1. Risk of hospital admission was lower in the ferric derisomaltose group versus usual care.
2. Treatment-related adverse events were comparable between both groups, with no deaths.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Iron deficiency is a common complication in patients with heart failure and may lead to worse clinical outcomes. Limited research exists surrounding the use of iron supplementation among patients with cardiac comorbidities. This randomized controlled trial aimed to assess the safety and efficacy of ferric derisomaltose in patients with heart failure with reduced ejection fractions. The primary outcome was heart failure-associated hospital admission and cardiovascular death. Patients were randomly assigned to either the ferric derisomaltose or usual care groups. According to results, ferric derisomaltose resulted in decreased risk of hospitalizations and death, although this was not statistically significant. There were no significant differences between groups regarding treatment-related adverse events or blood transfusion requirements. This study was strengthened by a large sample size with longitudinal follow-up over few years, thus increasing its validity.
Click to read the study in The Lancet
Relevant Reading: Ferric carboxymaltose for iron deficiency at discharge after acute heart failure: a multicentre, double-blind, randomised, controlled trial
In-depth [randomized-controlled trial]: Between Aug 25, 2016, and Oct 15, 2021, 1869 patients were assessed for eligibility from 70 hospitals in the UK. Included were patients ≥ 18 years old with heart failure (ejection fraction ≤ 45%), transferrin saturation < 20%, and serum ferritin < 100 ug/L. Altogether, 1137 patients (569 in ferric derisomaltose group and 568 in usual care group) were included in the final analysis. The primary outcome of recurrent hospital admissions was lower in the ferric derisomaltose group (22.4 per 100 patient-years) compared to usual care group (27.5 per 100 patient-years), although this was not statistically significant (rate ratio [RR] 0.82, 95% confidence interval [CI] 0.66 to 1.02, p=0.070). This was also the case for serious cardiac events (36% in ferric derisomaltose vs. 43% in usual care, 95% CI -12.69 to -1.32, p=0.016). With regard to treatment-related adverse events, both groups were comparable with no known deaths or infection-related hospitalizations. Overall, findings from this study suggest that ferric derisomaltose resulted in fewer heart failure-related hospital admissions and deaths.
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