Evaluation of the sucrosomial iron efficacy in the patient treatment with stage 1–2 iron deficiency anemia during heavy menstrual bleeding

Abstract

I.N. Kononova1,2, Yu.E. Dobrokhotova1, E.N. Kareva1,3, N.A. Shmakova4, I.V. Graban5, T.A. Ogurtsova6 1Pirogov Russian National Research Medical University, Moscow, Russian Federation 2Transregional Center for Continuing Professional Education LLC, Moscow, Russian Federation 3I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russian Federation 4Medical Center "Angio Line plus" LLC, Yekaterinburg, Russian Federation 5Medical Center "Edelweiss", Yekaterinburg, Russian Federation 6Yekaterinburg Clinical Perinatal Center, Yekaterinburg, Russian Federation Aim: to evaluate the clinical efficacy of Sucrosomial® iron (SiderAL® Forte) in the treatment of stage 1–2 iron deficiency anemia (IDA) in patients with menorrhagia in the setting of ovulation disorders. Patients and Methods: a prospective randomized multicenter clinical case study of 110 patients with stage 1–2 IDA developed in the setting of menorrhagia as a result of ovulation disorders was conducted. Female patients of the main group (n=74) received Sucrosomial® iron 30 mg 2 times a day for 60 days. In the control group (n=36), a liposomal iron preparation of 30 mg 2 times a day was also prescribed for 60 days. Results: during Sucrosomial® iron ferrotherapy, an increase in Hb levels by more than 20 g/L was observed after 30 days of administration in 65 (87%) female patients, after 60 days in 73 (98.6%) female patients, which demonstrated higher therapeutic efficacy versus liposomal iron preparation (69.4 and 88.8%, respectively, p=0.0001). There was also a greater adherence to therapy (98.6%) during Sucrosomial® iron intake versus liposomal iron intake (86.1%, p=0.0001), due to fewer (1.4%) adverse events compared with the control group (5.5%, p=0.0002). Conclusion: oral ferrotherapy with Sucrosomial® iron is a reasonable option for the IDA treatment in patients with menorrhagia due to its higher efficacy versus the liposomal iron. The effect occurs after 30 days of drug intake with a minimum number of adverse events, due to the unique structural, physico-chemical and pharmacokinetic characteristics of the sucrosomial iron, thanks to which it is protected from the gastric juice action, does not contact with the gastrointestinal mucosa and is absorbed through special intestinal M-cells with further iron release in liver cells. Keywords: iron deficiency anemia, menorrhagia, ovulation disorders, Sucrosomial® iron, women, therapy. For citation: Kononova I.N., Dobrokhotova Yu.E., Kareva E.N., Shmakova N.A., Graban I.V., Ogurtsova T.A. Evaluation of the sucrosomial iron efficacy in the patient treatment with stage 1–2 iron deficiency anemia during heavy menstrual bleeding. Russian Journal of Woman and Child Health. 2023;6(4):332–339 (in Russ.). DOI: 10.32364/2618-8430-2023-6-4-2.