Long-term Efficacy and Safety of Everolimus Versus Mycophenolate in Kidney Transplant Recipients Receiving Tacrolimus.

BACKGROUND: The short-term efficacy and safety of everolimus in combination with tacrolimus have been described in several clinical trials. Yet, detailed long-term data comparing the use of everolimus or mycophenolate in kidney transplant recipients receiving tacrolimus are lacking. METHODS: This is a 5-y follow-up post hoc analysis of a prospective trial including 288 patients who were randomized to receive a single 3-mg/kg dose of rabbit antithymocyte globulin, tacrolimus, everolimus (EVR), and prednisone (rabbit antithymocyte globulin/EVR, n = 85); basiliximab, tacrolimus, everolimus, and prednisone (basiliximab/EVR, n = 102); or basiliximab, tacrolimus, mycophenolate, and prednisone (basiliximab/mycophenolate, n = 101). RESULTS: There were no differences in the incidence of treatment failure (31.8% versus 40.2% versus 34.7%, P = 0.468), de novo donor-specific HLA antibodies (6.5% versus 11.7% versus 4.0%, P = 0.185), patient (92.9% versus 94.1% versus 92.1%, P = 0.854), and death-censored graft (87.1% versus 90.2% versus 85.1%, P = 0.498) survivals. Using a sensitive analysis, the trajectories of estimated glomerular filtration rate were comparable in the intention-to-treat (P = 0.145) and per protocol (P = 0.354) populations. There were no differences in study drug discontinuation rate (22.4% versus 30.4% versus 17.8%, P = 0.103). CONCLUSIONS: In summary, this analysis in a cohort of de novo low/moderate immunologic risk kidney transplant recipients suggests that the use of a single 3 mg/kg rabbit antithymocyte globulin dose followed by EVR combined with reduced tacrolimus concentrations was associated with similar efficacy and renal function compared with the standard of care immunosuppressive regimen.

Risk factors, mortality and acute kidney injury outcomes in cirrhotic patients in the emergency department.

BACKGROUND: Acute kidney injury (AKI) is common in cirrhotic patients and is associated with negative outcomes. The aim of this study was to evaluate the presence of AKI and its progression according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria in cirrhotic patients admitted to the emergency department and to determine the association of AKI with hospital mortality. METHODS: This retrospective study included 258 cirrhotic patients admitted to the emergency department of a university hospital from March 2015 to February 2017. AKI was diagnosed and classified according to the KDIGO criteria. RESULTS: The overall incidence of AKI in cirrhotic patients was 53.9%, and the overall hospital mortality was 28.4%. Mortality was associated with the presence, stage, and progression of AKI. Patients with AKI stage 1 and sCr < 1.5 mg/dl (KDIGO 1a) had a lower mortality rate than patients with AKI stage 1 and sCr > 1.5 mg/dl (KDIGO 1b). In the logistic regression analysis, three variables were independently associated with hospital mortality: cancer, AKI and progression of AKI. CONCLUSIONS: According to the data presented, a single measure of creatinine is not enough, and there is a need for meticulous follow-up of the renal function of patients with hepatic cirrhosis hospitalized in an emergency unit. In addition, this study reinforces the need for subclassification of KDIGO 1 in cirrhotic patients, since patients with acute renal injury and creatinine greater than 1.5 mg/dL present a worse clinical outcome.