Use of everolimus in liver transplantation

Table 2 Outcomes of everolimus-based immunosuppressant as maintenance for lt recipients in prospective RCT

Ref.	Treatment group	Time (mo) from transplant surgery EVR was initiated	Key inclusion and exclusion criteria	n	Follow-up period (mo)	Efficacy	Mean improvement in CrCl (mL/min)	Safety
De Simone et al[19] 2009 (RESCUE Study)	EVR with CNI reduction or elimination (EVR C0 3-8 ng/mL, FK C0 3-5 ng/mL or EVR C0 6-12 ng/mL with FK elimination	12 to 60 mo	Inclusion: CrCl ≤ 60 mL/min and ≥ 20 mL/min Exclusion: Renal dysfunction not due to CNI toxicity, proteinuria ≥ 1 g/24 h, acute rejection < 6 mo, hepatitis C infection need active antiviral therapy	72	12	BPAR, graft loss or death: 8.3% in EVR group vs 4.1% in control group	-1.1 (P = 0.463) at month 6	Higher incidence of hyperlipidemia, mouth ulceration, increased hepatitis C virus viral titer, dry skin, eczema, and rash in the EVR group
	Control: Standard exposure of FK or CsA			73

BPAR: Biopsy proven acute rejection; C₀: Trough level; CNI: Calcineurin inhibitor; CrCl: Creatinine clearance (based on Cockcroft-Gault formula); CsA: Cyclosporine; EVR: Everolimus; FK: Tacrolimus.