Renal function is often impaired after liver transplantation (LT). We present the preliminary results of a prospective trial on efficacy and safety of switching from calcineurin inhibitors (CNI) to everolimus (EVER) in maintenance LT recipients. Adult, consenting deceased donor LT recipients with a minimum follow-up of 12 months were included. EVER was introduced at 0.75 mg b.i.d. with overnight withdrawal of antimetabolites and a 50%-per-week reduction of CNI to a complete stop after 4 weeks. Steroids were kept at pre-switch levels. EVER target levels were 3-8ng/mL. Twenty-seven patients (mean age 56.4±9.6 years; M/F=18/9) on cyclosporine (21) or tacrolimus (6) were enrolled at a mean of 42.9±29.3 months post-LT. Native disease was HCV in 10 patients (37%). Indications were CrCl ≤80mL/min in 26 (96.3%) and CNI-related peripheral neuropathy in 1 (3.7%). At baseline, mean CrCl was 57.2±16.1mL/min (range 38.6/120.5). At a mean follow-up of 110.9±34.9 days, 17 (62.9%) patients had EVER-related complications: hypercholesterolemia/hypertriglyceridemia requiring medication in 5 (18.5%); oral ulcers in 4 (14.8%); acne in 2 (7.4%); eczema in 2 (7.4%); headache, urticaria, psoriasis, relapse of zoster infection in 1 patient each (3.7%). All cases were amenable to medication/EVER dose reduction. Two (7.4%) patients presented 1 episode of treated biopsy proven rejection each (1 RAI 6; 1 RAI 8), one of them (3.7%) dropped treatment. One further patient (3.7%) dropped treatment at 14 days for increase in HCV-RNA. Among the 17 patients (62.9%) with a minimum follow-up of 3 months, mean CrCl increased from 53.1±6.6mL/min (95% CI 49.6/56.5) to 58.7±12.3mL/min (95% CI 52.4/65.1). Preliminary data suggest that switching from CNI to EVER-based immunosuppression is feasible and associated with improvement in CrCl. Larger series and longer follow-ups are favored to tailor EVER on patients’ immunologic profile.

Switch to everolimus in maintenance liver transplant patients: preliminary results of a prospective, single-center trial

De Simone, Paolo;Filipponi, Franco
2007

Abstract

Renal function is often impaired after liver transplantation (LT). We present the preliminary results of a prospective trial on efficacy and safety of switching from calcineurin inhibitors (CNI) to everolimus (EVER) in maintenance LT recipients. Adult, consenting deceased donor LT recipients with a minimum follow-up of 12 months were included. EVER was introduced at 0.75 mg b.i.d. with overnight withdrawal of antimetabolites and a 50%-per-week reduction of CNI to a complete stop after 4 weeks. Steroids were kept at pre-switch levels. EVER target levels were 3-8ng/mL. Twenty-seven patients (mean age 56.4±9.6 years; M/F=18/9) on cyclosporine (21) or tacrolimus (6) were enrolled at a mean of 42.9±29.3 months post-LT. Native disease was HCV in 10 patients (37%). Indications were CrCl ≤80mL/min in 26 (96.3%) and CNI-related peripheral neuropathy in 1 (3.7%). At baseline, mean CrCl was 57.2±16.1mL/min (range 38.6/120.5). At a mean follow-up of 110.9±34.9 days, 17 (62.9%) patients had EVER-related complications: hypercholesterolemia/hypertriglyceridemia requiring medication in 5 (18.5%); oral ulcers in 4 (14.8%); acne in 2 (7.4%); eczema in 2 (7.4%); headache, urticaria, psoriasis, relapse of zoster infection in 1 patient each (3.7%). All cases were amenable to medication/EVER dose reduction. Two (7.4%) patients presented 1 episode of treated biopsy proven rejection each (1 RAI 6; 1 RAI 8), one of them (3.7%) dropped treatment. One further patient (3.7%) dropped treatment at 14 days for increase in HCV-RNA. Among the 17 patients (62.9%) with a minimum follow-up of 3 months, mean CrCl increased from 53.1±6.6mL/min (95% CI 49.6/56.5) to 58.7±12.3mL/min (95% CI 52.4/65.1). Preliminary data suggest that switching from CNI to EVER-based immunosuppression is feasible and associated with improvement in CrCl. Larger series and longer follow-ups are favored to tailor EVER on patients’ immunologic profile.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11568/893683
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