Side effect profile of everolimus in liver transplant patients

Document Type

Conference Proceeding

Publication Date


Publication Title

Am J Transplant


Introduction Use of calcineurin inhibitors has been the mainstay of antirejection medications after liver transplant (LT). However, renal toxicity from these drugs remains troublesome. By comparison, mTOR inhibitors tend to have better renal tolerance. Yet, prior studies (PROTECT trial) have shown that the overall side effect (SE) profile of everolimus (EVL) leads to adverse effects in 63.4% of patients, requiring discontinuation in many instances. We looked to explore the tolerance of EVL in LT patients. Methods All patients receiving a LT between 2011 and 2014 treated with EVL for renal dysfunction were evaluated for SE profile. Information including age, gender, race, BMI, history of pre-transplant renal disease, details of SEs, dose changes, severe infection meeting sepsis criteria, rejection events, lipid profile and general lab data were also included. Statistics were calculated using ANOVA, t-test and Chi-squared tests in R 3.4.2. Results Total of 75 patients were analyzed. 43 (57.3%) experienced SEs with 31 (41.3%) discontinuing EVL. GI symptoms were the most common: Mucosal ulceration (n=7, 9.3%), nausea (n=4, 5.3%), vomiting (n=3, 4%), diarrhea (n=6, 8%), and severe colitis (n=2, 2.7%). Two patients (2.7%) experienced significant weight loss, despite only one (1.3%) reporting loss of appetite. Three patients (4%) developed diabetes after starting EVL. Nonspecific complaints such as headaches (n=2, 2.7%), edema (n=11, 14.7%), pruritus (n=7, 9.3%), malaise (n=3, 4%) were noted in nearly a quarter of patients (n=18, 24%). 13 patients (17.3%) had documented rejection on EVL therapy. (Table presented) Discussion EVL was poorly tolerated in LT patients with discontinuation rates greater than 40% in our urban population. The SEs leading to discontinuation were of a wide range making future interventions to prevent these SEs difficult. Efficacy of therapy was not clearly demonstrated in this population given similar eGFR among those who continued or discontinued therapy, respectively.




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