The impact of intravenous ferric carboxymaltose on renal function: An analysis of the FAIR-HF study

European Journal of Heart Failure

Volumn 17, Issue 3, 2015, Pages 329-339

  Ponikowski, Piotr ^a   Filippatos, Gerasimos ^b   Colet, Josep Comin ^c,d   Willenheimer, Ronnie ^e,f   Dickstein, Kenneth ^g,h   Lüscher, Thomas ⁱ   Gaudesius, Giedrius ^j   Von Eisenhart Rothe, Barbara ^j   Mori, Claudio ^j   Greenlaw, Nicola ^k   Ford, Ian ^a   Macdougall, Iain ^l   Anker, Stefan D ^m  

^a WROCLAW MEDICAL UNIVERSITY   (Poland)

^b NATIONAL AND KAPODISTRIAN UNIVERSITY OF ATHENS   (Greece)

^c HOSPITAL DEL MAR   (Spain)

^d UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

^e Heart Health Group   (Sweden)

^f LUND UNIVERSITY   (Sweden)

^g STAVANGER UNIVERSITY HOSPITAL   (Norway)

^h UNIVERSITY OF BERGEN   (Norway)

ⁱ UNIVERSITY HOSPITAL ZURICH   (Switzerland)

^j Vifor (International) Inc   (Switzerland)

^k UNIVERSITY OF GLASGOW   (United Kingdom)

^l KING S COLLEGE HOSPITAL   (United Kingdom)

^m UNIVERSITY MEDICAL CENTER GÖTTINGEN   (Germany)

more..

Author keywords

Chronic heart failure; Ferric carboxymaltose; Iron deficiency; Renal function

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; C REACTIVE PROTEIN; CREATININE; FERRIC CARBOXYMALTOSE; FERRITIN; HEMOGLOBIN; PLACEBO; POTASSIUM; SODIUM; TRANSFERRIN; FERRIC ION; MALTOSE;

AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CHRONIC KIDNEY DISEASE; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; FERRITIN BLOOD LEVEL; FOLLOW UP; GASTROINTESTINAL DISEASE; GLOMERULUS FILTRATION RATE; HEART DISEASE; HEART FAILURE; HEMOGLOBIN BLOOD LEVEL; HUMAN; INFECTION; INFESTATION; INVESTIGATIVE PROCEDURES; IRON DEFICIENCY; KIDNEY DYSFUNCTION; KIDNEY FUNCTION; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MEAN CORPUSCULAR VOLUME; MEDIASTINUM DISEASE; MULTICENTER STUDY; NEW YORK HEART ASSOCIATION CLASS; POTASSIUM BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SIDE EFFECT; SODIUM BLOOD LEVEL; THORAX DISEASE; TRANSFERRIN BLOOD LEVEL; UREA NITROGEN BLOOD LEVEL; VASCULAR DISEASE; VITAL SIGN; ANALOGS AND DERIVATIVES; ANEMIA, IRON-DEFICIENCY; CLINICAL TRIAL; INTRAVENOUS DRUG ADMINISTRATION; KIDNEY; MIDDLE AGED; PATHOPHYSIOLOGY; RENAL INSUFFICIENCY; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANEMIA, IRON-DEFICIENCY; DOUBLE-BLIND METHOD; FEMALE; FERRIC COMPOUNDS; GLOMERULAR FILTRATION RATE; HEART FAILURE; HUMANS; INFUSIONS, INTRAVENOUS; KIDNEY; MALE; MALTOSE; MIDDLE AGED; RENAL INSUFFICIENCY;

EID: 84924333555     PISSN: 13889842     EISSN: 18790844     Source Type: Journal    
DOI: 10.1002/ejhf.229     Document Type: Article

References (51)

1. Ronco C, McCullough P, Anker SD, Anand I, Aspromonte N, Bagshaw SM, Bellomo R, Berl T, Bobek I, Cruz DN, Daliento L, Davenport A, Haapio M, Hillege H, House AA, Katz N, Maisel A, Mankad S, Zanco P, Mebazaa A, Palazzuoli A, Ronco F, Shaw A, Sheinfeld G, Soni S, Vescovo G, Zamperetti N, Ponikowski P, Acute Dialysis Quality Initiative Consensus Group. Cardio-renal syndromes: report from the consensus conference of the acute dialysis quality initiative. Eur Heart J 2010; 31: 703-711.
2. Hillege HL, Nitsch D, Pfeffer MA, Swedberg K, McMurray JJ, Yusuf S, Granger CB, Michelson EL, Ostergren J, Cornel JH, de Zeeuw D, Pocock S, van Veldhuisen DJ,. Candesartan in Heart Failure: Assessment of Reduction in Mortality Morbidity Investigators. Renal function as a predictor of outcome in a broad spectrum of patients with heart failure. Circulation 2006; 113: 671-678.
3. McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A, Task Force for the Diagnosis, Treatment of Acute Chronic Heart Failure of the European Society of Cardiology, Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, McDonagh T, Sechtem U, Bonet LA, Avraamides P, Ben Lamin HA, Brignole M, Coca A, Cowburn P, Dargie H, Elliott P, Flachskampf FA, Guida GF, Hardman S, Iung B, Merkely B, Mueller C, Nanas JN, Nielsen OW, Orn S, Parissis JT, Ponikowski P, ESC Committee for Practice Guidelines. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: the Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail 2012; 14: 803-869.
4. Silverberg DS, Wexler D, Iaina A,. The importance of anemia and its correction in the management of severe congestive heart failure. Eur J Heart Fail 2002; 4: 681-686.
5. van Veldhuisen DJ, Anker SD, Ponikowski P, Macdougall IC,. Anemia and iron deficiency in heart failure: mechanisms and therapeutic approaches. Nat Rev Cardiol 2011; 8: 485-493.
6. KDOQI; National Kidney Foundation. II. Clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease in adults. Am J Kidney Dis 2006; 47 (5 Suppl 3): S11-S145.
7. Mircescu G, Gârneata L, Capusa C, Ursea N,. Intravenous iron supplementation for the treatment of anaemia in pre-dialyzed chronic renal failure patients. Nephrol Dial Transplant 2006; 21: 120-124.
8. Toblli JE, Lombraña A, Duarte P, Di Gennaro F,. Intravenous iron reduces NT-pro-brain natriuretic peptide in anemic patients with chronic heart failure and renal insufficiency. J Am Coll Cardiol 2007; 50: 1657-1665.
9. Opasich C, Cazzola M, Scelsi L, De Feo S, Bosimini E, Lagioia R, Febo O, Ferrari R, Fucili A, Moratti R, Tramarin R, Tavazzi L,. Blunted erythropoietin production and defective iron supply for erythropoiesis as major causes of anaemia in patients with chronic heart failure. Eur Heart J 2005; 26: 2232-2237.
10. Nanas JN, Matsouka C, Karageorgopoulos D, Leonti A, Tsolakis E, Drakos SG, Tsagalou EP, Maroulidis GD, Alexopoulos GP, Kanakakis JE, Anastasiou-Nana MI,. Etiology of anemia in patients with advanced heart failure. J Am Coll Cardiol 2006; 48: 2485-2489.
11. Jankowska EA, Rozentryt P, Witkowska A, Nowak J, Hartmann O, Ponikowska B, Borodulin-Nadzieja L, Banasiak W, Polonski L, Filippatos G, McMurray JJ, Anker SD, Ponikowski P,. Iron deficiency: an ominous sign in patients with systolic chronic heart failure. Eur Heart J 2010; 31: 1872-1880.
12. Klip IT, Comin-Colet J, Voors AA, Ponikowski P, Enjuanes C, Banasiak W, Lok DJ, Rosentryt P, Torrens A, Polonski L, van Veldhuisen DJ, van der Meer P, Jankowska EA,. Iron deficiency in chronic heart failure: an international pooled analysis. Am Heart J 2013; 165: 575-582.
13. Okonko DO, Mandal AK, Missouris CG, Poole-Wilson PA,. Disordered iron homeostasis in chronic heart failure: prevalence, predictors, and relation to anemia, exercise capacity, and survival. J Am Coll Cardiol 2011; 58: 1241-1251.
14. Jankowska EA, Rozentryt P, Witkowska A, Nowak J, Hartmann O, Ponikowska B, Borodulin-Nadzieja L, von Haehling S, Doehner W, Banasiak W, Polonski L, Filippatos G, Anker SD, Ponikowski P,. Iron deficiency predicts impaired exercise capacity in patients with systolic chronic heart failure. J Card Fail 2011; 17: 899-906.
15. Comín-Colet J, Enjuanes C, González G, Torrens A, Cladellas M, Meroño O, Ribas N, Ruiz S, Gõmez M, Verdú JM, Bruguera J,. Iron deficiency is a key determinant of health-related quality of life in patients with chronic heart failure regardless of anaemia status. Eur J Heart Fail 2013; 15: 1164-1172.
16. Anker SD, Colet JC, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Lüscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart RB, Pocock SJ, Poole-Wilson PA, Ponikowski P, for the FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med 2009; 361: 2436-2448.
17. Bolger AP, Bartlett FR, Penston HS, O'Leary J, Pollock N, Kaprielian R, Chapman CM,. Intravenous iron alone for the treatment of anemia in patients with chronic heart failure. J Am Coll Cardiol 2006; 48: 1225-1227.
18. Okonko DO, Grzeslo A, Witkowski T, Mandal AK, Slater RM, Roughton M, Foldes G, Thum T, Majda J, Banasiak W, Missouris CG, Poole-Wilson PA, Anker SD, Ponikowski P,. Effect of intravenous iron sucrose on exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure and iron deficiency FERRIC-HF: a randomized, controlled, observer-blinded trial. J Am Coll Cardiol 2008; 51: 103-112.
19. Dunn LL, Rahmanto YS, Richardson DR,. Iron uptake and metabolism in the new millennium. Trends Cell Biol 2007; 17: 93-100.
20. Cairo G, Bernuzzi F, Recalcati S,. A precious metal: iron, an essential nutrient for all cells. Genes Nutr 2006; 1: 25-39.
21. Beard JL,. Iron biology in immune function, muscle metabolism and neuronal functioning. J Nutr 2001; 131 (Suppl 2): 568S-579S.
22. Agarwal R, Vasavada N, Sachs NG, Chase S,. Oxidative stress and renal injury with intravenous iron in patients with chronic kidney disease. Kidney Int 2004; 65: 2279-2289.
23. Anker SD, Colet JC, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Lüscher TF, Mori C, von Eisenhart Rothe B, Pocock S, Poole-Wilson PA, Ponikowski P, FAIR-HF committees and investigators. Rationale and design of Ferinject assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia. Eur J Heart Fail 2009; 11: 1084-1091.
24. Ganzoni AM,. Intravenous iron-dextran: therapeutic and experimental possibilities. Schweiz Med Wochenschr 1970; 100: 301-303 [in German].
25. Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF III, Feldman HI, Kusek JW, Eggers P, Van Lente F, Greene T, Coresh J,. CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). A new equation to estimate glomerular filtration rate. Ann Intern Med 2009; 150: 604-612.
26. National Kidney Foundation. Kidney disease outcomes quality initiative-clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. 2009; http://www.kidney.org/professionals/kdoqi/guidelines-ckd/p4-class-g1.htm.
27. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D,. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999; 130: 461-470.
28. Padala S, Tighiouart H, Inker LA, Contreras G, Beck GJ, Lewis J, Steffes M, Rodby RA, Schmid CH, Levey AS,. Accuracy of a GFR estimating equation over time in people with a wide range of kidney function. Am J Kidney Dis 2012; 60: 217-224.
29. Valente MA, Hillege HL, Navis G, Voors AA, Dunselman PH, van Veldhuisen DJ, Damman K,. The Chronic Kidney Disease Epidemiology Collaboration equation outperforms the Modification of Diet in Renal Disease equation for estimating glomerular filtration rate in chronic systolic heart failure. Eur J Heart Fail 2014; 16: 86-94.
30. Green CP, Porter CB, Bresnahan DR, Spertus JA,. Development and evaluation of the Kansas City Cardiomyopathy questionnaire: a new health status measure for heart failure. J Am Coll Cardiol 2000; 35: 1245-1255.
31. Rabin R, de Charro F,. EQ-5D: a measure of health status from the EuroQol Group. Ann Med 2001; 33: 337-343.
32. McCullagh P,. Regression models for ordinal data (with discussion). J R Stat Soc B 1980; 42: 109-142.
33. Smith GL, Lichtman JH, Bracken MB, Shlipak MG, Phillips CO, DiCapua P, Krumholz HM,. Renal impairment and outcomes in heart failure: systematic review and meta-analysis. J Am Coll Cardiol 2006; 47: 1987-1996.
34. Davenport A, Anker SD, Mebazaa A, Palazzuoli A, Vescovo G, Bellomo R, Ponikowski P, Anand I, Aspromonte N, Bagshaw S, Berl T, Bobek I, Cruz DN, Daliento L, Haapio M, Hillege H, House A, Katz N, Maisel A, Mankad S, McCullough P, Ronco F, Shaw A, Sheinfeld G, Soni S, Zamperetti N, Zanco P, Ronco C,. Acute Dialysis Quality Initiative (ADQI) consensus group. ADQI 7: the clinical management of the Cardio-Renal syndromes: work group statements from the 7th ADQI consensus conference. Nephrol Dial Transplant 2010; 25: 2077-2089.
35. Weiss G,. Iron metabolism in the anemia of chronic disease. Biochim Biophys Acta 2009; 1790: 682-693.
36. Filippatos G, Farmakis D, Colet JC, Dickstein K, Lüscher TF, Willenheimer R, Parissis J, Gaudesius G, Mori C, von Eisenhart RB, Greenlaw N, Ford I, Ponikowski P, Anker SD,. Intravenous ferric carboxymaltose in iron-deficient chronic heart failure patients with and without anaemia: a subanalysis of the FAIR-HF trial. Eur J Heart Fail 2011; 15: 1267-1276.
37. Walker PD, Shah SV,. Evidence suggesting a role for hydroxyl radical in gentamicin-induced acute renal failure in rats. J Clin Invest 1988; 81: 334-341.
38. Paller MS, Hedlund BE,. Role of iron in postischemic renal injury in the rat. Kidney Int 1988; 34: 474-480.
39. Bishu K, Agarwal R,. Acute injury with intravenous iron and concerns regarding long-term safety. Clin J Am Soc Nephrol 2006; 1 (Suppl 1): S19-S23.
40. Hayat A,. Safety issues with intravenous iron products in the management of anemia in chronic kidney disease. Clin Med Res 2008; 6: 93-102.
41. Hasin T, Topilsky Y, Schirger JA, Li Z, Zhao Y, Boilson BA, Clavell AL, Rodeheffer RJ, Frantz RP, Edwards BS, Pereira NL, Joyce L, Daly R, Park SJ, Kushwaha SS,. Changes in renal function after implantation of continuous-flow left ventricular assist devices. J Am Coll Cardiol 2012; 59: 26-36.
42. Garg N, Thomas G, Jackson G, Rickard J, Nally JV Jr, Tang WH, Navaneethan SD,. Cardiac resynchronization therapy in CKD: a systematic review. Clin J Am Soc Nephrol 2013; 8: 1293-1303.
43. Vaduganathan M, Gheorghiade M,. Return of digoxin and recovery of renal function. J Card Fail 2013; 19: 303-305.
44. Smilde TD, van Veldhuisen DJ, Navis G, Voors AA, Hillege HL,. Drawbacks and prognostic value of formulas estimating renal function in patients with chronic heart failure and systolic dysfunction. Circulation 2006; 114: 1572-1580.
45. Stevens LA, Greene T, Levey AS,. Surrogate end points for clinical trials of kidney disease progression. Clin J Am Soc Nephrol 2006; 1: 874-884.
46. Wright JT, Bakris G, Greene T, Agodoa L, Appel LJ, Charleston J, Cheek D, Douglas-Baltimore JG, Gassman J, Glassock R, Hebert L, Jamerson K, Lewis J, Phillips RA, Toto RD, Middleton JP, Rostand SG, African American Study of Kidney Disease and Hypertension Study Group. Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial. JAMA 2002; 288: 2421-2431.
47. McMahon LP, Kent AB, Kerr PG, Healy H, Irish AB, Cooper B, Kark A, Roger SD,. Maintenance of elevated versus physiological iron indices in non-anaemic patients with chronic kidney disease: a randomized controlled trial. Nephrol Dial Transplant 2010; 25: 920-926.
48. Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S, for the United States Iron Sucrose (Venofer) Clinical Trials Group. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int 2005; 68: 2846-2856.
49. Tokmakova MP, Skali H, Kenchaiah S, Braunwald E, Rouleau JL, Packer M, Chertow GM, Moyé LA, Pfeffer MA, Solomon SD,. Chronic kidney disease, cardiovascular risk, and response to angiotensin-converting enzyme inhibition after myocardial infarction: the Survival And Ventricular Enlargement (SAVE) study. Circulation 2004; 110: 3667-3673.
50. Ghali JK, Wikstrand J, Van Veldhuisen DJ, Fagerberg B, Goldstein S, Hjalmarson A, Johansson P, Kjekshus J, Ohlsson L, Samuelsson O, Waagstein F, Wedel H, MERIT-HF Study Group. The influence of renal function on clinical outcome and response to beta-blockade in systolic heart failure: insights from Metoprolol CR/XL Randomized Intervention Trial in Chronic HF (MERIT-HF). J Card Fail 2009; 15: 310-318.
51. Cohen-Solal A, Kotecha D, van Veldhuisen DJ, Babalis D, Böhm M, Coats AJ, Roughton M, Poole-Wilson P, Tavazzi L, Flather M, SENIORS Investigators. Efficacy and safety of nebivolol in elderly heart failure patients with impaired renal function: insights from the SENIORS trial. Eur J Heart Fail 2009; 11: 872-880.