-month
Single center
Retrospective
Not applicableInitial dose before transplant 0.75 mg, then mean 1.5–1.75 mg/day, and 3–8 ng/mL MMF before transplant 1.0 g, then mean 1.5–2.5 g/day Everolimus versus MMF:
1: 200–250, both groups
2: 175–200 versus 200–250
3-4: 150–175 versus 200–250
5-6: 100–150 versus 150–200
7–12: 80–120 versus 120–150
ATG 2.5 mg/kg/day on days 1 and 2Initially, high-dose methylprednisolone, then prednisolone 1 mg/kg/day, tapered to achieve 0.1 mg/kg/day by month 12

A2411 [3]12-month Multicenter
Randomized
Open-label
Noninferiority of renal function (calculated creatinine clearance at 6 months) Initial dosea 1.5 mg/day, 3–8 ng/mL MMFa 3.0 g/day
Everolimus versus MMF:
1: 200–350, both groups
2: 150–250 versus 200–350
3-4: 100–200 versus 200–300
5-6: 75–150 versus 150–250
7–12: 50–100 versus 100–250
Antithymocyte antibodies (68.4% of patients) or
IL-2RA (25.9% of patients)
Prednisone, tapered to achieve ≥0.1 mg/kg/day by month 6 and 0.1–0.05 mg/kg/day from month 6 to 12

A2310 [9]24 months
Multicenter
Randomized
Open-label
Noninferiority of composite efficacy failure at 12 months IVUS substudy: change in mean MIT at 12 monthsInitial dosea 1.5 mg/day, 3–8 ng/mL or 3.0 mg/day, 6–12 ng/mL MMFa 3.0 g/day
Everolimus versus MMF:
1: 200–350, both groups
2: 150–250 versus 200–350
3-4: 100–200 versus 200–300
5-6: 75–150 versus 150–250
7–24: 50–100 versus 100–250
Center-specific:
No induction or Thymoglobulin or basiliximab
Yes, according to local practice

ATG: antithymocyte globulin; CsA: cyclosporine; IL-2RA: interleukin-2 receptor antibody; IVUS: intravascular ultrasound; MIT: maximum intimal thickness.
aFirst dose administered within 72 hours after transplant surgery.

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