RESUMO
Background: Real-world evidence of the efficacy and safety of ferric carboxymaltose (FCM) infusion in Indian pregnant women with iron deficiency anemia (IDA) is lacking. Objective: To assess the efficacy and safety of intravenous (IV) FCM in Indian pregnant women with IDA in 4 weeks in a real-life scenario. Methods: This is a subgroup analysis of our previously conducted retrospective, multicenter, observational, real-world PROMISE study. Data on demographic and hematological parameters, patient-reported adverse events, and physicians' clinical impressions of efficacy and safety were analysed at 4 ± 1 week. Results: This subgroup analysis included 1191 pregnant women in whom IV FCM resulted in a significant increase in hemoglobin (Hb) by 2.8 g/dL and serum ferritin by 30.03 µg/L at 4 weeks (P < 0.001 for both). In 103 pregnant women with severe IDA, there was a significant increase in Hb by 3.6 g/dL (P < 0.001), and serum ferritin by 16.96 µg/L (P=0.12). In 978 pregnant women with moderate IDA, significant improvement in Hb by 2.74 g/dL and serum ferritin by 33 µg/L (P < 0.001 for both) was noted. Similarly, there was a significant increase in red blood cell count, hematocrit, mean corpuscular volume, and mean corpuscular hemoglobin (P < 0.001 for all). In pregnant women with mild IDA (n = 26), Hb increased significantly by 1.99 g/dL (P < 0.001). Adverse effects were reported in 8.6% of pregnant women. No new safety signals or serious adverse effects were observed. Based on physicians' global assessment, good to very good efficacy and safety of IV FCM was noted in 99.2% and 98.6% of pregnant women, respectively. Conclusions: IV FCM rapidly corrected anemia in a short period of 4 weeks with favorable safety in the second and third trimester of pregnancy with all severities of IDA (severe, moderate, and mild). The physicians' favorable global assessment of FCM's efficacy and safety in pregnant women with IDA supports its use in daily clinical practice. This trial is registered with CTRI/2021/12/039065.
RESUMO
Myo-Inositol and D-chiro-inositol (MI-DCI) are used in the treatment of polycystic Ovary syndrome (PCOS) due to their insulin-sensitizing actions. Therefore, it is of interest to evaluate the treatment patterns, clinical effectiveness and safety of MI-DCI combination in anagement of PCOS in Indian women. Data from 50 healthcare centers across India was collected between September 2019 and February 2020 and was used in the study. Women aged 12-45 years diagnosed with PCOS, who had received MI-DCI (550-150 mg) were included. The outcome parameters were change in weight, luteinizing hormone (LH)/follicle stimulating hormone (FSH) ratio, hirsutism, blood glucose and insulin levels, HOMA-IR, and lipid profile. A total of 283 women were included (mean age: 27.74 years; body mass index: 26.89 kg/m2); of which 197 (69.61%) reported reduction in weight after treatment with MI-DCI. The hirsutism scores considerably improved after treatment and the proportion of patients with, no hirsutism increased from 31.07% to 50.51% and moderate hirsutism reduced from 32.52% to 6.12% while, there were no patients with severe hirsutism after the treatment. There was a significant reduction in LH:FSH ratio (mean difference: 0.25 mg/dL; p=0.021), free testosterone (mean difference: 1.49; p<0.001) and dehydroepiandrosterone (mean difference: 21.49; P<0.001) levels after regular use of MI-DCI tablets. Treatment with MI-DCI resulted in significant improvement in insulin levels, HOMA-IR score, Fasting plasma glucose (FPG), post-prandial plasma glucose (PPG) and lipid profile. The therapy restored menstruation and spontaneous ovulation and significantly attenuated the LH/FSH ratio. Thus, MI-DCI (550-150 mg) has shown multidimensional benefits in improving the hormonal, glycemic, and lipid profile of women with PCOS with considerable efficacy and tolerability.
