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Abstract
Effectiveness of Ferrous Gluconate Plus Multivitamins and Minerals by Iron Deficiency Anemia Status, Menstrual Blood Flow and Pregnancy Status: A Subgroup Analysis of the SANOIN Study
NS Comia, Christopher Joseph L Soriano, Roger Gibb, Poonam Sule and James Wun Chiang Sia*
Background: The Phase IV, open-label, single arm, prospective, non-interventional SANOIN study demonstrated that an oral fixed dose combination of ferrous gluconate, multivitamins and minerals (Sangobion® IRON+) was effective and well-tolerated in treating mild to moderate Iron Deficiency Anemia (IDA) in women aged 15-55 years.
Methods: We present a subgroup analysis of the SANOIN Hemoglobin (Hb) and serum ferritin data over the 90-day treatment period based on menstrual flow (normal vs. heavy vs. very heavy) and pregnancy status (pregnant vs. non- pregnant). The frequency and severity of IDA symptoms at baseline and improvement at Days 30, 60 and 90 were assessed in these subgroups, and by IDA status (mild vs. moderate).
Results: Within the intent-to-treat population (n=87), 78 subjects were evaluated according to menstrual flow (normal, 44.9%; heavy, 47.4%; very heavy, 7.7%). Eight out of 87 subjects were pregnant. All subgroups demonstrated similar Hb normalization and increase in ferritin levels after 90 days. Overall, 72.4% of the subjects were anemia-free by Day 90. The most frequently occurring IDA symptoms at baseline were headache, dizziness and fatigue in most subgroups, while tachycardia and shortness of breath were frequent in the small pregnant subgroup. IDA symptoms significantly improved by Day 90 across all subgroups.
Conclusion: This subgroup analysis demonstrated the broad efficacy of an oral fixed dose combination of ferrous gluconate, multivitamins and minerals in providing rapid and sustainable improvement in IDA symptoms, Hb and ferritin levels in the diverse range of baseline IDA status, menstrual flow, and pregnancy status.
Published Date: 2024-08-26; Received Date: 2024-07-26