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

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  • dc.contributor.author Bajo Rubio, Maria Auxiladora
  • dc.contributor.author Ríos Moreno, Francisco
  • dc.contributor.author Arenas Jiménez, María Dolores
  • dc.contributor.author Devesa-Such, Ramón Jesús
  • dc.contributor.author Molina-Higueras, Maria José
  • dc.contributor.author Delgado, Margarita
  • dc.contributor.author Molina, Pablo
  • dc.contributor.author García-Fernández, Nuria
  • dc.contributor.author Martín-Malo, Alejandro
  • dc.contributor.author Peiró-Jordán, Roser
  • dc.contributor.author Cannata-Andia, Jorge
  • dc.contributor.author Martín de Francisco, Ángel Luis
  • dc.contributor.author Grupo VERIFIE español
  • dc.date.accessioned 2024-05-16T06:26:10Z
  • dc.date.available 2024-05-16T06:26:10Z
  • dc.date.issued 2013
  • dc.description.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.
  • dc.format.mimetype application/pdf
  • dc.identifier.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. DOI: 10.1016/j.nefroe.2021.04.012
  • dc.identifier.doi http://dx.doi.org/10.1016/j.nefroe.2021.04.012
  • dc.identifier.issn 2013-2514
  • dc.identifier.uri http://hdl.handle.net/10230/60166
  • dc.language.iso eng
  • dc.publisher Elsevier
  • dc.relation.ispartof Nefrologia (Engl Ed). 2022 Sep-Oct;42(5):594-606
  • dc.rights © 2021 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. This is an open access article under the CCBY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
  • dc.subject.keyword Clinical practice
  • dc.subject.keyword Dialysis
  • dc.subject.keyword Phosphate binder
  • dc.subject.keyword Safety
  • dc.subject.keyword Sucroferric oxyhydroxide
  • dc.title Safety and effectiveness of sucroferric oxyhydroxide in Spanish patients on dialysis: sub-analysis of the VERIFIE study
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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