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

Autor: María Auxiliadora Bajo, Francisco Ríos-Moreno, Maria Dolores Arenas, Ramón Jesús Devesa-Such, Maria Jose Molina-Higueras, Margarita Delgado, Pablo Molina, Nuria García-Fernández, Alejandro Martin-Malo, Roser Peiró-Jordán, Jorge Cannata-Andia, Ángel Luis Martín-De Francisco
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Nefrología (English Edition), Vol 42, Iss 5, Pp 594-606 (2022)
Druh dokumentu: article
ISSN: 2013-2514
DOI: 10.1016/j.nefroe.2021.04.012
Popis: 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 (386.66 ng/mL vs 447.55 ng/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 5.69 mg/dL at baseline to 4.84 mg/dL at the last visit (p
Databáze: Directory of Open Access Journals