Recommendations of the Spanish Society of Nephrology for the management of mineral and bone metabolism disorders in patients with chronic kidney disease: 2021 (SEN-MM).

As in 2011, when the Spanish Society of Nephrology (SEN) published the Spanish adaptation to the Kidney Disease: Improving Global Outcomes (KDIGO) universal Guideline on Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD), this document contains an update and an adaptation of the 2017 KDIGO guidelines to our setting. In this field, as in many other areas of nephrology, it has been impossible to irrefutably answer many questions, which remain pending. However, there is no doubt that the close relationship between the CKD-MBD/cardiovascular disease/morbidity and mortality complex and new randomised clinical trials in some areas and the development of new drugs have yielded significant advances in this field and created the need for this update. We would therefore highlight the slight divergences that we propose in the ideal objectives for biochemical abnormalities in the CKD-MBD complex compared to the KDIGO suggestions (for example, in relation to parathyroid hormone or phosphate), the role of native vitamin D and analogues in the control of secondary hyperparathyroidism and the contribution of new phosphate binders and calcimimetics. Attention should also be drawn to the adoption of important new developments in the diagnosis of bone abnormalities in patients with kidney disease and to the need to be more proactive in treating them. In any event, the current speed at which innovations are taking place, while perhaps slower than we might like, globally drives the need for more frequent updates (for example, through Nefrología al día).

Seguridad y efectividad del oxihidróxido sucroférrico en pacientes españoles en diálisis: subanálisis del estudio VERIFIE / Safety and effectiveness of sucroferric oxyhydroxide in Spanish dialysis patients: A sub-analysis of the VERIFIE study

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 12–36 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)