title: Treatment of Iron Deficiency with or without Anaemia with Intravenous Ferric Carboxymaltose in Gynaecological Practices - A Non-Interventional Study.
abstract: In this multi-centre, prospective, non-interventional study, the effectiveness and tolerance of ferric carboxymaltose (ferinject®; FCM) was tested through use in standard gynaecological practice. In total, data from 273 patients was evaluated. 193 of these patients displayed iron deficiency anaemia (IDA), and 68 had iron deficiency without anaemia (ID). The reasons for the ID/IDA were hypermenorrhoea (HyM) (n = 170), post-partum condition (PP) (n = 53) or another indication (n = 53). The average age of the patients was 40 years old, with 8 % of them being vegetarians. Half of the patients had already been treated for anaemia, primarily with oral iron products (94 %). The primary, serious accompanying symptoms of anaemia were fatigue (72 %), lack of concentration (42 %), pale mucous membranes (42 %), headache (26 %) and sleep disorders (21 %). Only one patient did not show serious symptoms at the start of the study. The most frequent indications for parenteral therapy were the need for rapid iron substitution to reduce symptoms (> 70 %), followed by the lower effectiveness or intolerance of oral products (42 % each) as well as patients not completing the course of treatment with oral products (12 %). Patient information was collected at both the beginning and the end of the observation period, which lasted 15 weeks on average. FCM was most frequently administered via infusion (92 %; average infusion duration 21 minutes). Seven percent of patients received bolus injections. The average total iron dosage per patient was 788.7 mg (median 550 mg; range: 50-3000 mg); the median individual dosage was 500 mg (range: 50-1000 mg). The total dosage was, in most cases, administered through a single application (range: 1-10). Symptoms, blood values (Hb), iron stores (serum-ferritin [S-ferritin]) and transport iron (transferrin saturation [TSAT]) normalised to a large extent. In all subgroups, 92 % of women displayed a marked improvement in all of their symptoms. The average increase in Hb-value in the group as a whole was statistically significant, increasing from 10.5 to 13.0 g/dl. In the group with anaemia, the value increased from 9.9 to 13.3 g/dl, with 80 % of women reaching normal Hb-values. The average S-ferritin value increased by a statistically significant > 70 µg/L from 17.2 to 88.8 µg/l and the value for the TSAT increased from 16.3 % to 22.8 %. Seven patients reported experiencing side effects. None of the results were severe. Overall, as part of this non-interventional study for everyday routine in a gynaecological practice, a rapid improvement in symptoms accompanied by the rectification of iron deficiency and anaemia was shown with low occurrences of mild undesirable events, and therefore the data obtained from controlled clinical studies on the effectiveness and tolerance of intravenous ferric carboxymaltose could be confirmed.
authors.affiliation: Gynaecological Practice, Grünwald.
authors.forename: R
authors.initials: R
authors.lastname: Herfs
authors.affiliation: Dortmund Gynaecology and Obstetrics, Dortmund.
authors.forename: L
authors.initials: L
authors.lastname: Fleitmann
authors.affiliation: Gynaecology and Obstetrics Practice, Bonn.
authors.forename: I
authors.initials: I
authors.lastname: Kocsis
keywords: ferric carboxymaltose; hypermenorrhoea; intravenous iron substitution; iron deficiency anaemia; menorrhagia; post partum
references.citation: Am J Gastroenterol. 2008 May;103(5):1182-92
references.pmid: 18371137
references.citation: Public Health Nutr. 2009 Apr;12(4):444-54
references.pmid: 18498676
references.citation: Am J Kidney Dis. 2001 Apr;37(4):743-9
references.pmid: 11273874
references.citation: Int J Gynaecol Obstet. 2008 Apr;101(1):67-73
references.pmid: 18234203
references.citation: J Perinat Med. 2012 Apr 02;40(4):397-402
references.pmid: 22752771
references.citation: J Clin Pathol. 2011 Apr;64(4):287-96
references.pmid: 21177268
references.citation: Drugs. 2009;69(6):739-56
references.pmid: 19405553
references.citation: N Engl J Med. 2009 Dec 17;361(25):2436-48
references.pmid: 19920054
references.citation: Transfusion. 2009 Dec;49(12):2719-28
references.pmid: 19682342
references.citation: Expert Opin Pharmacother. 2012 Apr;13(6):907-21
references.pmid: 22413903
references.citation: Value Health. 2007 May-Jun;10(3):183-94
references.pmid: 17532811
references.citation: Nephrol Dial Transplant. 2011 May;26(5):1599-607
references.pmid: 20929915
references.citation: Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78
references.pmid: 17666600
references.citation: Geburtshilfe Frauenheilkd. 2013 Mar;73(3):256-261
references.pmid: 26633902
references.citation: J Am Soc Nephrol. 2000 Feb;11(2):335-342
references.pmid: 10665941
references.citation: Best Pract Res Clin Haematol. 2005 Jun;18(2):319-32
references.pmid: 15737893
references.citation: Semin Hematol. 2009 Oct;46(4):339-50
references.pmid: 19786202
references.citation: J Am Soc Nephrol. 2004 Dec;15 Suppl 2:S107-11
references.pmid: 15585601
references.citation: J Clin Oncol. 2001 Jun 1;19(11):2865-74
references.pmid: 11387359
references.citation: Am J Obstet Gynecol. 2008 Oct;199(4):435.e1-7
references.pmid: 18928998
references.citation: N Engl J Med. 2005 Mar 10;352(10):1011-23
references.pmid: 15758012
references.citation: Eur J Heart Fail. 2009 Nov;11(11):1084-91
references.pmid: 19875408
references.citation: Nephrol Dial Transplant. 2004 Jan;19(1):121-32
references.pmid: 14671047
references.citation: Arzneimittelforschung. 2010;60(6a):399-412
references.pmid: 20648931
references.citation: Eur J Obstet Gynecol Reprod Biol. 2010 Oct;152(2):133-7
references.pmid: 20688424
references.citation: BMC Blood Disord. 2011 Sep 24;11:4
references.pmid: 21942989