Bajo, M.A. (María Auxiliadora)

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    Safety and effectiveness of sucroferric oxyhydroxide in Spanish patients on dialysis: sub-analysis of the VERIFIE study
    (Elsevier, 2023) Delgado, M. (Margarita); Cannata-Andia, J. (Jorge); Peiró-Jordán, R. (Roser); Malo, A.M. (Alejandro Martin); Bajo, M.A. (María Auxiliadora); Martín-De-Francisco, Á.L. (Ángel Luis); Molina, P. (Pablo); Ríos-Moreno, F. (Francisco); Molina-Higueras, M.J. (Maria Jose); Devesa-Such, R.J. (Ramón Jesús); Garcia-Fernandez, N. (Nuria); Dolores Arenas, M. (María)
    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.