losartan-potassium and ferrous-fumarate

Topics: Anemia, Neonatal; Erythropoietin; Ferrous Compounds; Gestational Age; Humans; Infant, Newborn; Recombinant Proteins; Treatment Outcome

The aim of this study was to compare two different doses and means of administration of iron in recombinant human erythropoietin (rHuEPO)-treated very low birth-weight (VLBW) infants. VLBW infants (n = 41) were randomized to one of three groups. Fourteen infants were treated with rHuEPO (300 IU/kg three times a week s.c.) and oral iron (ferrofumarate, 6 mg of iron/kg per day). Another 14 infants received the same erythropoietin dose and intramuscular iron (ferroxypolymaltose, once 12 mg of iron/kg weekly). Thirteen infants were treated with the same dose of intramuscular iron but did not receive rHuEPO. After the 3-week study period, haemoglobin concentrations and reticulocyte counts were similar in the rHuEPO-treated groups and both were higher than in the group not receiving rHuEPO (P < 0.001). In both rHuEPO-treated groups the transferrin receptor concentration increased from 6.8-7.2 mg/l to 10.5-11.3 mg/l.. In erythropoietin-treated very low birth weight infants the iron need for erythropoiesis can be met by oral administration of iron.

Topics: Administration, Oral; Anemia, Iron-Deficiency; Drug Therapy, Combination; Erythropoietin; Ferric Compounds; Ferrous Compounds; Humans; Infant, Newborn; Infant, Very Low Birth Weight; Injections, Intramuscular; Iron; Recombinant Proteins; Regression Analysis; Statistics, Nonparametric; Time Factors

Serum erythropoietin (EPO) and its relationship to hemoglobin (Hb), iron status markers and iron supplementation during normal pregnancy was assessed in a longitudinal, placebo-controlled study on 118 women, 61 took daily tablets containing 66 mg ferrous iron from the second trimester until delivery and 57 took placebo. Blood samples were obtained at 4-week intervals until delivery as well as post-partum. In the placebo-treated women, median serum EPO rose from 22.5 U/l at inclusion to 35.0 U/l at delivery (P = 0.0001). In the iron-treated women, median serum EPO rose from 23.9 to 29.9 U/l (P = 0.0001). Serum EPO showed a steeper increase in the placebo-treated women than in the iron-treated women (P < 0.05). After delivery, serum EPO became normal in both groups (P = 0.0001). Median Hb was lower in placebo-treated (iron depleted) than in iron-treated (iron repleted) women (P < 0.05). In the placebo-treated women there was a negative correlation and in the iron-treated women a positive correlation between serum EPO and Hb. In the placebo-treated women, inverse correlations existed between serum EPO and serum transferrin saturation and serum ferritin, reflecting the consequences of iron deficiency, whereas the iron-treated women displayed no correlation. A physiological, nonhypoxia-induced increase in EPO production accounts for the basic expansion of the red cell mass during pregnancy. In placebo-treated women, iron deficient erythropoiesis constitutes an additional hypoxic stimulus, which induces a further increase in serum EPO.

Topics: Anemia, Hypochromic; Double-Blind Method; Erythropoiesis; Erythropoietin; Female; Ferritins; Ferrous Compounds; Hemoglobins; Humans; Hypoxia; Iron; Iron Deficiencies; Longitudinal Studies; Placental Lactogen; Postpartum Period; Pregnancy; Pregnancy Complications, Hematologic; Transferrin

The effect of recombinant human (r-Hu) erythropoietin (Epo) (300 IU/Kg per week for 4 weeks) was studied in healthy preterm infants (n = 14) fed human milk with additional milk protein and high doses of iron. The controls (n = 15) were in themselves a study group and were used to follow the natural course of anaemia of prematurity on such nutrition. Serum immunoreactive Epo (SiEpo) increased significantly 24 h after r-HuEpo injections (range 36 to > 128 mU/ml) and remained at these levels throughout the treatment period. r-HuEpo in such moderate doses kept haemoglobin above 11 g/dl. Bodyweight gain, protein and iron parameters indicated adequacy of dietary protein and iron. In controls, siEpo increased during the first weeks after nutritional supplementation, with a concommitant rise in reticulocyte count. At age 3 weeks, despite low siEpo levels, reticulocyte counts indicated active erythropoiesis. Following further moderate increases in siEpo, the reticulocyte count increased to high levels (7%). The reticulocyte response suggests that erythropoiesis in preterm infants is less dependent upon Epo levels than in adults.

Topics: Anemia, Neonatal; Combined Modality Therapy; Dietary Proteins; Erythropoietin; Ferrous Compounds; Growth; Humans; Infant; Infant, Newborn; Infant, Premature, Diseases; Recombinant Proteins; Reticulocyte Count

Recombinant human erythropoietin (rHuEPO) was given subcutaneously three times per week in an escalating dose from 500 u/kg to 950 u/kg together with ferrous fumarate 305 mg and folic acid 5 mg/d, to 10 patients from four unrelated Arab families with homozygous beta-thalassaemia. Six splenectomized patients showed a mean (+/- standard error) increase in haemoglobin from 7.1 +/- 0.1 to 9.3 +/- 0.1 g/dl (P = 0.0001), in RBC from 4.0 to 5.0 x 10(12)/l (P = 0.0001) and in nucleated RBC from 32 +/- 7 x 10(10)/l to 82 +/- 6 x 10(10)/l while receiving 750 u/kg three times per week which persisted for 4-11 months. In two patients there was no need for further blood transfusions. In three out of four unsplenectomized patients there were no changes in Hb and RBC despite dose escalation. There were no significant changes in MVC, MCH and reticulocyte count, serum bilirubin, LDH, malonyldialdehyde (MDA) and vitamin E levels. After 13 weeks of rHuEPO there was a mean increase in the percentage of F cells from 31 +/- 10% to 86 +/- 6% (P < 0.003) in three splenectomized patients and in one unsplenectomized patient from 56.4% to 80% without changes in the levels of Hb F. Globin chain synthesis ratios did not change in four responding patients. Mean serum iron and transferrin saturation index did not change, whereas mean serum ferritin increased from 299 +/- 45 micrograms/l to 480 +/- 20 micrograms/l (P < 0.001). In seven responding patients an accelerated linear growth was indicated by positive changes in height standard deviation score for chronological age. Side-effects were minimal throughout the treatment period.

Topics: Administration, Cutaneous; Adolescent; beta-Thalassemia; Child; Dose-Response Relationship, Drug; Erythrocyte Count; Erythropoietin; Female; Ferritins; Ferrous Compounds; Folic Acid; Hemoglobins; Humans; Iron; Long-Term Care; Male; Recombinant Proteins; Splenectomy

Iron supplementation is required by most dialysis patients receiving recombinant human erythropoietin. The efficacy of oral iron is variable in these patients, and many require the use of intravenous iron dextran to maintain adequate iron levels, defined as transferrin saturation greater than 20%, serum ferritin greater than 100 ng/mL, and serum iron greater than 80 micrograms/dL. To determine the efficacy of different oral iron preparations in maintenance of iron status, we prospectively studied 46 recombinant human erythropoietin-treated patients and randomized them to receive different oral iron preparations. These four preparations included Chromagen (ferrous fumarate; Savage Laboratories, Melville, NY), Feosol (ferrous sulfate; SmithKline Beecham, Inc, Pittsburgh, PA), Niferex (polysaccharide; Central Pharmaceuticals, Inc, Seymour, IN), or Tabron (ferrous fumarate; Parke-Davis, Morris Plains, NJ). All patients were prescribed approximately 200 mg of elemental iron daily of their assigned iron preparation with at least 100 mg ascorbic acid daily for 6 months. At baseline and bimonthly during the study, serum iron, transferrin saturation, ferritin, hematocrit, and recombinant human erythropoietin dose were monitored; in addition, compliance and side effects were recorded by patient interview. All patients were able to maintain target hematocrit during the 6 months of study. However, there were differences in the trends of serum iron, percent transferrin saturation, and ferritin when considered singly or in combination between the four groups of iron medications. The percent of laboratory values measured over the study period in each group that met the criteria of transferrin saturation more than 20% was greatest in the Tabron group (58%), followed by the Feosol (47%), Chromagen (33%), and Niferex (31%) groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Oral; Anemia; Anemia, Iron-Deficiency; Delayed-Action Preparations; Erythropoietin; Female; Ferrous Compounds; Hematocrit; Humans; Iron; Kidney Failure, Chronic; Male; Middle Aged; Patient Compliance; Polysaccharides; Prospective Studies; Recombinant Proteins; Renal Dialysis

Anemia does not correct in many kidney transplant recipients, probably due to iron deficiency or inadequate erythropoietin (Epo) production. We evaluated effects of iron (Fe) availability on correction of anemia in renal transplant recipients and sought to characterize patterns of early Epo production by transplanted kidneys as related to peritransplant factors. In a prospective randomized trial, 51 consecutive renal transplant patients were followed for 6 months. Epo was measured on days 0, 3, 14, 48 and 168 posttransplantation. Fe status was monitored on days 14, 48 and 168. Pts were randomized at day 14 based on Fe status. Iron-deficient (FeD) patients (n = 24) were randomized to receive daily Fe supplementation (FeDs, n = 12) or no supplementation (FeDns, n = 12). Those with normal Fe status (FeN, n = 27) were followed as controls. No differences were found between groups at day 0 for Hct, Cr, Epo, age, dialysis history, or type of donor. Day 3 Creatinine and Hct were similar among groups, while Epo was significantly higher in FeD groups vs FeN (p < 0.004), and continued higher at 6 months. Though each pt improved Hct, most FeDns and FeN were anemic and Fe deficient at 6 months while all FeDs patients had corrected their anemia (p < or = 0.009) and Fe status. Four FeDs patients developed polycythemia. Epo production correlated inversely to cold ischemia time in cadaver renal allografts (p < 0.008).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Anemia, Iron-Deficiency; Creatinine; Erythropoietin; Female; Ferritins; Ferrous Compounds; Follow-Up Studies; Humans; Immunosuppressive Agents; Iron; Kidney Transplantation; Male; Prospective Studies; Time Factors; Transferrin

The effect of iron supplementation, 66 mg elemental iron daily, from the 16th week of gestation to delivery, on iron status markers during uncomplicated pregnancies was assessed in a randomised, double-blind, placebo controlled study of 207 healthy women (100 iron treated, 107 placebo treated) and their newborn babies. Haemoglobin (Hb) and serum (S-) human placental lactogen (HPL) were measured in all 207 females, while transferrin saturation, S-ferritin and S-erythropoietin (EPO) were measured in 120 females at monthly intervals. Hb: from 27th week of gestation to eight weeks post partum, the placebo treated group had significantly lower Hb levels than the iron treated group (p less than 0.001). Iron status markers: in the placebo group (n = 57), 92% developed exhausted iron stores (i.e. S-ferritin less than or equal to 20 micrograms/l), 65% latent iron deficiency (i.e. S-ferritin less than or equal to 20 micrograms/l and transferrin saturation less than 15%), and 18% iron deficiency anaemia (i.e. S-ferritin less than or equal to 20 micrograms/l, transferrin saturation less than 15% and Hb less than 110 g/l). In the iron treated group (n = 63), 54% developed exhausted iron stores, 6% latent iron deficiency, and none iron deficiency anaemia. S-EPO: the placebo group had significantly higher values than the iron treated group from the 27th week of gestation to one week post partum (p less than 0.01). S-HPL: levels were identical in placebo and iron treated females. Babies of iron treated mothers had higher S-ferritin than babies of placebo treated mothers (p less than 0.02).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Double-Blind Method; Erythropoietin; Female; Ferrous Compounds; Gestational Age; Hemoglobins; Humans; Infant, Newborn; Iron; Longitudinal Studies; Placental Lactogen; Pregnancy; Pregnancy Trimester, Second; Pregnancy Trimester, Third; Transferrin

The benefit of oral iron therapy (OIT) and factors predictive of OIT response are not established in hemodialysis (HD) patients with iron deficiency anemia (IDA). We examined the values of hepcidin-25, mean corpuscular volume (MCV), and ferritin as predictors of OIT response. Oral ferrous fumarate (50 mg/day, 8 weeks) was given to 51 HD patients with IDA (hemoglobin (Hb) < 12 g/dL, ferritin < 100 ng/mL) treated with an erythropoietin activator. Sixteen patients were responders (improvement of Hb (ΔHb) ≥ 2 g/dL) and 35 were non-responders (ΔHb < 2g/dL). Baseline Hb, MCV, serum hepcidin-25, ferritin, iron parameters, and C-reactive protein (CRP) before and ΔHb after OIT were compared between groups. Hepcidin-25, MCV, ferritin, and transferrin saturation were lower in the responders than in the non-responders. Hepcidin-25 positively correlated with ferritin. Hepcidin-25, MCV, and ferritin positively correlated with baseline Hb and negatively correlated with ΔHb. Despite normal CRP levels in all patients, CRP correlated positively with hepcidin-25 and ferritin. Stepwise multiple linear regression analysis and receiver operating characteristics curve analysis revealed that hepcidin-25, MCV, and ferritin could predict OIT response. We conclude that hepcidin-25, MCV, and ferritin could be useful markers of iron storage status and may help predict OIT response in HD patients.

Topics: Aged; Aged, 80 and over; Anemia, Iron-Deficiency; Biomarkers; Body Mass Index; C-Reactive Protein; Dietary Supplements; Erythrocyte Indices; Erythropoietin; Female; Ferritins; Ferrous Compounds; Hemoglobins; Hepcidins; Humans; Iron, Dietary; Linear Models; Male; Middle Aged; Renal Dialysis