Background: Recommendations given for intravenous iron treatment are typically not supported by a high level\r\nof evidence. This meta-analysis addressed this by summarising the available date from clinical trials of ferric\r\ncarboxymaltose using clinical trial reports and published reports.\r\nMethods: Clinical trial reports were supplemented by electronic literature searches comparing ferric\r\ncarboxymaltose with active comparators or placebo. Various outcomes were sought for efficacy (attainment of\r\nnormal haemoglobin (Hb), increase of Hb by a defined amount, for example), together with measures of harm,\r\nincluding serious adverse events and deaths.\r\nResults: Fourteen studies were identified with 2,348 randomised patients exposed to ferric carboxymaltose, 832 to\r\noral iron, 762 to placebo, and 384 to intravenous iron sucrose. Additional data were available from cohort studies.\r\nIntravenous ferric carboxymaltose was given up to the calculated iron deficit (up to 1,000 mg in one week) for iron\r\ndeficiency anaemia secondary to chronic kidney disease, blood loss in obstetric and gynaecological conditions,\r\ngastrointestinal disease, and other conditions like heart failure. The most common comparator was oral iron, and\r\ntrials lasted 1 to 24 weeks. Intravenous ferric carboxymaltose improved mean Hb, serum ferritin, and transferrin\r\nsaturation levels; the mean end-of-trial increase over oral iron was, for Hb 4.8 (95% confidence interval 3.3 to 6.3)\r\ng/L, for ferritin 163 (153 to 173) �µg/L, and for transferrin saturation 5.3% (3.7 to 6.8%). Ferric carboxymaltose was\r\nsignificantly better than comparator in achievement of target Hb increase (number needed to treat (NNT) 6.8; 5.3\r\nto 9.7) and target Hb NNT (5.9; 4.7 to 8.1). Serious adverse events and deaths were similar in incidence in ferric\r\ncarboxymaltose and comparators; rates of constipation, diarrhoea, and nausea or vomiting were lower than with\r\noral iron.\r\nConclusions: This review examined the available trials of intravenous ferric carboxymaltose using details from\r\npublished papers and unpublished clinical trial reports. It increases the evidence available to support\r\nrecommendations given for intravenous iron treatment, but there are limited trial data comparing different\r\nintravenous iron preparations.
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