Raleigh, NC (PressExposure) November 03, 2011 -- Dr. Charles F. Barish, gastroenterologist at Wake Gastroenterology in Raleigh, made a poster presentation at the American College of Gastroenterology's 76th annual meeting in Washington, D.C. on October 30, 2011. The six-day annual meeting features lectures and discussions about advances in gastrointestinal research, digestive disease treatments, and practice management.
Dr. Barish's presentation was titled Safety and Efficacy of Intravenous Ferric Carboxymaltose vs. Standard Medical Care in the Treatment of Iron Deficiency Anemia. Iron deficiency anemia (IDA) is a common hematological complication with potentially serious clinical consequences that may require intravenous iron therapy. This study looked at the use of Ferric carboxymaltose (FCM) as treatment for IDA. FCM is a stable, non-dextran iron formulation that can be administered intravenously in large single doses. The FCM complex is more physiologic and has less risk for side effects and allergic reactions than the currently available intravenous iron preparations. FCM also appears to be more stable than some of the currently used intravenous iron preparations and has a slow and controlled delivery of iron into target tissues. As a result, rapid infusion of up to 1000 mg of FCM over 15 minutes has been shown to be effective and well tolerated. Standard IV iron formulations currently available in the United States differ in that they must be given as lower doses over multiple visits due to instability of the drug. Another concern with the currently available agents is anaphylactic reactions due to dextran-containing iron formulations. FCM has been registered by the public health authorities in Europe since 2007 and is used to treat iron deficiency in over 35 countries; it is in clinical development in the United States.
The study that was completed looked at intravenous FCM compared to standard medical care (SMC) with currently available oral or intravenous iron in the treatment of IDA. The results showed that both FCM and SMC replenished iron, but the mean increases of most iron indices were significantly higher for FCM than for most IV or oral iron comparators.
Adverse events were similar in the FCM and SMC groups and most were mild. It was found that a single dose of 750 mg of FCM can be administered at a rate of 100 mg per minute, thereby permitting use of FCM on an outpatient basis and reducing clinic visits and venipunctures. Clinically, target hemoglobin levels may be achieved more rapidly than when using multiple small doses. Reduced frequency of infusions will reduce health care visits, reduce the risk of infection, and preserve vein integrity. A further potential clinical benefit of high dose intravenous iron is to overcome the inhibition of gastrointestinal iron absorption induced by hepcidin in patients with anemia of chronic disease or other inflammatory conditions. The comprehensive study results have been submitted to medical journals for publication.