Abstract

Objective. To evaluate safety and efficacy of intravenous ferric carboxymaltose (FCM) versus standard medical care (SMC) for iron-deficiency anemia (IDA) in postpartum women and women with heavy menstrual bleeding. Study Design. This open-label, multicenter study randomized women with IDA (hemoglobin ≤ 11.0 g/dL) to single doses of FCM (15 mg/kg [maximum 1000 mg]) or SMC (this treatment was determined by the investigator and there may have been no treatment). Safety data (primary outcome) were collected for 30 days. Results. Of 2045 subjects enrolled (FCM: n = 1023; SMC: n = 1022), 996 received FCM and 1022 received SMC. At least 1 serious adverse event (AE) was reported by 0.6% and 2.2% of subjects in the FCM and SMC groups, respectively; none were considered treatment related. The difference in serious AEs was primarily due to higher rates of uterine leiomyoma, uterine hemorrhage, and menorrhagia in SMC subjects with heavy menstrual bleeding. Common AEs were generally predictable, with higher rates of infusion site reactions in FCM subjects and gastrointestinal AEs in SMC subjects. Mean hemoglobin increases were greater in the FCM group than the SMC group. Conclusion. FCM was well tolerated and effectively increased mean hemoglobin levels in postpartum women or women with heavy menstrual bleeding and IDA. This trial is registered with ClinicalTrials.gov, NCT00548860.

Highlights

  • Iron deficiency is the most common cause of anemia [1, 2]

  • More than 80% of subjects in both treatment groups completed the study through day 30, including 860 (84.1%) in the ferric carboxymaltose (FCM) group and 847 (82.9%) in the standard medical care (SMC) group

  • Similar to 4 previous randomized, controlled trials of FCM [15,16,17,18], this large, open-label, randomized study supports that a single 15 mg/kg dose of IV FCM was safe and well tolerated for the treatment of subjects with Iron-deficiency anemia (IDA) in the postpartum period and subjects with IDA caused by heavy menstrual bleeding

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Summary

Introduction

Iron deficiency is the most common cause of anemia [1, 2]. Women who are of reproductive age are at risk owing to blood loss or increased iron demand attributed to menstruation, pregnancy, and lactation [3, 4]. Iron-deficiency anemia (IDA) is associated with adverse effects on cognitive function, physical activity, immune response, and pregnancy outcome. Postpartum anemia reportedly affects up to 27% of women, and approximately 20% of women suffer excessive menstrual blood loss [3, 6]. IDA associated with childbirth or heavy menstrual bleeding can be potentially reversed with iron repletion therapy [7]. Iron therapy for IDA has been shown to reduce morbidity by improving physical activity and reducing fatigue and cognitive deficits [3, 4, 7]

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