High-dose Iron Sucrose Research Articles

High-dose versus low-dose iron sucrose in individuals undergoing maintenance haemodialysis: a retrospective study

BackgroundIntravenous iron sucrose is becoming a prevailing treatment for individuals undergoing maintenance haemodialysis, but comparisons of dosing regimens are lacking. The aim of this retrospective review was to evaluate the safety and efficacy of proactively administered high-dose iron sucrose versus reactively administered low-dose iron sucrose in patients undergoing maintenance haemodialysis.MethodsWe analysed the data of 1500 individuals with maintenance haemodialysis who were treated with either high-dose iron sucrose that was proactively administered (Group HD) or low-dose iron sucrose that was reactively administered (Group LD) at the First Affiliated Hospital of Chongqing Medical University from Jan 1, 2008, to Dec 31, 2020. The primary endpoints were the cumulative doses of iron and erythropoiesis-stimulating agent; the secondary endpoints were the events of nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, infection rate, and death from any cause.ResultsOf the 2124 individuals, 624 individuals were excluded because they met one or more of the exclusion criteria, thus resulting in 1500 individuals who were eligible for inclusion in the study (Group HD, n = 760 and Group LD, n = 740). The median follow-up for the two cohorts was 32 months (range: 25–36). A significant median difference was detected in the monthly iron dose between the groups (1121 mg [range: 800–1274] in the HD group vs. 366 mg [range: 310–690] in the LD group; p < 0.05). The median dose of an erythropoiesis-stimulating agent was 26,323 IU/month (range: 17,596-44,712) in the HD group and 37,934 IU/month (range: 22,402-59,380) in the LD group (median difference: − 7901 IU/month; 95% CI: − 9632--5013; p = 0.000). A significant difference was detected in the secondary endpoints (266 events in 320 cases in the HD group vs. 344 events in 385 cases in the LD group) (HR: 0.62; 95% CI: 0.51–0.79; p < 0.001). A significant difference was not observed in death from any cause (HR: 0.57; 95% CI: 0.48–1.00; p = 0.361).ConclusionsFor individuals undergoing maintenance haemodialysis, high-dose iron sucrose that was proactively administered may be superior to low-dose iron sucrose that was reactively administered with low doses of erythropoiesis-stimulating agent.

Intravenous Iron in Patients Undergoing Maintenance Hemodialysis

BackgroundIntravenous iron is a standard treatment for patients undergoing hemodialysis, but comparative data regarding clinically effective regimens are limited.MethodsIn a multicenter, open-label trial with blinded end-point evaluation, we randomly assigned adults undergoing maintenance hemodialysis to receive either high-dose iron sucrose, administered intravenously in a proactive fashion (400 mg monthly, unless the ferritin concentration was >700 μg per liter or the transferrin saturation was ≥40%), or low-dose iron sucrose, administered intravenously in a reactive fashion (0 to 400 mg monthly, with a ferritin concentration of <200 μg per liter or a transferrin saturation of <20% being a trigger for iron administration). The primary end point was the composite of nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, or death, assessed in a time-to-first-event analysis. These end points were also analyzed as recurrent events. Other secondary end points included death, infection rate, and dose of an erythropoiesis-stimulating agent. Noninferiority of the high-dose group to the low-dose group would be established if the upper boundary of the 95% confidence interval for the hazard ratio for the primary end point did not cross 1.25.ResultsA total of 2141 patients underwent randomization (1093 patients to the high-dose group and 1048 to the low-dose group). The median follow-up was 2.1 years. Patients in the high-dose group received a median monthly iron dose of 264 mg (interquartile range [25th to 75th percentile], 200 to 336), as compared with 145 mg (interquartile range, 100 to 190) in the low-dose group. The median monthly dose of an erythropoiesis-stimulating agent was 29,757 IU in the high-dose group and 38,805 IU in the low-dose group (median difference, −7539 IU; 95% confidence interval [CI], −9485 to −5582). A total of 320 patients (29.3%) in the high-dose group had a primary end-point event, as compared with 338 (32.3%) in the low-dose group (hazard ratio, 0.85; 95% CI, 0.73 to 1.00; P<0.001 for noninferiority; P=0.04 for superiority). In an analysis that used a recurrent-events approach, there were 429 events in the high-dose group and 507 in the low-dose group (rate ratio, 0.77; 95% CI, 0.66 to 0.92). The infection rate was the same in the two groups.ConclusionsAmong patients undergoing hemodialysis, a high-dose intravenous iron regimen administered proactively was superior to a low-dose regimen administered reactively and resulted in lower doses of erythropoiesis-stimulating agent being administered. (Funded by Kidney Research UK; PIVOTAL EudraCT number, 2013-002267-25.)

Safety profiles of total dose infusion of low-molecular-weight iron dextran and high-dose iron sucrose in renal patients

Iron sucrose and low-molecular-weight iron dextran (LMW-ID), two commonly used iron solutions, have been compared in terms of allergic adverse event profiles to date. However, the safety of total dose infusion of LMW-ID has been investigated by only one study in chronic kidney disease (CKD) (not dialysis) patients. Thus, we aimed to compare adverse event profiles of total and high-dose LMW-ID and iron sucrose infusions in a heterogenous renal patient group comprising CKD, hemodialysis, and peritoneal dialysis. In this retrospective chart review study, we included 110 predialysis CKD, 101 peritoneal dialysis, and 118 hemodialysis patients. We included a total of 329 patients who were administered parenteral iron sucrose or LMW-ID between September 2006 and April 2010. Adverse events were determined both by medical and nursing follow-up notes. Laboratory data and clinical characteristics were collected from patient charts. Adverse event rates were compared between iron sucrose and LMW-ID infusions. In a total of 329 patients, 530 infusions (3470 ampules) were administered. We detected adverse reaction in only 1 patient. This adverse reaction, which manifested as generalized pruritus, occurred in a patient who received 500 mg of iron sucrose infusion. There were neither anaphylactic reactions nor deaths associated with infusion of either preparation. We did not observe any other adverse event related to administration of 500 and 1000 mg of iron sucrose at single infusion. The results of this study showed comparable safety of total dose LMW-ID and high-dose iron sucrose in a heterogenous group of renal patients.

Safety of high-dose iron sucrose infusion in hospitalized patients with chronic kidney disease

The safety of high-dose iron sucrose infusion in hospitalized patients with chronic kidney disease was studied. A retrospective analysis was conducted at a 478-bed community hospital. A medical informatics search was performed to identify all hospitalized patients who were prescribed i.v. iron sucrose to deliver elemental iron 300 mg every other day for three doses between January and December 2002. Patients were eligible for inclusion in the analysis if they had chronic kidney disease, had an estimated creatinine clearance of <60 mL/min, and were prescribed the above regimen. Information on iron administration, vital signs, hematologic values, and iron indexes was gathered from patients' medical records. Medical record review was also used to identify possible adverse events. A total of 73 patients met eligibility criteria and received a total of 167 doses of iron sucrose. Twenty adverse events were judged as possibly related to iron sucrose administration and included nausea (n = 8 events), reduced blood pressure (n = 4), vomiting (n = 2), dysgeusia (n = 2), constipation (n = 2), fatigue (n = 1), and anxiety (n = 1). The majority of these adverse events were low in severity, as determined by an objective scale. No severe adverse events occurred. There was no association between infusion rate and the occurrence of potential adverse events (p = 0.44). Every-other-day i.v. infusion of iron sucrose, to deliver elemental iron 300 mg/dose, was associated with adverse events that were relatively uncommon, minor in severity, and unlikely to require medical intervention.