BACKGROUND/AIMS: This 26-week pilot study was performed in de novo liver transplant recipients to evaluate the efficacy of tacrobell capsule as an immunosuppressant drugafter living donor liver transplant patients by determining the rate of acute cellular rejection after its use and evaluating its safety after transplantation. METHODOLOGY:From October 2005 to July 2007, 57 patients from four major medical centers in Seoul, South Korea were enrolled in the study. This open-label, noncomparative, multicenter pilot study lasted 26 weeks and assigned patients to receive tacrobell and corticosteroidafter liver transplantation. Tacrobell (0.05mg/ kg/day, bid) and methylprednisolone were injected either on the day of the operation or on postoperative day one. A retrospective matched control group consisting of living donor liver transplant recipients at one center (Asan medical center) was used for comparison. RESULTS: The rate of acute cellular rejection with Tacrobell after 26 weeks of administration was 0.0% (95% CI, 0.0%-6.27%), which was below our hypothesized 36%. The most common drug-related adverse events included endocrine/nutritional disorders followed by gastrointestinal and hepatobiliary disorders. No patients died during the study period. The side effect profile of this drug was no different than other tacrolimus based immunosuppressants. CONCLUSIONS: Although our study was based on a low risk population and had a shortterm follow up, we conclude that tacrobell, as a generic tacrolimus, can be considered safe and effective in liver transplant patients.
RCT Entities:
BACKGROUND/AIMS: This 26-week pilot study was performed in de novo liver transplant recipients to evaluate the efficacy of tacrobell capsule as an immunosuppressant drug after living donor liver transplant patients by determining the rate of acute cellular rejection after its use and evaluating its safety after transplantation. METHODOLOGY: From October 2005 to July 2007, 57 patients from four major medical centers in Seoul, South Korea were enrolled in the study. This open-label, noncomparative, multicenter pilot study lasted 26 weeks and assigned patients to receive tacrobell and corticosteroid after liver transplantation. Tacrobell (0.05mg/ kg/day, bid) and methylprednisolone were injected either on the day of the operation or on postoperative day one. A retrospective matched control group consisting of living donor liver transplant recipients at one center (Asan medical center) was used for comparison. RESULTS: The rate of acute cellular rejection with Tacrobell after 26 weeks of administration was 0.0% (95% CI, 0.0%-6.27%), which was below our hypothesized 36%. The most common drug-related adverse events included endocrine/nutritional disorders followed by gastrointestinal and hepatobiliary disorders. No patients died during the study period. The side effect profile of this drug was no different than other tacrolimus based immunosuppressants. CONCLUSIONS: Although our study was based on a low risk population and had a shortterm follow up, we conclude that tacrobell, as a generic tacrolimus, can be considered safe and effective in liver transplant patients.
Authors: Jong Man Kim; Pyoung-Jae Park; Geun Hong; Dong Jin Joo; Kwan Woo Kim; Je Ho Ryu; Young Seok Han; Jai Young Cho; Gi-Won Song; Bong-Wan Kim; Dong-Sik Kim; Seong Hoon Kim; Sang Tae Choi; Young Kyoung You; Kyung-Suk Suh; Yang-Won Na; Koo Jeong Kang; Jae-Won Joh Journal: Korean J Transplant Date: 2021-09-30
Authors: Amber O Molnar; Dean Fergusson; Anne K Tsampalieros; Alexandria Bennett; Nicholas Fergusson; Timothy Ramsay; Greg A Knoll Journal: BMJ Date: 2015-06-22
Authors: Ho Joong Choi; Dong Goo Kim; Bong Jun Kwak; Jae Hyun Han; Tae Ho Hong; Young Kyoung You Journal: Drug Des Devel Ther Date: 2018-02-13 Impact factor: 4.162