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      Generic Tacrolimus (Tacrobell ®) Shows Comparable Outcomes to Brand-Name Tacrolimus in the Long-Term Period After Adult Deceased Donor Liver Transplantation

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          Abstract

          Background

          Generic tacrolimus (Tacrobell ®) is commonly used in liver transplant patients in Korea. No previous studies have assessed the long-term efficacy and safety of generic tacrolimus for adult deceased donor liver transplantation (DDLT) patients. The aim of the present study was to evaluate the long-term efficacy and safety of generic tacrolimus compared to brand-name tacrolimus (Prograf ®) in adult DDLT recipients.

          Methods

          Two hundred sixty-five adult DDLTs were performed in our center between 2003 and 2017. To determine the efficacy and safety of generic tacrolimus, renal function (estimated glomerular filtration rate [eGFR] and creatinine), infectious complications, rejection-free survival rates, and patient survival rates were investigated.

          Results

          Of 265 patients, 193 were selected and divided into a generic tacrolimus group (n=147) and a brand-name group (n=46). Mean follow-up duration was 63.2 ± 44.3 months. The 1-year, 3-year, 5-year, and 10-year patient survival rates were 89.1%, 86.9%, 84.5%, and 75.2%, respectively, in the generic tacrolimus group and 95.7%, 88.9%, 86.3%, and 83.7% in the brand-name tacrolimus group. There were no statistically significant differences in the infectious complications, new-onset diabetes, and renal dysfunction included mean serum creatinine level or eGFR after DDLT between the two groups. Increased recipient age, continuous renal replacement therapy (CRRT) in the pre-transplant phase, and acute rejection were predisposing factors for patient death.

          Conclusion

          The present study shows that generic tacrolimus is an alternative comparable to brand-name tacrolimus in adult DDLT patients.

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          Most cited references 13

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          Comparative efficacy, acceptability, and tolerability of lisdexamfetamine in child and adolescent ADHD: a meta-analysis of randomized, controlled trials.

           Maneeton,  DeRosa,  SE Sedykh (2015)
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            Generic immunosuppression in solid organ transplantation: a Canadian perspective.

            The introduction of generic immunosuppressant medications may present an opportunity for cost savings in solid organ transplantation if equivalent clinical outcomes to the branded counterparts can be achieved. An interprofessional working group of the Canadian Society of Transplantation was established to develop recommendations on the use of generic immunosuppression in solid organ transplant recipients (SOTR) based on a review of the available data. Under current Health Canada licensing requirements, a demonstration of bioequivalence with the branded formulation in healthy volunteers allows for bridging of clinical data. Cyclosporine, tacrolimus, and sirolimus are designated as "critical dose drugs" and are held to stricter criteria. However, whether this provides sufficient guarantee of therapeutic equivalence in SOTR remains controversial, and failure to maintain an appropriate balance of immunosuppression may have serious consequences, including rejection, graft loss, and death. Published evidence supporting therapeutic equivalence of generic formulations in SOTR is lacking. Moreover, in the setting of multiple generic formulations the potential for uncontrolled product switching is a major concern, since generic preparations are not required to demonstrate bioequivalence with each other. Although close monitoring is recommended with any change in formulation, drug product switches are likely to occur without prescriber knowledge and may pose a significant patient safety risk. The advent of generic immunosuppression will require new practices including more frequent therapeutic drug and clinical monitoring, and increased patient education. The additional workload placed on transplant centers without additional funding will create challenges and could ultimately jeopardize patient outcomes. Until more robust clinical data are available and adequate regulatory safeguards are instituted, caution in the use of generic immunosuppressive drugs in solid organ transplantation is warranted.
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              An update on regulatory T cells in transplant tolerance and rejection.

              Several types of T cells with immunosuppressive properties have been identified, but FOXP3(+) regulatory T (T(REG)) cells have emerged as a dominant cell type; they are critically involved in the induction and maintenance of immune tolerance. Manipulation of this cell type for the induction of transplant tolerance including renal transplant tolerance has attracted considerable attention. Studies in this area have demonstrated unexpected complexities, and attempts to translate T(REG) cells towards clinical utility have met with unanticipated difficulties. In this Review, a broad overview is provided on recent progress in the study of T(REG) cells, focusing on challenges, opportunities, and emerging approaches in exploiting T(REG) cells for the induction of transplant tolerance.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                DDDT
                dddt
                Drug Design, Development and Therapy
                Dove
                1177-8881
                31 December 2019
                2019
                : 13
                : 4431-4438
                Affiliations
                [1 ]Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine , Seoul, Republic of Korea
                Author notes
                Correspondence: Jae-Won Joh Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine , Irwon-Ro 81, Gangnam-Gu, Seoul06351, Republic of KoreaTel +82-2-3410-3466Fax +82-2-3410-0040 Email jw.joh@samsung.com
                Article
                229114
                10.2147/DDDT.S229114
                6948198
                © 2019 Kim et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                Page count
                Figures: 3, Tables: 5, References: 17, Pages: 8
                Categories
                Original Research

                Pharmacology & Pharmaceutical medicine

                efficacy, safety, immunosuppression, liver transplantation

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