Publication: Safety and effectiveness of sucroferric oxyhydroxide in Spanish dialysis patients: A sub-analysis of the VERIFIE study
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2022-09-07
Authors
Auxiliadora Bajo, Maria
Rios Moreno, Francisco
Dolores Arenas, Maria
Deuesa Such, Ramon Jesus
Molina Higueras, Maria Jose
Delgado, Margarita
Molina, Pablo
Garcia Fernandez, Nuria
Martin Malo, Alejandro
Peiro-Jordan, Roser
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Soc espanola nefrologia dr rafael matesanz
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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, medical events of special interest, 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. Adverse drug reactions were observed in 35.1% of patients, the most common of which were gastrointestinal disorders (77.1%) and mild/moderate in severity (83.7%). Medical events of special interest 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 = .0013) and transferrin saturation (28.07% vs 30.34%; P=.043) was observed from baseline to the last visit. Serum phosphorus levels progressively decreased from 5.69 mg/dL at baseline to 4.84 mg/dL at the last visit (P
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Dialysis, Sucroferric oxyhydroxide, Phosphate binder, Safety, Clinical practice, Chronic kidney-disease, Phosphate binder pa21, Hemodialysis-patients, Hyperphosphatemia, Efficacy, Bone