03 September 2019 : Original article
A Prospective, Observational Study of Conversion From Immediate- to Prolonged-Release Tacrolimus in Renal Transplant Recipients in France: The OPALE Study
Valérie Moal1ABDE, Philippe Grimbert2ABE, Adrien Beauvais3ACE, Laurence Dubel4ADE*, Yann Le Meur5ABDEDOI: 10.12659/AOT.916043
Ann Transplant 2019; 24:517-526
Abstract
BACKGROUND: Potential benefits of once-daily, prolonged-release tacrolimus over the immediate-release formulation include improved adherence to immunosuppressives post transplantation. An observational study was performed to characterize real-world practice surrounding conversion from immediate- to prolonged-release tacrolimus in kidney transplant recipients.
MATERIAL AND METHODS: We performed a prospective, observational study of renal transplant recipients converted from immediate- to prolonged-release tacrolimus capsules. Conversion took place at the baseline visit, within the first 6 months of transplantation (early conversion group) or between 6 and 12 months of transplantation (late conversion group). Data collection was performed at routine follow-up at 6 and 12 months. Endpoints included conversion ratio from immediate- to prolonged-release tacrolimus, reasons for conversion, additional visits due to conversion, safety, and tolerability.
RESULTS: The analysis population comprised 591 patients. Baseline characteristics were similar between the 2 groups. The mean conversion ratio of the daily dose of tacrolimus was 0.98±0.17 in the early group and 0.99±0.09 in the late group. Time from conversion (mean ±SD) to first measurement of trough tacrolimus blood concentration was 12.1±11.6 and 27.6±26.7 days in the early and late groups, respectively. The highest number of additional visits required was 6 in the early conversion group, in 3 patients (0.7%), and 3 in the late conversion group, in 2 patients (1.6%). Conversion from immediate- to prolonged-release tacrolimus was associated with a very low rate of graft rejection.
CONCLUSIONS: Favorable clinical outcomes and safety profiles were observed with conversion from immediate- to prolonged-release tacrolimus over 1 year following renal transplantation, with no marked differences between the early and late conversion groups.
Keywords: Kidney Transplantation, observational study, Tacrolimus, Aged, Delayed-Action Preparations, Drug Administration Schedule, France, Immunosuppressive Agents, medication adherence, Middle Aged, Prospective Studies, Quality of Life, transplant recipients, Treatment Outcome
947 18
In Press
14 Sep 2023 : Case report
Intrahepatic Venous Collateral Circulation and Reverse Blood Flow After Main Hepatic Vein Obstruction: A Ca...Ann Transplant In Press; DOI: 10.12659/AOT.941521
12 Sep 2023 : Original article
Three-Dimensional Printing of Polycaprolactone/Nano-Hydroxyapatite Composite Scaffolds with a Pore Size of ...Ann Transplant In Press; DOI: 10.12659/AOT.940365
04 Sep 2023 : Original article
Analysis of Anxiety and Influencing Factors in Kidney Transplant Recipients and General Public During the C...Ann Transplant In Press; DOI: 10.12659/AOT.941489
04 Sep 2023 : Original article
Prolonged Tracheal Intubation in the ICU as a Possible Risk Factor for Arytenoid Dislocation After Liver Tr...Ann Transplant In Press; DOI: 10.12659/AOT.940727
Most Viewed Current Articles
24 Aug 2021 : Review article
Normothermic Machine Perfusion (NMP) of the Liver – Current Status and Future PerspectivesDOI :10.12659/AOT.931664
Ann Transplant 2021; 26:e931664
26 Jan 2022 : Review article
Recurrence of Hepatocellular Carcinoma After Liver Transplantation: Risk Factors and Predictive ModelsDOI :10.12659/AOT.934924
Ann Transplant 2022; 27:e934924
29 Dec 2021 : Original article
Efficacy and Safety of Tacrolimus-Based Maintenance Regimens in De Novo Kidney Transplant Recipients: A Sys...DOI :10.12659/AOT.933588
Ann Transplant 2021; 26:e933588
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