دورية أكاديمية
Modifying Tacrolimus-related Toxicity After Liver Transplantation Comparing Life Cycle Pharma Tacrolimus Versus Extended-released Tacrolimus:A Multicenter, Randomized Controlled Trial
| العنوان: | Modifying Tacrolimus-related Toxicity After Liver Transplantation Comparing Life Cycle Pharma Tacrolimus Versus Extended-released Tacrolimus:A Multicenter, Randomized Controlled Trial |
|---|---|
| المؤلفون: | Mulder, Midas B., van Hoek, Bart, Polak, Wojtek G., Alwayn, Ian P.J., de Winter, Brenda C.M., Murad, Sarwa Darwish, Verhey-Hart, Elke, Elshove, Lara, Erler, Nicole S., Hesselink, Dennis A., den Hoed, Caroline M., Metselaar, Herold J. |
| المصدر: | Mulder , M B , van Hoek , B , Polak , W G , Alwayn , I P J , de Winter , B C M , Murad , S D , Verhey-Hart , E , Elshove , L , Erler , N S , Hesselink , D A , den Hoed , C M & Metselaar , H J 2024 , ' Modifying Tacrolimus-related Toxicity After Liver Transplantation Comparing Life Cycle Pharma Tacrolimus Versus Extended-released Tacrolimus : A Multicenter, Randomized Controlled Trial ' , Transplantation Direct , vol. 10 , no. 4 , E1612 . https://doi.org/10.1097/TXD.0000000000001612Test |
| سنة النشر: | 2024 |
| مصطلحات موضوعية: | /dk/atira/pure/sustainabledevelopmentgoals/good_health_and_well_being, name=SDG 3 - Good Health and Well-being |
| الوصف: | Background: The aim of this open-label, multicenter, randomized controlled study was to investigate whether the life cycle pharma (LCP)-tacrolimus compared with the extended-release (ER)-tacrolimus formulation results in a difference in the prevalence of posttransplant diabetes, hypertension and chronic kidney disease (CKD) at 12 mo after liver transplantation. Methods: Patients were 1:1 randomized to either of the 2 tacrolimus formulations. The primary endpoint was defined as a composite endpoint of any of 3 events: sustained (>3 mo postrandomization) posttransplant diabetes, new-onset hypertension, and/or CKD, defined as estimated glomerular filtration rate <60 mL/min/1.73 m 2 for >3 m during the follow-up. Results: In total, 105 patients were included. In the intention-to-treat analysis, a statistically significant lower proportion of liver transplant recipients in the LCP-tacrolimus group reached the composite primary endpoint at 12 mo compared with the ER-tacrolimus group (50.9% [27/53], 95% confidence interval [CI], 37.9%-63.9% versus 71.2% [37/52], 95% CI, 57.7%-81.7%; risk difference: 0.202; 95% CI, 0.002-0.382; P = 0.046). No significant difference was found in the per protocol analysis. In the intention-to-treat and per protocol population, fewer liver transplant recipients in the LCP-tacrolimus group developed CKD and new-onset hypertension compared with the ER-tacrolimus group. No differences in rejection rate, graft and patient survival were found. Conclusions: A statistically significant and clinically relevant reduction in the prevalence of the composite primary endpoint was found in the LCP-tacrolimus group compared with the ER-tacrolimus group in the first year after liver transplantation with comparable efficacy. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://pure.eur.nl/en/publications/d33beb8d-17eb-458f-82d8-a4f71b872725Test |
| DOI: | 10.1097/TXD.0000000000001612 |
| الإتاحة: | https://doi.org/10.1097/TXD.0000000000001612Test https://pure.eur.nl/en/publications/d33beb8d-17eb-458f-82d8-a4f71b872725Test https://pure.eur.nl/ws/files/139937480/Modifying_Tacrolimus-related_Toxicity_After_Liver_Transplantation_Comparing_Life_Cycle_Pharma_Tacrolimus_Versus_Extended-released_Tacrolimus_A_Multicenter_Randomized_Controlled_Trial.pdfTest http://www.scopus.com/inward/record.url?scp=85187931387&partnerID=8YFLogxKTest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.1336E704 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1097/TXD.0000000000001612 |
|---|