Publication: Seguridad y efectividad del oxihidroxido sucroferrico en pacientes
españoles en diálisis: subanalisis del estudio VERIFIE
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Identifiers
Date
2021-04-18
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
Advisors
Journal Title
Journal ISSN
Volume Title
Publisher
Soc espanola nefrologia dr rafael matesanz
Elsevier
Elsevier
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.
Description
MeSH Terms
Drug Combinations
Ferric Compounds
Humans
Phosphorus
Renal Dialysis
Ferric Compounds
Humans
Phosphorus
Renal Dialysis
DeCS Terms
CIE Terms
Keywords
Dialysis, Sucroferric oxyhydroxide, Phosphate binder, Safety, Clinical practice, Chronic kidney-disease, Phosphate binder pa21, Hemodialysis-patients, Hyperphosphatemia, Efficacy, Bone, Dialisis, Oxihidroxido sucroferrico, Captor de fosforo, Seguridad, Practica clinica
Citation
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