This 56-week, open-label, multicentre randomised trial compared intravenous ferric carboxymaltose (FCM) targeting a higher (400-600 µg/L) or lower (100-200 µg/L) serum ferritin level or oral iron therapy in 626 patients with non-dialysis-dependent chronic kidney disease, anaemia and iron deficiency not receiving erythropoiesis-stimulating agents.
The primary end point, time to initiation of other anaemia management or two consecutive values <10 g/dL during weeks 8-52, occurred in 23.5%, 32.2% and 31.8% of the patients in the high-ferritin FCM, low-ferritin FCM and oral iron groups. The difference between high-ferrtin FCM and oral iron was statistically significant (hazard ratio, 0.65; 95% CI, 0.44-0.95; P = 0.026), with a number needed to treat of 12. The increase in Hb was greater with high-ferritin FCM than with oral iron (P = 0.014) and a greater proportion of patients achieved an Hb increase of 1 g/dL or greater with high-ferritin FCM than with oral iron (hazard ratio 2.04; 95% CI, 1.52-2.72; P < 0.001). Rates of adverse events and serious adverse events were similar in all groups. No differences were observed with regard to infections, cardiovascular disease and renal toxicity.
The results of this study are highly statistically significant and should put the final shroud on the relative benefits of intravenous iron compared with oral iron in chronic kidney disease patients not on dialysis. Unlike the conjectures made from observational studies, this prospective study provides convincing evidence.
– Michael Auerbach
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