Wound healing adverse events in kidney transplant recipients receiving everolimus with reduced calcineurin inhibitor exposure or current standard-of-care: Insights from the 24 month TRANSFORM study

Franco Citterio, Mitchell Henry, Dean Y. Kim, Myoung Soo Kim, Duck Jong Han, Takashi Kenmochi, Eytan Mor, Giuseppe Tisone, Peter Bernhardt, Maria Pilar Hernandez Gutierrez, Yoshihiko Watarai

研究成果: Article査読

1 被引用数 (Scopus)

抄録

Objectives: In TRANSFORM, de novo kidney transplant recipients received either everolimus in combination with reduced-exposure calcineurin inhibitor (EVR+rCNI) at standard EVR pre-dose concentrations of 3-8 ng/mL or mycophenolic acid plus standard-exposure CNI (MPA+sCNI). The authors analyzed the incidence of wound healing adverse events (WHAEs) over the 2-year study period. Methods: Patients were randomized to either EVR+rCNI or MPA+sCNI, both combined with induction therapy and steroids. Results: The safety population consisted of 2,026 patients (EVR+rCNI: 1,014, MPA+sCNI: 1,012). The proportion of patients with at least 1 WHAE was comparable between EVR+rCNI and MPA+sCNI treatment groups [20.6% vs. 17.3%; risk ratio (RR): 1.19; 95% confidence interval (CI): 0.99, 1.43] at month 24. The numerical difference between EVR+rCNI and MPA+sCNI was mainly caused by an increased proportion of EVR patients with lymphocele and wound dehiscence [7.5% vs. 5.1% (RR: 1.46; 95% CI: 1.04, 2.05) and 3.9 vs. 1.8% (RR: 2.22; 95%CI: 1.28, 3.84), respectively]. Conclusion: The immediate introduction of EVR+rCNI after kidney transplantation was associated with an overall comparable incidence of WHAEs versus current standard-of-care over the 24-month study period. There was an increased relative risk of experiencing lymphocele and wound dehiscence but the absolute risks were rather low in both groups. CT.gov identifier: NCT01950819.

本文言語English
ページ(範囲)1339-1348
ページ数10
ジャーナルExpert Opinion on Drug Safety
DOI
出版ステータスPublished - 2020

All Science Journal Classification (ASJC) codes

  • 薬理学(医学)

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