The impact of intravenous ferric carboxymaltose on renal function: An analysis of the FAIR-HF study
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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/1.73m2), 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/1.73m2, 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/1.73m2 (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/1.73m2.
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.