Comparison of the long-term efficacy and safety of generic Tacrobell with original tacrolimus (Prograf) in kidney transplant recipients

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.203-210
Main Authors: Son, Seung Yeon, Jang, Hye Ryoun, Lee, Jung Eun, Yoo, Heejin, Kim, Kyunga, Park, Jae Berm, Kim, Sung Joo, Oh, Ha Young, Huh, Wooseong
Format: Article
Language:English
Subjects:
Adult
Cardiovascular disease
Clinical trials
Comparative analysis
Confidence intervals
Coronary vessels
Cytomegalovirus
Diabetes mellitus
Dosage and administration
Drug dosages
Drug therapy
Drugs, Generic - administration & dosage
Drugs, Generic - adverse effects
Drugs, Generic - pharmacology
Effectiveness
FDA approval
Female
generic
Generic drugs
Graft rejection
Hazards
Health care
Health hazards
Humans
Immunosuppressive agents
Immunosuppressive Agents - administration & dosage
Immunosuppressive Agents - adverse effects
Immunosuppressive Agents - pharmacology
kidney transplant
Kidney transplantation
Kidney Transplantation - methods
Kidney transplants
Kidneys
Male
Medical personnel
Medical records
Medicine
Middle Aged
Organ transplant recipients
Original Research
Patient outcomes
Patients
Physicians
Product safety
Proportional Hazards Models
Proprietary drugs
Retrospective Studies
Safety
Survival
Survival Rate
Tacrolimus
Tacrolimus - administration & dosage
Tacrolimus - adverse effects
Tacrolimus - pharmacology
Transplantation
Transplants & implants
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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]
ISSN:1177-8881
1177-8881
DOI:10.2147/DDDT.S118154