ferric-carboxymaltose and Menorrhagia

The intravenous formulation for supplementing iron currently available in Japan requires frequent administration. In contrast, ferric carboxymaltose (FCM) can improve iron-deficiency anemia (IDA) with only a small number of administrations; however, its efficacy and safety have not been established in Japanese patients. In this randomized, open-label study, we verified the noninferiority of FCM to saccharated ferric oxide (SFO) in Japanese patients with IDA due to hypermenorrhea, with the mean change from baseline to the highest observed hemoglobin level as the primary endpoint. Two hundred and thirty-eight eligible subjects (119 in FCM group, 119 in SFO group) were administered the investigational medicinal product and included in the analysis. The adjusted mean change from baseline to the highest observed hemoglobin level (95% CI) was 3.90 g/dL (3.77, 4.04) in the FCM group and 4.05 g/dL (3.92, 4.19) in the SFO group, and the difference between the groups (95% CI) was - 0.15 g/dL (- 0.35, 0.04). The noninferiority of FCM was verified. Incidence of adverse events was < 60% in both groups, and no significant difference was observed between the treatment groups. These results indicate that FCM can be a new, well-tolerated, and rapid treatment option for Japanese patients with IDA.

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hemoglobins; Humans; Japan; Maltose; Menorrhagia; Middle Aged; Treatment Outcome; Young Adult

To compare ferric carboxymaltose (FCM) with iron sucrose (IS) for the effective and timely treatment of preoperative iron deficiency anemia (IDA) in women with menorrhagia.. This open-label, multicenter, two-arm study randomized patients to receive either a single dose of FCM or multiple doses of IS. The primary endpoint was the proportion of patients who achieved hemoglobin (Hb) levels ≥10 g/dL within 2 weeks after the first administration. Secondary endpoints included mean Hb levels, time to reach Hb ≥10 g/dL and quality of life (QoL).. In total, 101 patients (FCM n = 52; IS n = 49) were randomized to the study treatments. FCM was as effective as IS in achieving Hb ≥10 g/dL within 2 weeks after the first administration (78.8% vs 72.3%). The time to reach Hb ≥10 g/dL was significantly shorter in the FCM group than in the IS group (7.7 days vs 10.5 days). Mean Hb levels were higher in the FCM-treated patients than in the IS-treated patients with borderline significance. QoL scores did not differ between the two groups.. Ferric carboxymaltose is as effective as IS in correcting preoperative IDA among patients with menorrhagia. The added benefits of FCM over IS included significant rapid correction of IDA, replenishment of iron stores and reduced hospital visits.

Topics: Adult; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferric Oxide, Saccharated; Hematinics; Hemoglobins; Humans; Maltose; Menorrhagia; Middle Aged; Outcome Assessment, Health Care; Young Adult

Intravenous (IV) administration of iron is considered a safe and efficacious treatment for iron deficiency anemia (IDA), recommended in patients requiring rapid replenishment of iron, or intolerant or unresponsive to oral administration of iron. Recent randomized controlled trials (RCTs) have shown high incidence of hypophosphatemia after administration of two IV iron preparations: saccharated ferric oxide (SFO) and ferric carboxymaltose (FCM). The present study aimed to conduct matching-adjusted indirect comparison (MAIC) of hypophosphatemia incidence with these iron formulations and ferric derisomaltose (FDI) based on data from head-to-head RCTs conducted in Japan.. A MAIC of hypophosphatemia incidence was conducted on the basis of data from two head-to-head RCTs. The relative odds of hypophosphatemia with FDI versus SFO were obtained from patient-level data from a recent RCT and adjusted for cumulative iron dose, while parametric models of serum phosphate levels from a separate RCT were used to estimate the relative odds of hypophosphatemia with FCM with SFO. An anchored MAIC was then conducted comparing FDI with FCM.. The adjusted odds of experiencing hypophosphatemia were significantly lower with FDI than SFO [odds ratio (OR) of 0.02; 95% confidence interval (CI) 0.01-0.05]. The parametric models of serum phosphate from the RCT comparing FCM with SFO provided an estimated OR of 1.17 for the incidence of hypophosphatemia with FCM versus SFO. Combining the two estimates in the MAIC showed that the odds of experiencing hypophosphatemia would be 52.5 (95% CI 27.7-99.4) times higher with FCM than FDI in patients with IDA associated with heavy menstrual bleeding in Japan.. Direct comparison of patient-level data and a MAIC from two RCTs in Japanese patients with heavy menstrual bleeding indicated that hypophosphatemia is less frequent in patients treated with FDI than those with FCM or SFO. Results are in agreement with RCTs comparing FDI and FCM in patients with various etiologies conducted in the USA and Europe.

Topics: Administration, Intravenous; Anemia, Iron-Deficiency; East Asian People; Female; Ferric Oxide, Saccharated; Humans; Hypophosphatemia; Incidence; Iron; Menorrhagia; Phosphates; Randomized Controlled Trials as Topic

Heavy menstrual bleeding (HMB) is the most common cause of iron deficiency anemia (IDA) in premenopausal women. Clinical studies have shown that iron carboxymaltose (ICM) is an appropriate, effective, and well-tolerated treatment option for clinical situations associated with iron deficiency (ID).. This study took 78 out of 400 consecutive patients diagnosed with IDA due to HMB and intolerant or insufficient response of oral iron. All patients were administered the total calculated dose of ICM separately, based on the body weight and current hemoglobin (Hb) level. All the anemia parameters of the patients were compared before and after treatment.. All anemia parameters, including median Hb, ferritin, and transferrin saturation, significantly increased four weeks after treatment. Pre- and post-treatment mean Hb levels were 8.9 (± 1.7) g/dL and 12.3 (± 1.2) g/dL, respectively. The mean ferritin level of the patients before treatment was 3.93 (± 2.7) ng/mL. After treatment, the mean ferritin level was 244 (± 185) ng/mL. The mean transferrin saturation levels before and after treatment were 5.7% (± 5.0) and 43.1% (± 20.9), respectively. Although no serious side effects were observed in all patients, headache was detected in 2 patients (2.6%), urticaria in 3 patients (3.8%), and flushing in 2 patients (2.6%).. ICM is an effective and safe treatment option for patients with IDA due to HMB, in which oral iron therapy is insufficient or intolerant. In fact, without waiting for the failure or intolerance of oral iron therapy, moving ICM to the frontline could be cost-effective and more convenient to patients with HMB and health care providers.

Topics: Anemia; Anemia, Iron-Deficiency; Female; Ferric Compounds; Ferritins; Hemoglobins; Humans; Iron; Maltose; Menorrhagia; Transferrins

Topics: Adult; Anemia, Iron-Deficiency; Chronic Disease; Diagnosis, Differential; Erythrocyte Indices; Female; Ferric Compounds; Ferritins; Hemoglobinometry; Humans; Infusions, Intravenous; Iron Deficiencies; Maltose; Menorrhagia; Transferrin