An Open Label, Single Arm Multi-Centric Study to Assess the Safety and Efficacy of Sodium Feredetate (Fedate Syrup) within 21 Days in Patients with Iron Deficiency Anemia in Ivory Coast

Abstract

Introduction: Iron deficiency anemia is a common disease prevalent mostly in developing countries Replenishing iron stores via oral route supplementation takes longer time, however for safety reasons it is considered as the most convenient route. There is always search of better oral iron supplement which can replenish the iron deficiency at short duration of time.

Objectives: A post-marketing surveillance study to assess the safety and efficacy of Fedate syrup (Sodium Feredetate) within 21 days in clinical practice.

Materials and Methods: A total 40 patients visiting 2 gynaecologists, who had a hemoglobin (Hb) level of < 10 gm/dl, and had a body mass index (BMI) of < 24 kg /m² were included in the study. All patients were prescribed either 10-15 ml Fedate syrup once or twice a day. Clinical effectiveness was assessed over a period of 21 days. Treatment response was recorded as responders or non-responders based on a minimum 1 gm/dl increase in Hb levels.

Results: A total of 33 patients (82.5%) responded to the treatment within 21 days as compared to 7 patients (17.5%) who did not respond to the treatment. There was significant difference in global efficacy and assessment of tolerability which was recorded on a scale of poor to excellent. The drug was tolerated well in all patients responding either as “good” or “excellent” to the treatment. Global efficacy was “poor” in 6 patients (15%) and “excellent” in 20 (50%). The paired student’s T-test score for increase in hemoglobin from baseline to 21^st day was 5.4995 (P<0.0001).

Conclusions: We conclude that Sodium Feredetate is an effective compound as Fedate syrup in improving the symptoms of anemia in majority of the patients.