Ugo Salvadori, 1 Marco Sandri, 2 Cristina Melli, 3 Francesca Polese, 4 Maria Simeoni, 5 Stefano Capelli, 6 and Ahmad Al-Khaffaf1
From the 1Immunohaematology and Transfusion Service, Bozen/Bolzano Hospital, and the 2Centre for Biomedicine, European Academy Bozen/Bolzano (EURAC), Bozen/Bolzano, Italy; the 3Transfusion Medicine Department, Udine University Hospital, Udine, Italy; the 4Immunohaematology and Transfusion Service, Mestre Hospital, Mestre, Venezia, Italy; the 5Transfusion Service, San Dona di Piave Hospital, San Dona di Piave, Italy; and the 6Transfusion Service, Belluno Hospital, Belluno, Italy
Abstract
Background
The aim of this study was to evaluate the effectiveness of ferric carboxymaltose (FCM) in patients with iron deficiency anemia (IDA) secondary to gastrointestinal chronic blood loss (CBL), who received chronic transfusion support.
Study design and Methods
We retrospectively evaluated 38 patients with IDA (hemoglobin [Hb] < 10 g/dL and ferritin < 12 ng/mL or transferrin saturation [TSAT] < 16%) refractory or intolerant to oral iron therapy that necessitated transfusion support in the previous 12 months. They were treated with FCM (500-2500 mg). The primary endpoint was to evaluate the reduction of transfusion requirements (red blood cell [RBC] units) after FCM treatment.
Results
The median age of the cohort was 78 years, with a male:female ratio of 22:16. Before FCM treatment a median of 6 RBC units had been transfused. At the treatment (T0) the median value of Hb was 8.7 g/dL, the TSAT 6%, and ferritin 12 ng/mL. The median FCM dose was 1000 mg. At 5 weeks from T0 the median Hb level was 11 g/dL, with a median increase of 2.4 g/dL. With a median follow-up of 326 days, the median transfusion requirement was 0 RBC units, significantly lower than before T0 (p < 0.001). Overall 17 patients still necessitated transfusion support. Twenty-three patients needed retreatment with FCM for recurrence of IDA: 10 of them obtained a response again. The percentage of transfusion-independent patients at median follow-up was equal to 52%.
Conclusion
In patients with IDA secondary to CBL, FCM significantly reduces the need of transfusions and achieves transfusion independence in half of the cases.
(Reference link : http://onlinelibrary.wiley.com/doi/10.1111/trf.13794/abstract)
Randomised clinical trial: oral vs. intravenous iron after upper gastrointestinal haemorrhage – a placebo-controlled study
Bager & J. F. Dahlerup
Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
Summary
Background
Nonvariceal acute upper gastrointestinal bleeding (AUGIB) is often accompanied by post-discharge anaemia.
Aim
To investigate whether iron treatment can effectively treat anaemia and to compare a 3-month regimen of oral iron treatment with a single administration of intravenous iron prior to discharge.
Methods
Ninety-seven patients with nonvariceal AUGIB and anaemia were enrolled in a double-blind, placebo-controlled, randomised study. The patients were allocated to one of three groups, receiving a single intravenous administration of 1000 mg of iron; oral iron treatment, 200 mg daily for 3 months; or placebo, respectively. The patients were followed up for 3 months.
Results
From week 4 onwards, patients receiving treatment had significantly higher haemoglobin levels compared with patients who received placebo only. At the end of treatment, the proportion of patients with anaemia was significantly higher in the placebo group (P < 0.01) than in the treatment groups. Intravenous iron appeared to be more effective than oral iron in ensuring sufficient iron stores.
Conclusions
Iron treatment is effective and essential for treating anaemia after nonvariceal acute upper gastrointestinal bleeding. The route of iron supplementation is less important in terms of the increase in haemoglobin levels. Iron stores are filled most effectively if intravenous iron supplementation is administered (ClinicalTrials.gov identifier: NCT00978575).
(Reference link : http://onlinelibrary.wiley.com/doi/10.1111/apt.12556/full)
FERGIcor, a Randomized Controlled Trial on Ferric Carboxymaltose for Iron Deficiency Anemia in Inflammatory Bowel Disease
Rayko Evstatiev,1 Phillppe Marteau,2 Tariq Iqbal,3 Igorl. Khalif,4 Jurgen Stein, 5Bernd Bokemeyer,6Ivan V. Chopey,7 Florian S. Gutzwiller,8 Lise Riopel,9 and Christoph Gasche,1 for the FERGI Study Group
1Department of Medicine 3, Division of Gastroenterology and Hepatology, Christian Doppler Laboratory for Molecular Cancer Chemoprevention, Medical University of Vienna, Vienna, Austria; 2AP-HP, Département medico-chirurgical de pathologie digestive Hôpital Lariboisière & Université Denis Diderot- Paris7, Paris, France; 3University Hospital, Birmingham, United Kingdom; 4State Scientific Centre of Coloproctology, Moscow, Russia; 5Department of Gastroenterology and Clinical Nutrition and Crohn Colitis Centre Rhein Main, Frankfurt/Main, Germany; 6Gastroenterologische Gemeinschaftspraxis, Minden, Germany; 7National University, Uzhgorod, Ukraine; 8Institute of Pharmaceutical Medicine (ECPM), University of Basel, Basel, Switzerland; and 9Vifor Pharma, Glattbrugg, Switzerland
Background and aims
Iron deficiency anemia (IDA) is common in chronic diseases and intravenous iron is an effective and recommended treatment. However, dose calculations and inconvenient administration may affect compliance and efficacy. We compared the efficacy and safety of a novel fixed-dose ferric carboxymaltose regimen (FCM) with individually calculated iron sucrose (IS) doses in patients with inflammatory bowel disease (IBD) and IDA.
Methods
This randomized, controlled, open-label, multicenter study included 485 patients with IDA (ferritin <100 μg/L, hemoglobin [Hb] 7–12 g/dL [female] or 7–13 g/dL [male]) and mild-to-moderate or quiescent IBD at 88 hospitals and clinics in 14 countries. Patients received either FCM in a maximum of 3 infusions of 1000 or 500 mg iron, or Ganzoni-calculated IS dosages in up to 11 infusions of 200 mg iron. Primary end point was Hb response (Hb increase ≥2g/dL); secondary end points included anemia resolution and iron status normalization by week 12.
Results
The results of 240 FCM-treated and 235 IS-treated patients were analyzed. More patients with FCM than IS achieved Hb response (150 [65.8%] vs 118 [53.6%]; 12.2% difference, P =.004) or Hb normalization (166 [72.8%] vs 136 [61.8%]; 11.0%difference, P =.015). Both treatments improved quality of life scores by week 12. Study drugs were well tolerated and drug-related adverse events were in line with drug-specific clinical experience. Deviations from scheduled total iron dosages were more frequent in the IS group.
Conclusion
The simpler FCM-based dosing regimen showed better efficacy and compliance, as well as a good safety profile, compared with the Ganzoni-calculated IS dose regimen.
View this article’s video abstract at www.gastrojournal.org.
(Reference link : www.gastrojournal.org/article/S0016-5085(11)00762-1/pdf )
