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In a two-way study, we treated renal anemia in chronic hemodialysis patients with recombinant human erythropoietin (rh-EPO) and followed heart morphology and function dynamics by echocardiography. Thirty-eight patients were randomly divided in two equal groups: the therapy group, treated with rh-EPO for 24 months, and the control group, not treated during the first 12 months and treated with rh-EPO during the second 12 months. Anemia was corrected, and hematocrit was maintained between 30 and 35 vol% by subcutaneous rh-EPO administration. Echocardiographic assessment was performed at the end of the untreated control phase and was repeated after 12 months of rh-EPO treatment in the control group and after 12 and 24 months of treatment in the therapy group. The results revealed significant morphologic, hemodynamic, and eventually functional changes. After 12 months of rh-EPO treatment, the end-diastolic volume (EDV) decreased from 135.8 +/- 23.7 to 109.8 +/- 25.3 ml, p < 0.001; stroke volume (SV) from 91.9 +/- 17.6 to 71.3 +/- 12.4 ml, p < 0.001; left ventricular mass-Devereux (LVMD) from 297.2 +/- 57.8 to 218.0 +/- 50.4 g, p < 0.01; cardiac output (CO) from 7,279 +/- 1,932 to 5,711 +/- 1,276 ml/min, p < 0.002; total peripheral resistance (TPR) rose from 1,330 +/- 390 to 1,707 +/- 373 dynes x s/cm5, p < 0.007. After 24 months, LVMD decreased further from 224.6 +/- 43.1 to 195.7 +/- 46.3 g, p < 0.004. The relaxation time index (RTI) decreased from 64.7 +/- 20.4 to 52.4 +/- 18.0 ms, p < 0.045, suggesting improved diastolic function.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Analysis of heart morphology and function following erythropoietin treatment of anemic dialysis patients. 811 72

To examine the effects of recombinant human erythropoietin (rHuEPO) on hospital utilization, hospital costs, and Medicare reimbursements for hospital care, a longitudinal, matched cohort study was conducted using Medicare claims data of 23,806 Medicare-eligible, dialysis patients who received rHuEPO, did not have a transplant, and were alive for 18 mo or longer and 22,720 controls matched on age, sex, race, cause of ESRD, and dialysis modality. The relative odds (rHuEPO versus control) of admission for all causes and for specific causes over 9 mo, adjusted for admission in the prior 9 mo and the per patient change in total admissions, inpatient days, hospital costs, and Medicare hospital payments between the prior 9-mo period and the subsequent 9-mo period was examined. The adjusted relative odds (95% confidence interval) of admission (rHuEPO versus control) was: higher and statistically significant for all causes, 1.08 (1.03 to 1.14); seizure, 1.52 (1.28 to 1.75); vascular access revision, 1.11 (1.06 to 1.17), and heart failure, 1.17 (1.09 to 1.26); higher but not statistically significant for angina, 1.09 (0.99 to 1.20) and stroke, 1.08 (0.86 to 1.31); and lower but not statistically significant for myocardial infarction, 0.91 (0.72 to 1.10); peripheral vascular disease, 0.81 (0.60 to 1.02); anemia, 0.86 (0.56 to 1.17); and depression, 0.89 (0.37 to 1.40). The mean change per 1,000 patients in admissions was less by 38 (P = 0.03) because of fewer readmissions, and in days was 1,309 less (P < 0.001), for patients treated with rHuEPO versus controls. The mean change per patient in hospital costs was $371 less and was statistically significant (P = 0.03) and in Medicare hospital payments was $132 less but was not statistically significant (P = 0.43) for patients treated with rHuEPO versus controls. rHuEPO was associated with an increase in the probability of hospital admission (particularly admissions potentially related to adverse effects) but a decrease in readmissions, overall admissions, hospital days, and cost to hospitals in this cohort of patients surviving for 18 mo. Although not realized short term, Medicare savings from potential rHuEPO-related reductions in hospital care may be long term through future adjustments in diagnosis-related group-based hospital payment.
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PMID:Effect of recombinant erythropoietin on hospital admissions, readmissions, length of stay, and costs of dialysis patients. 816 27

An 85-year-old woman had a right-sided renal cell carcinoma removed 20 years ago. At haemoglobin concentration. Two years ago she had a syncope, at which time the haemoglobin concentration was 16.9 g/dl. Ultrasound and computed tomography (CT) revealed an extensive retroperitoneal space-occupying lesion, which however was not investigated further, and no therapeutic consequences were drawn. An erythrocytosis (7.5 x 10(6)/microliters) and elevated haemoglobin concentration (> 20 g/dl) were found when she was examined after a fall in which she had sustained only minimal injury. The retroperitoneal mass had slightly increased in size. Histological examination of a CT-guided fine-needle biopsy revealed metastases of the hypernephroid carcinoma. The serum erythropoietin concentration was increased (42.4 U/l) and failed to increase even after repeated venesections, indicating erythropoietin production by the late metastases of the renal cell carcinoma. There was no evidence for any systemic haematological disease. Six months after the diagnosis of metastases the patient died at home, presumably of a cerebrovascular accident.
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PMID:[Polycythemia in the late metastasis of an erythropoietin-producing renal-cell carcinoma]. 818 21

The normal response to 45 degrees head-up tilt (decreased stroke volume and cardiac output and increased heart rate and peripheral resistance) is not seen in the majority of haemodialysis patients. This is due to both an abnormal baroreceptor reflex and increased venous tone which may be explained by a number of factors including hypoxia, acidosis and sodium retention. We have studied this response by impedance cardiography in eight chronic haemodialysis patients, both before and after 3 months of treatment with human recombinant erythropoietin. Before treatment the cardiovascular parameters were abnormal both at rest and on tilting in each patient. The change in each measurement following tilting was: stroke volume, 0.5 +/- 6%; cardiac output, 6 +/- 5%; peripheral resistance, -8 +/- 4%; and heart rate, 10 +/- 4%. After 3 months of erythropoietin (150 U/kg/week intravenously) the mean haematocrit had risen from 19.5 +/- 3% to 32.9 +/- 4% and all patients felt physically fitter. Impedance showed no change in the supine-indices but after tilting there was a dramatic fall in stroke volume (-26 +/- 7%) and cardiac output (-17 +/- 7%) and an increase in heart rate (15 +/- 4%) and peripheral resistance (28 +/- 10%) each moving towards the normal response. These results indicate that human recombinant erythropoietin normalizes the response to postural stress in these patients and suggest that anaemia is the principal cause of the abnormal venoconstriction seen in haemodialysis patients. The mechanisms involved warrant further investigation.
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PMID:The effect of recombinant human erythropoietin on cardiovascular responses to postural stress in dialysis patients. 829 83

The objectives of this study were to quantify the amount of blood required to suppress synthesis of hemoglobin S (HbS) in patients with hemoglobin SS on a long-term transfusion regimen and to evaluate factors that might contribute to variations in transfusion-induced patterns of responsiveness. Eleven patients with hemoglobin SS (age range, 2 years 4 months to 19 years 9 months) who had had a cerebrovascular accident were monitored during a period of 1 1/2 to 4 years for HbS percentages, reticulocyte percentages, the amount of erythrocytes infused, and weight. From these data the amount of blood necessary to maintain the HbS concentration at less than 30% was expressed as units of packed erythrocytes administered per week per kilogram of body weight. Percentage of HbS were significantly lower in three subjects than in the other eight (6.1 +/- 0.6 vs 23.0 +/- 2.1; p = 0.0009) as were the reticulocyte percentages (2.9 +/- 0.3 vs 7.9 +/- 0.7; p = 0.0021). However, there were no significant differences between pretransfusion hematocrit (0.278 +/- 0.012 vs 0.281 +/- 0.01; p = 0.90) and units of erythrocytes given per week per kilogram (0.0147 +/- 0.0008 vs 0.0156 +/- 0.0009; p = 0.58). Factors explored to define the reason that HbS synthesis was more easily suppressed in some patients than in others included measurements of serum chemistry values and erythropoietin, identification of erythrocyte alloantibodies, and a survey for Howell-Jolly bodies. No significant differences were seen. Although the reasons for the marked variation in transfusion-induced depression of HbS synthesis are unclear, this study emphasizes the importance of determining the units of packed erythrocytes needed per week per kilogram and correlating this value with the pretransfusion HbS percentage. By doing so, one can select the minimal amount of blood necessary to achieve the desired HbS percentage and thereby decrease the risks of transfusion.
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PMID:Variable degrees of suppression of hemoglobin S synthesis in subjects with hemoglobin SS disease on a long-term transfusion regimen. 830 25

The purpose of this study was to estimate the net cost effect to Medicare of the increasing use of recombinant human erythropoietin (EPO) instead of red blood cell transfusions or androgens in the management of anemia for the approximately 100,000 hemodialysis patients in the U.S. End-Stage Renal Disease (ESRD) program. A computerized decision model that takes into account the effectiveness and possible side effects of transfusions, androgens, and EPO and predicts 1- and 5-yr direct medical costs to Medicare associated with each therapy was constructed. Probability estimates for clinical events were derived from the literature. Costs were assigned by use of the amounts Medicare pays providers of ESRD care for: (1) use of EPO, transfusions, and androgens; and (2) health care services related to the treatment of anemia (including complications of treatment and possible reductions in morbidity). For every 10,000 hemodialysis patients treated with EPO, net Medicare expenditures will be much greater than if only transfusions are used by $42,530,000 at 1 yr (6% of ESRD program costs) and by $118,050,000 at 5 yr and also much greater than if androgens are used (by $42,700,000 at 1 yr and $118,370,000 at 5 yr). The increase in cost was highly sensitive to the dose of EPO; moderately sensitive to changes in estimated anemia response rates for EPO, frequency of EPO-induced vascular access clotting, and reduction in cardiovascular or overall morbidity; and slightly sensitive to transfusion rates, estimated anemia response rates for androgens, frequency of EPO-induced seizure or hypertensive complications (stroke, myocardial infarction), frequency of transfusion-related viral infection, and frequency of androgen-induced virilization. Considering both effectiveness and side effects of alternative treatments for the anemia of ESRD, it was projected that the increasing use of EPO will markedly increase the cost to Medicare of ESRD medical care.
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PMID:Cost implications to Medicare of recombinant erythropoietin therapy for the anemia of end-stage renal disease. 831 82

Children with end stage renal failure and anaemia have an increased cardiac index and often gross ventricular hypertrophy. The contribution of anaemia to these abnormalities is uncertain. Eleven children with end stage renal failure and anaemia (haemoglobin concentration < 90 g/l) were enrolled into a single blind, placebo controlled, crossover study to assess the cardiovascular effects of reversing anaemia using subcutaneous human recombinant erythropoietin (r-HuEpo). Each limb lasted 24 weeks; seven children completed both limbs of the study. Haemoglobin increased with r-HuEpo, remaining above 100 g/l for a mean of 11 weeks. Cardiac index fell as a result of a reduction in both left ventricular stroke volume and heart rate. Left ventricular end diastolic diameter also decreased. In five children left ventricular wall thickness and left ventricular mass decreased with r-HuEpo, but this failed to reach significance for the whole group. Blood pressure did not change in six normotensive children completing an r-HuEpo limb; the decrease in cardiac index was therefore balanced by an increase in peripheral vascular resistance. Three children were taking anti-hypertensive treatment at the start of the study; one required an increase, and one a decrease, in treatment during the r-HuEpo limb. Short term treatment with r-HuEpo reduces cardiac index. A longer study is needed to determine whether this will, in time, result in a significant reduction in left ventricular hypertrophy.
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PMID:Short term correction of anaemia with recombinant human erythropoietin and reduction of cardiac output in end stage renal failure. 832 33

To determine the effects of anemia in children with end-stage renal disease, we studied cardiac performance before and 1 and 6 months after recombinant erythropoietin (Epogen). Children with end-stage renal disease were included if they had significant anemia [hematocrit (Hct) < 30%]. Epogen 50 U/kg was given subcutaneously or intravenously three times per week until the Hct was > or = 33%. Echocardiography, cardiac output (acetylene rebreathing), and treadmill (modified Bruce) tests were performed. Boys (9) and girls (9), 11.9 +/- 5.6 years, were given Epogen and the Hct increased (from 21.7 +/- 2.7% to 33.4 +/- 2.1%, P = 0.001). Heart rate decreased (P = 0.04) and stroke volume did not change. Blood pressure did not change. Cardiac thickness, chamber dimensions, left ventricular wall stress, velocity of circumferential fiber shortening, and indices of diastolic function were normal and did not change after Epogen. Exercise time increased (from 10.3 +/- 1.9 to 11.2 +/- 1.9 min, P = 0.01) after 1 month of Epogen. Resting oxygen consumption (VO2) decreased (from 7.8 +/- 1.8 to 6.9 +/- 1.4 ml/min per kg, P = 0.01) 1 month after Epogen and peak exercise VO2 did not change after Epogen. There were no differences in exercise tests between the 1 and 6 month measurements. Exercise tolerance improves after the short-term correction of anemia and there is no further improvement after long-term correction.
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PMID:Recombinant erythropoietin (Epogen) improves cardiac exercise performance in children with end-stage renal disease. 851 98

The aim of the study was to assess the efficacy of low dose subcutaneous (sc) recombinant human erythropoietin (rHuEpo) therapy in hemodialysis (hd) patients, with particular emphasis on their quality of life. 25 anemic (Ht < 25%) hd patients with end-stage renal disease were given small sc doses of rHuEpo once or twice weekly for 12 months. During first 4 months of the therapy there was a significant increase of Ht (21.1 +/- 0.5 vs 28.5 +/- 0.6%; p < 0.0001) and serum hb (6.68 +/- 0.12 vs 8.51 +/- 0.18 g/dl; p < 0.0001) at mean induction dose of 52.5 +/- 2.5 IU/kg/week and this was maintained with a mean dose 67.0 +/- 10.5 IU/kg/week. RHuEpo was effective in 24 patients; all of them required no blood transfusions after starting the therapy. In majority of patients an substantial (p < 0.01) improvements in exercise tolerance, well-being, cold tolerance, sexual satisfaction and libido were observed, although sexual hormones profile revealed no significant changes during the treatment. Within first 6 months of the study cardiac index decreased substantially (p < 0.01), mainly because of stroke volume reduction, but after one year this hemodynamic improvement was noted only in patients who maintained a stable blood pressure. Hypertension worsened in 31% of patients. Low-dose s.c. rHuEpo: (1) is effective and safe treatment for anemia in hds patients, sufficient to abolish blood transfusion requirements; (2) produces significant improvements in quality of life; and (3) allows for 50% costs reduction.
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PMID:[Evaluation of treating anemia in patients undergoing chronic dialysis with small doses of human recombinant erythropoietin]. 865 50

An increase in blood pressure is common during treatment of renal anaemia with recombinant human erythropoietin (rhEPO). Concomitant findings of a decrease in cardiac output indicate that an increase in the peripheral flow resistance underlies the increase in blood pressure. The aim of this study was to elucidate the haemodynamic changes during rhEPO treatment in patients with ischaemic heart disease (IHD). Haemodynamic variables were assessed by impedance cardiography in 18 consecutive patients with renal anaemia before and after rhEPO treatment. IHD was found in eleven of these patients. The remaining seven served as controls. Before rhEPO treatment, the cardiac index was decreased in the group of patients with IHD, compared with controls and healthy subjects. Due to an increase in stroke index, the cardiac index increased during rhEPO treatment and reached values equal to those in the control group. The blood pressure increased and the increase in mean arterial pressure was correlated to the increase in cardiac index. Apparently the patients with IHD were unable to compensate for anaemia by increasing their cardiac index. Anaemia treatment increased cardiac index, which in turn caused an increase in blood pressure in these patients.
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PMID:Renal anaemia treatment with recombinant human erythropoietin increases cardiac output in patients with ischaemic heart disease. 873 56


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