RT Journal Article
T1 Seguridad y efectividad del oxihidroxido sucroferrico en pacientesespañoles en diálisis: subanalisis del estudio VERIFIE
T2 Safety and effectiveness of sucroferric oxyhydroxide in Spanish dialysis patients: A sub-analysis of the VERIFIE study
A1 Auxiliadora Bajo, Maria
A1 Rios Moreno, Francisco
A1 Dolores Arenas, Maria
A1 Deuesa Such, Ramon Jesus
A1 Molina Higueras, Maria Jose
A1 Delgado, Margarita
A1 Molina, Pablo
A1 Garcia Fernandez, Nuria
A1 Martin Malo, Alejandro
A1 Peiro-Jordan, Roser
A1 Cannata-Andia, Jorge
A1 Martin de Franciscorl, Angel Luis
K1 Dialysis
K1 Sucroferric oxyhydroxide
K1 Phosphate binder
K1 Safety
K1 Clinical practice
K1 Chronic kidney-disease
K1 Phosphate binder pa21
K1 Hemodialysis-patients
K1 Hyperphosphatemia
K1 Efficacy
K1 Bone
K1 Dialisis
K1 Oxihidroxido sucroferrico
K1 Captor de fosforo
K1 Seguridad
K1 Practica clinica
AB 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. 
PB Soc espanola nefrologia dr rafael matesanz
PB Elsevier
SN 0211-6995
YR 2021
FD 2021-04-18
LK http://hdl.handle.net/10668/22412
UL http://hdl.handle.net/10668/22412
LA es
NO Bajo MA, Ríos-Moreno F, Arenas MD, Devesa-Such RJ, Molina-Higueras MJ, Delgado M, et al. Safety and effectiveness of sucroferric oxyhydroxide in Spanish patients on dialysis: sub-analysis of the VERIFIE study. Nefrologia (Engl Ed). 2022 Sep-Oct;42(5):594-606
DS RISalud
RD Apr 8, 2025