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 |
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| المؤلفون: | Midas B. Mulder, PharmD, Bart van Hoek, MD, PhD, Wojtek G. Polak, MD, PhD, Ian P.J. Alwayn, MD, PhD, Brenda C.M. de Winter, PharmD, PhD, Sarwa Darwish Murad, MD, PhD, Elke Verhey-Hart, BSc, Lara Elshove, MSc, Nicole S. Erler, Dipl-Stat, PhD, Dennis A. Hesselink, MD, PhD, Caroline M. den Hoed, MD, PhD, Herold J. Metselaar, MD, PhD |
| المصدر: | Transplantation Direct, Vol 10, Iss 4, p e1612 (2024) |
| بيانات النشر: | Wolters Kluwer, 2024. |
| سنة النشر: | 2024 |
| المجموعة: | LCC:Surgery |
| مصطلحات موضوعية: | Surgery, RD1-811 |
| 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 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 |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2373-8731 00000000 |
| العلاقة: | http://journals.lww.com/transplantationdirect/fulltext/10.1097/TXD.0000000000001612Test; https://doaj.org/toc/2373-8731Test |
| DOI: | 10.1097/TXD.0000000000001612 |
| الوصول الحر: | https://doaj.org/article/e000db20ac504b629c8bfe70cc940d02Test |
| رقم الانضمام: | edsdoj.000db20ac504b629c8bfe70cc940d02 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 23738731 00000000 |
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| DOI: | 10.1097/TXD.0000000000001612 |