Anemia · 2025
Early Haematologic Response to Oral Iron Treatment in Adults With Moderate Iron-Deficiency Anaemia.
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Cacoub Patrice, Otieno Fredrick O, Trichereau Julie, Gobert Océane, Kerveillant Anne-Laure, Escola Julie, Verrière François
Аннотация
BACKGROUND: Identifying early response to oral iron supplementation in anaemic patients is key. This study aims to assess the onset-of-action of oral liquid solution of ferrous gluconate, copper and manganese gluconate in adults with moderate iron deficiency anaemia.
METHODS: This prospective, open-label study was conducted in France, Bulgaria and Kenya. All patients received 150 mg of oral ferrous gluconate/day for 12 weeks. Eleven blood samples were taken at Day 7 and at Days 0, 3, 5, 7, 10, 14, 21, 28, 56 and 84. The primary endpoint was to assess treatment duration required to observe a +0.5 g/dL haemoglobin (Hb) level increase.
RESULTS: Ninety-five moderately anaemic patients were included in the analysis. Hb increase ≥ 0.5 g/dL was observed within 9-10 days of treatment (0.51 g/dL at Day 10, 95% CI: 0.45-0.57 and p < 0.0001). Serum iron increased within the first 3 days (mean change from baseline: 67.21 ± 91.57 μg/dL). An improvement of quality of life (physical component mean change: 8.20 ± 7.34 and mental component: 6.72 ± 6.67) was reported after treatment. The safety profile was very good.
CONCLUSION: This study demonstrates for the first time the rapid onset-of-action of oral liquid solution of ferrous gluconate and confirms its good tolerability.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04309669.
METHODS: This prospective, open-label study was conducted in France, Bulgaria and Kenya. All patients received 150 mg of oral ferrous gluconate/day for 12 weeks. Eleven blood samples were taken at Day 7 and at Days 0, 3, 5, 7, 10, 14, 21, 28, 56 and 84. The primary endpoint was to assess treatment duration required to observe a +0.5 g/dL haemoglobin (Hb) level increase.
RESULTS: Ninety-five moderately anaemic patients were included in the analysis. Hb increase ≥ 0.5 g/dL was observed within 9-10 days of treatment (0.51 g/dL at Day 10, 95% CI: 0.45-0.57 and p < 0.0001). Serum iron increased within the first 3 days (mean change from baseline: 67.21 ± 91.57 μg/dL). An improvement of quality of life (physical component mean change: 8.20 ± 7.34 and mental component: 6.72 ± 6.67) was reported after treatment. The safety profile was very good.
CONCLUSION: This study demonstrates for the first time the rapid onset-of-action of oral liquid solution of ferrous gluconate and confirms its good tolerability.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04309669.