Reducing the Pill Burden: Immunosuppressant Adherence and Safety after Conversion from a Twice-Daily (IR-Tac) to a Novel Once-Daily (LCP-Tac) Tacrolimus Formulation in 161 Liver Transplant Patients.
Max M MaurerMarius IbachJulius PleweAxel WinterPaul Viktor RitschlBrigitta GlobkeRobert OellingerGeorg LurjeWenzel SchöningJohann PratschkeDennis EurichPublished in: Biomedicines (2022)
Non-adherence to immunosuppressant therapy reduces long-term graft and patient survival after solid organ transplantation. The objective of this 24-month prospective study was to determine adherence, efficacy and safety after conversion of stable liver transplant (LT) recipients from a standard twice-daily immediate release Tacrolimus (IR-Tac) to a novel once-daily life cycle pharma Tacrolimus (LCP-Tac) formulation. We converted a total of 161 LT patients at baseline, collecting Tacrolimus trough levels, laboratories, physical examination data and the BAASIS © questionnaire for self-reported adherence to immunosuppression at regular intervals. With 134 participants completing the study period (17% dropouts), the overall adherence to the BAASIS © increased by 57% until month 24 compared to baseline (51% vs. 80%). Patients who required only a morning dose of their concomitant medications reported the largest improvement in adherence after conversion. The intra-patient variability (IPV) of consecutive Tacrolimus trough levels after conversion did not change significantly compared to pre-conversion levels. Despite reducing the daily dose by 30% at baseline as recommended by the manufacturer, Tac-trough levels remained stable, reflected by an increase in the concentration-dose (C/D) ratio. No episodes of graft rejection or loss occurred. Our data suggest that the use of LCP-Tac in liver transplant patients is safe and can increase adherence to immunosuppression compared to conventional IR-Tac.
Keyphrases
- physical activity
- end stage renal disease
- ejection fraction
- newly diagnosed
- chronic kidney disease
- glycemic control
- type diabetes
- peritoneal dialysis
- stem cells
- case report
- big data
- risk factors
- patient reported outcomes
- machine learning
- insulin resistance
- skeletal muscle
- kidney transplantation
- weight loss
- bone marrow
- intimate partner violence