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Comparative Review of the Safety and Efficacy of Ferric Carboxymaltose Versus Standard Medical Care for the Treatment of Iron Deficiency Anemia in Bariatric and Gastric Surgery Patients

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Abstract

Background

Iron deficiency anemia (IDA) is a common finding in patients after bariatric surgery. The cause is multifactorial including reduced oral iron intake and malabsorption. While many patients can be managed with oral supplements, parenteral iron may be needed to restore and maintain iron stores.

Methods

Subjects who had previous bariatric surgery and had participated in phase 3 industry-sponsored clinical trials designed to assess the safety and/or efficacy of intravenous (IV) ferric carboxymaltose (FCM) were retrospectively selected from the databases of each of these studies. Demographic data, efficacy measures [hemoglobin, ferritin, and transferrin saturation (TSAT)], and adverse events were compared between FCM and other agents utilized as comparators in the trials.

Results

Two hundred eighty-one subjects from the intention to treat (ITT) population were included (mean age 49 years, BMI 33 kg/m2, including 253 females). FCM had similar or improved efficacy (p < 0.05) in terms of increasing hemoglobin, ferritin, and TSAT values when compared to other iron products used as standard of care for IDA. The incidence of adverse events in the FCM patients (n = 123) versus patients receiving any IV iron (n = 126) was 61 and 56.3 %, respectively. The adverse events were similar in both groups with the exception of a transient decrease in serum phosphate which was observed more frequently in the FCM group.

Conclusions

These data in post-bariatric surgery IDA patients suggest that FCM is a safe and effective alternative to existing iron products permitting higher and thus less frequent individual doses.

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Conflict of Interest

Margaret Malone declares no conflict of interest; Charles Barish has received grant from Wake Research Associates and is a consultant for Luitpold Pharmaceuticals, Inc; Andy He is a post-doctoral fellow sponsored by St John’s University and Luitpold Pharmaceuticals, Inc.; and David Bregman is an employee of Luitpold Pharmaceuticals, Inc.

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Authors and Affiliations

  1. Department of Pharmacy Practice, Albany College of Pharmacy and Health Sciences, 106 New Scotland Ave., Albany, NY, 12208, USA

    Margaret Malone

  2. Wake Gastroenterology and Wake Research Associates, Raleigh, NC, USA

    Charles Barish

  3. Luitpold Pharmaceuticals, Inc., 800 Adams Ave, Suite 100, Norristown, PA, USA

    Andy He & David Bregman

  4. Department of Pathology, Albert Einstein College of Medicine, 1300 Morris Park Ave, Bronx, NY, 10461, USA

    David Bregman

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  1. Margaret Malone
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  2. Charles Barish
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  3. Andy He
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  4. David Bregman
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Corresponding author

Correspondence to Margaret Malone.

Additional information

Data were extracted from Luitpold Pharmaceuticals sponsored clinical trial database.

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Malone, M., Barish, C., He, A. et al. Comparative Review of the Safety and Efficacy of Ferric Carboxymaltose Versus Standard Medical Care for the Treatment of Iron Deficiency Anemia in Bariatric and Gastric Surgery Patients. OBES SURG 23, 1413–1420 (2013). https://doi.org/10.1007/s11695-013-0939-6

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  • DOI: https://doi.org/10.1007/s11695-013-0939-6

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