دورية أكاديمية
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
| العنوان: | 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 |
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| المساهمون: | 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, Kim, Myoung Soo |
| بيانات النشر: | Taylor & Francis |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Adult, Calcineurin Inhibitors / administration & dosage, Calcineurin Inhibitors / adverse effects, Everolimus / administration & dosage, Everolimus / adverse effects, Female, Humans, Immunosuppressive Agents / administration & dosage, Immunosuppressive Agents / adverse effects, Incidence, Kidney Transplantation, Lymphocele / epidemiology, Lymphocele / etiology, Male, Middle Aged, Mycophenolic Acid / administration & dosage, Mycophenolic Acid / adverse effects, Risk, Surgical Wound Dehiscence / epidemiology, Surgical Wound Dehiscence / etiology, Wound Healing / drug effects, Calcineurin inhibitor, everolimus, randomized, safety, wound healing |
| الوصف: | 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 15. Methods: Patients were randomized to either EVR+rCNI or MPA+sCNI, both combined with induction therapy and steroids 19. 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] 20. 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 21. Ct.gov identifier: NCT01950819. ; restriction |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1474-0338 1744-764X 32633157 |
| العلاقة: | EXPERT OPINION ON DRUG SAFETY; J03925; OAK-2021-05745; https://ir.ymlib.yonsei.ac.kr/handle/22282913/185010Test; T999202325; EXPERT OPINION ON DRUG SAFETY, Vol.19(10) : 1339-1348, 2020-10 |
| DOI: | 10.1080/14740338.2020.1792441 |
| الإتاحة: | https://doi.org/10.1080/14740338.2020.1792441Test https://ir.ymlib.yonsei.ac.kr/handle/22282913/185010Test |
| حقوق: | CC BY-NC-ND 2.0 KR |
| رقم الانضمام: | edsbas.E620A79A |
| قاعدة البيانات: | BASE |
| تدمد: | 14740338 1744764X 32633157 |
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| DOI: | 10.1080/14740338.2020.1792441 |