Lower Variability in 24-Hour Exposure During Once-Daily Compared to Twice-Daily Tacrolimus Formulation in Kidney Transplantation

Stifft, Frank; Stolk, L. M. L.; Undre, Nasrullah; Hooff, J. P. van; Christiaans, Maarten H. L.

doi:10.1097/01.tp.0000437561.31212.0e

Cited by 99 publications

(109 citation statements)

References 15 publications

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“…In the EVOLUTION study (EValuation Of Advagraf conversion and Long-term Use in kidney TransplantatION), for example, a 34% improvement in adherence to tacrolimus was observed in the patients receiving the prolonged-release versus immediate-release formulation. 79 These findings were consistent with Stifft et al 77 who reported a 23% reduction in intrapatient variability after conversion from immediate-to prolonged-release tacrolimus. Previously published studies have also demonstrated a lower variability of tacrolimus exposure and improved adherence to treatment with prolonged-release versus immediate-release tacrolimus.…”

Section: Underimmunosuppression In Kidney Transplantationsupporting

confidence: 82%

“…Previously published studies have also demonstrated a lower variability of tacrolimus exposure and improved adherence to treatment with prolonged-release versus immediate-release tacrolimus. 76,77,80 Previously reported data from 40 000 patients over 6 years of follow-up suggest that there is an annual decrease in renal function in the posttransplant period of~1.6 mL/min per 1.73 m 2 per year, 81 with similar findings being reported for 4000 kidney transplant patients in the Catalan Registry (−1.5 mL/min per 1.73 m 2 per year). These data suggest that even 'stable' patients are experiencing a decline in renal function over time and that we need to continue to monitor this decline and to modify our therapeutic regimens to improve outcomes for our patients.…”

Section: Underimmunosuppression In Kidney Transplantationsupporting

confidence: 71%

“…67 Converting patients from immediate-release to prolonged-release tacrolimus preparations has been shown to reduce intrapatient variability in both South Asian 76 and European populations. 77 The clinical consequences of this degree of improved adherence cannot be easily mapped, but logically, a high-variability cohort should benefit in terms of clinical outcome measures from a once-daily, prolongedrelease formulation of tacrolimus.…”

Section: Variability Of Immunosuppressive Exposure In Kidney Transplamentioning

confidence: 99%

“…These interventions include education on the impact of variability and nonadherence to treatment, and conversion to prolonged-release tacrolimus, which has been shown to have lower variability of exposure and to improve adherence to treatment versus immediaterelease tacrolimus. 67,77 High intrapatient variability of tacrolimus exposure defines a group of patients proven to manifest rejection, graft failure and dysfunction at a higher rate than the lower-variability population. Intervention to reduce variability would, therefore, seem justified and sensible.…”

Section: Variability Of Immunosuppressive Exposure In Kidney Transplamentioning

confidence: 99%

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Advancing Transplantation

et al. 2017

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Section: Underimmunosuppression In Kidney Transplantationsupporting

confidence: 82%

Section: Underimmunosuppression In Kidney Transplantationsupporting

confidence: 71%

Section: Variability Of Immunosuppressive Exposure In Kidney Transplamentioning

confidence: 99%

Section: Variability Of Immunosuppressive Exposure In Kidney Transplamentioning

confidence: 99%

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Advancing Transplantation

et al. 2017

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“…151,154 The conversion from twice-daily to prolonged-release tacrolimus (capsules), both in kidney and liver transplant recipients, leads to lower blood trough concentrations and a reduced IPVof tacrolimus. 155,156 In a single study performed in liver transplant recipients, the early conversion to prolonged-release tacrolimus capsules was accompanied by a significant reduction of TCMR rates. 114 It remains unclear, however, whether a reduction in IPV motivated by conversion to prolonged-release tacrolimus capsules would also lead to improved clinical outcomes; prospective trials are needed.…”

Section: Highly Modifiable Contributors To Variabilitymentioning

confidence: 99%

Practical Recommendations for Long-term Management of Modifiable Risks in Kidney and Liver Transplant Recipients

et al. 2017

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Short-term patient and graft outcomes continue to improve after kidney and liver transplantation, with 1-year survival rates over 80%; however, improving longer-term outcomes remains a challenge. Improving the function of grafts and health of recipients would not only enhance quality and length of life, but would also reduce the need for retransplantation, and thus increase the number of organs available for transplant. The clinical transplant community needs to identify and manage those patient modifiable factors, to decrease the risk of graft failure, and improve longer-term outcomes. COMMIT was formed in 2015 and is composed of 20 leading kidney and liver transplant specialists from 9 countries across Europe. The group's remit is to provide expert guidance for the long-term management of kidney and liver transplant patients, with the aim of improving outcomes by minimizing modifiable risks associated with poor graft and patient survival posttransplant. The objective of this supplement is to provide specific, practical recommendations, through the discussion of current evidence and best practice, for the management of modifiable risks in those kidney and liver transplant patients who have survived the first postoperative year. In addition, the provision of a checklist increases the clinical utility and accessibility of these recommendations, by offering a systematic and efficient way to implement screening and monitoring of modifiable risks in the clinical setting. 12 Department of Gastroenterology and Hepatology, Erasmus MC, University Hospital Rotterdam, the Netherlands. 13 Department of Gastroenterology and Hepatology, University Hospitals KU Leuven, Belgium.14 Abdominal Transplant Surgery, Microbiology and Immunology Department, University Hospitals KU Leuven, Belgium. 15 Department of Hepatology and Liver Transplantation, Reina Sofía University Hospital, IMIBIC, CIBERehd, Spain. www.transplantjournal.com S1 S olid organ transplantation has evolved from an experimental procedure to an established treatment option for many types of end-stage organ failure. Both patient and graft outcomes are continuing to improve, and 1-year patient and graft survival currently exceed 80%.1,2 However, survival rates gradually decline over the long term. In kidney transplant, 5-and 10-year graft survival rates in Europe are 77% and 56%, and for liver transplant, 64% and 54% (Figures 1 and 2). 3,4 Although most European countries have seen an increase in both living and deceased donation, transplantation is not available to all who would benefit from the procedure, and there is considerable morbidity and mortality for those listed for transplant.6 Therefore, maximizing long-term graft survival and reducing the need for retransplantation is paramount, not only in improving outcomes for the recipients but also for those awaiting a graft. The improvement in outcomes is predominantly due to reduction in (Transplantation. 2017;101:S1-S41). The authors were approached by Astellas to discuss the practical implementation o...

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Intrapatient Variability of Tacrolimus Exposure in Solid Organ Transplantation: A Novel Marker for Clinical Outcome

Kuypers

2019

Clin Pharma and Therapeutics

136

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The calcineurin-inhibitor tacrolimus provides an acceptable balance between prevention of allograft rejection and drug-related adverse effects, making it the standard of care in all types of solid organ transplantation for the last two decades. Recent data have demonstrated that high intra-patient variability (IPV) in tacrolimus pre-dose trough concentrations has deleterious effects on allograft survival. The underlying mechanisms by which a high tacrolimus IPV shortens allograft survival are acute and chronic rejection, donor-specific anti-HLA antibodies and progressive fibrotic damage to the graft. Modifiable causes of high tacrolimus IPV include medication non-adherence, drug interactions, nutritional interferences and concurrent diseases. Recognizing high tacrolimus IPV as an important prognostic risk factor after solid organ transplantation requires understanding of the definitions, the use of correct diagnostic metrics and methodology. Therapeutic interventions aimed at reducing tacrolimus IPV are targeted on improving medication non-adherence, avoiding or adjusting drug interactions, drug dosing assists and educational support of recipients.

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Lower Variability in 24-Hour Exposure During Once-Daily Compared to Twice-Daily Tacrolimus Formulation in Kidney Transplantation

Cited by 99 publications

References 15 publications

Advancing Transplantation

Advancing Transplantation

Practical Recommendations for Long-term Management of Modifiable Risks in Kidney and Liver Transplant Recipients

Intrapatient Variability of Tacrolimus Exposure in Solid Organ Transplantation: A Novel Marker for Clinical Outcome

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