Logo Annals of Transplantation Logo Annals of Transplantation Logo Annals of Transplantation

27 August 2019 : Original article  

A Multicenter, Prospective, Observational Study of Conversion from Twice-Daily Immediate-Release to Once-Daily Prolonged-Release Tacrolimus in Liver Transplant Recipients in France: The COBALT Study

Jérôme Dumortier1ABDE, Christophe Duvoux2ABDE, Laurence Dubel3ADE*, Fabienne Bazin4ACE, Pauline Houssel-Debry5ABDE

DOI: 10.12659/AOT.916041

Ann Transplant 2019; 24:506-516

Abstract

BACKGROUND: In adult liver transplant patients, the use of prolonged-release tacrolimus may have treatment adherence benefits over the immediate-release formulation. The aim of this study was to characterise real-world practice data on conversion of liver transplant recipients from immediate- to prolonged-release tacrolimus in France.

MATERIAL AND METHODS: A prospective, observational study (NCT02143479) was conducted in 18 transplant centers in France between June 2014 and March 2016. Liver transplant recipients (n=398) included patients who changed from immediate-release to prolonged-release tacrolimus within the first three months (early conversion group) (n=205) or between three and 12 months after transplantation (late conversion group) (n=184). Clinical data were collected at an initial baseline outpatient visit and six-month and 12-month follow-up visits. Endpoints included the dose conversion ratio from immediate-release to prolonged-release tacrolimus, number of and reasons for additional visits due to conversion, safety, and tolerability.

RESULTS: Baseline clinical and demographic characteristics were similar between the two cohorts. The mean ±SD ratio of conversion of tacrolimus dose was 1.04±0.28; 1.01±0.28 (early) and 1.08±0.28 (late) (p=0.0247). The mean ±SD time from conversion to the first tacrolimus trough blood concentration was 30.8±42.8 days; 24.8±45.4 days (early) and 37.5±38.7 days (late). Only one patient required an additional visit due to conversion. Reasons for conversion included the physician’s preference (56.3%), center practice (38.6%), and the dosing frequency (36.0%). Conversion was associated with a low rate of graft rejection, and no new safety issues were reported.

CONCLUSIONS: Conversion of liver transplant recipients from immediate-release to prolonged-release tacrolimus within three to 12 months of transplantation was easy to manage and associated with favorable clinical outcomes and safety profiles.

Keywords: Liver Transplantation, observational study, Tacrolimus, Delayed-Action Preparations, Drug Administration Schedule, France, Immunosuppressive Agents, medication adherence, Prospective Studies, Quality of Life, transplant recipients

Add Comment 0 Comments

In Press

08 Mar 2024 : Original article  

Association of Coronary Calcium Score on Cardiac PET During Pre-Kidney Transplant Assessment with Persisten...

Ann Transplant In Press; DOI: 10.12659/AOT.943532  

14 Mar 2024 : Original article  

Impact of Blood Products Transfusion on Patients in the Immediate Post-Lung Transplant Period: A Cohort Study

Ann Transplant In Press; DOI: 10.12659/AOT.943652  

14 Mar 2024 : Case report  

Treatment of Cavernous Transformation of Portal Vein Caused by Hepatic Cystic Echinococcosis Using Ex Vivo ...

Ann Transplant In Press; DOI: 10.12659/AOT.942358  

15 Mar 2024 : Review article  

Approaches and Challenges in the Current Management of Cytomegalovirus in Transplant Recipients: Highlighti...

Ann Transplant In Press; DOI: 10.12659/AOT.941185  

Most Viewed Current Articles

05 Apr 2022 : Original article  

Impact of Statins on Hepatocellular Carcinoma Recurrence After Living-Donor Liver Transplantation

DOI :10.12659/AOT.935604

Ann Transplant 2022; 27:e935604

12 Jan 2022 : Original article  

Risk Factors for Developing BK Virus-Associated Nephropathy: A Single-Center Retrospective Cohort Study of ...

DOI :10.12659/AOT.934738

Ann Transplant 2022; 27:e934738

22 Nov 2022 : Original article  

Long-Term Effects of Everolimus-Facilitated Tacrolimus Reduction in Living-Donor Liver Transplant Recipient...

DOI :10.12659/AOT.937988

Ann Transplant 2022; 27:e937988

15 Mar 2022 : Case report  

Combined Liver, Pancreas-Duodenum, and Kidney Transplantation for Patients with Hepatitis B Cirrhosis, Urem...

DOI :10.12659/AOT.935860

Ann Transplant 2022; 27:e935860

Your Privacy

We use cookies to ensure the functionality of our website, to personalize content and advertising, to provide social media features, and to analyze our traffic. If you allow us to do so, we also inform our social media, advertising and analysis partners about your use of our website, You can decise for yourself which categories you you want to deny or allow. Please note that based on your settings not all functionalities of the site are available. View our privacy policy.

Annals of Transplantation eISSN: 2329-0358
Annals of Transplantation eISSN: 2329-0358