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Belatacept Compared With Tacrolimus for Kidney Transplantation: A Propensity Score Matched Cohort Study.

ABSTRACT: BACKGROUND:Although tacrolimus is the basis of most maintenance immunosuppression regimens for kidney transplantation, concerns about toxicity have made alternative agents, such as belatacept, attractive to clinicians. However, limited data exist to directly compare outcomes with belatacept-based regimens to tacrolimus. METHODS:We performed a propensity score matched cohort study of adult kidney transplant recipients transplanted between May 1, 2001, and December 31, 2015, using national transplant registry data to compare patient and allograft survival in patients discharged from their index hospitalization on belatacept-based versus tacrolimus-based regimens. RESULTS:In the primary analysis, we found that belatacept was not associated with a statistically significant difference in risk of patient death (hazard ratio, 0.84; 95% confidence interval [CI], 0.61-1.15, P = 0.28) or allograft loss (hazard ratio, 0.83; 95% CI, 0.62-1.11; P = 0.20) despite an increased risk of acute rejection in the first year posttransplant (odds ratio, 3.12; 95% CI, 2.13-4.57; P < 0.001). These findings were confirmed in additional sensitivity analyses that accounted for use of belatacept in combination with tacrolimus, transplant center effects, and differing approaches to matching. CONCLUSIONS:Belatacept appears to have similar longitudinal risk of mortality and allograft failure compared with tacrolimus-based regimens. These data are encouraging but require confirmation in prospective randomized controlled trials.

SUBMITTER: Cohen JB

PROVIDER: S-EPMC5462868 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Belatacept Compared With Tacrolimus for Kidney Transplantation: A Propensity Score Matched Cohort Study.

Cohen Jordana B JB Eddinger Kevin C KC Forde Kimberly A KA Abt Peter L PL Sawinski Deirdre D

Transplantation 20171001 10

<h4>Background</h4>Although tacrolimus is the basis of most maintenance immunosuppression regimens for kidney transplantation, concerns about toxicity have made alternative agents, such as belatacept, attractive to clinicians. However, limited data exist to directly compare outcomes with belatacept-based regimens to tacrolimus.<h4>Methods</h4>We performed a propensity score matched cohort study of adult kidney transplant recipients transplanted between May 1, 2001, and December 31, 2015, using n ...[more]

PMID: 27941427

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Project description:BackgroundMonitoring and maintaining a stable tacrolimus trough level is essential because of its narrow therapeutic window and considerable fluctuation in the early phase after kidney transplantation. However, optimal tacrolimus exposure early after transplantation remains unclear among Chinese patients.MethodsIn this propensity score-matched cohort study, we thoroughly investigated the association between tacrolimus trough level at the first month and acute rejection (AR) as well as infection within the first year after kidney transplantation.ResultsIn a first step, a total of 1415 patients were divided into 3 groups according to the receiver operating characteristic curve: low-level group (410 patients with a tacrolimus trough level <5.35 ng/mL at the first month), median-level group (466 patients with a tacrolimus trough level from 5.35 to 7.15 ng/mL), and high-level group (539 patients with a tacrolimus trough level >7.15 ng/mL). Ultimately, 363 and 459 pairs of cases were enrolled by using 2 propensity score matches between low- and median-level groups and between high- and median-level groups, respectively. Compared with patients in the low-level group, patients in the median-level group had lower risk of AR without increased incidence of infection (AR, 12.4% versus 5.7%, P = 0.02; infection, 13.2% versus 13.2%, P = 1.00 for low- and median-level groups, respectively) within the first year. Compared with patients in the high-level group, patients in the median-level group had lower incidence of infection without the growing risk of AR (infection, 17.6% versus 12.2%, P = 0.021; AR, 4.6% versus 5.4%, P = 0.545 for high- and median-level groups, respectively) within the first year. Multilogistic analysis showed that tacrolimus trough levels were an independent factor for AR (odds ratio, 0.749, 95% confidence interval, 0.632-0.888, P = 0.001). Tacrolimus trough levels were also associated with infection (odds ratio 1.110, 95% confidence interval, 1.013-1.218, P = 0.001). Serum creatinine levels were similar among groups. No difference was found in 1-, 3-, and 5-year graft survival and patient survival among groups.ConclusionsThe tacrolimus trough level maintained between 5.35 and 7.15 ng/mL at the first posttransplant month may prevent AR without increasing the incidence of infection within the first year after living kidney transplantation among Chinese patients.

Project description:ObjectivesWe examined the relationship between dominant sedation strategy, risk of delirium and patient-centred outcomes in adults admitted to intensive care units (ICUs).DesignRetrospective propensity-matched cohort study.SettingMechanically ventilated adults (≥ 18 years) admitted to four Canadian hospital medical/surgical ICUs from 2014 to 2016 in Calgary, Alberta, Canada.Participants2837 mechanically ventilated adults (≥ 18 years) requiring admission to a medical/surgical ICU were evaluated for the relationship between sedation strategy and delirium.InterventionsNone.Primary and secondary outcome measuresThe primary exposure was dominant sedation strategy, defined as the sedative infusion, including midazolam, propofol or fentanyl, with the longest duration before the first delirium assessment. The primary outcome was 'ever delirium' identified using the Intensive Care Delirium Screening Checklist. Secondary outcomes included mortality, length of stay (LOS), ventilation duration and days with delirium. The cohort was analysed in two propensity score (patient characteristics and therapies received) matched cohorts (propofol vs fentanyl and propofol vs midazolam).Results2837 patients (60.7% male; median age 57 years (IQR 43-68)) were considered for propensity matching. In propensity score-matched cohorts(propofol vs midazolam, n=712; propofol vs fentanyl, n=1732), the odds of delirium were significantly higher with midazolam (OR 1.46 (95% CI 1.06 to 2.00)) and fentanyl (OR 1.22 (95% CI 1.00 to 1.48)) compared with propofol dominant sedation strategies. Dominant sedation strategy with midazolam and fentanyl were associated with a longer duration of ventilation compared with propofol. Fentanyl was also associated with increased ICU mortality (OR 1.50, 95% CI 1.07 to 2.12)) ICU and hospital LOS compared with a propofol dominant sedation strategy.ConclusionsWe identified a novel association between fentanyl dominant sedation strategies and an increased risk of delirium, a composite outcome of delirium or death, duration of mechanical ventilation, ICU LOS and hospital LOS. Midazolam dominant sedation strategies were associated with increased delirium risk and mechanical ventilation duration.

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Belatacept Compared With Tacrolimus for Kidney Transplantation: A Propensity Score Matched Cohort Study.

Publications

Belatacept Compared With Tacrolimus for Kidney Transplantation: A Propensity Score Matched Cohort Study.

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