Ferric carboxymaltose in the management of iron deficiency anemia in women and men: sub-group analysis of a multi-center real-world study from India

Pushpa Jaiswal; Preeti Gupta; Bharati Hiremath; Gayathree V. Nirgund; R. Lalitha; Ketan Kulkarni; Rutuja Tope; Prashant Katke; Sachin Suryawanshi

doi:10.18203/2320-1770.ijrcog20243164

Authors

Pushpa Jaiswal Department of Obstetrics & Gynecology, Shriram Memorial Hospital, Lucknow, Uttar Pradesh, India
Preeti Gupta Department of Obstetrics & Gynecology, First Step IVF, Vikaspuri, Delhi, India
Bharati Hiremath Department of Obstetrics & Gynecology, Hiremath Hospital, Pune, Maharashtra, India
Gayathree V. Nirgund Department of Obstetrics & Gynecology, Gayathree Medical Centre, Theni, Tamil Nadu, India
R. Lalitha Department of Obstetrics & Gynecology, Sri Ramakrishna Hospital, Coimabatore, Tamil Nadu, India
Ketan Kulkarni Department of Medical Services, Emcure Pharmaceuticals Ltd., Pune, Maharashtra, India
Rutuja Tope Department of Medical Services, Emcure Pharmaceuticals Ltd., Pune, Maharashtra, India
Prashant Katke Department of Medical Services, Emcure Pharmaceuticals Ltd., Pune, Maharashtra, India
Sachin Suryawanshi Department of Medical Services, Emcure Pharmaceuticals Ltd., Pune, Maharashtra, India

DOI:

https://doi.org/10.18203/2320-1770.ijrcog20243164

Keywords:

Anemia, Efficacy, Ferric carboxymaltose, India, Iron deficiency, Real-world, Safety

Abstract

Background: Ferric carboxymaltose (FCM) is commonly used to treat moderate to severe anemia in India. However, real-world data on its use in the treatment of iron anemia of unspecified etiology is lacking.

Methods: The real-world PROMISE study assessed the efficacy and safety of intravenous FCM in adolescents and adults with IDA across 269 centers in India. This sub-group included non-pregnant women and men with a diagnosis of anemia. Data was analysed by the study population and by severity of anemia.

Results: In 555 anemia patients, there was a significant increase in Hb by 2.71 g/dl, serum ferritin by 58.6 µg/l, hematocrit, mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH) (p<0.001 for all) at 4 weeks.

In severe anemia patients (n=222), there was significant increase in Hb by 3.18 g/dL, serum ferritin by 55.7 µg/l, RBC count, hematocrit, MCV and MCH (p<0.001 for all) at 4 weeks. In moderate anemia patients (n=294), there was a significant increase in Hb by 2.37 g/dl and serum ferritin by 62.37µg/L (p<0.001 for both); MCV (p<0.001) and MCH (p=0.003). Only two subjects had mild anemia. No serious adverse events (SAEs) were reported. The physicians rated efficacy and safety of FCM as very good to good in 94.7% and 94.8% of subjects, respectively.

Conclusions: The improvement in the hematological parameters and physicians’ clinical impression highlights that FCM can be effectively and safely used in daily clinical practice to quickly correct anemia of unknown etiology in Indian population in short span of 4 weeks.

Metrics

Metrics Loading ...

References

Moriarty-Craige SE, Ramakrishnan U, Neufeld L, Rivera J, Martorell R. Multivitamin-mineral supplementation is not as efficacious as is iron supplementation in improving hemoglobin concentrations in nonpregnant anemic women living in Mexico. Ame J Clin Nutrit. 2004;80(5):1308-11.

Gardner W, Kassebaum N. Global, regional, and national prevalence of anemia and its causes in 204 countries and territories, 1990–2019. Curr Developm Nutrit. 2020;4:nzaa053_035.

Shukla A. NFHS 2019-21: Anemia rising across all age-groups, fertility rate falls below replacement rate for first time, 2021. Available at: https://www.cnbctv18.com/healthcare/national-family-health-survey-points-to-rising-anemia-lower-fertility-rate-11586522.htm. Accessed 01 June 2024.

Ministry of Health and Family Welfare, Government of India. Anemia Mukt Bharat: Intensified National Iron Plus Initiative (I-NIPI): Operational Guidelines for Programme Managers, 2018. Available at: https://www.fitterfly.com/site/pdf/anemia-mukt-bharat.pdf. Accessed 01 June 2024.

Bora K. Temporal trends and differential patterns in the prevalence of severe anaemia in India: observations from country-wide haemoglobin determinations 2008-2018. Trop Med Int Heal. 2019;24(7):829-38.

Ratre BK, Patel NP, Patel U, Jain R, Sharma VK. Clinical and Epidemiological profile of Anemia in central India. Int J Medi Res Revi. 2014;2(1):45-52.

Tefferi A. Anemia in adults: a contemporary approach to diagnosis. Mayo Clin Proceed. 2003;78(10):1274-80.

Kanuri G, Chichula D, Sawhney R, Kuriakose K, De’Souza S, Pais F, et al. Optimizing diagnostic biomarkers of iron deficiency anemia in community-dwelling Indian women and preschool children. Haematologica. 2018;103(12):1991-6.

Chatterjee P. A study of prevalence of anemia along with its diagnosis and treatment. Hematol Transfus Inter J. 2018;6(2):84-7.

Allen LH, Rosado JL, Casterline JE, López P, Muñoz E, Garcia OP, et al. Lack of hemoglobin response to iron supplementation in anemic Mexican preschoolers with multiple micronutrient deficiencies. Ame J Clin Nutrit 2000;71(6):1485-94.

Neogi SB, Sharma J, Pandey S, Zaidi N, Bhattacharya M, Kar R, et al. Diagnostic accuracy of point-of-care devices for detection of anemia in community settings in India. BMC Health Serv Res. 2020;20:468.

Gupte SA, Venkataraman G, Shah AS, Mudholkar AS, Jangam SM. Clinical effects and safety of ferric carboxymaltose in pregnancy: An Indian real-life experience. J Obstetr Gynaecol Res. 2021;47(10):3464-70.

Muñoz M, Martín-Montañez E. Ferric carboxymaltose for the treatment of iron-deficiency anemia. [corrected]. Expert Opin Pharmacother. 2012;13(6):907-21.

Kaur R, Kant S, Haldar P, Ahamed F, Singh A, Dwarakanathan V, et al. Single dose of intravenous ferric carboxymaltose prevents anemia for 6 months among moderately or severely anemic postpartum women: a case study from India. Curr Developm Nutrit. 2021;5(7):nzab078.

Mishra V, Verneker R, Gandhi K, Choudhary S, Lamba S. Iron deficiency anemia with menorrhagia: ferric carboxymaltose a safer alternative to blood transfusion. J Midlife Health. 2018;9(2):92-6.

Wani S, Noushad M, Ashiq S. REGAIN study: retrospective study to assess the effectiveness, tolerability, and safety of ferric carboxymaltose in the management of iron deficiency anemia in pregnant women. Anemia. 2019;2019(1):4640635.

Jones JJ, Mundy LM, Blackman N, Shwarz M. Ferric carboxymaltose for anemic perioperative populations: a systematic literature review of randomized controlled trials. JBM. 2021;12:337-59.

Qian C, Kwong WJ. Real world outcomes of ferric carboxymaltose and ferumoxytol iron replacement therapy: a retrospective analysis of electronic health records. Blood. 2017;130:2087.

Charmila A, Natarajan S, Chitra TV, Pawar N, Kinjawadekar S, Firke Y, et al. Efficacy and safety of ferric carboxymaltose in the management of iron deficiency anemia: a multi-center real-world study from India. JBM. 2022;13:303-13.

World Health Organization. WHO: Haemoglobin concentrations for the diagnosis of anaemia and assessment of severity. Vitamin and Mineral Nutrition Information System, 2011. Available at: https://apps.who.int/iris/bitstream/handle/10665/85839/WHO_NMH_NHD_MNM_11.1_eng.pdf. Accessed 01 June 2024.

Kundrapu S, Noguez J. Chapter Six - Laboratory Assessment of Anemia. In: Makowski GS, editor. Advances in Clinical Chemistry. Elsevier; 2018:197-225.

Mohapatra D, Bhatia V, Parida SP. Diagnostic dilemma in catching anaemia early. Ind J Commu Fami Medi. 2018;4(1):69-74.

Didzun O, Neve J-WD, Awasthi A, Dubey M, Theilmann M, Bärnighausen T, et al. Anaemia among men in India: a nationally representative cross-sectional study. Lancet Global Health. 2019;7(12):e1685-94.

DeLoughery TG. Microcytic anemia. N Engl J Med. 2014;371(14):1324-31.

Thomas DW, Hinchliffe RF, Briggs C, Macdougall IC, Littlewood T, Cavill I. Guideline for the laboratory diagnosis of functional iron deficiency. Brit J Haematol. 2013;161(5):1.

DeMaeyer EM, Dallman P, Gurney JM, Hallberg L, Sood SK, Srikantia SG, World Health Organization. Preventing and controlling iron deficiency anaemia through primary health care: a guide for health administrators and programme managers. World Health Organization; 1989. Available at: https://apps.who.int/iris/handle/10665/39849. Accessed 01 June 2024.

Guyatt GH, Oxman AD, Ali M, Willan A, McIlroy W, Patterson C. Laboratory diagnosis of iron-deficiency anemia. J Gen Intern Med. 1992;7:145-53.

Alleyne M, Horne MK, Miller JL. Individualized treatment for iron deficiency anemia in adults. Am J Med. 2008;121(11):943-8.

Pfeiffer CM, Looker AC. Laboratory methodologies for indicators of iron status: strengths, limitations, and analytical challenges. Am J Clin Nutrit. 2017;106:1606S-14S.

Alvarez-Uria G, Naik PK, Midde M, Yalla PS, Pakam R. Prevalence and severity of anaemia stratified by age and gender in rural India. Anemia 2014;2014(1):e176182.