Alternatives to immediate release tacrolimus in solid organ transplant recipients: When the gold standard is in short supply

Jorgenson, Margaret R.; Descourouez, Jillian L.; Brady, Bethany L.; Bowman, Lyndsey J.; Hammad, S.; Kaiser, Tiffany E.; Laub, Melissa R.; Melaragno, Jennifer I.; Park, Jeong Mi; Chandran, Mary Moss

doi:10.1111/ctr.13903

Cited by 8 publications

(11 citation statements)

References 96 publications

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“…Indeed, tacrolimus alternatives are plagued with reduced efficacy in the prevention of allograft rejection, which must be weighed in the risk–benefit assessment, given the association of rejection versus long-term cardiovascular risk. 120 A careful evaluation of the patient’s overall risk of rejection should be done before switching to belatacept, and patients should be followed closely after conversion.…”

Section: Risk Factors Of Cvd In Ktrsmentioning

confidence: 99%

New Approaches to Cardiovascular Disease and Its Management in Kidney Transplant Recipients

et al. 2022

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Cardiovascular events, including ischemic heart disease, heart failure, and arrhythmia, are common complications after kidney transplantation and continue to be leading causes of graft loss. Kidney transplant recipients have both traditional and transplant-specific risk factors for cardiovascular disease. In the general population, modification of cardiovascular risk factors is the best strategy to reduce cardiovascular events; however, studies evaluating the impact of risk modification strategies on cardiovascular outcomes among kidney transplant recipients are limited. Furthermore, there is only minimal guidance on appropriate cardiovascular screening and monitoring in this unique patient population. This review focuses on the limited scientific evidence that addresses cardiovascular events in kidney transplant recipients. Additionally, we focus on clinical management of specific cardiovascular entities that are more prevalent among kidney transplant recipients (ie, pulmonary hypertension, valvular diseases, diastolic dysfunction) and the use of newer evolving drug classes for treatment of heart failure within this cohort of patients. We note that there are no consensus documents describing optimal diagnostic, monitoring, or management strategies to reduce cardiovascular events after kidney transplantation; however, we outline quality initiatives and research recommendations for the assessment and management of cardiovascular-specific risk factors that could improve outcomes.

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Section: Risk Factors Of Cvd In Ktrsmentioning

confidence: 99%

New Approaches to Cardiovascular Disease and Its Management in Kidney Transplant Recipients

et al. 2022

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“…According to reports, the occurrence of CNI-related renal damage after lung transplantation is closely related to the dosage of CNI. Reducing the dosage of CNI and controlling the blood concentration within a certain range play an important role in reducing the occurrence of nephrotoxicity [ 23 ]. Previous studies have found that CNI has obvious and clear nephrotoxicity in kidney transplantation [ 24 ].…”

Section: Discussionmentioning

confidence: 99%

Effect of MMF Immunosuppression Based on CNI Reduction on CNI-Related Renal Damage after Lung Transplantation

Tang

Wang

Xue

et al. 2022

Journal of Healthcare Engineering

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In this paper, numerous effects of immunosuppressive regimen of mycophenolate mofetil (MMF) on CNI-related renal damage after lung transplantation are evaluated thoroughly. For this purpose, 110 lung transplant recipients who were treated in our hospital from March 2016 to January 2018 were randomly selected. All patients took prednisone acetate tablets or rapamycin at the same time or not at the same time. MMF is 1 g every time, twice a day, and adjusted according to the re-examination. According to the different drugs taken by 110 patients, they were divided into cyclosporine A group and tacrolimus group. Among them, 92 patients in cyclosporine A group took cyclosporine A; 18 patients in tacrolimus group took tacrolimus. The clinical data of age and gender of the two groups were collected, To observe and compare the occurrence of CNI-related renal damage in lung transplant recipients and different immunosuppressants. The CNI dosage of tacrolimus group and cyclosporine A group was compared before and after MMF. The changes of serum creatinine level and serum creatinine clearance rate were measured before MMF administration and 30, 60, and 90 days after MMF administration, to observe the complications of CNI-related renal damage after lung transplantation. Experimental results showed that there were 16 cases (14.55%) of CNI-related renal damage in lung transplant recipients and different immunosuppressants, including 10 cases (11.36%) in males, 6 cases (27.27%) in females, 11 cases (12.09%) in tacrolimus group, and 5 cases (26.32%) in cyclosporine A group. There was no significant difference between the two groups ( P > 0.05 ). Compared with MMF before and after administration, CNI dosage of cyclosporine A group and tacrolimus group decreased significantly ( P < 0.01 ). Compared with MMF before administration, serum creatinine level decreased and serum creatinine clearance rate increased significantly ( P < 0.05 ). In the follow-up, 16 patients with CNI-related renal damage were found to be immune rejection before the adjustment of immunosuppression program, no complications such as immune rejection, myelosuppression, and infection occurred within 15 months after the adjustment of immunosuppression program, blood glucose increased in 3 patients within 2 years after operation, blood lipid increased in 1 patient, urea increased in 1 patient, and uric acid increased in 1 patient. MMF immunosuppressive therapy based on CNI reduction is a safe and effective immunosuppressive therapy, which can significantly reduce immune rejection, improve renal function, and play an important role in improving CNI-related renal damage after lung transplantation.

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“…Insurance companies may deny these medications that are necessary for graft and patient survival. Furthermore, the transplant community continues to struggle with the ongoing shortage of immediate‐release tacrolimus, which has required us to utilize off‐label medications such as LCPT in non‐FDA approved organ indications to prevent disruptions in therapy 34 . This report not only provides critical reference data that may be actionable to expand immunosuppression options and access to heart transplant recipients, but also highlights the need to continue to work on prioritization of heart transplant specific trials to ensure optimal use of immunosuppression.…”

Section: Discussionmentioning

confidence: 99%

De novo tacrolimus extended‐release tablets (LCPT) versus twice‐daily tacrolimus in adult heart transplantation: Results of a single‐center non‐inferiority matched control trial

Zyl

Sam

Clark

et al. 2021

Clinical Transplantation

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Extended‐release tacrolimus for prophylaxis of allograft rejection in orthotopic heart transplant (OHT) recipients is currently not FDA‐approved. One such extended‐release formulation of tacrolimus known as LCPT allows once‐daily dosing and improves bioavailability compared to immediate‐release tacrolimus (IR‐tacrolimus). We compared the efficacy and safety of LCPT to IR‐tacrolimus applied de novo in adult OHT recipients. Twenty‐five prospective recipients on LCPT at our center from 2017 to 2019 were matched 1:2 with historical control recipients treated with IR‐tacrolimus based on age, gender, and baseline creatinine. The primary composite outcome of death, acute cellular rejection, and/or new graft dysfunction within 1 year was compared using non‐inferiority analysis. LCPT demonstrated non‐inferiority to IR‐tacrolimus, with a primary outcome risk reduction of 20% (90% CI: ‐40%, ‐.5%; non‐inferiority P = .001). Tacrolimus trough levels peaked at 2–3 months and were higher in LCPT (median 14.5 vs. 12.7 ng/ml; P = .03) with similar dose levels (LCPT vs. IR‐tacrolimus: .08 vs. .09 mg/kg/day; P = .33). Cardiovascular‐related readmissions were reduced by 62% (P = .046) in LCPT patients. The complication rate per transplant admission and all‐cause readmission rate did not differ significantly. These results suggest that LCPT is non‐inferior in efficacy to IR‐tacrolimus with a similar safety profile and improved bioavailability in OHT.

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Alternatives to immediate release tacrolimus in solid organ transplant recipients: When the gold standard is in short supply

Cited by 8 publications

References 96 publications

New Approaches to Cardiovascular Disease and Its Management in Kidney Transplant Recipients

New Approaches to Cardiovascular Disease and Its Management in Kidney Transplant Recipients

Effect of MMF Immunosuppression Based on CNI Reduction on CNI-Related Renal Damage after Lung Transplantation

De novo tacrolimus extended‐release tablets (LCPT) versus twice‐daily tacrolimus in adult heart transplantation: Results of a single‐center non‐inferiority matched control trial

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