ferric-oxide--saccharated and Renal-Insufficiency

It has been suggested that iron increases oxidative stress and that an excess of iron contributes to cardiovascular disease and infections in haemodialysis patients. In the present study, the effects of parenterally administered iron on leucocyte surface molecule expression and the production of reactive oxygen species (ROS) were evaluated.. Ten chronic haemodialysis (HD) patients without iron overload were studied. To each patient, four different regimens were applied: placebo; iron sucrose, either 30 or 100 mg, administered via the outflow dialyser line; and 100 mg of iron sucrose infused via the inflow dialyser line. Blood was sampled at different time points: before, during and after infusion and immediately before the next dialysis session. Levels of CD11b and CD45 expression on granulocytes and of CD11b, CD14 and CD36 on monocytes were determined using flow cytometric analysis. The generation of ROS was quantified using chemiluminescence with and without ex vivo stimulation by phorbol myristate acetate (PMA).. No significant differences among the four different treatment regimes were found, neither in chemilumescence activity nor in the expression of CD11b and CD45 on granulocytes, and of CD11b, CD14 and CD36 on monocytes.. Our results suggest that parenteral infusion of iron sucrose during haemodialysis in patients who have no signs of iron overload has no significant effect on the expression of leucocyte surface molecules and does not increase production of ROS.

Topics: Aged; CD11b Antigen; Female; Ferric Compounds; Ferric Oxide, Saccharated; Flow Cytometry; Glucaric Acid; Granulocytes; Hematinics; Humans; Leukocyte Common Antigens; Leukocytes; Lipopolysaccharide Receptors; Luminescence; Male; Middle Aged; Monocytes; Reactive Oxygen Species; Renal Dialysis; Renal Insufficiency

Endothelial injury is prevalent in patients with chronic renal failure (CRF) and may be exacerbated by commonly used intravenous (IV) iron therapy. The effects of high-dose IV iron sucrose treatment (200 mg daily in 250 mL of 0.9% saline, administered over 1 hour, median treatment duration 5 days) on circulating endothelium and/or tissue injury markers such as hepatocyte growth factor, thrombomodulin, von Willebrand factor, and C-reactive protein levels were studied. The markers were determined in 24 anemic (mean hemoglobin 9.48 g/dL) pre-dialysis (median creatinine clearance 21.5 mL/min) patients with CRF and defined absolute and/or functional iron deficiency. The measurements were performed before iron administration and 24 hours after the last infusion. All the markers remained unchanged following the IV iron therapy (all p < 0.172); no thrombotic or other adverse effects were observed. In conclusion, the above high-dose IV iron sucrose supplementation does not cause evident endothelial or other tissue injury in patients with CRF, and is clinically safe.

Topics: Adult; Aged; Biomarkers; Endothelium, Vascular; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glucaric Acid; Hepatocyte Growth Factor; Humans; Infusions, Intravenous; Iron; Male; Middle Aged; Renal Insufficiency; Thrombomodulin; Thrombosis; von Willebrand Factor

Congestive heart failure is extremely common in octogenarians and is associated with severe fatigue, shortness of breath, recurrent hospitalizations, and death. These patients, many of whom are anemic, are often resistant to standard CHF therapy including angiotensin-converting enzyme inhibitors, beta-blockers and diuretics.. To examine whether correction of the anemia (hemoglobin < 12 g/dl) in CHF patients can improve their clinical condition.. Forty octogenarians with anemia and severe resistant CHF were administered a combination of subcutaneous erythropoietin and intravenous iron sucrose.. This combination therapy led to a marked improvement in cardiac function, shortness of breath and fatigue, a marked reduction in the rate of hospitalization and a stabilizing of renal function.. Anemia appears to be an important but ignored contributor to the progression of CHF, and its correction may improve cardiac and renal status as well as the quality of life in elderly patients.

Topics: Age Factors; Aged; Aged, 80 and over; Anemia; Drug Therapy, Combination; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Glomerular Filtration Rate; Glucaric Acid; Heart Failure; Hemodynamics; Humans; Infusions, Intravenous; Male; Renal Insufficiency; Severity of Illness Index; Time Factors

Correction of anaemia as a result of renal failure improves cardiovascular function and also provides significant cognitive and emotional benefits. The most appropriate route for iron supplementation has not been determined for patients with chronic renal failure who are not yet on dialysis.. Forty-five anaemic patients with progressive renal insufficiency (PRI) were prospectively randomized to receive oral (ferrous sulphate 200 mg tds) or intravenous (300 mg iron sucrose monthly) iron treatment. Erythropoietin (rHuEpo) was simultaneously commenced and the dose adjusted according to a pre-established protocol.. There were no significant differences in baseline patient characteristics between the two groups. The average follow-up was 5.2 months. Three patients suffered possible allergic reactions to iron sucrose. Haemoglobin response and changes in red cell hypochromasia were similar in the two groups, but serum ferritin was significantly higher in the intravenous group. The starting dose of rHuEpo could be temporarily discontinued in 43% of patients on oral iron and 33% of patients receiving iron sucrose (NS). rHuEpo was increased after 3 months in 9% of patients on oral iron and 19% of patients receiving iron sucrose (NS). Final doses of rHuEpo were 33.5 (0-66) and 41.6 (0-124) U/kg/week respectively in the oral and intravenous groups (NS). Although gastro-intestinal symptoms were more commonly reported in patients taking oral iron, these were mild according to scores on visual analogue scales. Dietary protein and energy intake were not significantly different in the two groups at 0, 3 and 6 months.. In pre-dialysis patients, the efficacy of monthly 300 mg iron sucrose given intravenously is not superior with regard to haemoglobin response and rHuEpo dose as compared with a daily oral dose of 600 mg of ferrous sulphate or equivalent. Where intravenous iron is preferred, lower doses may help to reduce the incidence of allergic or "free iron" reactions, especially in patients with low body mass.

Topics: Administration, Oral; Aged; Disease Progression; Dose-Response Relationship, Drug; Erythropoietin; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Ferrous Compounds; Gastrointestinal Diseases; Glucaric Acid; Hemoglobins; Humans; Injections, Intravenous; Male; Middle Aged; Recombinant Proteins; Renal Insufficiency

It is now recognized that the majority of patients on epoetin therapy require intravenous (IV) iron supplementation to maximize the response to treatment. Of the IV iron preparations available, iron sucrose has proved its efficacy and safety; however, there are no guidelines or systematic studies examining the optimum safe dosage regimen for this compound. The aim of the present study was to investigate prospectively a variety of dosing regimens for IV iron sucrose in patients with renal failure to develop treatment strategies for this preparation. A total of 335 iron infusions was administered to 249 patients in this study, which was conducted in four phases. In phase I, 89 patients were administered a dose of 200 mg as an IV infusion over 2 hours. No adverse events were seen. A 500-mg dose by 2-hour infusion was then assessed, but was abandoned after 8 of 22 patients developed reactions characterized by dizziness, hypotension, and nausea. The dose was then reduced to 300 mg by 2-hour infusion for the next 189 patients, and again, no adverse reactions were witnessed. Finally, a 400-mg dose by 2-hour infusion was examined in 35 patients, but 2 patients experienced such symptoms as hypotension, nausea, and lower back pain. Both the 200- and 300-mg doses of IV iron sucrose administered over 2 hours appear to be safe. The incidence of adverse events with the 400- and 500-mg doses administered as a 2-hour infusion seems too high to recommend their routine use, although it may be possible to administer these doses over a longer period.

Topics: Abdominal Pain; Adult; Aged; Aged, 80 and over; Back Pain; Dose-Response Relationship, Drug; Female; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Hypotension; Infusions, Intravenous; Kidney Transplantation; Male; Middle Aged; Nausea; Peritoneal Dialysis; Prospective Studies; Renal Dialysis; Renal Insufficiency; Vomiting

The high pill burden of many phosphate binders (PBs) may contribute to increased prevalence of hyperphosphatemia and poor nutritional status observed among patients undergoing maintenance hemodialysis therapy. We examined the real-world effectiveness of sucroferric oxyhydroxide (SO), a PB with low pill burden, in managing serum phosphorus in patients with prevalent hemodialysis over a 1-year period.. Historical cohort analyses of de-identified electronic medical records.. In-center hemodialysis patients switched from another PB to SO therapy as part of routine care with 12 months of uninterrupted SO prescriptions recorded, and documented serum phosphorus levels were eligible for inclusion. Clinical data were extracted from a pharmacy service, FreseniusRx, database and Fresenius Kidney Care clinical data warehouse.. Comparisons were made between the 91-day period before SO initiation (i.e., baseline) and the 4 consecutive 91-day intervals of SO treatment (Q1-Q4). Clinical measures included achievement of target phosphorus levels (≤5.5 mg/dL) and mean number of PB pills/day.. Among 530 analyzed patients, the proportion achieving target serum phosphorus levels increased by >100% 1 year after switching to SO therapy, that is, from 17.7% at baseline to 24.5%, 30.5%, 36.4%, and 36.0% at Q1 through Q4, respectively (P < .0001 for all). Reductions in serum phosphorus were observed at all follow-up timepoints (P < .0001), irrespective of baseline PB. From a mean baseline PB pill burden of 8.5 pills/day, patients experienced an average 50% pill burden reduction during SO treatment (P < .0001). Phosphorus-attuned albumin and phosphorus-attuned protein intake (normalized protein catabolic rate) improved significantly after transition to SO (P < .0001). The effectiveness of SO was evident in prespecified subgroups of interest (i.e., black/African-American patients, Hispanic/Latino patients, and women).. Among patients on hemodialysis, switching to SO resulted in a 2-fold greater likelihood of achieving target phosphorus levels while halving daily PB pill burden. Increases in phosphorus-attuned albumin and protein intake suggest improved nutritional status.

Topics: Adult; Aged; Chelating Agents; Cohort Studies; Drug Combinations; Female; Ferric Compounds; Humans; Hyperphosphatemia; Male; Medication Adherence; Middle Aged; Nutritional Status; Phosphates; Phosphorus; Renal Dialysis; Renal Insufficiency; Sucrose; Time Factors; Treatment Outcome

The preferable route of iron delivery for most iron-deficient patients is oral. Parenteral iron therapy is used in patients who cannot tolerate oral iron or in cases in which oral iron is not sufficiently effective. The most frequent indications for parenteral iron therapy are unbearable gastrointestinal side effects induced by oral iron itself, worsening of inflammatory bowel disease symptoms, insufficient intestinal absorption, renal failure-caused anemia that is treated with erythropoietin, and unresolved ongoing bleeding, which would cause the acceptable oral doses of iron therapy to be exceeded. The serious adverse effects of iron dextran that was used in the past could explain the reluctance of medical personnel to prescribe this effective treatment. Patients with iron deficiency anemia were treated with intravenous iron in a primary care clinic. The iron gluconate was given in a dosage of 62.5 mg diluted in 150 mL of normal saline and was infused intravenously over 30 min, while iron sucrose was given in a dosage of 100 mg diluted in the same volume of normal saline and given at the same rate. In total, 724 infusions were administered to 57 patients. Iron sucrose was used in 628 infusions, and iron gluconate was used in the remaining 96. The frequency of the infusion treatments depended on the underlying disease and ranged from three times a week to once a month. Adverse effects were seldom observed and were minor in patients receiving iron gluconate, and were not registered at all in patients treated with iron sucrose. Two cases of flushing with paresthesias occurred. Slowing the infusion rate successfully eliminated these side effects. One case of hypotension was treated successfully with 500 cc of normal saline infusion. One case of dropout occurred, due to the patient's refusal to cooperate. No anaphylactic reactions were observed. Iron gluconate and iron sucrose are effective and safe for use in primary care clinics. The risk of adverse effects is low.

Topics: Anemia, Iron-Deficiency; Ferric Compounds; Ferric Oxide, Saccharated; Ferritins; Glucaric Acid; Humans; Injections, Intravenous; Renal Insufficiency; Sucrose