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Modifying Tacrolimus-related Toxicity After Liver Transplantation Comparing Life Cycle Pharma Tacrolimus Versus
Midas B Mulder1,2, Bart van Hoek3, Wojtek G Polak2,4
1Department of Hospital Pharmacy, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.
Transplantation Direct
|March 14, 2024
Summary
Life cycle pharma (LCP)-tacrolimus showed a significant reduction in posttransplant diabetes, hypertension, and CKD compared to extended-release (ER)-tacrolimus in liver transplant recipients. This formulation offers comparable efficacy with improved safety outcomes in the first year post-transplant.
Area of Science:
- Transplantation Medicine
- Pharmacology
- Nephrology
Background:
- Liver transplantation is a complex procedure with significant post-transplant complications.
- Tacrolimus is a key immunosuppressant, but its formulations can impact patient outcomes.
- Post-transplant complications such as diabetes, hypertension, and chronic kidney disease (CKD) affect long-term graft and patient survival.
Purpose of the Study:
- To compare the efficacy and safety of LCP-tacrolimus versus ER-tacrolimus.
- To investigate the impact of tacrolimus formulations on the incidence of posttransplant diabetes, hypertension, and CKD.
- To evaluate differences in rejection rates, graft survival, and patient survival between the two formulations.
Main Methods:
- An open-label, multicenter, randomized controlled study involving 105 liver transplant recipients.
- Patients were randomized 1:1 to receive either LCP-tacrolimus or ER-tacrolimus.
- The primary endpoint was a composite of sustained posttransplant diabetes, new-onset hypertension, and/or CKD (eGFR <60 mL/min/1.73 m² for >3 months) within 12 months post-transplantation.
Main Results:
- The LCP-tacrolimus group demonstrated a statistically significant lower proportion of patients reaching the composite primary endpoint (50.9%) compared to the ER-tacrolimus group (71.2%) at 12 months (P=0.046).
- Fewer patients in the LCP-tacrolimus group developed CKD and new-onset hypertension.
- No significant differences were observed in rejection rates, graft survival, or patient survival between the two groups.
Conclusions:
- LCP-tacrolimus significantly reduces the prevalence of key posttransplant complications, including diabetes, hypertension, and CKD, within the first year after liver transplantation.
- The LCP-tacrolimus formulation offers a clinically relevant benefit over ER-tacrolimus in terms of safety outcomes.
- Both tacrolimus formulations demonstrated comparable efficacy in terms of graft and patient survival.
