Generic Tacrolimus (Tacrobell®) Shows Comparable Outcomes to Brand-Name Tacrolimus in the Long-Term Period After Adult Deceased Donor Liver Transplantation
Jong Man Kim, Jae-Won Joh, Gyu-Seong Choi, Suk-Koo Lee Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of KoreaCorrespondence: Jae-Won JohDepartment of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Irwon-Ro 81,...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2019-12-01
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| Series: | Drug Design, Development and Therapy |
| Subjects: | |
| Online Access: | https://www.dovepress.com/generic-tacrolimus-tacrobellreg-shows-comparable-outcomes-to-brand-nam-peer-reviewed-article-DDDT |
| _version_ | 1819277742898675712 |
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| author | Kim JM Joh JW Choi GS Lee SK |
| author_facet | Kim JM Joh JW Choi GS Lee SK |
| author_sort | Kim JM |
| collection | DOAJ |
| description | Jong Man Kim, Jae-Won Joh, Gyu-Seong Choi, Suk-Koo Lee Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of KoreaCorrespondence: Jae-Won JohDepartment of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Irwon-Ro 81, Gangnam-Gu, Seoul 06351, Republic of KoreaTel +82-2-3410-3466Fax +82-2-3410-0040Email jw.joh@samsung.comBackground: 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.Keywords: liver transplantation, immunosuppression, safety, efficacy |
| first_indexed | 2024-12-24T00:00:57Z |
| format | Article |
| id | doaj.art-d88c99fb06514b9899d845bf4d6f9c95 |
| institution | Directory Open Access Journal |
| issn | 1177-8881 |
| language | English |
| last_indexed | 2024-12-24T00:00:57Z |
| publishDate | 2019-12-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Drug Design, Development and Therapy |
| spelling | doaj.art-d88c99fb06514b9899d845bf4d6f9c952022-12-21T17:25:09ZengDove Medical PressDrug Design, Development and Therapy1177-88812019-12-01Volume 134431443850800Generic Tacrolimus (Tacrobell®) Shows Comparable Outcomes to Brand-Name Tacrolimus in the Long-Term Period After Adult Deceased Donor Liver TransplantationKim JMJoh JWChoi GSLee SKJong Man Kim, Jae-Won Joh, Gyu-Seong Choi, Suk-Koo Lee Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of KoreaCorrespondence: Jae-Won JohDepartment of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Irwon-Ro 81, Gangnam-Gu, Seoul 06351, Republic of KoreaTel +82-2-3410-3466Fax +82-2-3410-0040Email jw.joh@samsung.comBackground: 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.Keywords: liver transplantation, immunosuppression, safety, efficacyhttps://www.dovepress.com/generic-tacrolimus-tacrobellreg-shows-comparable-outcomes-to-brand-nam-peer-reviewed-article-DDDTliver transplantationimmunosuppressionsafetyefficacy |
| spellingShingle | Kim JM Joh JW Choi GS Lee SK Generic Tacrolimus (Tacrobell®) Shows Comparable Outcomes to Brand-Name Tacrolimus in the Long-Term Period After Adult Deceased Donor Liver Transplantation Drug Design, Development and Therapy liver transplantation immunosuppression safety efficacy |
| title | Generic Tacrolimus (Tacrobell®) Shows Comparable Outcomes to Brand-Name Tacrolimus in the Long-Term Period After Adult Deceased Donor Liver Transplantation |
| title_full | Generic Tacrolimus (Tacrobell®) Shows Comparable Outcomes to Brand-Name Tacrolimus in the Long-Term Period After Adult Deceased Donor Liver Transplantation |
| title_fullStr | Generic Tacrolimus (Tacrobell®) Shows Comparable Outcomes to Brand-Name Tacrolimus in the Long-Term Period After Adult Deceased Donor Liver Transplantation |
| title_full_unstemmed | Generic Tacrolimus (Tacrobell®) Shows Comparable Outcomes to Brand-Name Tacrolimus in the Long-Term Period After Adult Deceased Donor Liver Transplantation |
| title_short | Generic Tacrolimus (Tacrobell®) Shows Comparable Outcomes to Brand-Name Tacrolimus in the Long-Term Period After Adult Deceased Donor Liver Transplantation |
| title_sort | generic tacrolimus tacrobell reg shows comparable outcomes to brand name tacrolimus in the long term period after adult deceased donor liver transplantation |
| topic | liver transplantation immunosuppression safety efficacy |
| url | https://www.dovepress.com/generic-tacrolimus-tacrobellreg-shows-comparable-outcomes-to-brand-nam-peer-reviewed-article-DDDT |
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