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

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 pr...

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Autores: Bajo, M.A. (María Auxiliadora)|||/items/7525867e-f85e-45ec-a773-95343bd13291, Ríos-Moreno, F. (Francisco)|||/items/f273a7a7-5947-4735-92ed-42703772fc72, Dolores Arenas, M. (María)|||/items/7b7e4183-237e-4716-8c8a-dc8744393948, Devesa-Such, R.J. (Ramón Jesús)|||/items/e11355fe-e988-444c-a3f1-71f9f75b8723, Molina-Higueras, M.J. (Maria Jose)|||/items/aa16f671-b286-4e4c-af2a-d379756455a1, Delgado, M. (Margarita)|||/items/922e4a07-2ec3-4334-a9ce-d5cbe038a5ac, Molina, P. (Pablo)|||/items/8b9aac46-b822-4813-9e1a-cea3af51515b, Garcia-Fernandez, N. (Nuria)|||/items/775bfac6-047c-423c-b940-e5e2dba00f55, Malo, A.M. (Alejandro Martin)|||/items/c1277c1d-bac1-4a5e-b86f-21e65df3603c, Peiró-Jordán, R. (Roser)|||/items/ccff4fa1-cc14-404f-9c7c-4bd13a05d61b, Cannata-Andia, J. (Jorge)|||/items/1f81d854-063f-4788-9001-9ce063354071, Martín-De-Francisco, Á.L. (Ángel Luis)|||/items/ed8dc0db-c348-4bd2-a765-a3ce8ba2d079
Formato: artículo
Fecha de publicación:2023
País:España
Recursos:Universidad de Navarra
Repositorio:Dadun. Depósito Académico Digital de la Universidad de Navarra
Idioma:español
OAI Identifier:oai:dadun.unav.edu:10171/69752
Acesso em linha:https://hdl.handle.net/10171/69752
Access Level:acceso abierto
Palavra-chave:Dialysis
Sucroferric oxyhydroxide
Phosphate binder
Safety
Clinical practice
Práctica clínica
Seguridad
Captor de fósforo
Oxihidróxido sucroférrico
Diálisis
Descrição
Resumo: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.

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