Effect of Ferric Sodium EDTA administration, in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine, on cardiovascular risk evaluation: exploration of the HRV frequency domain

Abstract

diseases. Using the Heart Rate Variability (HRV) analysis is possible to provide an evaluation of the safety and the effectiveness of intervention. Objective: To evaluate the efficacy and safety of Ferric Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel forte®) 2 tabs/day for 24 days in elderly patients with secondary anaemia, by exploring the HRV frequency domain. Methods: In 45 elderly patients with secondary anaemia and/or low-moderate kidney failure, laboratory values after administration of Ferric Sodium EDTA, 2 tabs a day, in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel forte®) for 24 days (N=16 patients) or ferrous gluconate 63 mg/day added to saline solution, administered using intravenous access during the hospitalization period of 15 ± 5 days (N=29 patients) were evaluated. Also, ECG signals and bioelectrical impedance (BIA) were measured. Results: Oral iron supplementation with Ferric Sodium EDTA, in combination with vitamin C, folic acid, copper gluconate, zinc gluconate and selenomethionine (Ferachel forte®) confirmed to be effective and safe about the cardiovascular risk in old patients. This study showed the real superiority of the oral administration about the cardiovascular risk in elderly patients in comparison with intravenous administration of ferrous gluconate. Conclusion: This study confirms that Ferric Sodium EDTA combination (Ferachel forte®) can be a valid alternative to ferrous gluconate intravenous therapy (gold standard) in the treatment of secondary anaemia in elderly patients. In fact, during the treatment, efficacy results have been maintained without statistically significant variations about cardiovascular risk, evaluated by exploring the HRV frequency domain