Results of a subanalysis from the FAIR-HF (Ferinject(R) Assessment in patients with IRon deficiency and Chronic Heart Failure) study demonstrate that correcting iron deficiency with Ferinject(R) (ferric carboxymaltose) can improve renal function in chronic heart failure patients. Ferinject(R) is an intravenous (i.v.) iron product used to treat iron deficiency and iron deficiency anaemia. These results were now presented at the Heart Failure Association's Late Breaking Clinical Trials Session in Berlin, Germany, by Dr. Piotr Ponikowski, Professor of Cardiology from Wroclaw, Poland.
The authors of the FAIR-HF studied the effects of Ferinject(R) (ferric carboxymaltose) on renal function in iron deficient, anaemic or non-anaemic patients with chronic heart failure (CHF). Renal dysfunction commonly complicates the natural course of CHF as it makes patients susceptible to more severe symptoms and increases the risk of hospitalisation and death. Current CHF therapies appear to have little or no beneficial effect on declining renal function due to CHF.
"The results of the subanalysis are exciting findings for cardiologists and nephrologists who treat these patients, and need to be investigated further," said Dr. Piotr Ponikowski, Professor of Cardiology at the Medical University in Wroclaw, Poland. "Many patients with CHF have renal dysfunction which is strongly related to poor health outcomes. None of the therapies used currently or recommended for CHF patients have a favourable effect on renal function. Thus, there is great interest in treatments which may have renoprotective properties."
In total, 459 patients with CHF and iron deficiency were studied in 75 sites around the world. Two-thirds of the patients received Ferinject(R) weekly until the iron deficiency was reversed, with monthly treatment (maintenance phase) thereafter until week 24. The remaining patients received a placebo. Renal function was evaluated by assessing the estimated glomerular filtration rate (eGFR) at baseline and throughout the study (at weeks 4, 12 and 24). Increased eGFR corresponds to increased renal function, i.e. improvement.
At study weeks 4, 12 and 24, eGFR was found to be increased in patients receiving Ferinject(R), compared to a small decrease in renal function in the placebo group. At the end of the study, eGFR had increased by a mean of 3.2 ml/min/1.73m2 from baseline in Ferinject(R)-treated patients, whereas in the placebo group, eGFR was reduced by 0.6 ml/min/1.73m2. The difference between the Ferinject(R) and placebo groups was statistically significant (p = 0.017 at week 24). These improvements in eGFR were seen as early as week 4 of the study. The response to Ferinject(R) was independent of the level of renal function at the start of the study, age, sex, CHF severity, or the presence of anaemia.
35% of patients treated with Ferinject(R) achieved an increase in eGFR of more than 5 ml/min/1.73m2, which is considered to be clinically meaningful, whilst 32% of patients on placebo showed a decline in eGFR of more than 5ml/min/1.73m2. Dr. Iain Macdougall, of King's College Hospital, London, United Kingdom, commented: "There has been increasing interest and collaboration among nephrologists and cardiologists in elucidating the causes and improving the management of the cardio-renal anaemia syndrome. The synergy between the heart and the kidney is now well-recognised, and any impact on heart function appears to impact kidney function, and vice versa." He added: "The data presented here continue on this theme and show that intravenous iron therapy may be able to improve the function of both organs simultaneously. Further elucidation of the mechanisms involved are required."
SOURCE Vifor Pharma