Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Chronic Heart Failure and Iron Deficiency.

BACKGROUND: Iron deficiency is common in patients with heart failure (HF) and is associated with reduced exercise capacity and poor outcomes. Whether correction of iron deficiency with (intravenous) ferric carboxymaltose (FCM) affects peak oxygen consumption [peak VO2], an objective measure of exercise intolerance in HF, has not been examined. METHODS: We studied patients with systolic HF (left ventricular ejection fraction ≤45%) and mild to moderate symptoms despite optimal HF medication. Patients were randomized 1:1 to treatment with FCM for 24 weeks or standard of care. The primary end point was the change in peak VO2 from baseline to 24 weeks. Secondary end points included the effect on hematinic and cardiac biomarkers, quality of life, and safety. For the primary analysis, patients who died had a value of 0 imputed for 24-week peak VO2. Additional sensitivity analyses were performed to determine the impact of imputation of missing peak VO2 data. RESULTS: A total of 172 patients with HF were studied and received FCM (n=86) or standard of care (control group, n=86). At baseline, the groups were well matched; mean age was 64 years, 75% were male, mean left ventricular ejection fraction was 32%, and peak VO2 was 13.5 mL/min/kg. FCM significantly increased serum ferritin and transferrin saturation. At 24 weeks, peak VO2 had decreased in the control group (least square means -1.19±0.389 mL/min/kg) but was maintained on FCM (-0.16±0.387 mL/min/kg; P=0.020 between groups). In a sensitivity analysis, in which missing data were not imputed, peak VO2 at 24 weeks decreased by -0.63±0.375 mL/min/kg in the control group and by -0.16±0.373 mL/min/kg in the FCM group; P=0.23 between groups). Patients' global assessment and functional class as assessed by the New York Heart Association improved on FCM versus standard of care. CONCLUSIONS: Treatment with intravenous FCM in patients with HF and iron deficiency improves iron stores. Although a favorable effect on peak VO2 was observed on FCM, compared with standard of care in the primary analysis, this effect was highly sensitive to the imputation strategy for peak VO2 among patients who died. Whether FCM is associated with an improved outcome in these high-risk patients needs further study. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01394562.

Cost of managing anemia in end-stage renal disease: the experience of five French dialysis centers.

OBJECTIVE: The aim of this retrospective study was to evaluate the direct cost of anemia treatment in hemodialysis patients and to evidence factors predictive of 1-year cost. METHODS: Retrospective study which included hemodialyzed patients during year 2009 in five centers. Patients were evaluable if they had at least one hemoglobin (Hb) assay per month and were monitored for at least 4 months. Patients were classified in different "annual Hb category" according to their monthly mean Hb [Hb categories: Ideal (10 ≤ Hb ≤ 12 g/dL); High (Hb > 12 g/dL) and Low (Hb < 10 g/dL) if >75% of time in respective category, otherwise classified in the Fluctuating category]. RESULTS: We analyzed 636 patients (male, 59.4%) with a mean age of 67 years who underwent 144 hemodialysis sessions (median number per patient) in 2009. The cost of anemia treatment was largely driven by erythropoiesis-stimulating agents (ESA) (68% of total cost for Low Hb category and approximately 90% for the other Hb categories). Adjusted predictive factors for 1-year direct cost of anemia treatment (p < 0.0001) were dialysis center (2,518-5,617), death (6,091 vs. 4,911), age (4,911 for ≤55 years and 5,378 for 65-75 years), female gender (4,911 vs. 4,398 for male), Low Hb category (13,005 vs. 5,034 for Ideal, 4,911 for Fluctuating and 2,418 for High), serum ferritin level (5,102 for 200-500 µg/mL and 4,646 for ≥500 µg/mL) and duration of dialysis (4,911 if ≤2 years and 2,952 if 4-6 years). LIMITATIONS: Retrospective study, and low number of patients in the Low Hb category. CONCLUSIONS: The main factors that were predictive of 1-year cost of anemia treatment in hemodialysis patients were centers, patients in the Low Hb category, and dialysis duration of less than 2 years.

Administration of intravenous iron complexes on implantable central venous access port in cancer patients in France: the FERPAC survey.

PURPOSE: Implantable central venous access port (portacath) is used to provide long-term venous access and to deliver chemotherapy in cancer patients. Intravenous iron complexes are frequently prescribed in this setting, and some physicians use a portacath for their administration. The aim of this survey was to assess the frequency of this practice and the reasons supporting it. METHODS: This declarative survey was conducted in France; 497 oncologists/hematologists were contacted to answer a survey on their practices regarding the administration of intravenous iron via a portacath. RESULTS: A total of 141 recipients (29.5 %) completed the questionnaire. The intravenous iron complexes most frequently used were iron sucrose and ferric carboxymaltose, and 55.2 % of the responders reported using a portacath to administer intravenous iron complexes. The main reasons mentioned for this practice were ease of administration (27.9 %) and preservation of venous capital (27.6 %). The main reasons reported for not using a portacath to administer intravenous iron were a history of thrombosis (45.1 %) or potential drug interactions (17.7 %). Efficacy and safety were expected to be similar to those observed with peripheral administration. A 47.6 % of physicians declared that they usually did not observe adverse reactions after use of a portacath for iron administration. Intravenous iron administration was always planned after chemotherapy for 46.6 % of the responders and before chemotherapy for 38.2 %, whereas 15.3 % did not have any preference for either option. CONCLUSIONS: Intravenous iron complexes (mainly iron sucrose and ferric carboxymaltose) are commonly administered through a portacath in cancer patients in France. The choice for this route of administration is supported by clinical considerations, but further studies are needed to confirm the efficacy and safety of this practice.