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

Ponikowski, Piotr; Filippatos, Gerasimos; Comín Colet, Josep; Willenheimer, Ronnie; Dickstein, Kenneth; Lüscher, Thomas F.; Gaudesius, Giedrius; von Eisenhart Rothe, Barbara; Mori, Claudio; Greenlaw, Nicola; Ford, Ian; Macdougall, Iain; Anker, Stefan D.; FAIR-HF Trial Investigators

doi:http://dx.doi.org/10.1002/ejhf.229

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

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Ponikowski P, Filippatos G, Colet JC, Willenheimer R, Dickstein K, Lüscher T. et al. The impact of intravenous ferric carboxymaltose on renal function: an analysis of the FAIR-HF study. Eur J Heart Fail. 2015 Mar;17(3):329-39. doi: 10.1002/ejhf.229.

Abstract

AIMS: Anaemia and iron deficiency are constituents of the cardio-renal syndrome in chronic heart failure (CHF). We investigated the effects of i.v. iron in iron-deficient CHF patients on renal function, and the efficacy and safety of this therapy in patients with renal dysfunction. METHODS AND RESULTS: The FAIR-HF trial randomized 459 CHF patients with iron deficiency (ferritin <100 µg/L, or between 100 and 299 µg/L if transferrin saturation was <20%): 304 to i.v. ferric carboxymaltose (FCM) and 155 to placebo, and followed-up for 24 weeks. Renal function was assessed at baseline and at weeks 4, 12, and 24, using the estimated glomerular filtration rate (eGFR, mL/min/1.73 m(2) ), calculated from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. At baseline, renal function was similar between groups (62.4 ± 20.6 vs. 62.9 ± 23.4 mL/min/1.73 m(2) , FCM vs. placebo). Compared with placebo, treatment with FCM was associated with an increase in eGFR [treatment effect: week 4, 2.11 ± 1.21 (P = 0.082); week 12, 2.41 ± 1.33 (P = 0.070); and week 24, 2.98 ± 1.44 mL/min/1.73 m(2) (P = 0.039)]. This effect was seen in all pre-specified subgroups (P > 0.20 for interactions). No interaction between the favourable effects of FCM and baseline renal function was seen for the primary endpoints [improvement in Patient Global Assessment (P = 0.43) and NYHA class (P = 0.37) at 24 weeks]. Safety and adverse event profiles were similar in patients with baseline eGFR <60 and ≥60 mL/min/1.73 m(2) . CONCLUSIONS: Treatment of iron deficiency in CHF patients with i.v. FCM was associated with an improvement in renal function. FCM therapy was effective and safe in CHF patients with renal dysfunction.