Dataset Information

Pretransplantation erythropoiesis-stimulating agent hyporesponsiveness is associated with increased kidney allograft failure and mortality.

ABSTRACT: Poor response to erythropoiesis-stimulating agents (ESA) is associated with morbidity and mortality among dialysis patients. It is unclear whether the risk associated with poor ESA response during dialysis extends beyond kidney transplantation. We examined pretransplantation ESA response and its effect on allograft failure and mortality.The cohort included all adult Medicare recipients from the U.S. Renal Data System who had received a kidney transplant during years 2000 to 2007 and had at least 6 months of hemodialysis immediately before transplantation. ESA hyporesponsiveness was primarily defined as a monthly ESA dose of 75,000 units or higher and hematocrit 33% or less for at least 3 consecutive months in the pretransplantation period. Crude and adjusted Cox proportional hazards models and Kaplan-Meier methods were used to estimate the effect of ESA hyporesponsiveness on allograft failure and all-cause mortality.The study group consisted of 36,450 patients; 1004 exhibited hyporesponsiveness. The adjusted hazard ratios (95% confidence interval) for allograft failure and mortality after transplantation were 1.23 (1.10-1.42) and 1.61 (1.43-1.81), respectively, supporting that poor ESA response during hemodialysis is associated with adverse posttransplantation outcomes.ESA hyporesponsiveness may be useful in identifying potential allograft recipients who are at high risk for subsequent morbidity and mortality and may benefit from more intensive pretransplantation and posttransplantation monitoring.

SUBMITTER: Costa NA

PROVIDER: S-EPMC4089212 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Pretransplantation erythropoiesis-stimulating agent hyporesponsiveness is associated with increased kidney allograft failure and mortality.

Costa Nadiesda A NA Kshirsagar Abhijit V AV Wang Lily L Detwiler Randal K RK Brookhart M Alan MA

Transplantation 20131101 9

<h4>Background</h4>Poor response to erythropoiesis-stimulating agents (ESA) is associated with morbidity and mortality among dialysis patients. It is unclear whether the risk associated with poor ESA response during dialysis extends beyond kidney transplantation. We examined pretransplantation ESA response and its effect on allograft failure and mortality.<h4>Methods</h4>The cohort included all adult Medicare recipients from the U.S. Renal Data System who had received a kidney transplant during ...[more]

PMID: 23982339

Similar Datasets

Project description:Rationale & objectiveSince the change in erythropoiesis-stimulating agent (ESA) labeling and bundling of dialysis services in the United States, few studies have addressed the clinical importance of ESA hyporesponsiveness and none have considered health care resource use in this population. We aimed to further explore ESA hyporesponsiveness and its consequences.Study designRetrospective observational cohort study.Setting & participantsUS Renal Data System Medicare participants receiving dialysis with a minimum 6 months of continuous ESA use from 2012 to 2014.PredictorsErythropoietin resistance index (≥2.0 U/kg/wk/g/L) and ESA dose were used to identify ESA hyporesponders and hyporesponsive subgroups: isolated, intermittent, and chronic.OutcomesAssociations between ESA responsiveness and mortality, cardiovascular hospitalization rates, and health care resource use were evaluated and compared across subgroups.Analytical approachBaseline characteristics were compared using Wilcoxon rank sum tests for continuous variables and χ2 tests for categorical variables. Incidence rates of health care resource use were modeled using an unadjusted and adjusted generalized linear model.ResultsOf 834,115 dialysis patients in the CROWNWeb database, 38,891 ESA hyporesponders and 59,412 normoresponders met all inclusion criteria. Compared with normoresponders, hyporesponders were younger women, weighed less, and had longer durations of dialysis (all P < 0.001). Hyporesponders received 3.8-fold higher ESA doses (mean, 94,831 U/mo) and erythropoietin resistance index was almost 5 times higher than in normoresponders. Hyporesponders had lower hemoglobin levels and parathyroid hormone levels > 800 pg/mL, and iron deficiency was present in 26.5% versus 10.9% in normoresponders. One-year mortality was higher among hypo- compared with normoresponders (25.3% vs 22.6%). Hyporesponders also had significantly higher rates of hospitalization for cardiovascular events, emergency department visits, inpatient stays, home health agency visits, skilled nursing facility, and hospice days.LimitationsOnly US Medicare patients were included and different hyporesponder definitions may have influenced the results.ConclusionsThis study explored ESA hyporesponsiveness using new definitions and incorporated clinical and economic outcomes. It established that ESA-hyporesponsive dialysis patients had higher mortality, cardiovascular hospitalization rates, and health care costs as compared with ESA-normoresponsive patients.

Project description:BACKGROUND:Evidences show that around 20% of biosimilar or originator erythropoiesis-stimulating agents (ESAs) users are hyporesponsive. Controversial post-marketing data exist on the predictors of ESA hyporesponsiveness. The aim of this study was to identify predictors of ESA hyporesponsiveness in patients with chronic kidney disease (CKD) or cancer in clinical practice. METHODS:During the years 2009-2015, a multi-center, population-based, cohort study was conducted using claims databases of Treviso and Caserta Local Health Units (LHUs). All incident ESA users were characterized at baseline and the differences between the baseline hemoglobin (Hb) value, that is the Hb registered within 30 days prior to the first ESA dispensing (index date, ID) and each outcome Hb value (registered between 30 and 180 days after ID) were calculated and defined as delta Hb (ΔHb). Incident ESA users were defined as hyporesponsive if, during follow-up, they registered at least one ΔHb < 0 g/dL. Including all potential predictors of ESA hyporesponsiveness and stratifying by indication for use, univariate and multivariate binary logistic regression models and Receiver Operating Characteristic (ROC) curves were carried out. RESULTS:In general, 1080 incident ESA users (CKD: 57.0%; cancer: 43.0%) were identified. In CKD, predictors of ESA hyporesponsiveness were C-reactive protein (OR = 1.2, 95% CI: 1.0-1.5; P-value = 0.060) and high levels of baseline Hb (OR = 1.7, 95% CI: 1.2-2.2; P-value< 0,001), the latter being also predictor of ESA hyporesponsiveness in cancer (OR = 1.7, 95% CI: 1.1-2.4; P-value = 0.007). Both in CKD and in cancer, the type of ESA, biosimilar or originator, was not a predictor of ESA hyporesponsiveness. In CKD, concomitant use of iron preparations (OR = 0.3, 95% CI: 0.2-0.7; P-value = 0.002) and of high dosage of angiotensin-converting enzyme inhibitors/angiotensin II-receptor blockers (OR = 0.5, 95% CI: 0.3-0.9; P-value = 0.022) were protective factors against ESA hyporesponsiveness. CONCLUSIONS:The study confirmed traditional potential predictors of hyporesponsiveness to ESA. The use of biosimilar or originator ESA was not a predictor of hyporesponsiveness in an outpatient setting from two large Italian areas. A better knowledge of the predictors of ESA response would allow a better anemia management to improve patients' quality of life.

Dataset Information

Pretransplantation erythropoiesis-stimulating agent hyporesponsiveness is associated with increased kidney allograft failure and mortality.

Publications

Pretransplantation erythropoiesis-stimulating agent hyporesponsiveness is associated with increased kidney allograft failure and mortality.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets