ABSTRACT
Antecedentes y objetivo: En este estudio presentamos los resultados del subgrupo de pacientes españoles del estudio VERIFIE, primer estudio postautorización prospectivo que evalúa la seguridad y efectividad a largo plazo del oxihidróxido sucroférrico (OHS) en pacientes en diálisis con hiperfosfatemia durante la práctica clínica habitual. Pacientes y métodos: Se incluyeron pacientes en hemodiálisis y diálisis peritoneal con indicación de tratamiento con OHS. La duración del seguimiento fue de 12 a 36 meses desde el inicio del tratamiento con OHS. Las variables primarias de seguridad fueron la incidencia de reacciones adversas a medicamentos, eventos médicos de interés especial y variaciones en los parámetros del hierro. La efectividad del OHS se evaluó mediante el cambio en los niveles de fósforo sérico. Resultados: Se reclutaron 286 pacientes y se analizaron los datos de 282. De estos 282 pacientes, 161 (57,1%) abandonaron el estudio de manera prematura y un 52,5% recibieron tratamiento concomitante con otros captores de fósforo. Un 35,1% reportaron reacciones adversas a medicamentos y la mayoría fueron de tipo gastrointestinal (77,1%) y de intensidad leve/moderada (83,7%). Un 14,2% de los pacientes presentaron eventos médicos de interés especial, de los que el 93,7% fueron leves/moderados. Se observó un incremento de la ferritina (386,66 vs. 447,55ng/mL; p=0,0013) y saturación de la transferrina (28,07 vs. 30,34%; p=0,043) desde el inicio hasta la última visita. Los niveles de fósforo sérico disminuyeron progresivamente desde 5,69mg/dL al inicio hasta 4,84mg/dL en la última visita (p<0,0001), aumentando la proporción de pacientes con niveles de fósforo≤5,5mg/dL un 32,2%, y con una dosis diaria media de 1,98 comprimidos/día. (AU)
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 1236 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 (386.66ng/mL vs 447.55ng/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 5.69mg/dL at baseline to 4.84mg/dL at the last visit (P<.0001), increasing by 32.2% the proportion of patients who achieved serum phosphorus levels≤5.5mg/dL, with a mean daily SFOH dose of 1.98pills/day. (AU)
Subject(s)
Humans , Male , Female , Young Adult , Adult , Middle Aged , Aged , Aged, 80 and over , Safety , Effectiveness , Prospective Studies , Spain , Dialysis , Phosphorus , Drug-Related Side Effects and Adverse ReactionsABSTRACT
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.
Subject(s)
Ferric Compounds , Renal Dialysis , Humans , Renal Dialysis/adverse effects , Ferric Compounds/adverse effects , Drug Combinations , PhosphorusABSTRACT
BACKGROUND: The efficacy and safety of sucroferric oxyhydroxide (SO) have been reported in clinical trials. However, real-life data are scarce. This study presents data on the use, efficacy and safety of SO in real clinical practice. METHODS: We performed a retrospective multicentre study, without any influence on the prescription decisions, that included 220 patients from 11 Spanish centres. Demographic, treatment, analytical and nutritional parameters and adherence, side effects and dropout rates were collected during 6 months. RESULTS: SO was initiated due to inadequate control of serum phosphate (P) in 70% of participants and in 24.5% to reduce the number of tablets. Monotherapy with SO increased from 44% to 74.1%, with a reduction in the average daily number of sachets/tablets from six to two. Serum P decreased by 20% (4.6 ± 1.2 versus 5.8 ± 1.3 mg/dL; P < 0.001), with a significant reduction in intact parathyroid hormone levels (P < 0.01). The percentage of patients with adequate serum P control at threshold levels of 5 and 4.5 mg/dL increased by 45.4% and 35.9%, respectively. Serum ferritin was not modified, while the transferrin saturation index increased significantly (P = 0.04). Serum albumin and normalized protein catabolic rate, when normalized by serum P, increased, averaging 37% and 39%, respectively (P < 0.001). Adherent patients increased from 28.2% to 52.7%. Adverse effects were reported by 14.1% of participants, with abandonment of treatment in 9.5%. CONCLUSIONS: The use of SO in real-life results in better control of serum P, a reduction in the number of tablets and an improvement in therapeutic adherence. In addition, it may be beneficial with regards to secondary hyperparathyroidism and nutritional status.
