Wound events in kidney transplant patients receiving de novo everolimus: a pooled analysis of three randomized controlled trials
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Wound events in kidney transplant patients receiving de novo everolimus: a pooled analysis of three randomized controlled trials. / Cooper, M; Wiseman, A C; Zibari, G; McCague, K; Kim, Y; Geissler, F; Nashan, B.
In: CLIN TRANSPLANT, Vol. 27, No. 6, 2013, p. E625-35.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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T1 - Wound events in kidney transplant patients receiving de novo everolimus: a pooled analysis of three randomized controlled trials
AU - Cooper, M
AU - Wiseman, A C
AU - Zibari, G
AU - McCague, K
AU - Kim, Y
AU - Geissler, F
AU - Nashan, B
N1 - © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
PY - 2013
Y1 - 2013
N2 - Data were pooled from three prospective, multicenter trials in which 1996 de novo kidney transplant recipients were randomized to everolimus 1.5 or 3.0 mg or mycophenolic acid (MPA), with cyclosporine and steroids. Wound healing complications reported as adverse events were retrospectively reviewed in a blinded manner. The incidence of wound healing adverse events was 17.6% (351 of 1996) by day 90 and was similar for everolimus 1.5 mg (16.6% [110 of 661]) vs. MPA (14.3% [95 of 665]) (p = 0.255), but higher with everolimus 3.0 mg (21.8% [146 of 670]) (p < 0.001 vs. MPA). Similar results were observed for wound healing complications reported as serious adverse events. The 12-month incidence of lymphocele was 11.2% with everolimus 1.5 mg and 8.9% with MPA (p = 0.171), but lymphocele reported as a serious adverse event were more frequent with everolimus 1.5 mg (6.5% vs. 3.5%; p = 0.012). The hazard ratio (HR) for any wound healing complication vs. MPA was not significantly higher for everolimus <3 ng/mL (HR 1.33; 95% CI 0.94-1.88; p = 0.104), but increased to 1.46 (95% CI 1.12-1.90; p = 0.005) for 3-8 ng/mL and 1.69 (95% CI 1.20-2.38; p = 0.002) for >8 ng/mL. These results suggest that de novo kidney transplant patients receiving an initial everolimus dose of 1.5 mg do not appear to have a pronounced increased risk of wound healing complications vs. patients receiving MPA.
AB - Data were pooled from three prospective, multicenter trials in which 1996 de novo kidney transplant recipients were randomized to everolimus 1.5 or 3.0 mg or mycophenolic acid (MPA), with cyclosporine and steroids. Wound healing complications reported as adverse events were retrospectively reviewed in a blinded manner. The incidence of wound healing adverse events was 17.6% (351 of 1996) by day 90 and was similar for everolimus 1.5 mg (16.6% [110 of 661]) vs. MPA (14.3% [95 of 665]) (p = 0.255), but higher with everolimus 3.0 mg (21.8% [146 of 670]) (p < 0.001 vs. MPA). Similar results were observed for wound healing complications reported as serious adverse events. The 12-month incidence of lymphocele was 11.2% with everolimus 1.5 mg and 8.9% with MPA (p = 0.171), but lymphocele reported as a serious adverse event were more frequent with everolimus 1.5 mg (6.5% vs. 3.5%; p = 0.012). The hazard ratio (HR) for any wound healing complication vs. MPA was not significantly higher for everolimus <3 ng/mL (HR 1.33; 95% CI 0.94-1.88; p = 0.104), but increased to 1.46 (95% CI 1.12-1.90; p = 0.005) for 3-8 ng/mL and 1.69 (95% CI 1.20-2.38; p = 0.002) for >8 ng/mL. These results suggest that de novo kidney transplant patients receiving an initial everolimus dose of 1.5 mg do not appear to have a pronounced increased risk of wound healing complications vs. patients receiving MPA.
U2 - 10.1111/ctr.12223
DO - 10.1111/ctr.12223
M3 - SCORING: Journal article
C2 - 24033455
VL - 27
SP - E625-35
JO - CLIN TRANSPLANT
JF - CLIN TRANSPLANT
SN - 0902-0063
IS - 6
ER -
