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 AND AIMS: The efficacy of phosphate binders is difficult to be estimated clinically. This study analyzes the changes in serum phosphate and urinary phosphate excretion after the prescription of phosphate binders (PB) in patients with chronic kidney disease stage 4-5 pre-dialysis, and the usefulness of the ratio between total urinary phosphate and protein catabolic rate (Pu/PCR) for estimating the efficacy of PB. METHODS: This retrospective observational cohort study included adult chronic kidney disease patients. Biochemical parameters were determined baseline and after 45-60 days on a low phosphate diet plus PB ("binder" subgroup=260 patients) or only with dietary advice ("control" subgroup=79 patients). RESULTS: Phosphate load (total urinary excretion) per unit of renal function (Pu/GFR) was the best parameter correlated with serum phosphate levels (R2=0.61). Mean±SD level of Pu/PCR was 8.2±2.3mg of urinary phosphate per each g of estimated protein intake. After treatment with PB, serum phosphate levels decreased by 11%, urinary phosphate 22%, protein catabolic rate 7%, and Pu/PCR 15%. In the control subgroup, Pu/PCR increased by 20%. Urinary phosphate and urea nitrogen excretion correlated strongly, both baseline and after PB or dietary advice. CONCLUSIONS: The proposed parameter Pu/PCR may reflect the rate of intestinal phosphate absorption, and therefore, its variations after PB prescription may be a useful tool for estimating the pharmacological efficacy of these drugs.
