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Randomized controlled trial comparing ferric carboxymaltose and iron sucrose for treatment of iron deficiency anemia due to abnormal uterine bleeding
Author(s) -
Mahey Reeta,
Kriplani Alka,
Mogili Krishna D.,
Bhatla Neerja,
Kachhawa Garima,
Saxena Renu
Publication year - 2016
Publication title -
international journal of gynecology and obstetrics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.895
H-Index - 97
eISSN - 1879-3479
pISSN - 0020-7292
DOI - 10.1016/j.ijgo.2015.09.007
Subject(s) - medicine , hemoglobin , anemia , randomized controlled trial , iron sucrose , adverse effect , iron deficiency anemia , iron deficiency , gastroenterology , surgery , intravenous iron
Objective To evaluate the efficacy and safety of intravenous ferric carboxymaltose (FCM) in comparison with intravenous iron sucrose (ISC) in the treatment of anemia due to abnormal uterine bleeding (AUB). Methods A randomized controlled trial was conducted between April 2013 and May 2014 in patients older than 18 years of age presenting at a hospital in New Delhi, India, with anemia due to AUB. Patients were randomized in a 1:1 ratio to receive treatment with intravenous FCM or ISC. The primary outcome, increase in hemoglobin above baseline, was monitored over a 12‐week period. Patients completing the full treatment and follow‐up protocol were included in the analyses. Participants and investigators were not masked to treatment allocations. Results Overall, 30 patients were assigned to each group. Increases in mean hemoglobin levels from baseline were significantly higher in the FCM group at 6 weeks ( P = 0.005). At 12 weeks, there was no significant difference in hemoglobin increase from baseline between the two groups ( P = 0.11). Adverse events were similar between both treatment groups. Conclusion Treatment with FCM resulted in a rapid increase in hemoglobin levels in patients with anemia due to AUB, with similar increases in hemoglobin over a 12‐week period. Clinical Trial Registration ( www.ctri.nic.in ): CTRI/2015/09/006224