Autor: |
Van Keer, Jan, Derthoo, David, Van Caenegem, Olivier, De Pauw, Michel, Nellessen, Eric, Duerinckx, Nathalie, Droogne, Walter, Vörös, Gábor, Meyns, Bart, Belmans, Ann, Janssens, Stefan, Van Cleemput, Johan, Vanhaecke, Johan |
Předmět: |
|
Zdroj: |
Journal of Transplantation; 2/20/2017, p1-8, 8p |
Abstrakt: |
In this 3-year, open-label, multicenter study, 57 maintenance heart transplant recipients (>1 year after transplant) with renal insufficiency (eGFR 30–60 mL/min/1.73 m2) were randomized to start everolimus with CNI withdrawal (N=29) or continue their current CNI-based immunosuppression (N=28). The primary endpoint, change in measured glomerular filtration rate (mGFR) from baseline to year 3, did not differ significantly between both groups (+7.0 mL/min in the everolimus group versus +1.9 mL/min in the CNI group, p=0.18). In the on-treatment analysis, the difference did reach statistical significance (+9.4 mL/min in the everolimus group versus +1.9 mL/min in the CNI group, p=0.047). The composite safety endpoint of all-cause mortality, major adverse cardiovascular events, or treated acute rejection was not different between groups. Nonfatal adverse events occurred in 96.6% of patients in the everolimus group and 57.1% in the CNI group (p<0.001). Ten patients (34.5%) in the everolimus group discontinued the study drug during follow-up due to adverse events. The poor adherence to the everolimus therapy might have masked a potential benefit of CNI withdrawal on renal function. [ABSTRACT FROM AUTHOR] |
Databáze: |
Complementary Index |
Externí odkaz: |
|