Journal of Clinical & Experimental Pharmacology

Abstract

Management of Iron Deficiency Anemia with Fixed Dose Combination of Ferrous Gluconate, Multivitamins and Multi-mineral Capsule: A 12 Week, Open Label Single Arm Prospective, Non-Interventional (Observational) Study in Philippines

Christopher Joseph L. Soriano, V Abalos, CM Romero, R. Manalastas, G Villanueva, Poonam Sule*, Roger D Gibb, Sue Aspley and NS Comia

Aim: The study evaluated the efficacy and safety of an Iron+multivitamin and multi mineral capsule (SB+) capsule in subjects with mild to moderate Iron Deficiency Anemia (IDA).

Methods: This was a Phase IV/post-marketing, open label, single arm, prospective, non-interventional study to evaluate the SB+ capsule’s performance in real life scenario. The study enrolled 97 female subjects aged ≥ 15 years to ≤ 55 years (mean ± SD age: 34.9 ± 10.24 years) with mild to moderate IDA. The primary efficacy outcome was mean Hemoglobin (Hb) concentration after administering an SB+ capsule orally for up to 90 days. 66 subjects received 30 mg elemental iron once a day and 31 subjects received 60 mg elemental iron twice a day at baseline depending on their anemia status. The secondary efficacy outcomes were change in Hb concentration at days 14, 30, and 60; ferritin concentration at day 90; assessment of Quality of Life (QoL) with the EQ-5D-5L questionnaire and IDA symptoms; and safety outcomes. Statistical analysis was performed with SAS version 9.4.

Results: Of 97 subjects enrolled, 32 (33%) subjects had mild IDA and 64 (66%) had moderate IDA. One subject (1%) had no IDA at baseline. A total of 83 subjects completed the study. The mean Hb value was significantly increased at day 90 when compared to baseline visit for all subjects (12.6 g/dL vs. 10.1 g/dL, P<0.0001), mild IDA subjects (12.5 g/dL vs. 11.5 g/dL, P<0.0001) and moderate IDA subjects (12.6 g/dL vs. 9.4 g/dL, P<0.0001). The mean Hb value was significantly increased at day 30 (P=0.0054) and 60 (P=0.0002) for mild IDA subjects and at day 14, 30 and 60 (P<0.0001) for moderate IDA subjects. The median ferritin value was significantly elevated from 7.8 ng/mL to 28.8 ng/mL at day 90 (P<0.0001). The data also demonstrated significant improvements in QoL and IDA symptoms. Safety analysis revealed that the SB+ capsule was well-tolerated. The limitation of the current study is its single arm design.

Conclusion: SB+ capsule (containing Iron equivalent to 30 mg) is effective in treating mild to moderate IDA. Importantly, the safety analysis revealed that the SB+ capsule was well-tolerated by the subjects for the entire 90 days duration of the study.

Published Date: 2023-11-10; Received Date: 2023-10-11