Journal ArticleDOI
Normalization of Hemoglobin Level in Patients with Chronic Kidney Disease and Anemia
Tilman B. Drüeke,Francesco Locatelli,Naomi Clyne,Kai-Uwe Eckardt,Iain C. Macdougall,Dimitrios Tsakiris,Hans-Ulrich Burger,Armin Scherhag +7 more
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TLDR
In patients with chronic kidney disease, early complete correction of anemia does not reduce the risk of cardiovascular events and there was no significant difference in the combined incidence of adverse events between the two groups.Abstract:
BACKGROUND Whether correction of anemia in patients with stage 3 or 4 chronic kidney disease improves cardiovascular outcomes is not established. METHODS We randomly assigned 603 patients with an estimated glomerular filtration rate (GFR) of 15.0 to 35.0 ml per minute per 1.73 m 2 of body-surface area and mild-to-moderate anemia (hemoglobin level, 11.0 to 12.5 g per deciliter) to a target hemoglobin value in the normal range (13.0 to 15.0 g per deciliter, group 1) or the subnormal range (10.5 to 11.5 g per deciliter, group 2). Subcutaneous erythropoietin (epoetin beta) was initiated at randomization (group 1) or only after the hemoglobin level fell below 10.5 g per deciliter (group 2). The primary end point was a composite of eight cardiovascular events; secondary end points included left ventricular mass index, quality-of-life scores, and the progression of chronic kidney disease. RESULTS During the 3-year study, complete correction of anemia did not affect the likelihood of a first cardiovascular event (58 events in group 1 vs. 47 events in group 2; hazard ratio, 0.78; 95% confidence interval, 0.53 to 1.14; P = 0.20). Left ventricular mass index remained stable in both groups. The mean estimated GFR was 24.9 ml per minute in group 1 and 24.2 ml per minute in group 2 at baseline and decreased by 3.6 and 3.1 ml per minute per year, respectively (P = 0.40). Dialysis was required in more patients in group 1 than in group 2 (127 vs. 111, P = 0.03). General health and physical function improved significantly (P = 0.003 and P<0.001, respectively, in group 1, as compared with group 2). There was no significant difference in the combined incidence of adverse events between the two groups, but hypertensive episodes and headaches were more prevalent in group 1. CONCLUSIONS In patients with chronic kidney disease, early complete correction of anemia does not reduce the risk of cardiovascular events. (ClinicalTrials.gov number, NCT00321919.)read more
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Journal ArticleDOI
The normalization heuristic: an untested hypothesis that may misguide medical decisions.
TL;DR: This paper operationally defines this heuristic and discusses its limitations as a rule of thumb for clinical decision making and reviews historical and contemporaneous examples of normalization practices as empirical evidence for the normalization heuristic to highlight its frailty.
Journal ArticleDOI
Interpreting results of clinical trials: a conceptual framework.
TL;DR: A conceptual framework for readers, reviewers, and those involved in guideline development is introduced, based on evaluating a study on its statistical merits as well as the clinical relevance of the potential treatment effect, which incorporates a decision matrix that incorporates these ideas in formulating the acceptability of a study for publication and/or inclusion in a guideline.
Journal ArticleDOI
DMOG, a Prolyl Hydroxylase Inhibitor, Increases Hemoglobin Levels without Exacerbating Hypertension and Renal Injury in Salt-Sensitive Hypertensive Rats.
TL;DR: DMOG and rHuEPO are equally effective in increasing hemoglobin levels in Dahl S rats; however, rHu EPO aggravates hypertension and renal injury, whereas DMOG has marked renoprotective effects, suggesting that PHD inhibitors may have a therapeutic advantage for the treatment of anemia in CKD.
Journal ArticleDOI
Erythropoiesis-stimulating agent slows the progression of chronic kidney disease: a possibility of a direct action of erythropoietin
Kazuhiko Tsuruya,Hisako Yoshida,Takaichi Suehiro,Kiichiro Fujisaki,Kosuke Masutani,Takanari Kitazono +5 more
TL;DR: ESA therapy slows the progression of CKD and part of the effect might be attributed to the direct renoprotective action of ESA, according to multivariable logistic regression analysis.
Journal ArticleDOI
Major Declines in Epoetin Dosing after Prospective Payment System Based on Dialysis Facility Organizational Status
TL;DR: Historically, important differences in anemia management were evident by dialysis organizational status, but the confluence of financial incentives bundling epoetin payments and mounting scientific evidence linking higher hematocrit targets and higher epoETin doses to adverse outcomes have culminated in lower access to epOetin and lower doses across all dialysis providers in the first year after PPS.
References
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Recommendations for quantitation of the left ventricle by two-dimensional echocardiography. American Society of Echocardiography Committee on Standards, Subcommittee on Quantitation of Two-Dimensional Echocardiograms.
Nelson B. Schiller,P. M. Shah,Michael H. Crawford,Anthony N. DeMaria,Richard B. Devereux,Harvey Feigenbaum,H. Gutgesell,Nathaniel Reichek,David J. Sahn,Ingela Schnittger +9 more
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Journal ArticleDOI
Correction of Anemia with Epoetin Alfa in Chronic Kidney Disease
Ajay K. Singh,Lynda A. Szczech,Kezhen L. Tang,Huiman X. Barnhart,Shelly Sapp,Marsha Wolfson,Donal N. Reddan,Abstr Act +7 more
TL;DR: The use of a target hemoglobin level of 13.5 g per deciliter (as compared with 11.3 g perDeciliter) was associated with increased risk and no incremental improvement in the quality of life and the use of epoetin alfa targeted to achieve a level of 11.4 g perdeciliter was not associated with an increased risk.
Journal ArticleDOI
The effects of normal as compared with low hematocrit values in patients with cardiac disease who are receiving hemodialysis and epoetin.
Anatole Besarab,W K Bolton,J K Browne,Joan C. Egrie,Allen R. Nissenson,D M Okamoto,Steve J. Schwab,David A. Goodkin +7 more
TL;DR: In patients with clinically evident congestive heart failure or ischemic heart disease who are receiving hemodialysis, administration of epoetin to raise their hematocrit to 42 percent is not recommended.
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