A randomized trial on the efficacy and safety of Advagraf vs tacrolimus in prevention of acute liver allograft rejection
10.3760/cma.j.issn.0254-1785.2011.04.007
- VernacularTitle:他克莫司胶囊和缓释胶囊预防肝移植急性排斥反应的效果和安全性
- Author:
Guangming LI
;
Shushen ZHENG
;
Yongfeng LIU
;
Zhijun ZHU
;
Qiang XIA
;
Jian ZHOU
;
Zhiren FU
;
Lei HUANG
;
Jiye ZHU
;
Xisheng LENG
- Publication Type:Journal Article
- Keywords:
Liver transplantation;
Tacrolimus;
Delayed-action preparations;
Treatment outcome;
Security
- From:
Chinese Journal of Organ Transplantation
2011;32(4):217-220
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and safety of tacrolimus exposure in stable liver transplant recipients converted from FK506 twice a day to Advagraf (tacrolimus extended-release capsules) once daily. Methods This was an open-label, random, control and multi-center study.Eligible patients were 19 to 70 years of age, 6 months post-transplant with stable renal and hepatic function and receiving stable doses of tacrolimus twice a day for 2 weeks prior to enrollment. There were 86 patients in the experimental group and the control group, separately. The average age of experimental group and control group was 46 ± 10 and 49 ± 9, respectively. Patients in experimental group received Advagraf, once daily, and the dose was adjusted according to the drug concentration,and the drug concentration was between 2 to 10 μg/L. The control group given tacrolimus, twice daily, and the drug concentration was between 2 to 10 μg/L. Results The incidence of acute rejection reaction was 1.20 % and 1.18 % respectively in experimental group and control group, and the 95 %confidence interval was -3.25% ～3.31 % and -3.26% ～ 3.34 %, individually. There was 1 case of acute rejection reaction in experimental group and control group, respectively. The patient and organ survival rate was 100%. Sixteen adverse events occurred in 15 patients (17.65 %) of the experimental group, and 10 adverse events occurred in 10 patients (11.63 %) of control group. Severe adverse events relating to the test drug in experimental group occurred in 4 patients (4. 71 %). and 2 patients (2. 33) in control group.Conclision Clinical trials indicated that Advagraf has efficacy and safety profiles similar to those of tacrolimus. The drug is safe and may improve patient compliance.
