Safety and effectiveness of sucroferric oxyhydroxide in Spanish patients on dialysis: sub-analysis of the VERIFIE study.

Fecha de publicación: 01/09/2022 Fecha Ahead of Print: 02/02/2023

Autores de IDIVAL

Ángel Luis Martín De Francisco Hernández

Autor

Autores ajenos al IDIVAL

Bajo MA
Ríos-Moreno F
Arenas MD
Devesa-Such RJ
Molina-Higueras MJ
Delgado M
Molina P
García-Fernández N
Martin-Malo A
Peiró-Jordán R
Cannata-Andia J
en representación del Grupo VERIFIE español

Abstract

BACKGROUND AND AIMS: In this study, we show the results of the subset of Spanish patients of the VERIFIE study, the first post-marketing study assessing the long-term safety and effectiveness of sucroferric oxyhydroxide (SFOH) in patients with hyperphosphatemia undergoing dialysis during clinical practice. PATIENTS AND METHODS: Patients undergoing hemodialysis and peritoneal dialysis with indication of SFOH treatment were included. Follow-up duration was 12-36 months after SFOH initiation. Primary safety variables were the incidence of adverse drug reactions (ADRs), medical events of special interest (MESIs), and variations in iron-related parameters. SFOH effectiveness was evaluated by the change in serum phosphorus levels. RESULTS: A total of 286 patients were recruited and data from 282 were analyzed. Among those 282 patients, 161 (57.1%) withdrew the study prematurely and 52.5% received concomitant treatment with other phosphate binders. ADRs were observed in 35.1% of patients, the most common of which were gastrointestinal disorders (77.1%) and mild/moderate in severity (83.7%). MESIs were reported in 14.2% of patients, and 93.7% were mild/moderate. An increase in ferritin (386.66ng/mL vs 447.55ng/mL; p=0.0013) and transferrin saturation (28.07% vs 30.34%; p=0.043) was observed from baseline to the last visit (p=0.0013). Serum phosphorus levels progressively decreased from 5.69mg/dL at baseline to 4.84mg/dL at the last visit (p<0.0001), increasing by 32.2% the proportion of patients who achieved serum phosphorus levels =5.5mg/dL, with a mean daily SFOH dose of 1.98 pills/day. CONCLUSIONS: SFOH showed a favorable effectiveness profile, a similar safety profile to that observed in the international study with most adverse events of mild/moderate severity, and a low daily pill burden in Spanish patients in dialysis.

Datos de la publicación

ISSN/ISSNe:: 2013-2514, 2013-2514
Tipo:: Article
Páginas:: 594-606
DOI:: 10.1016/j.nefroe.2021.04.012
PubMed:: 36739246

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Filiaciones

Bajo MA:: Hospital Universitario La Paz, Madrid, Instituto de Investigación Sanitaria del HULP (IdiPAZ), Madrid, Spain

Red de Investigación Renal (REDINREN) del Instituto de Salud Carlos III, Universidad Autónoma Madrid, Madrid, Spain. Electronic address:
Ríos-Moreno F:: Fresenius Medical Care San Luciano, Madrid, Spain
Arenas MD:: Hospital Vithas Perpetuo Socorro, Alicante, Spain

Hospital del Mar, Barcelona, Spain
Devesa-Such RJ:: Servicio de Nefrología, Hospital Universitari y Politècnic La Fe, Valencia, Spain
Molina-Higueras MJ:: Centro de Hemodiálisis Nefrolinares, Linares, Jaén, Spain
Delgado M:: Hospital Quiron Salud La Coruña, La Coruña, Spain
Molina P:: Hospital Doctor Peset, Valencia, FISABIO, Valencia, Spain

Departamento de Medicina de la Universitat de València, Valencia, Spain
García-Fernández N:: Departamento de Nefrología, Clínica Universidad de Navarra, Pamplona, Spain

Instituto de Investigación Sanitaria de Navarra (IDISNA), Pamplona, Spain
Martin-Malo A:: Hospital Universitario Reina Sofía, IMIBIC, REDinREN, Córdoba, Spain

Universidad de Córdoba, Córdoba, Spain
Peiró-Jordán R:: Vifor Pharma España S.L., Barcelona, Spain
Cannata-Andia J:: Universidad de Oviedo, Oviedo, Spain
Martín-de Francisco ÁL:: Hospital Marqués de Valdecilla, Santander, Spain

Keywords

Captor de fósforo; Clinical practice; Dialysis; Diálisis; Oxihidróxido sucroférrico; Phosphate binder; Práctica clínica; Safety; Seguridad; Sucroferric oxyhydroxide

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