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      Risk-based individualisation of target haemoglobin in haemodialysis patients with renal anaemia in the post-TREAT era: theoretical attitudes versus actual practice patterns (MONITOR-CKD5 study)

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          Abstract

          Purpose

          Data from an ongoing European pharmacoepidemiological study (MONITOR-CKD5) were used to examine congruence between physician-reported risk-based individualisation of target haemoglobin (Hb) and the actual Hb targets set by these physicians for their patients, as well as actual Hb levels in their patients.

          Methods

          Physician investigators participating in the study completed a questionnaire about their anaemia practice patterns and attitudes post-TREAT at the start of the study (T1) and in summer 2013 (T2). These data were compared with the Hb targets identified at baseline for actual patients ( n = 1197) enrolled in the study. Risk groups included presence/absence of hypertension, diabetes, cardiovascular complications, history of stroke, history of cancer, and age/activity level (elderly/inactive or young/active).

          Results

          At each time point, more than three quarters of physicians responded that results from the TREAT study, in patients not on dialysis, have influenced their use of erythropoiesis-stimulating agents in patients on haemodialysis. At T1, there was a clear difference in physician-reported (theoretical) target Hb levels for patients across the different risk groups, but there was no difference in patients’ actual Hb levels across the risk groups. A similar disparity was noted at T2.

          Conclusions

          Physicians’ theoretical attitudes to anaemia management in patients on haemodialysis appear to have been influenced by the results of the TREAT study, which involved patients not on dialysis. Physicians claim to use risk-based target Hb levels to guide renal anaemia care. However, there is discrepancy between these declared risk-based target Hb levels and actual target Hb levels for patients with variable risk factors.

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          Most cited references13

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          A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease.

          Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately tested. In this study involving 4038 patients with diabetes, chronic kidney disease, and anemia, we randomly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo, with rescue darbepoetin alfa when the hemoglobin level was less than 9.0 g per deciliter. The primary end points were the composite outcomes of death or a cardiovascular event (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia) and of death or end-stage renal disease. Death or a cardiovascular event occurred in 632 patients assigned to darbepoetin alfa and 602 patients assigned to placebo (hazard ratio for darbepoetin alfa vs. placebo, 1.05; 95% confidence interval [CI], 0.94 to 1.17; P=0.41). Death or end-stage renal disease occurred in 652 patients assigned to darbepoetin alfa and 618 patients assigned to placebo (hazard ratio, 1.06; 95% CI, 0.95 to 1.19; P=0.29). Fatal or nonfatal stroke occurred in 101 patients assigned to darbepoetin alfa and 53 patients assigned to placebo (hazard ratio, 1.92; 95% CI, 1.38 to 2.68; P<0.001). Red-cell transfusions were administered to 297 patients assigned to darbepoetin alfa and 496 patients assigned to placebo (P<0.001). There was only a modest improvement in patient-reported fatigue in the darbepoetin alfa group as compared with the placebo group. The use of darbepoetin alfa in patients with diabetes, chronic kidney disease, and moderate anemia who were not undergoing dialysis did not reduce the risk of either of the two primary composite outcomes (either death or a cardiovascular event or death or a renal event) and was associated with an increased risk of stroke. For many persons involved in clinical decision making, this risk will outweigh the potential benefits. (ClinicalTrials.gov number, NCT00093015.) 2009 Massachusetts Medical Society
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            Kidney Disease: Improving Global Outcomes guidelines on anaemia management in chronic kidney disease: a European Renal Best Practice position statement.

            Recently, the Kidney Disease: Improving Global Outcomes (KDIGO) group has produced comprehensive clinical practice guidelines for the management of anaemia in CKD patients. These guidelines addressed all of the important points related to anaemia management in CKD patients, including therapy with erythropoieis stimulating agents (ESA), iron therapy, ESA resistance and blood transfusion use. Because most guidelines were 'soft' rather than 'strong', and because global guidelines need to be adapted and implemented into the regional context where they are used, on behalf of the European Renal Best Practice Advisory Board some of its members, and other external experts in this field, who were not participants in the KDIGO guidelines group, were invited to participate in this anaemia working group to examine and comment on the KDIGO documents in this position paper. In this article, the group concentrated only on those guidelines which we considered worth amending or adapting. All guidelines not specifically mentioned are fully endorsed.
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              • Article: not found

              Association of kidney function with anemia: the Third National Health and Nutrition Examination Survey (1988-1994).

              Kidney failure is known to cause anemia, which is associated with a higher risk of cardiac failure and mortality. The impact of milder decreases in kidney function on hemoglobin levels and anemia in the US population, however, is unknown. We analyzed a population-based sample of 15419 participants 20 years and older in the Third National Health and Nutrition Examination Survey, conducted from 1988 to 1994. Lower kidney function was associated with a lower hemoglobin level and a higher prevalence and severity of anemia below, but not above, an estimated glomerular filtration rate (GFR) of 60 mL/min per 1.73 m(2). Adjusted to the age of 60 years, the predicted median hemoglobin level among men (women) decreased from 14.9 (13.5) g/dL at an estimated GFR of 60 mL/min per 1.73 m(2) to 13.8 (12.2) g/dL at an estimated GFR of 30 mL/min per 1.73 m(2) and to 12.0 (10.3) g/dL at an estimated GFR of 15 mL/min per 1.73 m(2). The prevalence of anemia (hemoglobin level <12 g/dL in men and <11 g/dL in women) increased from 1% (95% confidence interval, 0.7%-2%) at an estimated GFR of 60 mL/min per 1.73 m(2) to 9% (95% confidence interval, 4%-19%) at an estimated GFR of 30 mL/min per 1.73 m(2) and to 33% (95% confidence interval, 11%-67%) at an estimated GFR of 15 mL/min per 1.73 m(2) among men and to 67% (95% confidence interval, 30%-90%) at an estimated GFR of 15 mL/min per 1.73 m(2) among women. An estimated GFR of 15 to 60 mL/min per 1.73 m(2) was present in 4% of the entire population and in 17% of the individuals with anemia. Below an estimated GFR of 60 mL/min per 1.73 m(2), lower kidney function is strongly associated with a higher prevalence of anemia among the US adult population.
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                Author and article information

                Contributors
                +44 (0)7876 870444 , matthew.turner@sandoz.com
                Journal
                Int Urol Nephrol
                Int Urol Nephrol
                International Urology and Nephrology
                Springer Netherlands (Dordrecht )
                0301-1623
                1573-2584
                17 April 2015
                17 April 2015
                2015
                : 47
                : 5
                : 837-845
                Affiliations
                [ ]Università degli Studi di Bari, Bari, Italy
                [ ]Centre Hospitalier de Bordeaux and Unité INSERM 1026, University of Bordeaux, Bordeaux, France
                [ ]G.I. Popa University Hospital of Medicine and Pharmacy, Iasi, Romania
                [ ]Dialysezentrum, Düsseldorf, Germany
                [ ]Guy’s and St Thomas’ NHS Foundation Hospital, London, UK
                [ ]Centre Hospitalier F.H. Manhés, Fleury-Mérogis, France
                [ ]Friedrich Alexander Universität Erlangen-Nürnberg, Erlangen, Germany
                [ ]Université de Grenoble, Grenoble, France
                [ ]Sandoz International GmbH, Industriestr. 25, 83607 Holzkirchen, Germany
                [ ]Matrix 45, Tucson, AZ USA
                [ ]University of Arizona College of Pharmacy, Tucson, AZ USA
                Article
                970
                10.1007/s11255-015-0970-8
                4555197
                25894959
                5c806119-cb2e-4a4b-a1e8-72487eae4728
                © The Author(s) 2015

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                : 26 March 2015
                : 29 March 2015
                Categories
                Nephrology - Original Paper
                Custom metadata
                © Springer Science+Business Media Dordrecht 2015

                Nephrology
                anaemia,biosimilar epoetin alfa,congruence,guidelines,haemodialysis,hb targets
                Nephrology
                anaemia, biosimilar epoetin alfa, congruence, guidelines, haemodialysis, hb targets

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