Safety Events in Kidney Transplant Recipients

Weir, Matthew R.; Gravens-Muller, Lisa; Costa, Nadiesda; Ivanova, Anastasia; Manitpisitkul, Wana; Bostom, Andrew G.; Diamantidis, Clarissa J.

doi:10.1097/tp.0000000000000454

Cited by 5 publications

(4 citation statements)

References 20 publications

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“… 9 However, the probability of a PSI in our cohort was similar to that reported in kidney-alone transplant recipients (39%), which suggests that this is likely attributed to transplant recipients being at high risk for adverse events. 10 As such, the high probability of PSIs during admission for SPK transplantation may reflect the higher acuity of multi-organ transplantation rather than a higher prevalence of modifiable adverse events. Regardless of the location of postoperative care, units must be adequately equipped to identify and respond to adverse events to support high-acuity patients.…”

Section: Discussionmentioning

confidence: 99%

Perioperative Outcomes Following Kidney-Pancreas Transplantation in Alberta, Canada: Research Letter

Fox

Quinn

Ronksley

et al. 2021

Can J Kidney Health Dis

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Background: Simultaneous kidney-pancreas transplantation (SPK) has benefits for patients with kidney failure and type I diabetes mellitus, but is associated with greater perioperative risk compared with kidney-alone transplantation. Postoperative care settings for SPK recipients vary across Canada and may have implications for patient outcomes and hospital resource use. Objective: To compare outcomes following SPK transplantation between patients receiving postoperative care in the intensive care unit (ICU) compared with the ward. Design: Retrospective cohort study using administrative health data. Setting: In Alberta, the 2 transplant centers (Calgary and Edmonton) have different protocols for routine postoperative care of SPK recipients. In Edmonton, SPK recipients are routinely transferred to the ICU, whereas in Calgary, SPK recipients are transferred to the ward. Patients: 129 adult SPK recipients (2002-2019). Measurements: Data from the Canadian Institute for Health Information Discharge Abstract Database (CIHI-DAD) were used to identify SPK recipients (procedure codes) and the outcomes of inpatient mortality, length of initial hospital stay (LOS), and the occurrence of 16 different patient safety indicators (PSIs). Methods: We followed SPK recipients from the admission date of their transplant hospitalization until the first of hospital discharge or death. Unadjusted quantile regression was used to determine differences in LOS, and age- and sex-adjusted marginal probabilities were used to determine differences in PSIs between centers. Results: There were no perioperative deaths and no major differences in the demographic characteristics between the centers. The majority of the SPK transplants were performed in Edmonton (n = 82, 64%). All SPK recipients in Edmonton were admitted to the ICU postoperatively, compared with only 11% in Calgary. There was no statistically significant difference in the LOS or probability of a PSI between the 2 centers (LOS for Edmonton vs Calgary:16 vs 13 days, P = .12; PSIs for Edmonton vs Calgary: 60%, 95% confidence interval [CI] = 0.50-0.71 vs 44%, 95% CI = 0.29-0.59, P = .08). Limitations: This study was conducted using administrative data and is limited by variable availability. The small sample size limited precision of estimated differences between type of postoperative care. Conclusions: Following SPK transplantation, we found no difference in inpatient outcomes for recipients who received routine postoperative ICU care compared with ward care. Further research using larger data sets and interventional study designs is needed to better understand the implications of postoperative care settings on patient outcomes and health care resource utilization.

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Section: Discussionmentioning

confidence: 99%

Perioperative Outcomes Following Kidney-Pancreas Transplantation in Alberta, Canada: Research Letter

Fox

Quinn

Ronksley

et al. 2021

Can J Kidney Health Dis

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“…Kidney transplant recipients, particularly the elderly, often take multiple medications under multidrug immunosuppressive regimens, as well as for the treatment of comorbidities, which leaves them at risk for drug interactions 5, 22, 23, 24, 25. Most of the commonly used immunosuppressants are metabolized by CYP and are substrates for various transporters, which may lead to interactions with commonly prescribed drugs and other immunosuppressants 5, 26, 27.…”

Section: Discussionmentioning

confidence: 99%

“…Most of the commonly used immunosuppressants are metabolized by CYP and are substrates for various transporters, which may lead to interactions with commonly prescribed drugs and other immunosuppressants 5, 26, 27. Adverse events, including those resulting from the concurrent prescription of agents with potential drug interactions, are not uncommon among kidney transplant recipients, and an increased incidence of such events has been associated with a history of cardiovascular disease or diabetes 22. This emphasizes the importance of understanding potential drug interactions in belatacept‐treated patients.…”

Section: Discussionmentioning

confidence: 99%

Use of a cocktail probe to assess potential drug interactions with cytochrome P450 after administration of belatacept, a costimulatory immunomodulator

Williams

Tao

Zhu

et al. 2016

Brit J Clinical Pharma

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AimThis open‐label study investigated the effect of belatacept on cytokine levels and on the pharmacokinetics of caffeine, losartan, omeprazole, dextromethorphan and midazolam, as CYP probe substrates after oral administration of the Inje cocktail in healthy volunteers.MethodsTwenty‐two evaluable subjects received the Inje cocktail on Days 1, 4, 7 and 11 and belatacept infusion on Day 4.ResultsSince belatacept caused no major alterations to cytokine levels, there were no major effects on CYP‐substrate pharmacokinetics, except for a slight (16–30%) increase in omeprazole exposure, which was probably due to omeprazole‐mediated, time‐dependent CYP inhibition. Belatacept did not cause major alterations in the pharmacokinetics, as measured by the geometric mean ratios and associated 90% confidence interval for area under the plasma concentration ‐time curve from time zero to infinity on Day 7 comparing administration with and without belatacept for caffeine (1.002 [0.914, 1.098]), dextromethorphan (1.031 [0.885, 1.200]), losartan (1.016 [0.938, 1.101)], midazolam (0.968 [0.892, 1.049]) or their respective metabolites.ConclusionsTherefore, no dose adjustments of CYP substrates are indicated with belatacept coadministration.

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“…10 In a safety analysis of the Folic Acid for Vascular Outcome Reduction in Transplant (FAVORIT) trial, metformin use in kidney transplant recipients with lower GFR tertile (mean 31, range 9.5–39 ml/min per 1.73 m 2 ) was not associated with more adverse events, based on the Agency for Healthcare Research and Quality (AHRQ) Quality Indicators, compared with use in recipients with upper tertile GFR (mean 69, range 54–132 ml/min per 1.73 m 2 ), although there was a greater association with diabetic ketoacidosis/coma. 11 …”

Section: Introductionmentioning

confidence: 99%

Metformin use in the first year after kidney transplant, correlates, and associated outcomes in diabetic transplant recipients: A retrospective analysis of integrated registry and pharmacy claims data

Vest

Koraishy

Zhang

et al. 2018

Clinical Transplantation

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While guidelines support metformin as a therapeutic option for diabetic patients with mild-to-moderate renal insufficiency, the frequency and outcomes of metformin use in kidney transplant recipients are not well described. We integrated national U.S. transplant registry data with records from a large pharmaceutical claims clearinghouse (2008-2015). Associations (adjusted hazard ratio, aHR ) of diabetes regimens (with and excluding metformin) in the first year post-transplant with patient and graft survival over the subsequent year were quantified by multivariate Cox regression, adjusted for recipient, donor, and transplant factors and propensity for metformin use. Among 14 144 recipients with pretransplant type 2 diabetes mellitus, 4.7% filled metformin in the first year post-transplant; most also received diabetes comedications. Compared to those who received insulin-based regimens without metformin, patients who received metformin were more likely to be female, have higher estimated glomerular filtration rates, and have undergone transplant more recently. Metformin-based regimens were associated with significantly lower adjusted all-cause (aHR 0.41 ), malignancy-related (aHR 0.45 ), and infection-related (aHR 0.32 ) mortality, and nonsignificant trends toward lower cardiovascular mortality, graft failure, and acute rejection. No evidence of increased adverse graft or patient outcomes was noted. Use of metformin-based diabetes treatment regimens may be safe in carefully selected kidney transplant recipients.

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Safety Events in Kidney Transplant Recipients

Cited by 5 publications

References 20 publications

Perioperative Outcomes Following Kidney-Pancreas Transplantation in Alberta, Canada: Research Letter

Perioperative Outcomes Following Kidney-Pancreas Transplantation in Alberta, Canada: Research Letter

Use of a cocktail probe to assess potential drug interactions with cytochrome P450 after administration of belatacept, a costimulatory immunomodulator

Metformin use in the first year after kidney transplant, correlates, and associated outcomes in diabetic transplant recipients: A retrospective analysis of integrated registry and pharmacy claims data

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