Journal of Clinical & Experimental Pharmacology

Abstract

Real-World Effectiveness of Livogen®Z an oral iron, folic acid, plus zinc fixed dose combination supplement in pregnant and non-pregnant women with Iron Deficiency Anaemia - Insights from a phase IV Observational study in India (LIBERTY)

Parag Biniwale, Lakshmi Swetha Karlapudi, Nimisha Pagare, Roger D Gibb, Sue Aspley and Poonam Sule*

Background: Iron Deficiency Anaemia (IDA) is a major health concern in India. Livogen®Z (manufactured by Procter and Gamble Health Ltd.) combines ferrous fumarate (152mg), folic acid (750mcg) and zinc sulphate (61.8mg) for management of anaemia, but real-world data from India is scarce.

Methods: A phase IV, prospective observational study was conducted at four sites in India in pregnant and non pregnant women with IDA aged 18-55 years. Subjects received Livogen®Z tablet twice daily for 90 days between June 2022 and October-2023. The primary objective was to evaluate the Change from Baseline (CFB) in Hemoglobin (Hb) after 90 days of treatment. CFB at Days 21 and 60, CFB in ferritin at end-of-study. IDA symptoms and Adverse Events (AE) were secondary endpoints.

Results: Of the 102 recruited subjects, data for 69 women were included (62.3% nonpregnant, 11.6% first trimester, 26.1% second trimester) in the final analysis after excluding data for 33 subjects at one site that was non-compliant with good clinical practices. At Day 90, the mean Hb CFB was 2.2 g/dL (p<0.0001). Mean Hb CFB was 1.1 g/ dL (p<0.0001) on Day 21 and 1.9 g/dL (p<0.0001) on Day 60. At Day 90, median ferritin CFB was 12.0 ng/mL (p<0.0001) and 29.5% of women were symptom-free vs. 2.9% at study start. The treatment was well tolerated with no AEs reported by 49.3% of subjects and no serious AEs reported.

Conclusion: Livogen®Z improves iron status, alleviates symptoms in women with IDA and is well-tolerated. Clinically significant improvements in Hb and ferritin levels with accompanying meaningful symptom benefits with relatively few AEs highlight Livogen®Z treatment as a favorable IDA management option.

The study was registered on the Clinical Trial Registry of India (CTRI) http://ctri.nic.in/Clinicaltrials/login.php (CTRI No. CTRI/2023/04/051785).

Published Date: 2025-05-21; Received Date: 2025-04-17