Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency

被引：888

作者：

Ponikowski, Piotr ^{[1
]}

van Veldhuisen, Dirk J. ^{[2
,3
]}

Comin-Colet, Josep ^{[4
]}

Ertl, Georg ^{[5
,6
]}

Komajda, Michel ^{[7
]}

Mareev, Viacheslav ^{[8
]}

McDonagh, Theresa ^{[9
]}

Parkhomenko, Alexander ^{[10
]}

Tavazzi, Luigi ^{[11
]}

Levesque, Victoria ^{[12
]}

Mori, Claudio ^{[12
]}

Roubert, Bernard ^{[12
]}

Filippatos, Gerasimos ^{[13
]}

Ruschitzka, Frank ^{[14
]}

Anker, Stefan D. ^{[15
]}

机构：

[1] Med Univ, Dept Heart Dis, Wroclaw, Poland

[2] Clin Mil Hosp, Ctr Heart Dis, Dept Cardiol, Wroclaw, Poland

[3] Univ Groningen, Univ Med Ctr Groningen, Dept Cardiol, Groningen, Netherlands

[4] Hosp Mar Med Res Inst, IMIM, Heart Dis Biomed Res Grp, Barcelona, Spain

[5] Univ Hosp Wurzburg, Dept Internal Med 1, Wurzburg, Germany

[6] Univ Wurzburg, Comprehens Heart Failure Ctr, D-97070 Wurzburg, Germany

[7] CHU Pitie Salpetriere, Inst Cardiol, Paris, France

[8] Moscow MV Lomonosov State Univ, Moscow, Russia

[9] Kings Coll London, Dept Cardiol, London SE5 9RS, England

[10] Ukranian Strazhesko Inst Cardiol, UA-03151 Kiev, Ukraine

[11] GVM Care & Res ES Hlth Sci Fdn, Maria Cecilia Hosp, Cotignola, Italy

[12] Vifor Pharma, Glattbrugg, Switzerland

[13] Univ Athens, Hosp Attikon, Athens, Greece

[14] Univ Zurich Hosp, Dept Cardiol, Zurich, Switzerland

[15] Univ Med Ctr Gottingen, Dept Innovat Clin Trials, Gottingen, Germany

来源：

EUROPEAN HEART JOURNAL | 2015年 / 36卷 / 11期

关键词：

Heart failure; Iron deficiency; Ferric carboxymaltose; EXERCISE CAPACITY; WALK TEST; ANEMIA; HOMEOSTASIS; HF; HOSPITALIZATION; SURVIVAL; TRIAL; RISK;

D O I：

10.1093/eurheartj/ehu385

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Aim The aim of this study was to evaluate the benefits and safety of long-term i.v. iron therapy in iron-deficient patients with heart failure (HF). Methods and results CONFIRM-HF was a multi-centre, double-blind, placebo-controlled trial that enrolled 304 ambulatory symptomatic HF patients with left ventricular ejection fraction <= 45%, elevated natriuretic peptides, and iron deficiency (ferritin < 100 ng/mL or 100-300 ng/mL if transferrin saturation < 20%). Patients were randomized 1 : 1 to treatment with i.v. iron, as ferric carboxymaltose (FCM, n = 152) or placebo (saline, n = 152) for 52 weeks. The primary end-point was the change in 6-min-walk-test (6MWT) distance from baseline to Week 24. Secondary end-points included changes in New York Heart Association (NYHA) class, Patient Global Assessment (PGA), 6MWT distance, health-related quality of life (QoL), Fatigue Score at Weeks 6, 12, 24, 36, and 52 and the effect of FCM on the rate of hospitalization for worsening HF. Treatment with FCM significantly prolonged 6MWT distance at Week 24 (difference FCM vs. placebo: 33 +/- 11 m, P = 0.002). The treatment effect of FCM was consistent in all subgroups and was sustained to Week 52 (difference FCM vs. placebo: 36 +/- 11 m, P < 0.001). Throughout the study, an improvement in NYHA class, PGA, QoL, and Fatigue Score in patients treated with FCM was detected with statistical significance observed from Week 24 onwards. Treatment with FCM was associated with a significant reduction in the risk of hospitalizations for worsening HF [hazard ratio (95% confidence interval): 0.39 (0.19-0.82), P = 0.009]. The number of deaths (FCM: 12, placebo: 14 deaths) and the incidence of adverse events were comparable between both groups. Conclusion Treatment of symptomatic, iron-deficient HF patients with FCM over a 1-year period resulted in sustainable improvement in functional capacity, symptoms, and QoL and may be associated with risk reduction of hospitalization for worsening HF.

引用

页码：657 / 668

页数：12