Safety and Efficacy of Ferric Carboxymaltose in the Treatment of Iron Deficiency Anaemia in Patients with Inflammatory Bowel Disease, in Routine Daily Practice.

摘要: Introduction Iron deficiency and iron anaemia are common complications in inflammatory bowel disease [IBD] patients. Anaemia IBD is attributable to chronic blood loss and/or impaired intake absorption. International guidelines recommend intravenous supplementation patients, since oral supplements frequently poorly tolerated can exacerbate inflammation. Intravenous ferric carboxymaltose [FCM; Ferinject® 50 mg iron[III]/mL suspension] was approved Europe 2007 for correction of deficiency, be administered single 15-min infusions up 1000 mg. Methods A prospective non-interventional post-marketing study performed 101 centres Germany assess the efficacy, tolerability, convenience clinical practice a large cohort Primary endpoints were haemoglobin [Hb] normalisation or increase ≥2 g/dL [responders], serum ferritin [s-ferritin] transferrin saturation. Adverse events [AEs], signs/symptoms, activity indices also analysed. Results In all, 224 subjects (127 Crohn's [CD]; 97 ulcerative colitis [UC]) treated. Mean total dose 1139 [range: 100 mg-4800 mg], with 76.7% doses between 500 2000 mg; 63.3% patients responded, no adverse drug reactions drug-attributed serious [SAEs] deaths occurred. increases Hb [10.0 12.3 g/dL], [52 μg/L 103 μg/L], saturation [TSAT, 15% 25%], s-iron [6.1 12.4 μmol/L] significant [p = 0.0001]. Clinical scores quality life improved due amelioration symptoms. Conclusions Ferinject®-therapy proven effective safe IBD-associated routine practice. Rapid, high-dose application convenient physicians reduces patients' time lost from work.