Weight gain after liver transplant may lead to post-transplant complications, and is a risk factor for post-transplant metabolic syndrome (PTMS), cardiovascular events, and renal insufficiency. The impact of mammalian target of rapamycin (mTOR) inhibition on post-transplant weight gain, laboratory parameters and the development of PTMS after liver transplantation was examined in a randomized, controlled study.

After run-in, patients (N=719) were randomized at 30±5 days post-transplant in a 1:1:1 ratio to: (i) everolimus (EVR) + reduced tacrolimus (TAC) (n=245); (ii) TAC control (n=243) or (iii) TAC elimination (n=231). In this post-hoc analysis, weight change at 12 and 24 months was compared. Changes in vital signs, lipids and laboratory parameters at 12 and 24 months and rates of PTMS were assessed. PTMS was defined as at least 3 of the following: obesity (body mass index >30 kg/m²), serum triglyceride level >150 mg/dL (1.7 mmol/L) or treatment for high lipids, high density lipoprotein level <39 mg/dL (1 mmol/L) in men and <50 mg/dL (1.3 mmol/L) in women, hypertension (SBP ≥140 mmHg or treatment for hypertension), and fasting plasma glucose ≥100mg/dL (5.6 mmol/L) or glucose-lowering therapy.

Mean increase in weight from baseline was higher at Month 12 in the TAC control arm (8.15 ± 9.27 kg) than in the EVR + reduced TAC (5.88 ± 12.60 kg, P=0.056) and the TAC elimination arms (4.76 ± 9.94 kg, P=0.007). At Month 24, the TAC control arm displayed a significantly greater weight increase (9.54 ± 10.21 kg) than either the EVR + reduced TAC (6.69 ± 8.37 kg, P=0.011) or the TAC elimination groups (6.01 ± 9.98 kg, P=0.024). Significantly lower weight gain was observed with EVR + reduced TAC than TAC control for patients with hypertension (SBP ≥140 mmHg) or a normal BMI (< 25) pre-transplant. Rates of PTMS were similar for the EVR + reduced TAC (80.0%), TAC elimination (80.8%) and TAC control (78.5%) arms (P=NS). Hyperlipidemia and stomatitis were more frequent in the EVR

arms.

EVR with reduced-exposure tacrolimus showed reduced post liver transplantation weight gain at 1 and 2 years post-transplant in comparison to a standard tacrolimus immunosuppression regimen. Rates of PTMS were comparable between the EVR-containing and TAC control regimens.

CITATION INFORMATION: Charlton M, Rinella M, Patel D, McCague K, Heimbach J, Watt K. Everolimus Is Associated with Less Weight Gain Than Tacrolimus Two Years Following Liver Transplantation: Results of a Randomized Multicenter Study. Am J Transplant. 2017;17 (suppl 3).

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