Dataset Information

Restricted Use of Erythropoiesis-Stimulating Agent is Safe and Associated with Deferred Dialysis Initiation in Stage 5 Chronic Kidney Disease.

ABSTRACT: The effect of erythropoiesis-stimulating agent (ESA) on dialysis initiation in advanced chronic kidney disease (CKD) patients is not clear. We retrospectively analyzed the outcome of dialysis initiation in a stage 5 CKD cohort with ESA reimbursement limited to the maximal standardized monthly ESA dose equivalent to epoetin beta 20,000?U by the National Health Insurance program. Totally 423 patients were followed up for a median of 1.37 year. A time-dependent Cox regression model, adjusted for monthly levels of estimated glomerular filtration rate (eGFR) and hemoglobin, was constructed to investigate the association between ESA and outcome. The standardized monthly ESA dose in ESA users was 16,000?±?3,900?U of epoetin beta. Annual changes of hemoglobin were -0.29?±?2.19 and -0.99?±?2.46?g/dL in ESA users and ESA non-users, respectively (P?=?0.038). However, annual eGFR decline rates were not different between ESA users and non-users. After adjustment, ESA use was associated with deferred dialysis initiation (hazard ratio 0.63, 95% confidence interval 0.42-0.93, P?=?0.021). The protective effect remained when the monthly ESA doses were incorporated. Our data showed that restricted use of ESA was safe and associated with deferred dialysis initiation in stage 5 CKD patients.

SUBMITTER: Pan SY

PROVIDER: S-EPMC5341043 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Restricted Use of Erythropoiesis-Stimulating Agent is Safe and Associated with Deferred Dialysis Initiation in Stage 5 Chronic Kidney Disease.

Pan Szu-Yu SY Chiang Wen-Chih WC Chen Ping-Min PM Liu Heng-Hsiu HH Chou Yu-Hsiang YH Lai Tai-Shuan TS Lai Chun-Fu CF Chiu Yen-Ling YL Lin Wan-Yu WY Chen Yung-Ming YM Chu Tzong-Shinn TS Lin Shuei-Liong SL

Scientific reports 20170308

The effect of erythropoiesis-stimulating agent (ESA) on dialysis initiation in advanced chronic kidney disease (CKD) patients is not clear. We retrospectively analyzed the outcome of dialysis initiation in a stage 5 CKD cohort with ESA reimbursement limited to the maximal standardized monthly ESA dose equivalent to epoetin beta 20,000 U by the National Health Insurance program. Totally 423 patients were followed up for a median of 1.37 year. A time-dependent Cox regression model, adjusted for mo ...[more]

PMID: 28272424

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Project description:Patients with non-dialysis-dependent chronic kidney disease (ND-CKD) often receive an erythropoiesis-stimulating agent (ESA) and oral iron treatment. This study evaluated whether a switch from oral iron to intravenous ferric carboxymaltose can reduce ESA requirements and improve iron status and hemoglobin in patients with ND-CKD.This prospective, single arm and single-center study included adult patients with ND-CKD (creatinine clearance ?40 mL/min), hemoglobin 11-12 g/dL and iron deficiency (ferritin <100 ?g/L or transferrin saturation <20%), who were regularly treated with oral iron and ESA during 6 months prior to inclusion. Study patients received an intravenous ferric carboxymaltose dose of 1,000 mg iron, followed by a 6-months ESA/ ferric carboxymaltose maintenance regimen (target: hemoglobin 12 g/dL, transferrin saturation >20%). Outcome measures were ESA dose requirements during the observation period after initial ferric carboxymaltose treatment (primary endpoint); number of hospitalizations and transfusions, renal function before and after ferric carboxymaltose administration, number of adverse reactions (secondary endpoints). Hemoglobin, mean corpuscular volume, ferritin and transferrin saturation were measured monthly from baseline until end of study. Creatinine clearance, proteinuria, C-reactive protein, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase bimonthly from baseline until end of study.Thirty patients were enrolled (age 70.1±11.4 years; mean±SD). Mean ESA consumption was significantly reduced by 83.2±10.9% (from 41,839±3,668 IU/patient to 6,879±4,271 IU/patient; p<0.01). Hemoglobin increased by 0.7±0.3 g/dL, ferritin by 196.0±38.7 ?g/L and transferrin saturation by 5.3±2.9% (month 6 vs. baseline; all p<0.01). No ferric carboxymaltose-related adverse events were reported and no patient withdrew or required transfusions during the study.Among patients with ND-CKD and stable normal or borderline hemoglobin, switching from oral iron to intravenous ferric carboxymaltose was associated with significant improvements in hematological and iron parameters and a significant reduction in ESA dose requirements in this single-center pilot study.ClinicalTrials.gov NCT02232906.

Project description:BackgroundSeveral major ESRD-related regulatory and reimbursement changes were introduced in the United States in 2011. In several large, national datasets, these changes have been associated with decreases in erythropoiesis stimulating agent (ESA) utilization and hemoglobin concentrations in the ESRD population, as well as an increase in the use of red blood cell (RBC) transfusions in this population. Our objective was to examine the use of RBC transfusion before and after the regulatory and reimbursement changes implemented in 2011 in a prevalent population of chronic dialysis patients in a large national claims database.MethodsPatients in the Truven Health MarketScan Commercial and Medicare Databases with evidence of chronic dialysis were selected for the study. The proportion of chronic dialysis patients who received any RBC transfusion and RBC transfusion event rates per 100 patient-months were calculated in each month from January 1, 2007 to March 31, 2012. The results were analyzed overall and stratified by primary health insurance payer (commercial payer or Medicare).ResultsOverall, the percent of chronic dialysis patients with RBC transfusion and RBC transfusion event rates per 100 patient-months increased between January 2007 and March 2012. When stratified by primary health insurance payer, it appears that the increase was driven by the primary Medicare insurance population. While the percent of patients with RBC transfusion and RBC transfusion event rates did not increase in the commercially insured population between 2007 and 2012 they did increase in the primary Medicare insurance population; the majority of the increase occurred in 2011 during the same time frame as the ESRD-related regulatory and reimbursement changes.ConclusionsThe regulatory and reimbursement changes implemented in 2011 may have contributed to an increase in the use of RBC transfusions in chronic dialysis patients in the MarketScan dataset who were covered by Medicare plus Medicare supplemental insurance.

Project description:BackgroundEpoetin alfa and darbepoetin alfa are erythropoiesis-stimulating agents (ESAs) indicated for the treatment of anemia in chronic renal failure, including patients on dialysis and patients not on dialysis. Clinical experience demonstrates that the dose conversion ratio (DCR) between epoetin alfa and darbepoetin alfa is nonproportional across the dosing spectrum. However, previous calculations of the dose relationship between epoetin alfa and darbepoetin alfa, described in previous work as the "dose ratio" (DR), (a) used cross-sectional designs (i.e., compared mean doses for patient groups using each ESA) and were therefore vulnerable to confounding or (b) did not adjust for the nonproportional dose relationship. DRs reported in the literature range from 217:1 to 287:1 epoetin alfa (Units [U]):darbepoetin alfa (micrograms [micrograms]). Payers may need a single DCR that accounts for the nonproportional dose relationship to evaluate the economic implications of converting a nondialyzed patient population with chronic kidney disease (CKD) from epoetin alfa to darbepoetin alfa.ObjectiveTo estimate a single mean maintenance DCR between epoetin alfa and darbepoetin alfa in subjects with CKD not receiving dialysis, using methods that take into account the nonproportional dose relationship between the 2 ESAs.MethodsThis was a post-hoc analysis of a subset of patients enrolled in an unpublished, open-label, single arm phase 3 clinical trial (ClinTrial. gov identifier NCT00093977) that was completed in 2006. Although the clinical trial enrolled both dialyzed and nondialyzed patients, the present study used a patient subset comprising nondialyzed patients with CKD previously receiving weekly or every-other-week (Q2W) epoetin alfa who were switched to Q2W darbepoetin alfa to maintain hemoglobin (Hb) levels between 11.0 and 13.0 grams per deciliter. A population mean DCR was estimated using 2 methods: (a) a regression-based method in which the log-transformed (natural logarithm) mean weekly darbepoetin alfa dose over the evaluation period of the study (weeks 25 to 33) was regressed on the log-transformed (natural logarithm) weekly epoetin alfa dose over the 2-week screening period; and (b) a mean ratio method in which the DCR was calculated for each individual patient and then averaged for the study population to give a population-level DCR. Sensitivity analyses estimated the DCR in various subgroups.ResultsOf 1,127 patients enrolled in clinical trial NCT00093977, 567 patients on dialysis were excluded. Of the remaining 560 patients, 104 received weekly or Q2W epoetin alfa, were switched to Q2W darbepoetin alfa, received at least 1 non-zero dose of darbepoetin alfa during the evaluation period, and were included in the DCR calculation for the present study. Analysis of the log-log plot for the regression-based method indicated 2 or more possible regression lines with separate slopes. However, based on our a priori analysis plan to estimate a single DCR for the patient sample, the estimated sample mean maintenance DCR in the regression analysis was 330.6 U epoetin alfa to 1 micrograms darbepoetin alfa. In the mean ratio analysis, the DCR was 375.6 U:1 micrograms. Sensitivity analyses in which DCRs were calculated for different subgroups with different baseline differences identified a variable DCR range of 302-380 U:1 micrograms.ConclusionsThe methodology used in estimating the DCR accounts for the nonproportional dose relationship between epoetin alfa and darbepoetin alfa and may represent an advance over the methods used in previous research. The mean maintenance DCR between the 2 ESAs exceeds a threshold of 300 U:1 micrograms, which is greater than previously reported DRs. This methodology provides payers the means to compare ESA doses in CKD patients not receiving dialysis.

Dataset Information

Restricted Use of Erythropoiesis-Stimulating Agent is Safe and Associated with Deferred Dialysis Initiation in Stage 5 Chronic Kidney Disease.

Publications

Restricted Use of Erythropoiesis-Stimulating Agent is Safe and Associated with Deferred Dialysis Initiation in Stage 5 Chronic Kidney Disease.

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