Uso de Derisomaltosa Férrica en Insuficiencia Cardíaca: Revisión de Alcance

Sofía Suárez Sánchez
Departamento de Investigación, Hospital Clínica Bíblica, San José.

Esteban Zavaleta Monestel
Departamento de Farmacia, Hospital Clínica Bíblica, San José.

Jeaustin Arón Mora Jiménez
Departamento de Farmacia, Hospital Clínica Bíblica, San José.

Kevin Cruz Mora
Departamento de Farmacia, Hospital Clínica Bíblica, San José.

Sebastián Arguedas Chacón
Departamento de Investigación, Hospital Clínica Bíblica, San José.

Resumen

Introducción: La deficiencia de hierro (ID) es una comorbilidad frecuente en pacientes con insuficiencia cardíaca (IC) y se asocia con una peor calidad de vida, un mayor riesgo de hospitalización y una mayor mortalidad, incluso en ausencia de anemia. El hierro intravenoso ha emergido como una estrategia terapéutica eficaz; la derisomaltosa férrica (FDI) es una formulación moderna con ventajas en términos de seguridad y de perfil farmacológico.

Objetivo: Mapear la literatura existente sobre el uso de la derisomaltosa férrica en IC, evaluar su eficacia clínica, seguridad y rol terapéutico, e identificar brechas de conocimiento y estudios en curso.

Métodos: Se realizó una revisión de alcance (scoping review) según la guía PRISMA-ScR. Se incluyeron ensayos clínicos aleatorizados, análisis post hoc y revisiones sistemáticas y metaanálisis sobre el hierro intravenoso en IC con ID, publicados hasta el 8 de abril de 2025.

Resultados: La mayor parte de la evidencia sobre FDI proviene del ensayo IRONMAN y de sus análisis post hoc, mientras que el beneficio “consistente” en la reducción de hospitalizaciones por IC se observa al considerar conjuntamente los ensayos con hierro intravenoso (principalmente FCM y FDI). En estos estudios, el hierro IV se asocia de forma robusta con una disminución de las hospitalizaciones por IC y una mejoría clínicamente relevante de la calidad de vida, sin demostrar una reducción significativa de la mortalidad. Los análisis post hoc sugieren que los subgrupos con deficiencia de hierro más severa (TSAT <20%) y los pacientes de mayor edad podrían obtener un beneficio mayor. En comparación con la carboximaltosa férrica (FCM), el FDI presenta un menor riesgo de hipofosfatemia.

Conclusiones: La evidencia disponible respalda el uso de hierro intravenoso como estrategia eficaz para reducir hospitalizaciones por IC y mejorar la calidad de vida en pacientes con deficiencia de hierro; para FDI, este beneficio se sustenta principalmente en IRONMAN y en sus análisis posteriores. No se ha demostrado una reducción significativa de la mortalidad, por lo que se requieren estudios adicionales enfocados en desenlaces duros y poblaciones específicas.

Palabras claves

Insuficiencia cardíaca, deficiencia de hierro, compuestos férricos, infusiones intravenosas, calidad de vida.

Abstract

Introduction: Iron deficiency (ID) is a frequent comorbidity in patients with heart failure (HF) and is associated with worse quality of life, higher risk of hospitalization, and increased mortality, even in the absence of anemia. Intravenous iron has emerged as an effective therapeutic strategy; Ferric Derisomaltose (FDI) is a modern formulation with advantages in terms of safety and pharmacological profile.

Objective: To map the existing literature on the use of Ferric Derisomaltose in HF, evaluating its clinical efficacy, safety, and therapeutic role, and to identify knowledge gaps and ongoing studies.

Methods: We conducted a scoping review in accordance with PRISMA-ScR guidelines. Randomized clinical trials, post hoc analyses, and systematic reviews/meta-analyses of intravenous iron in HF with ID published up to April 8, 2025, were included.

Results: Most of the specific evidence for FDI comes from the IRONMAN trial and its associated post hoc analyses, whereas the consistent benefit in reducing HF hospitalizations is observed when considering the overall body of trials of intravenous iron (mainly FCM and FDI). Across these studies, IV iron is robustly associated with fewer HF hospitalizations and clinically meaningful improvements in quality of life, without a significant reduction in mortality. Post hoc analyses suggest that patients with more severe iron deficiency (TSAT <20%) and older age groups may derive greater benefit. Compared with Ferric Carboxymaltose (FCM), FDI shows a lower risk of hypophosphatemia.

Conclusions: Current evidence supports IV iron as an effective strategy to reduce HF hospitalizations and improve quality of life in patients with iron deficiency; for FDI, this signal relies largely on IRONMAN and its subsequent analyses. No significant reduction in mortality has been demonstrated, underscoring the need for additional studies focused on hard outcomes and specific HF phenotypes.

Keywords

Heart Failure, Iron Deficiency, Ferric Compounds, Infusions, Intravenous, Quality of Life.

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