PMID- 19920054 OWN - NLM STAT- MEDLINE DCOM- 20100105 LR - 20220408 IS - 1533-4406 (Electronic) IS - 0028-4793 (Linking) VI - 361 IP - 25 DP - 2009 Dec 17 TI - Ferric carboxymaltose in patients with heart failure and iron deficiency. PG - 2436-48 LID - 10.1056/NEJMoa0908355 [doi] AB - 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 microg per liter or between 100 and 299 microg 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). CI - Copyright 2009 Massachusetts Medical Society FAU - Anker, Stefan D AU - Anker SD AD - Department of Cardiology, Campus Virchow-Klinikum, Charite Universitatsmedizin, Berlin. FAU - Comin Colet, Josep AU - Comin Colet J FAU - Filippatos, Gerasimos AU - Filippatos G FAU - Willenheimer, Ronnie AU - Willenheimer R FAU - Dickstein, Kenneth AU - Dickstein K FAU - Drexler, Helmut AU - Drexler H FAU - Luscher, Thomas F AU - Luscher TF FAU - Bart, Boris AU - Bart B FAU - Banasiak, Waldemar AU - Banasiak W FAU - Niegowska, Joanna AU - Niegowska J FAU - Kirwan, Bridget-Anne AU - Kirwan BA FAU - Mori, Claudio AU - Mori C FAU - von Eisenhart Rothe, Barbara AU - von Eisenhart Rothe B FAU - Pocock, Stuart J AU - Pocock SJ FAU - Poole-Wilson, Philip A AU - Poole-Wilson PA FAU - Ponikowski, Piotr AU - Ponikowski P CN - FAIR-HF Trial Investigators LA - eng SI - ClinicalTrials.gov/NCT00520780 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20091117 PL - United States TA - N Engl J Med JT - The New England journal of medicine JID - 0255562 RN - 0 (Ferric Compounds) RN - 0 (Hematinics) RN - 6897GXD6OE (ferric carboxymaltose) RN - 69-79-4 (Maltose) RN - 9007-73-2 (Ferritins) SB - IM CIN - N Engl J Med. 2009 Dec 17;361(25):2475-7. PMID: 19920053 CIN - Ann Intern Med. 2010 Apr 20;152(8):JC4-5. PMID: 20404374 MH - Aged MH - Anemia, Iron-Deficiency/complications/*drug therapy MH - Chronic Disease MH - Female MH - Ferric Compounds/adverse effects/*therapeutic use MH - Ferritins/blood MH - Follow-Up Studies MH - Heart Failure/blood/complications/*drug therapy/physiopathology MH - Hematinics/adverse effects/*therapeutic use MH - Humans MH - *Iron Deficiencies MH - Male MH - Maltose/adverse effects/*analogs & derivatives/therapeutic use MH - Quality of Life MH - Stroke Volume/drug effects MH - Ventricular Dysfunction, Left/etiology FIR - Anker, S D IR - Anker SD FIR - Ponikowski, P IR - Ponikowski P FIR - Dickstein, K IR - Dickstein K FIR - Filippatos, G S IR - Filippatos GS FIR - Luscher, T F IR - Luscher TF FIR - Willenheimer, R IR - Willenheimer R FIR - Comin Colet, J IR - Comin Colet J FIR - Drexler, H IR - Drexler H FIR - Poole-Wilson, P A IR - Poole-Wilson PA FIR - Wuthrich, R P IR - Wuthrich RP FIR - Lubsen, J IR - Lubsen J FIR - Altamirano, J H IR - Altamirano JH FIR - Taquini, Alberto C IR - Taquini AC FIR - Rodriguez, S V IR - Rodriguez SV FIR - Spinar, J IR - Spinar J FIR - Povolny, J IR - Povolny J FIR - Belohlavek, J IR - Belohlavek J FIR - Paluch, Z IR - Paluch Z FIR - Horak, J IR - Horak J FIR - Anker, S IR - Anker S FIR - Wolf, D IR - Wolf D FIR - Natour, M IR - Natour M FIR - Durak, M IR - Durak M FIR - Manolis, A IR - Manolis A FIR - Nanas, J IR - Nanas J FIR - Kremastinos, D T IR - Kremastinos DT FIR - Alexopoulos, D IR - Alexopoulos D FIR - Volterrani, M IR - Volterrani M FIR - Vescovo, G IR - Vescovo G FIR - Dickstein, K IR - Dickstein K FIR - Mysliwiec, M IR - Mysliwiec M FIR - Dluskiego, K IR - Dluskiego K FIR - Ogorek, M IR - Ogorek M FIR - Kopernika, M IR - Kopernika M FIR - Staneta, P IR - Staneta P FIR - Niegowska, J IR - Niegowska J FIR - Dluzniewski, M IR - Dluzniewski M FIR - Ponikowski, P IR - Ponikowski P FIR - Polonski, L IR - Polonski L FIR - Radoi, M IR - Radoi M FIR - Macarie, C E IR - Macarie CE FIR - Iliescu, C C IR - Iliescu CC FIR - Dan, G A IR - Dan GA FIR - Kikeli, P I IR - Kikeli PI FIR - Pasechnik, E S IR - Pasechnik ES FIR - Eremenko, A A IR - Eremenko AA FIR - Gorbachenkov, A A IR - Gorbachenkov AA FIR - Bragina, A E IR - Bragina AE FIR - Ivleva, A Y IR - Ivleva AY FIR - Bart, B Y IR - Bart BY FIR - Arutyunov, G P IR - Arutyunov GP FIR - Khokhlov, R A IR - Khokhlov RA FIR - Tereschenko, S N IR - Tereschenko SN FIR - Lusov, V A IR - Lusov VA FIR - Ardashev, V N IR - Ardashev VN FIR - Mareev, V Y IR - Mareev VY FIR - Kobalava, Z D IR - Kobalava ZD FIR - Alexeeva, O P IR - Alexeeva OP FIR - Oleynikov, V E IR - Oleynikov VE FIR - Koziolova, N A IR - Koziolova NA FIR - Duplyakov, D V IR - Duplyakov DV FIR - Petrov, A A IR - Petrov AA FIR - Butko, D U IR - Butko DU FIR - Sitnikova, M Y IR - Sitnikova MY FIR - Berkovich, O A IR - Berkovich OA FIR - Boldueva, S A IR - Boldueva SA FIR - Minkin, S R IR - Minkin SR FIR - Kostenko, V A IR - Kostenko VA FIR - Shvarts, Y G IR - Shvarts YG FIR - Karpov, Y B IR - Karpov YB FIR - Nedogoda, S V IR - Nedogoda SV FIR - Bruguera, J IR - Bruguera J FIR - Gonzalez Costello, J IR - Gonzalez Costello J FIR - Martinez Selles, M IR - Martinez Selles M FIR - Quiles Granado, J IR - Quiles Granado J FIR - Koval, O A IR - Koval OA FIR - Ignatenko, G A IR - Ignatenko GA FIR - Kraiz, I G IR - Kraiz IG FIR - Prohorov, O V IR - Prohorov OV FIR - Tseluyko, V I IR - Tseluyko VI FIR - Parkhomenko, O M IR - Parkhomenko OM FIR - Amosova, K M IR - Amosova KM FIR - Rudenko, L V IR - Rudenko LV FIR - Gyrina, O M IR - Gyrina OM FIR - Lishnevska, V Y IR - Lishnevska VY FIR - Pavlyk, S S IR - Pavlyk SS FIR - Kovalsky, I P IR - Kovalsky IP FIR - Popik, G S IR - Popik GS FIR - Telyatnikova, Z Y IR - Telyatnikova ZY FIR - Chopey, I V IR - Chopey IV FIR - Vizir, V A IR - Vizir VA EDAT- 2009/11/19 06:00 MHDA- 2010/01/06 06:00 CRDT- 2009/11/19 06:00 PHST- 2009/11/19 06:00 [entrez] PHST- 2009/11/19 06:00 [pubmed] PHST- 2010/01/06 06:00 [medline] AID - NEJMoa0908355 [pii] AID - 10.1056/NEJMoa0908355 [doi] PST - ppublish SO - N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.