EFFECTIVENESS OF INTRAVENOUS ADMINISTRATION OF FE-GLUCONATE-NA COMPLEX TO MAINTAIN ADEQUATE BODY IRON STORES IN HEMODIALYSIS-PATIENTS

The evolution of body iron stores was prospectively analyzed during a stable erythropoiesis period in 27 subjects (14 males and 13 females) on hemodialysis for more than 2 years in order to clarify the iron req uirements of these patients and the effectiveness and safety of the ad ministration of sodium ferric gluconate as a method to maintain adequa te body iron stores. All patients had a stable hemoglobin level (varia tion <1 g/dl). Sixteen subjects were on maintenance recombinant human erythropoietin therapy at regular doses. All patients received intrave nous sodium ferric gluconate for 6 months (62.5 mg/month). The iron re quirements were estimated as the difference between the amount of iron administered and the variation of body iron stores (calculated by the empirical formula of Cook and coworkers). The hemoglobin remained sta ble (basal 10.7 +/- 1.1, at 6th month 10.6 +/- 1 g/dl). Considering al l cases, there were no significant variations in body iron stores (bas al 457 +/- 273, at 6th month 451 +/- 316 mg). The patients were classi fied into three groups according to whether their body iron stores dec reased (group A, n = 8), remained stable (group B, n = 11), or increas ed (group C, n = 8). There were no differences among groups concerning sex, age, time on hemodialysis, or erythropoietin therapy. However, t here were statistically significant differences concerning their basal body iron stores (group A 457 +/- 228 mg, group B 593 +/- 146, and gr oup C 230 +/- 297 mg; p < 0.05, analysis of variance). The iron needs, considering the total group, were 2.12 +/- 2 mg/day. There were no di fferences in iron requirements according to sex, but menstruating wome n had higher iron needs than the nonmenstruating ones (4.29 +/- 2 vs. 2.08 +/- 1.45 mg/day; p < 0.01). The iron requirements in patients on erythropoietin therapy were higher than in those without (2.63 +/- 1.5 9 vs. 1.88 +/- 1.68 mg/ day; p < 0.05). However, excluding the menstru ating women, the iron needs in patients on erythropoietin were similar to those in subjects without this treatment (2.16 +/- 1.13 vs. 1.88 /- 1.68 mg/day). All patients showed good compliance with an excellent tolerance. We have observed that in subjects on maintenance erythropo ietin therapy, the iron requirements are stable. The administration of sodium ferric gluconate is safe and efficient in maintaining adequate body iron stores.