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Piotr Ponikowski - One of the best experts on this subject based on the ideXlab platform.

  • intravenous Ferric Carboxymaltose does not provide benefits in reperfused acute myocardial infarction in the rat with normal iron status
    Biomedicine & Pharmacotherapy, 2021
    Co-Authors: Aleksandra Paterek, Piotr Ponikowski, Marta Okninska, Przemyslaw Leszek, Urszula Mackiewicz, Ewa A Jankowska, Micha Mączewski
    Abstract:

    Abstract Background Iron deficiency has been implicated in the pathophysiology of heart failure and myocardial ischemia and reperfusion injury. Moreover, reperfused heart seems to lose iron, thus even subjects with normal iron status could benefit from iron therapy. Impaired mitochondrial respiration and energy starvation may be among possible consequences of myocardial iron deficiency. So far no attempts have been made to treat acute coronary syndromes with iron. Thus our aim was to verify the hypothesis that intravenous iron therapy given during reperfusion of an acute myocardial infarction will reduce left ventricular remodeling and hemodynamic abnormalities in a 2-month follow-up as well as early mitochondrial dysfunction and mortality, in the rat with normal iron status. Methods and results A single dose of Ferric Carboxymaltose was administered intravenously at 30 min of reperfusion following 30 min of ischemia in the rat model of myocardial infarction. Ventricular arrhythmias were monitored using a telemetric system, activity of mitochondrial enzymes was assessed using spectrophotometry, serum markers of oxidative stress and inflammation were determined and left ventricular function and remodeling were monitored using echocardiography and pressure-volume loops. Intravenous iron therapy did not affect post-myocardial infarction mortality, left ventricular size or function, ventricular arrhythmias, activity of mitochondrial respiratory chain, oxidative stress or markers of inflammation, but was not associated with any adverse effects. Conclusions Although Ferric Carboxymaltose given at reperfusion was safe, it was ineffective in this model of reperfused myocardial infarction in the rat with normal iron status.

  • Ferric Carboxymaltose for the treatment of iron deficiency in heart failure a multinational cost effectiveness analysis utilising affirm ahf
    European Journal of Heart Failure, 2021
    Co-Authors: Phil Mcewan, Piotr Ponikowski, Andrew J S Coats, Jason A Davis, Giuseppe M C Rosano, Fabio Dorigotti, Donal Osullivan, Antonio Ramirez De Arellano, Ewa A Jankowska
    Abstract:

    AIMS Iron deficiency is common in patients with heart failure (HF). In AFFIRM-AHF, Ferric Carboxymaltose (FCM) reduced the risk of hospitalisations for HF (HHF) and improved quality of life vs. placebo in iron-deficient patients with a recent episode of acute HF. The objective of this study was to estimate the cost-effectiveness of FCM compared with placebo in iron-deficient patients with left ventricular ejection fraction <50%, stabilised after an episode of acute HF, using data from the AFFIRM-AHF trial from Italian, UK, US and Swiss payer perspectives. METHODS AND RESULTS A lifetime Markov model was built to characterise outcomes in patients according to the AFFIRM-AHF trial. Health states were defined using the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Subsequent HHF were incorporated using a negative binomial regression model with cardiovascular and all-cause mortality incorporated via parametric survival analysis. Direct healthcare costs (2020 GBP/USD/EUR/CHF) and utility values were sourced from published literature and AFFIRM-AHF. Modelled outcomes indicated that treatment with FCM was dominant (cost saving with additional health gains) in the UK, USA and Switzerland, and highly cost-effective in Italy [incremental cost-effectiveness ratio (ICER) EUR 1269 per quality-adjusted life-year (QALY)]. Results were driven by reduced costs for HHF events combined with QALY gains of 0.43-0.44, attributable to increased time in higher KCCQ states (representing better functional outcomes). Sensitivity and subgroup analyses demonstrated data robustness, with the ICER remaining dominant or highly cost-effective under a wide range of scenarios, including increasing treatment costs and various patient subgroups, despite a moderate increase in costs for de novo HF and smaller QALY gains for ischaemic aetiology. CONCLUSION Ferric Carboxymaltose is estimated to be a highly cost-effective treatment across countries (Italy, UK, USA and Switzerland) representing different healthcare systems.

  • Ferric Carboxymaltose for iron deficiency at discharge after acute heart failure a multicentre double blind randomised controlled trial
    The Lancet, 2020
    Co-Authors: Piotr Ponikowski, Stefan D Anker, Bridgetanne Kirwan, Theresa Mcdonagh, Maria Dorobantu, Jaroslaw Drozdz, Vincent Fabien, Gerasimos Filippatos
    Abstract:

    Summary Background Intravenous Ferric Carboxymaltose has been shown to improve symptoms and quality of life in patients with chronic heart failure and iron deficiency. We aimed to evaluate the effect of Ferric Carboxymaltose, compared with placebo, on outcomes in patients who were stabilised after an episode of acute heart failure. Methods AFFIRM-AHF was a multicentre, double-blind, randomised trial done at 121 sites in Europe, South America, and Singapore. Eligible patients were aged 18 years or older, were hospitalised for acute heart failure with concomitant iron deficiency (defined as ferritin Findings Between March 21, 2017, and July 30, 2019, 1525 patients were screened, of whom 1132 patients were randomly assigned to study groups. Study treatment was started in 1110 patients, and 1108 (558 in the Carboxymaltose group and 550 in the placebo group) had at least one post-randomisation value. 293 primary events (57·2 per 100 patient-years) occurred in the Ferric Carboxymaltose group and 372 (72·5 per 100 patient-years) occurred in the placebo group (rate ratio [RR] 0·79, 95% CI 0·62–1·01, p=0·059). 370 total cardiovascular hospitalisations and cardiovascular deaths occurred in the Ferric Carboxymaltose group and 451 occurred in the placebo group (RR 0·80, 95% CI 0·64–1·00, p=0·050). There was no difference in cardiovascular death between the two groups (77 [14%] of 558 in the Ferric Carboxymaltose group vs 78 [14%] in the placebo group; hazard ratio [HR] 0·96, 95% CI 0·70–1·32, p=0·81). 217 total heart failure hospitalisations occurred in the Ferric Carboxymaltose group and 294 occurred in the placebo group (RR 0·74; 95% CI 0·58–0·94, p=0·013). The composite of first heart failure hospitalisation or cardiovascular death occurred in 181 (32%) patients in the Ferric Carboxymaltose group and 209 (38%) in the placebo group (HR 0·80, 95% CI 0·66–0·98, p=0·030). Fewer days were lost due to heart failure hospitalisations and cardiovascular death for patients assigned to Ferric Carboxymaltose compared with placebo (369 days per 100 patient-years vs 548 days per 100 patient-years; RR 0·67, 95% CI 0·47–0·97, p=0·035). Serious adverse events occurred in 250 (45%) of 559 patients in the Ferric Carboxymaltose group and 282 (51%) of 551 patients in the placebo group. Interpretation In patients with iron deficiency, a left ventricular ejection fraction of less than 50%, and who were stabilised after an episode of acute heart failure, treatment with Ferric Carboxymaltose was safe and reduced the risk of heart failure hospitalisations, with no apparent effect on the risk of cardiovascular death. Funding Vifor Pharma.

  • effect of Ferric Carboxymaltose on calculated plasma volume status and clinical congestion a fair hf substudy
    Esc Heart Failure, 2019
    Co-Authors: Josep Comin Colet, Gerasimos Filippatos, Piotr Ponikowski, Claudio Mori, Darlington O Okonko, Fadi Jouhra, Huda Abuown, Chainey Suki, Stefan D Anker
    Abstract:

    Aims Iron deficiency worsens symptoms, quality of life, and exercise capacity in chronic heart failure (CHF) and might do so by promoting fluid retention. We assessed whether iron repletion improved congestion in CHF and appraised the prognostic utility of calculated plasma volume status (PVS), a novel index of congestion, in the FAIR-HF data set. Methods and results In FAIR-HF, 459 iron deficient CHF patients were randomized to intravenous Ferric Carboxymaltose (FCM) or saline and assessed at 4, 12, and 24 weeks. Using weight and haematocrit, we calculated PVS in 436 patients. At baseline, PVS and weight were -5.5 ± 7.7% and 76.9 ± 14.3 kg, with peripheral oedema evident in 35% of subjects. Higher PVS values correlated to other congestion surrogates such as lower serum albumin. At 4 weeks, FCM was associated with greater reductions in weight (0.02) and PVS (P -4% at baseline predicted worse outcomes even after adjustment for treatment assignment (hazard ratio 1.88, 95% confidence interval 1.01-3.51, 0.046). Conclusions Intravenous iron therapy with FCM is associated with early reductions in PVS and weight, implying that decongestion might be one mechanism via which iron repletion aids CHF patients. Calculated PVS is of prognostic utility in this cohort.

  • a cost effectiveness analysis of Ferric Carboxymaltose in patients with iron deficiency and chronic heart failure in spain
    Revista Espanola De Cardiologia, 2015
    Co-Authors: Josep Comincolet, Stefan D Anker, Dario Rubiorodriguez, C Rubioterres, Cristina Enjuanesgrau, Florian S Gutzwiller, Piotr Ponikowski
    Abstract:

    Abstract Introduction and objectives Treatment with Ferric Carboxymaltose improves symptoms, functional capacity, and quality of life in patients with chronic heart failure and iron deficiency. The aim of this study was to assess the cost-effectiveness of Ferric Carboxymaltose treatment vs no treatment in these patients. Methods We used an economic model based on the Spanish National Health System, with a time horizon of 24 weeks. Patient characteristics and Ferric Carboxymaltose effectiveness (quality-adjusted life years) were taken from the Ferinject ® Assessment in patients with IRon deficiency and chronic Heart Failure trial . Health care resource use and unit costs were taken either from Spanish sources, or from the above mentioned trial. Results In the base case analysis, patients treated with and without Ferric Carboxymaltose treatment acquired 0.335 and 0.298 quality-adjusted life years, respectively, representing a gain of 0.037 quality-adjusted life years for each treated patient. The cost per patient was €824.17 and €597.59, respectively, resulting in an additional cost of €226.58 for each treated patient. The cost of gaining 1 quality adjusted life year with Ferric Carboxymaltose was €6123.78. Sensitivity analyses confirmed the robustness of the model. The probability of Ferric Carboxymaltose being cost-effective ( Conclusions Treatment with Ferric Carboxymaltose in patients with chronic heart failure and iron deficiency, with or without anemia, is cost-effective in Spain.

Christoph Gasche - One of the best experts on this subject based on the ideXlab platform.

Bernd Froessler - One of the best experts on this subject based on the ideXlab platform.

  • treatment of iron deficiency and iron deficiency anemia with intravenous Ferric Carboxymaltose in pregnancy
    Archives of Gynecology and Obstetrics, 2018
    Co-Authors: Bernd Froessler, Gustaaf A Dekker, Tijana Gajic, Nicolette A Hodyl
    Abstract:

    To evaluate the efficacy and safety of intravenous Ferric Carboxymaltose administration to pregnant women with varying severities of iron deficiency anemia and iron deficiency without anemia. In this prospective observational study of local obstetric practice, we analyzed data from 863 pregnant women with iron deficiency according to anemia status and severity. All women were treated with intravenous Ferric Carboxymaltose in pregnancy. Treatment efficacy was assessed by repeat hemoglobin measurements at 3 and 6 week post-infusion and ferritin levels, where available. Safety was assessed by analysis of adverse events, fetal heart rate monitoring, and newborn health outcome data. Ferric Carboxymaltose significantly increased hemoglobin in women with mild, moderate, and severe iron deficiency anemia and women with iron deficiency alone at 3 and 6 week post-infusion (p < 0.01 for all). No hemoconcentration occurred in iron-deficient women without anemia. No serious adverse events were recorded, with minor temporary side effects (including local skin irritation, nausea, and headache) occurring in 96 (11%) women. No adverse fetal or neonatal outcomes were observed. Ferric Carboxymaltose infusion corrects iron deficiency or various degrees of iron deficiency anemia efficaciously and safely pregnant women, and does not cause hemoconcentration.

  • assessing the costs and benefits of perioperative iron deficiency anemia management with Ferric Carboxymaltose in germany
    Risk Management and Healthcare Policy, 2018
    Co-Authors: Bernd Froessler, Alexandra M Rueger, Mark P Connolly
    Abstract:

    Background: Perioperative administration of Ferric Carboxymaltose (FCM) was previously shown to reduce both the need for transfusions and the hospital length of stay in patients with preoperative iron deficiency anemia (IDA). In this study, we estimated the economic consequences of perioperative administration using FCM vs usual care in patients with IDA from the perspective of a German hospital using decision-analytic modeling. Materials and methods: The model was populated with clinical inputs (transfusion rates, blood units transfused, hospital length of stay) from a previously reported randomized trial comparing FCM vs usual care for managing IDA patients undergoing elective abdominal surgery. We applied a hospital perspective to all costs, excluding surgery-related costs in both treatment arms. One-way sensitivity analyses were undertaken to evaluate key drivers of cost analysis. Results: The average costs per case treated using FCM compared to usual care were (sic)2,461 and (sic)3,246, respectively, for resource expenses paid by hospital per case. This would suggest potential savings achieved with preoperative intravenous iron treatment per patient of (sic)786 per case. A sensitivity analysis varying the key input parameters indicated the cost analysis is most sensitive to changes in the length of stay and the cost of hospitalization per day. Conclusion: Perioperative administration of FCM results in cost savings to hospitals based on reduced blood transfusions and length of stay following elective abdominal surgery.

  • intravenous Ferric Carboxymaltose for anaemia in pregnancy
    BMC Pregnancy and Childbirth, 2014
    Co-Authors: Bernd Froessler, Joshua Collingwood, Nicolette A Hodyl, Gustaaf A Dekker
    Abstract:

    Background: Iron deficiency is a common nutritional deficiency amongst women of childbearing age. Peri-partum iron deficiency anaemia (IDA) is associated with significant maternal, fetal and infant morbidity. Current options for treatment are limited: these include oral iron supplementation, which can be ineffective and poorly tolerated, and red blood cell transfusions, which carry an inherent risk and should be avoided. Ferric Carboxymaltose is a new treatment option that may be better tolerated. The study was designed to assess the safety and efficacy of iron deficiency anaemia (IDA) correction with intravenous Ferric Carboxymaltose in pregnant women with mild, moderate and severe anaemia in the second and third trimester. Methods: Prospective observational study; 65 anaemic pregnant women received Ferric Carboxymaltose up to 15 mg/kg between 24 and 40 weeks of pregnancy (median 35 weeks gestational age, SD 3.6). Treatment effectiveness was assessed by repeat haemoglobin (Hb) measurements and patient report of well-being in the postpartum period. Safety was assessed by analysis of adverse drug reactions and fetal heart rate monitoring during the infusion. Results: Intravenous Ferric Carboxymaltose infusion significantly increased Hb values (p < 0.01) above baseline levels in all women. Increased Hb values were observed at 3 and 6 weeks post infusion and up to 8 weeks post-infusion. Ferritin values increased significantly after the infusion. Only 4 women had repeat ferritin values post-partum which remained above baseline levels. Fetal heart rate monitoring did not indicate a drug related negative impact on the fetus. Of the 29 (44.6%) women interviewed, 19 (65.5%) women reported an improvement in their well-being and 9 (31%) felt no different after the infusion. None of the women felt worse. No serious adverse effects were found and minor side effects occurred in 13 (20%) patients. Conclusions: Our prospective data is consistent with existing observational reports of the safe and effective use of Ferric Carboxymaltose in the treatment of iron deficiency anaemia in pregnancy.

Gerasimos Filippatos - One of the best experts on this subject based on the ideXlab platform.

  • Ferric Carboxymaltose for iron deficiency at discharge after acute heart failure a multicentre double blind randomised controlled trial
    The Lancet, 2020
    Co-Authors: Piotr Ponikowski, Stefan D Anker, Bridgetanne Kirwan, Theresa Mcdonagh, Maria Dorobantu, Jaroslaw Drozdz, Vincent Fabien, Gerasimos Filippatos
    Abstract:

    Summary Background Intravenous Ferric Carboxymaltose has been shown to improve symptoms and quality of life in patients with chronic heart failure and iron deficiency. We aimed to evaluate the effect of Ferric Carboxymaltose, compared with placebo, on outcomes in patients who were stabilised after an episode of acute heart failure. Methods AFFIRM-AHF was a multicentre, double-blind, randomised trial done at 121 sites in Europe, South America, and Singapore. Eligible patients were aged 18 years or older, were hospitalised for acute heart failure with concomitant iron deficiency (defined as ferritin Findings Between March 21, 2017, and July 30, 2019, 1525 patients were screened, of whom 1132 patients were randomly assigned to study groups. Study treatment was started in 1110 patients, and 1108 (558 in the Carboxymaltose group and 550 in the placebo group) had at least one post-randomisation value. 293 primary events (57·2 per 100 patient-years) occurred in the Ferric Carboxymaltose group and 372 (72·5 per 100 patient-years) occurred in the placebo group (rate ratio [RR] 0·79, 95% CI 0·62–1·01, p=0·059). 370 total cardiovascular hospitalisations and cardiovascular deaths occurred in the Ferric Carboxymaltose group and 451 occurred in the placebo group (RR 0·80, 95% CI 0·64–1·00, p=0·050). There was no difference in cardiovascular death between the two groups (77 [14%] of 558 in the Ferric Carboxymaltose group vs 78 [14%] in the placebo group; hazard ratio [HR] 0·96, 95% CI 0·70–1·32, p=0·81). 217 total heart failure hospitalisations occurred in the Ferric Carboxymaltose group and 294 occurred in the placebo group (RR 0·74; 95% CI 0·58–0·94, p=0·013). The composite of first heart failure hospitalisation or cardiovascular death occurred in 181 (32%) patients in the Ferric Carboxymaltose group and 209 (38%) in the placebo group (HR 0·80, 95% CI 0·66–0·98, p=0·030). Fewer days were lost due to heart failure hospitalisations and cardiovascular death for patients assigned to Ferric Carboxymaltose compared with placebo (369 days per 100 patient-years vs 548 days per 100 patient-years; RR 0·67, 95% CI 0·47–0·97, p=0·035). Serious adverse events occurred in 250 (45%) of 559 patients in the Ferric Carboxymaltose group and 282 (51%) of 551 patients in the placebo group. Interpretation In patients with iron deficiency, a left ventricular ejection fraction of less than 50%, and who were stabilised after an episode of acute heart failure, treatment with Ferric Carboxymaltose was safe and reduced the risk of heart failure hospitalisations, with no apparent effect on the risk of cardiovascular death. Funding Vifor Pharma.

  • effect of Ferric Carboxymaltose on calculated plasma volume status and clinical congestion a fair hf substudy
    Esc Heart Failure, 2019
    Co-Authors: Josep Comin Colet, Gerasimos Filippatos, Piotr Ponikowski, Claudio Mori, Darlington O Okonko, Fadi Jouhra, Huda Abuown, Chainey Suki, Stefan D Anker
    Abstract:

    Aims Iron deficiency worsens symptoms, quality of life, and exercise capacity in chronic heart failure (CHF) and might do so by promoting fluid retention. We assessed whether iron repletion improved congestion in CHF and appraised the prognostic utility of calculated plasma volume status (PVS), a novel index of congestion, in the FAIR-HF data set. Methods and results In FAIR-HF, 459 iron deficient CHF patients were randomized to intravenous Ferric Carboxymaltose (FCM) or saline and assessed at 4, 12, and 24 weeks. Using weight and haematocrit, we calculated PVS in 436 patients. At baseline, PVS and weight were -5.5 ± 7.7% and 76.9 ± 14.3 kg, with peripheral oedema evident in 35% of subjects. Higher PVS values correlated to other congestion surrogates such as lower serum albumin. At 4 weeks, FCM was associated with greater reductions in weight (0.02) and PVS (P -4% at baseline predicted worse outcomes even after adjustment for treatment assignment (hazard ratio 1.88, 95% confidence interval 1.01-3.51, 0.046). Conclusions Intravenous iron therapy with FCM is associated with early reductions in PVS and weight, implying that decongestion might be one mechanism via which iron repletion aids CHF patients. Calculated PVS is of prognostic utility in this cohort.

  • determinants of quality of life of patients with heart failure and iron deficiency treated with Ferric Carboxymaltose fair hf sub analysis
    International Journal of Cardiology, 2013
    Co-Authors: Florian S Gutzwiller, Gerasimos Filippatos, Josep Comincolet, Piotr Ponikowski, Claudio Mori, Alena M Pfeil, Peter Braunhofer, Thomas D Szucs, Matthias Schwenkglenks
    Abstract:

    Abstract Background Heart failure (HF) is a burden to patients and health care systems. The objectives of HF treatment are to improve health related quality of life (HRQoL) and reduce mortality and morbidity. We aimed to evaluate determinants of health-related quality of life (HRQoL) in patients with iron deficiency and HF treated with intravenous (i.v.) iron substitution or placebo. Methods A randomised, double-blind, placebo-controlled trial (n=459) in iron-deficient chronic heart failure (CHF) patients with or without anaemia studied clinical and HRQoL benefits of i.v. iron substitution using Ferric Carboxymaltose (FCM) over a 24-week trial period. Multivariate analysis was carried out with various clinical variables as independent variables and HRQoL measures as dependent variables. Results Mean change from baseline of European Quality of Life — 5 Dimensions (EQ-5D) (value set-based) utilities (on a 0 to 100 scale) at week 24 was 8.91 (i.v. iron) and 0.68 (placebo; p Conclusion In this study, i.v. iron substitution, exercise tolerance, stroke, country of residence and renal function influenced measures of HRQoL in patients with heart failure and iron deficiency.

  • the effect of intravenous Ferric Carboxymaltose on health related quality of life in patients with chronic heart failure and iron deficiency a subanalysis of the fair hf study
    European Heart Journal, 2013
    Co-Authors: Josep Comincolet, Gerasimos Filippatos, Ronnie Willenheimer, Kenneth Dickstein, Thomas F Luscher, Mitja Lainscak, Patrick Johnson, Claudio Mori, Piotr Ponikowski
    Abstract:

    Aims Patients with chronic heart failure (CHF) show impaired health-related quality of life (HRQoL), an important target for therapeutic intervention. Impaired iron homeostasis may be one mechanism underlying the poor physical condition of CHF patients. This detailed subanalysis of the previously published FAIR-HF study evaluated baseline HRQoL in iron-deficient patients with CHF and the effect of intravenous Ferric Carboxymaltose (FCM) on HRQoL. Methods and results FAIR-HF randomized 459 patients with reduced left ventricular ejection fraction and iron deficiency, with or without anaemia, to FCM or placebo (2:1). Health-related quality of life was assessed at baseline and after 4, 12, and 24 weeks of therapy using the generic EQ-5D questionnaire and disease-specific Kansas City Cardiomyopathy Questionnaire (KCCQ). Baseline mean Visual Analogue Scale (VAS) score was 54.3 ± 16.4 and KCCQ overall summary score was 52.4 ± 18.8. Ferric Carboxymaltose significantly improved VAS and KCCQ (mean differences from baseline in KCCQ overall, clinical and total symptom scores, P < 0.001 vs. placebo) at all time points. At Week 24, significant improvement vs. placebo was observed in four of the five EQ-5D dimensions: mobility ( P = 0.004), self-care ( P < 0.001), pain/discomfort ( P = 0.006), anxiety/depression ( P = 0.012), and usual activity ( P = 0.035). Ferric Carboxymaltose improved all KCCQ domain mean scores from Week 4 onward ( P ≤ 0.05), except for self-efficacy and social limitation. Effects were present in both anaemic and non-anaemic patients. Conclusions HRQoL is impaired in iron-deficient patients with CHF. Intravenous FCM significantly improved HRQoL after 4 weeks, and throughout the remaining study period. The positive effects of FCM were independent of anaemia status.

  • Ferric Carboxymaltose in patients with heart failure and iron deficiency
    The New England Journal of Medicine, 2009
    Co-Authors: Stefan D Anker, Josep Comin Colet, Gerasimos Filippatos, Ronnie Willenheimer, Kenneth Dickstein, Helmut Drexler, Thomas F Luscher, Boris Bart, Waldemar Banasiak
    Abstract:

    BACKGROUND Iron deficiency may impair aerobic performance. This study aimed to determine whether treatment with intravenous iron (Ferric Carboxymaltose) would improve symptoms in patients who had heart failure, reduced left ventricular ejection fraction, and iron deficiency, either with or without anemia. METHODS We enrolled 459 patients with chronic heart failure of New York Heart Association (NYHA) functional class II or III, a left ventricular ejection fraction of 40% or less (for patients with NYHA class II) or 45% or less (for NYHA class III), iron deficiency (ferritin level <100 μg per liter or between 100 and 299 μg per liter, if the transferrin saturation was <20%), and a hemoglobin level of 95 to 135 g per liter. Patients were randomly assigned, in a 2:1 ratio, to receive 200 mg of intravenous iron (Ferric Carboxymaltose) or saline (placebo). The primary end points were the self-reported Patient Global Assessment and NYHA functional class, both at week 24. Secondary end points included the distance walked in 6 minutes and the health-related quality of life. RESULTS Among the patients receiving Ferric Carboxymaltose, 50% reported being much or moderately improved, as compared with 28% of patients receiving placebo, according to the Patient Global Assessment (odds ratio for improvement, 2.51; 95% confidence interval [CI], 1.75 to 3.61). Among the patients assigned to Ferric Carboxymaltose, 47% had an NYHA functional class I or II at week 24, as compared with 30% of patients assigned to placebo (odds ratio for improvement by one class, 2.40; 95% CI, 1.55 to 3.71). Results were similar in patients with anemia and those without anemia. Significant improvements were seen with Ferric Carboxymaltose in the distance on the 6-minute walk test and quality-of-life assessments. The rates of death, adverse events, and serious adverse events were similar in the two study groups. CONCLUSIONS Treatment with intravenous Ferric Carboxymaltose in patients with chronic heart failure and iron deficiency, with or without anemia, improves symptoms, functional capacity, and quality of life; the side-effect profile is acceptable. (ClinicalTrials.gov number, NCT00520780.)

Julie Krop - One of the best experts on this subject based on the ideXlab platform.

  • comparative safety of intravenous ferumoxytol versus Ferric Carboxymaltose in iron deficiency anemia a randomized trial
    American Journal of Hematology, 2018
    Co-Authors: Franklin N Adkinson, Iain C. Macdougall, William Strauss, Kristine Bernard, Michael Auerbach, Robert F Kaper, Glenn M Chertow, Julie Krop
    Abstract:

    Few trials have examined rates of hypersensitivity reactions (HSRs) with intravenous iron formulations used to treat iron deficiency anemia (IDA). This randomized, multicenter, double-blind clinical trial compared the safety, and efficacy of ferumoxytol versus Ferric Carboxymaltose (FCM), focusing on rates of HSRs and hypotension as the primary end point. Patients with IDA of any etiology in whom oral iron was unsatisfactory or intolerable received ferumoxytol (n = 997) or FCM (n = 1000) intravenously over ≥15 minutes on days 1 and 8 or 9 for total respective doses of 1.02 g and 1.50 g. Composite incidences of moderate-to-severe HSRs, including anaphylaxis, or moderate-to-severe hypotension from baseline to week 5 (primary safety end point) were 0.6% and 0.7% in the ferumoxytol and FCM groups, respectively, with ferumoxytol noninferior to FCM. No anaphylaxis was reported in either group. The secondary safety end point of incidences of moderate-to-severe HSRs, including anaphylaxis, serious cardiovascular events, and death from baseline to week 5 were 1.3% and 2.0% in the ferumoxytol and FCM groups, respectively (noninferiority test P < .0001). Least-squares mean changes in hemoglobin at week 5 were 1.4 g/dL and 1.6 g/dL in the ferumoxytol and FCM groups, respectively (noninferiority test P < .0001). Incidence of hypophosphatemia was 0.4% for ferumoxytol and 38.7% for FCM.