Comparison of the long-term efficacy and safety of generic Tacrobell with original tacrolimus

This study aimed to evaluate the long-term efficacy and safety of a generic tacrolimus (Tacrobell [TCB]) compared to the original tacrolimus (Prograf [PGF]) in kidney transplant recipients. In this retrospective observational study, we analyzed the data from 444 patients who took TCB as a first-line...

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Bibliographic Details
Published in:Drug design, development and therapy development and therapy, 2017-01, Vol.11, p.203
Main Authors: Oh, Ha Young, Son, Seung Yeon, Jang, Hye Ryoun, Kim, sung Joo, Huh, Wooseong, Kim, Kyunga, Park, Jae Berm, Yoo, Heejin, Lee, Jung Eun
Format: Article
Language:English
Subjects:
Comparative analysis
Dosage and administration
Drug therapy
Generic drugs
Organ transplant recipients
Patient outcomes
Proprietary drugs
Tacrolimus
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Summary:This study aimed to evaluate the long-term efficacy and safety of a generic tacrolimus (Tacrobell [TCB]) compared to the original tacrolimus (Prograf [PGF]) in kidney transplant recipients. In this retrospective observational study, we analyzed the data from 444 patients who took TCB as a first-line immunosuppressive drug and 245 patients who took PGF. The 5-year graft survival rate was 92% for patients in the PGF group and 97% for patients in the TCB group, respectively. Cox proportional hazards for a one-sided, noninferiority model showed noninferiority (upper confidence interval [CI] limit of the hazard ratio [HR] < 1.2) for TCB compared to PGF (HR: 0.58; 95% CI: 0-1.14). The 5-year patient survival rate was 96% for patients in the PGF group and 97% for patients in the TCB group. Cox proportional hazards for a one-sided, noninferiority model showed noninferiority (upper confidence interval limit of the HR
ISSN:1177-8881
1177-8881