title: Comparison of the long-term efficacy and safety of generic Tacrobell with original tacrolimus (Prograf) in kidney transplant recipients.
abstract: 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<2.0) for TCB compared to PGF (HR: 0.83; 95% CI: 0-1.95). The 5-year acute rejection-free graft survival rate was not significantly different between the groups (TCB 67%, PGF 68.8%;P=0.6286). The incidence of adverse events including adverse cardiovascular or cerebrovascular events, malignancies, new-onset diabetes after transplantation, and infection events did not differ significantly between the two groups. We conclude that TCB is a comparable alternative to the original tacrolimus as a first-line immunosuppressive drug. Producers of generics should support further study of their products after approval to assure physicians of their efficacy and safety.
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine.
authors.forename: Seung Yeon
authors.initials: SY
authors.lastname: Son
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine.
authors.forename: Hye Ryoun
authors.initials: HR
authors.lastname: Jang
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine.
authors.forename: Jung Eun
authors.initials: JE
authors.lastname: Lee
authors.affiliation: Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center.
authors.forename: Heejin
authors.initials: H
authors.lastname: Yoo
authors.affiliation: Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center; Department of Digital Health, SAIHST.
authors.forename: Kyunga
authors.initials: K
authors.lastname: Kim
authors.affiliation: Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Jae Berm
authors.initials: JB
authors.lastname: Park
authors.affiliation: Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: Sung Joo
authors.initials: SJ
authors.lastname: Kim
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine.
authors.forename: Ha Young
authors.initials: HY
authors.lastname: Oh
authors.affiliation: Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine.
authors.forename: Wooseong
authors.initials: W
authors.lastname: Huh
mesh_terms: D000328:Adult; D016568:Drugs, Generic / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology*; D016030:Kidney Transplantation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D015996:Survival Rate; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology*
chemical_list: D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D016559:Tacrolimus
keywords: generic; kidney transplant; tacrolimus