Everolimus monotherapy or combined therapy in liver transplantation: indications and results.

INTRODUCTION

Everolimus is a potent immunosuppressant with several advantages over calcineurin inhibitors, such as good tolerance, preventive effects on cardiovascular morbidity, and mortality and cancer prevention as it inhibits cell proliferation.

PATIENTS AND METHODS

Between April 1986 and December 2010, we performed 1500 liver transplants (OLT) in 1341 recipients, including 57 patients who were prescribed everolimus 24 (42.1%) as monotherapy and 33 (57.9%) as treatments combined with other immunosuppressants. We performed a retrospective analysis of our experience with conversion to everolimus in OLT recipients.

RESULTS

The 43 men and 14 women had a mean overall age at transplantation of 59.1 ± 10 years. The most frequent indication for OLT was hepatocellular carcinoma (HCC; 53.8%). Everolimus was introduced to prevent HCC recurrence (53%), development of de novo tumors (33%), address renal dysfunction (7%), or overcome side effects of other immunosuppressants (7%). We observed a significant improvement in renal function using the estimated glomerular filtration rate (Crockcroft-Gault formula) from 68.5 mL/min before to 74.5 mL/min after switching to everolimus. The 72% of recipients who developed ≥1 adverse event, most frequently showed hyperlipidemia (34.4%).

CONCLUSION

Both monotherapy and combined everolimus regimens were well-tolerated immunosuppressive regimens in liver transplant recipients with recurrent or de novo malignancies. Everolimus improved renal function. The most common side effects were hyperlipidemia, edema, and mouth ulcerations, which were well controlled with anti-lipidemic agents or decreased everolimus dosages.