Böbrek nakli hastalarında de novo uzatılmış salımlı takrolimus; Güvenli mi?
Year 2023,
Volume: 13 Issue: 3, 478 - 483, 30.09.2023
Mahmud İslam
,
Necattin Fırat
,
Musa Pınar
,
Kenan Evren Öztop
,
Gözde Çakırsoy Çakar
,
Zafer Ercan
,
Enes Sarıgedik
,
Hamad Dheir
Abstract
Amaç: Bu çalışma, de novo uzatılmış salımlı takrolimus (UST) tedavisinin böbrek alıcılarında güvenli olup olmadığını araştırmayı amaçladık.
Yöntem ve gereçler: Çalışmamız tek merkezli, retrospektif olup, UST grubundan 30 hasta (Grup 1) ve hılzı salımlı takrolimus (HST) grubundan 27 hasta (Grup 2) olmak üzere toplam 57 hastayı içermektedir. Hastaların demografik ve laboratuvar özellikleri kaydedildi. Akut ilaç toksisitesi, akut rejeksiyon, transplantasyon sonrası yeni başlayan diabetes mellitus, hipertansiyon gelişmesi, fırsatçı enfeksiyon ve hastaneye yatış verileri ve diğer olası komplikasyonlar kaydedildi.
Bulgular: Hastaların yaş ortalaması UST grubunda 46,23±14,2 yıl iken HST grubunda 47,04±14,6 yıl idi. Grup 1'de 21 (%70), grup 2'de 20 (%74) hasta erkek idi (P>0,05). Postoperatif 1. haftada serum kreatinin değerlerinde düzelme oranı her iki grupta da benzerdi. Postoperatif 1. gün ortalama takrolimus seviyeleri grup-1'de anlamlı olarak düşük iken (P<0.05), postoperatif 2-7. günlerde takrolimus seviyeleri arasında anlamlı fark yoktu. İlk altı aylık izlemde fırsatçı enfeksiyonlar, diabetes mellitus ve hastaneye yatış ihtiyacı açısından gruplar arasında anlamlı fark yoktu.
Sonuç: Böbrek alıcılarında de novo uzatılmış salımlı takrolimus tedavisinin başlatılması uzun vadede güvenlidir ve greft fonksiyonunu korur.
References
- Krieger N, Chodoff L, Leventhal JR, Ho B, Richards M, Schaumberg DA, et al. Immune tolerance via FCR001 cell therapy compared with maintenance immunosuppression for kidney transplantation: Real-world evidence analysis of safety and efficacy. Clin Transplant. Published online August 3, 2023:e15074. doi:10.1111/ctr.15074
- Salcedo-Herrera S, Pinto Ramirez JL, García-Lopez A, Amaya-Nieto J, Girón-Luque F. Acute Rejection in Kidney Transplantation and Early Beginning of Tacrolimus. Transplant Proc. 2019;51(6):1758-1762. doi:10.1016/j.transproceed.2019.04.048
- Sforza D, Iaria G, Petagna L, Parente A, Anselmo A, Sergi F, et al. Switch From Twice-daily Tacrolimus to Once-daily, Prolonged-release Tacrolimus in Kidney Transplantation: Long-term Outcome. Transplant Proc. 2019;51(1):140-142. doi:10.1016/j.transproceed.2018.04.079
- Banas B, Krämer BK, Krüger B, Kamar N, Undre N. Long-Term Kidney Transplant Outcomes: Role of Prolonged-Release Tacrolimus. Transplant Proc. 2020;52(1):102-110. doi:10.1016/j.transproceed.2019.11.003
- Butler JA, Roderick P, Mullee M, Mason JC, Peveler RC. Frequency and impact of nonadherence to immunosuppressants after renal transplantation: a systematic review. Transplantation. 2004;77(5):769-776. doi:10.1097/01.tp.0000110408.83054.88
- Vadcharavivad S, Saengram W, Phupradit A, Poolsup N, Chancharoenthana W. Once-Daily versus Twice-Daily Tacrolimus in Kidney Transplantation: A Systematic Review and Meta-analysis of Observational Studies. Drugs. 2019;79(18):1947-1962. doi:10.1007/s40265-019-01217-7
- McCormack PL. Extended-release tacrolimus: a review of its use in de novo kidney transplantation. Drugs. 2014;74(17):2053-2064. doi:10.1007/s40265-014-0316-3
- Shuker N, van Gelder T, Hesselink DA. Intra-patient variability in tacrolimus exposure: causes, consequences for clinical management. Transplant Rev . 2015;29(2):78-84. doi:10.1016/j.trre.2015.01.002
- Beckebaum S, Iacob S, Sweid D, Sotiropoulos GC, Saner F, Kaiser G, et al. Efficacy, safety, and immunosuppressant adherence in stable liver transplant patients converted from a twice-daily tacrolimus-based regimen to once-daily tacrolimus extended-release formulation. Transpl Int. 2011;24(7):666-675. doi:10.1111/j.1432-2277.2011.01254.x
- Fellström B, Holmdahl J, Sundvall N, Cockburn E, Kilany S, Wennberg L. Adherence of Renal Transplant Recipients to Once-daily, Prolonged-Release and Twice-daily, Immediate-release Tacrolimus-based Regimens in a Real-life Setting in Sweden. Transplant Proc. 2018;50(10):3275-3282. doi:10.1016/j.transproceed.2018.06.027
- Gonzales HM, McGillicuddy JW, Rohan V, Chandler JL, Nadig SN, Dubay DA, et al. A comprehensive review of the impact of tacrolimus intrapatient variability on clinical outcomes in kidney transplantation. Am J Transplant. 2020;20(8):1969-1983. doi:10.1111/ajt.16002
- Kuypers DRJ, Peeters PC, Sennesael JJ, Kianda MN, Vrijens B, Kristanto P, et al. Improved adherence to tacrolimus once-daily formulation in renal recipients: a randomized controlled trial using electronic monitoring. Transplantation. 2013;95(2):333-340. doi:10.1097/TP.0b013e3182725532
- T A M, Chng R, Yau WP. Efficacy and Safety of Tacrolimus-Based Maintenance Regimens in De Novo Kidney Transplant Recipients: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Ann Transplant. 2021;26:e933588. doi:10.12659/AOT.933588
De novo extended-release Tacrolimus in Kidney Transplant Patients; Is it safe?
Year 2023,
Volume: 13 Issue: 3, 478 - 483, 30.09.2023
Mahmud İslam
,
Necattin Fırat
,
Musa Pınar
,
Kenan Evren Öztop
,
Gözde Çakırsoy Çakar
,
Zafer Ercan
,
Enes Sarıgedik
,
Hamad Dheir
Abstract
Background: This study aimed to investigate whether de novo extended-release tacrolimus (ERT) therapy is safe in kidney recipients.
Methods: The study was single-center, retrospective, and included a total of 57 patients, including 30 patients in the ERT group (Group 1) and 27 patients in the immediate-release tacrolimus (IRT) group (Group 2). Demographic and laboratory characteristics of the patients were recorded. Complications such as acute drug toxicity, acute rejection, new-onset diabetes mellitus after transplantation, and development of hypertension, opportunistic infection, and hospitalization data were recorded.
Results: The mean age of the patients was 46.23±14.2 years in the ERT group and 47.04±14.6 years in the IRT group. There were 21 (70%) males in group 1, while 20 (74%) patients in group 2 had a male gender (P=0.73). The rate of improved serum creatinine values in the first week postoperatively was similar in both groups. While the mean tacrolimus levels on postoperative day 1 were significantly lower in the group- 1 (P<0.05), there was no significant difference between tacrolimus levels on postoperative days 2-7. There was no significant difference between the groups regarding opportunistic infections, diabetes mellitus, and the need for hospitalization in the first six months of follow-up.
Conclusion: Initiation of de novo extended-release tacrolimus therapy in kidney recipients is safe in the long term and preserves graft function.
Thanks
We would thank Dr. Fehmi Celebi, Dr. Fatih Altintoprak and Dr. Emrah Akin for their logistic support and help in our study.
References
- Krieger N, Chodoff L, Leventhal JR, Ho B, Richards M, Schaumberg DA, et al. Immune tolerance via FCR001 cell therapy compared with maintenance immunosuppression for kidney transplantation: Real-world evidence analysis of safety and efficacy. Clin Transplant. Published online August 3, 2023:e15074. doi:10.1111/ctr.15074
- Salcedo-Herrera S, Pinto Ramirez JL, García-Lopez A, Amaya-Nieto J, Girón-Luque F. Acute Rejection in Kidney Transplantation and Early Beginning of Tacrolimus. Transplant Proc. 2019;51(6):1758-1762. doi:10.1016/j.transproceed.2019.04.048
- Sforza D, Iaria G, Petagna L, Parente A, Anselmo A, Sergi F, et al. Switch From Twice-daily Tacrolimus to Once-daily, Prolonged-release Tacrolimus in Kidney Transplantation: Long-term Outcome. Transplant Proc. 2019;51(1):140-142. doi:10.1016/j.transproceed.2018.04.079
- Banas B, Krämer BK, Krüger B, Kamar N, Undre N. Long-Term Kidney Transplant Outcomes: Role of Prolonged-Release Tacrolimus. Transplant Proc. 2020;52(1):102-110. doi:10.1016/j.transproceed.2019.11.003
- Butler JA, Roderick P, Mullee M, Mason JC, Peveler RC. Frequency and impact of nonadherence to immunosuppressants after renal transplantation: a systematic review. Transplantation. 2004;77(5):769-776. doi:10.1097/01.tp.0000110408.83054.88
- Vadcharavivad S, Saengram W, Phupradit A, Poolsup N, Chancharoenthana W. Once-Daily versus Twice-Daily Tacrolimus in Kidney Transplantation: A Systematic Review and Meta-analysis of Observational Studies. Drugs. 2019;79(18):1947-1962. doi:10.1007/s40265-019-01217-7
- McCormack PL. Extended-release tacrolimus: a review of its use in de novo kidney transplantation. Drugs. 2014;74(17):2053-2064. doi:10.1007/s40265-014-0316-3
- Shuker N, van Gelder T, Hesselink DA. Intra-patient variability in tacrolimus exposure: causes, consequences for clinical management. Transplant Rev . 2015;29(2):78-84. doi:10.1016/j.trre.2015.01.002
- Beckebaum S, Iacob S, Sweid D, Sotiropoulos GC, Saner F, Kaiser G, et al. Efficacy, safety, and immunosuppressant adherence in stable liver transplant patients converted from a twice-daily tacrolimus-based regimen to once-daily tacrolimus extended-release formulation. Transpl Int. 2011;24(7):666-675. doi:10.1111/j.1432-2277.2011.01254.x
- Fellström B, Holmdahl J, Sundvall N, Cockburn E, Kilany S, Wennberg L. Adherence of Renal Transplant Recipients to Once-daily, Prolonged-Release and Twice-daily, Immediate-release Tacrolimus-based Regimens in a Real-life Setting in Sweden. Transplant Proc. 2018;50(10):3275-3282. doi:10.1016/j.transproceed.2018.06.027
- Gonzales HM, McGillicuddy JW, Rohan V, Chandler JL, Nadig SN, Dubay DA, et al. A comprehensive review of the impact of tacrolimus intrapatient variability on clinical outcomes in kidney transplantation. Am J Transplant. 2020;20(8):1969-1983. doi:10.1111/ajt.16002
- Kuypers DRJ, Peeters PC, Sennesael JJ, Kianda MN, Vrijens B, Kristanto P, et al. Improved adherence to tacrolimus once-daily formulation in renal recipients: a randomized controlled trial using electronic monitoring. Transplantation. 2013;95(2):333-340. doi:10.1097/TP.0b013e3182725532
- T A M, Chng R, Yau WP. Efficacy and Safety of Tacrolimus-Based Maintenance Regimens in De Novo Kidney Transplant Recipients: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Ann Transplant. 2021;26:e933588. doi:10.12659/AOT.933588