Real-World Study of Once-Daily, Extended-Release Tacrolimus Versus Twice-Daily, Immediate-Release Tacrolimus in Kidney Transplantation: Clinical Outcomes and Healthcare Resource Utilization

Bing Ho, Hardik Bhagat, Jason J. Schwartz, Kofi Atiemo, Amna Daud, Raymond Kang, Samantha E. Montag, Lihui Zhao, Edward Lee, Anton I. Skaro, Daniela P. Ladner*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

Abstract

Introduction: Real-world data with extended-release tacrolimus (ER-T) are lacking in the USA. This study examined clinical outcomes and healthcare resource utilization in kidney transplant patients receiving ER-T in clinical practice. Methods: This was a retrospective, single-center analysis (February–June 2016) using data from Northwestern University’s Enterprise Data Warehouse. Adult patients receiving a kidney transplant in the preceding 4 years, treated de novo or converted to ER-T from immediate-release tacrolimus (IR-T) within 10 days post-transplantation, and maintained on ER-T (at least 3 months) were included. Patients were matched for demographic and clinical characteristics with IR-T-treated control patients. Endpoints included clinical outcomes and healthcare resource utilization up to 1 year post-transplantation. Results: A total of 19 ER-T-treated patients were matched with 55 IR-T-treated patients. No ER-T-treated patients experienced biopsy-confirmed acute rejection (BCAR) or graft failure versus 3 (5.5%) and 3 (5.5%) IR-T-treated patients, respectively. Mean estimated glomerular filtration rate (eGFR), the number of all-cause outpatient visits, readmissions, and all-cause hospitalization days were comparable between groups. Tacrolimus trough levels, days to target level (6–10 ng/mL), and number of required dose adjustments were also similar. Conclusion: Real-world clinical outcomes and healthcare resource utilization were similar with ER-T and IR-T. Larger studies will need to investigate the trend toward fewer BCAR events, and increased graft survival with ER-T. Funding: Astellas Pharma Global Development, Inc. Plain Language Summary: Plain language summary available for this article.

Original languageEnglish (US)
JournalAdvances in Therapy
DOIs
StatePublished - Jan 1 2019

Keywords

  • Calcineurin inhibitor
  • Glomerular filtration rate (GFR)
  • Graft survival
  • Immunosuppressant
  • Kidney (allograft) function/dysfunction
  • Patient characteristics
  • Tacrolimus
  • Urology

ASJC Scopus subject areas

  • Pharmacology (medical)

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