Everolimus is Associated With Less Weight Gain Than Tacrolimus 2 Years Following Liver Transplantation: Results of a Randomized Multicenter Study.
Charlton M, Rinella M, et al.Transplantation 2017; 15: 15.
Aims
To examine the impact of mTOR inhibition on posttransplant weight gain and the development of posttransplant metabolic syndrome (PTMS) components post liver transplantation using data from the previous randomized, controlled RAD001H2304 study*.
Interventions
This was a post hoc analysis where participants were randomized at 30±5 days posttransplant to one of three treatment groups, consisting of either everolimus (EVR) plus reduced tacrolimus (TAC) (group 1), TAC control (group 2) or TAC elimination (group 3). The immunosuppression regimen was identical for all groups prior to randomization.
Participants
719 adult (18–70 years) recipients of a primary full-size liver transplant from a deceased donor from the previous randomised controlled study.
Outcomes
Outcomes measured included weight gain, weight change by subgroups, PTMS, safety outcomes such as adverse events, serious adverse events, infections, cardiovascular events and new onset diabetes and PTMS-related factors including blood pressure, heart rate, glycosylated hemoglobin, cholesterol, triglycerides and fasting glucose.
Follow-up
12 and 24 months
CET Conclusions
This manuscript reports an analysis of data from the RAD001H2304 trial, in which the authors investigate the metabolic consequences of early conversion to everolimus following liver transplantation. They report a significant reduction in weight gain in the everolimus group compared to tacrolimus controls at both 12 and 24 months post-transplant. There was, however, no difference in patients classified as obese, or in the incidence of metabolic syndrome, between arms. Delving deeper, there are some issues. The difference in mean weight gain between the everolimus and tacrolimus arms is only around 3kg at 24 months, which is of doubtful clinical significance, and there is little else here to separate the groups. The analysis is post-hoc, so the cynics out there may view this as an example of salami slicing at its best!
Data analysis
Modified intention-to-treat analysis
Quality notes
Previously assessed as *Saliba F, et al. Renal function at two years in liver transplant patients receiving everolimus: results of a randomized, multicenter study. American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons. 2013;13(7):1734-45.
Trial registration
Clinicaltrials.gov - NCT00622869