Efficacy and safety of a switch from twice- daily tacrolimus to once-daily generic tacrolimus in stable liver transplant patients
- 주제(키워드) Tacrolimus , Liver transplantation , Therapeutic equivalence , Immunosuppression
- 주제(기타) 의학일반
- 설명문(URI) https://www.kci.go.kr/kciportal/ci/sereArticleSearch/ciSereArtiView.kci?sereArticleSearchBean.artiId=ART002760449
- 등재 KCI등재
- 발행기관 대한이식학회
- 발행년도 2021
- URI http://www.dcollection.net/handler/ewha/000000183090
- 본문언어 영어
초록/요약
Background: Once-daily tacrolimus reduces non-compliance relative to twice-daily tacrolimus. However, little is known about the safety and efficacy of conversion from twice-daily tacrolimus to generic once-daily tacrolimus in liver transplantation (LT). Herein, we investigated the efficacy and safety of a switch from twice-daily tacrolimus to generic once-daily tacrolimus in patients with stable liver graft function. Methods: This prospective, multicenter, open-label, single-arm study was conducted in 17 medical centers for 1 year from July 2019 to July 2020 (NCT04069065). Primary end- point was the incidence of biopsy-proven acute rejection (BPAR) for 24 weeks after con- version. Secondary endpoints were graft failure, patient death, and adverse events (AEs). Results: Of 151 screened LT patients, 144 patients were enrolled. BPAR, graft failure, and patient death did not occur in this patient population. There were no statistical dif- ferences in blood tests, liver function tests, or biochemical tests between visits in any of the patients. Median tacrolimus trough level decreased abruptly from 4.7 ng/mL to 3.2 ng/mL after generic once-daily tacrolimus conversion, but median tacrolimus dose in- creased due to low tacrolimus trough level. Ninety-two adverse events occurred in 54 pa- tients. Liver enzyme levels increased in seven patients (4.9%) after the switch to generic once-daily tacrolimus, but the liver function tests of these patients normalized thereafter. There were three cases of severe AEs not related to investigational drug. Conclusions: Present study suggests that conversion from twice-daily tacrolimus to ge- neric once-daily tacrolimus is effective and safe in stable LT patients.
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