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2017 ; 2017
(ä): 6347138
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The CECARI Study: Everolimus (Certican®) Initiation and Calcineurin Inhibitor
Withdrawal in Maintenance Heart Transplant Recipients with Renal Insufficiency: A
Multicenter, Randomized Trial
#MMPMID28316834
Van Keer J
; Derthoo D
; Van Caenegem O
; De Pauw M
; Nellessen E
; Duerinckx N
; Droogne W
; Vörös G
; Meyns B
; Belmans A
; Janssens S
; Van Cleemput J
; Vanhaecke J
J Transplant
2017[]; 2017
(ä): 6347138
PMID28316834
show ga
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?m(2)) 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.