Dataset Information

Nadir hemoglobin levels after discontinuation of epoetin in hemodialysis patients.

ABSTRACT:

Background and objectives

In hemodialysis patients, both hemoglobin variability and targeting normalization of hemoglobin may have adverse consequences. There are few data on epoetin management in patients achieving high hemoglobin levels.

Design, setting, participants, & measurements

Maintenance hemodialysis patients within Dialysis Clinic Inc. (DCI) who were treated with a 20 to 30% epoetin dose reduction versus epoetin discontinuation following achievement of a hemoglobin level of > or = 13 g/dl were evaluated. The primary outcome was nadir hemoglobin within 2 months of epoetin reduction or discontinuation.

Results

There were 2789 patients in whom epoetin was discontinued and 754 patients in whom epoetin was reduced after hemoglobin > or = 13 g/dl. Patients treated with reduction received significantly more epoetin over the subsequent 2 months. More patients dropped below 11 (21.5 versus 10.1%) and 10 g/dl (7.2 versus 3.6%) within 2 months of discontinuing epoetin, whereas reduction was associated with more frequent nadir hemoglobin levels >12 g/dl (31.1 versus 62.8%). In multivariable models including age, ferritin, albumin, and baseline epoetin dose, discontinuation was associated with nadir hemoglobin below 10 g/dl [OR = 1.91 (CI: 1.22, 2.99)], whereas reduction was associated with a hemoglobin nadir above 12 g/dl [OR = 4.41 (CI: 3.63, 5.37)].

Conclusions

In hemodialysis patients with baseline hemoglobin >13 g/dl, epoetin discontinuation is associated with lower epoetin use and a higher probability of reaching a hemoglobin target range of 10 to 12 g/dl within 2 months; discontinuation is also associated with a higher likelihood nadir hemoglobin <10 g/dl.

SUBMITTER: Calvo JA

PROVIDER: S-EPMC2974403 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature

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Publications

Nadir hemoglobin levels after discontinuation of epoetin in hemodialysis patients.

Calvo Jose A JA Miskulin Dana C DC Meyer Klemens B KB Weiner Daniel E DE

Clinical journal of the American Society of Nephrology : CJASN 20100722 9

<h4>Background and objectives</h4>In hemodialysis patients, both hemoglobin variability and targeting normalization of hemoglobin may have adverse consequences. There are few data on epoetin management in patients achieving high hemoglobin levels.<h4>Design, setting, participants, & measurements</h4>Maintenance hemodialysis patients within Dialysis Clinic Inc. (DCI) who were treated with a 20 to 30% epoetin dose reduction versus epoetin discontinuation following achievement of a hemoglobin level ...[more]

PMID: 20651155

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Project description:AimTo determine if temporary discontinuation of epoetin therapy in anemic patients with end stage renal disease (ESRD) influences their responsiveness to epoetin.MethodsWe performed a post hoc analysis of the data from two consecutive single-center randomized trials (T1 and T2) comparing the efficacy of two epoetin products (E1 and E2) in anemic patients with ESRD. The analysis included a subset of 44 patients who participated in both trials and were not receiving epoetin in the period (median, 12 months; range 5-15) between the trials due to epoetin shortage. Two co-primary outcomes were average weekly hemoglobin difference from the baseline and average weekly epoetin dose.ResultsWith adjustment for potential differences between E1 and E2, average weekly hemoglobin difference of 1.21 g/dL from the baseline was lower in T2 than that of 1.71 g/dL in T1: difference -0.49 (95% confidence interval [CI], -0.68 to -0.29; P<0.001). Average weekly epoetin dose of 107 IU/kg in T2 was higher than 96 IU/kg in T1 (ratio, 1.13; 95% CI, 1.04-1.24; P=0.009). With additional adjustment for within-subject changes in baseline covariates from T1 to T2 (baseline hemoglobin, body mass index, serum albumin, ferritin and transferrin saturation, intact parathormone, C-reactive protein, dialysis dose, and use of angiotensin converting enzyme inhibitors), hemoglobin response remained lower (adjusted difference, -0.44 g/dL; 95% CI, -0.73 to -0.16; P=0.004) and weekly epoetin dose remained higher in T2 than inT1 (adjusted ratio, 1.17; 95% CI, 1.03-1.34; P=0.016).ConclusionsIn patients with ESRD, responsiveness to epoetin was lower in T2 after a period of epoetin therapy discontinuation than in T1 epoetin trial. Since this could not be explained by within-subject changes in factors known to affect response to epoetin, a prolonged withdrawal of epoetin in patients with ESRD might independently contribute to a reduced responsiveness to epoetin at a later re-exposure.Clinical trial registrationClinicalTrials.gov Identifier for T1 trial: NCT00322413.

Project description:BackgroundOptimal iron levels in patients on hemodialysis are currently unknown, and a higher level than that for the healthy population is usually set for such patients considering the use of erythropoiesis-stimulating agents or the occurrence of chronic inflammation. However, excessive iron causes oxidative stress and impairment of its utilization by cells. Therefore we investigated the relationship between hemoglobin (Hb) level and iron status in hemodialysis patients to identify the optimal iron levels for patients undergoing hemodialysis.MethodsA total of 208 outpatients on maintenance hemodialysis were followed up between July 2006 and June 2007. Men accounted for 64.9% cases [mean age, 59.3 ± 13.1 years and median dialysis history, 7.7 (3.6-13.2) years], and diabetic nephropathy accounted for 25.0% cases. Hemoglobin level was measured twice a month and serum ferritin, serum iron, and total iron-binding capacity were measured once a month. The doses of recombinant human erythropoietin and low-dose iron supplement were adjusted to maintain a hemoglobin level of 10-11 g/dL, according to the guidelines of the Japanese Society for Dialysis Therapy. Hepcidin was measured at baseline. Using the mean values for 1-year period, the relationships among hemoglobin, serum ferritin levels, and transferrin saturation levels were investigated based on a receiver operating characteristic curve and a logistic regression model. In addition, the correlations among serum ferritin, transferrin saturation, and hepcidin levels were analyzed by Pearson product-moment correlation coefficient and linear regression model.ResultsBy receiver operating characteristic curve, the cutoff point of serum ferritin and transferrin saturation levels with a hemoglobin ≥10 g/dL showed <90 ng/mL (sensitivity: 69.1%, specificity: 72.1%, p < 0.001) and ≥20% (sensitivity: 77.6%, specificity: 48.8%, p = 0.302). Upon logistic regression model analysis with a hemoglobin ≥10 g/dL as the endpoint, the analysis of odds ratios relative to a group with serum ferritin ≥90 ng/mL and transferrin saturation <20% revealed that the group with serum ferritin <90 ng/mL and transferrin saturation ≥20% had the highest ratio: 46.75 (95% confidence interval: 10.89-200.70, p < 0.001). In Pearson product-moment correlation coefficient, hepcidin showed a strong positive correlation with serum ferritin [r = 0.78 (95% confidence interval: 0.72-0.83, p < 0.001)] and a weak positive correlation with transferrin saturation [r = 0.18 (95% confidence interval: 0.04-0.31, p = 0.010)]. In the multivariable analyses of the linear regression model, a positive relationship was shown between hepcidin and serum ferritin [β-coefficient of 0.30 (95% confidence interval: 0.27-0.34, p < 0.001)]; however, no relationship was shown with transferrin saturation [β-coefficient of 0.09 (95% confidence interval: -0.31-0.49, p = 0.660)].ConclusionsIn this study, the iron status of serum ferritin <90 ng/mL and transferrin saturation ≥20% was optimal in hemodialysis patients receiving recombinant human erythropoietin for anemia therapy. This result indicates that the threshold values for the optimal iron status may be lower than those currently recommended in iron-level management guideline.

Project description:BackgroundAnemia of chronic kidney disease is associated with adverse outcomes and a reduced quality of life. Erythropoiesis-stimulating agents (ESAs) have improved anemia management, and 2 agents are available in Canada, epoetin alfa (EPO) and darbepoetin alfa (DA). EPO and DA are considered equally effective in achieving target hemoglobin (Hb), but it is not clear whether there is a cost difference. There have been few head-to-head comparisons; most published studies are observational switch studies.ObjectiveTo compare the cost of DA and EPO and to determine the dose conversion ratio over a 12-month period.DesignRandomized controlled trial.SettingCanadian outpatient hemodialysis center.PatientsEligible patients were adult hemodialysis patients requiring ESA therapy.MeasurementsThe primary outcome was ESA cost (Can$) per patient over 12 months. Secondary outcomes included the dose conversion ratio, deviation from target ranges in anemia indices, iron dose and cost, and time and number of dose changes.MethodsAn open-label randomized controlled trial of intravenous (IV) DA versus EPO was conducted in 50 hemodialysis patients. Participants underwent a minimum 6-week run-in phase followed by a 12-month active study phase. ESA and iron were dosed using a study algorithm.ResultsThe median cost was $4179 (interquartile range [IQR]: $2416-$5955) for EPO and $2303 (IQR: $1178-$4219) for DA with a difference of $1876 (P = .02). The dose conversion ratio was 280:1 (95% confidence interval [CI]: 197-362:1) at the end of the run-in phase, 360:1 (95% CI: 262-457:1) at the 3-month point of the active phase, and 382:1 (95% CI: 235-529:1) at the 6-month point of the active phase. There were no significant differences between the 2 groups in weekly iron dose, Hb, serum ferritin, or transferrin saturation. The number of dose changes and the time to Hb stability were similar.LimitationsResults may not be generalizable to hemodialysis units without algorithm-based anemia management, with subcutaneous ESA administration, or to the nondialysis chronic kidney disease population. The effective conversion ratio between EPO and DA is known to increase at higher doses; the Hb targets used in the study were slightly higher than those recommended today so it is possible that the doses used were also higher. Because of this, the cost savings estimated for DA could differ somewhat from the savings realizable in current practice.ConclusionsIn this study of hemodialysis patients with comparable anemia management, IV DA cost $1876 less per year per patient than IV EPO. The dose conversion ratio was greater than 350:1 by the 3-month point.Trial registrationClinicalTrials.gov (NCT02817555).

Dataset Information

Nadir hemoglobin levels after discontinuation of epoetin in hemodialysis patients.

Background and objectives

Design, setting, participants, & measurements

Results

Conclusions

Publications

Nadir hemoglobin levels after discontinuation of epoetin in hemodialysis patients.

Similar Datasets

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