Eficacia y seguridad de oxihidróxido sucroférrico en el tratamiento de la hiperfosforemia en la enfermedad renal crónica. Estudio FOSFASTUR / Efficacy and safety of sucroferric oxyhydroxide in the treatment of hyperphosphataemia in chronic kidney disease. FOSFASTUR study

INTRODUCCIÓN: Las alteraciones del metabolismo óseo y mineral son muy frecuentes en la enfermedad renal crónica (ERC). El aumento en los niveles de fósforo condiciona enfermedad ósea, riego de calcificación y mayor mortalidad, por lo que cualquier estrategia encaminada a su reducción debe ser bienvenida. El último fármaco incorporado al arsenal terapéutico para tratar la hiperfosforemia en la ERC es el oxihidróxido sucroférrico (OSF). OBJETIVO: Analizar la eficacia y seguridad de OSF en 3 cohortes de pacientes, una con ERC avanzada no en diálisis, otra en diálisis peritoneal y finalmente otra en hemodiálisis, seguidas durante 6 meses. MÉTODOS: Estudio observacional multicéntrico, prospectivo, de práctica clínica. Se analizaron variables clínicas y epidemiológicas. Se valoró la evolución de parámetros relacionados con las alteraciones del metabolismo óseo y mineral y la anemia. RESULTADOS: Se incluyeron en el estudio 85 pacientes (62 ± 12 años, 64% varones, 34% diabéticos), 25 con ERC avanzada no en diálisis, 25 en diálisis peritoneal y finalmente 35 en hemodiálisis. En 66 pacientes (78%) OSF fue el primer captor del fósforo; en los otros 19 se sustituyó un captor previo por OSF, por falta de tolerancia o eficacia. La dosis inicial de OSF fue 964 ± 323 mg/día. Globalmente los niveles séricos de fósforo experimentaron un descenso significativo a los 3 meses de tratamiento (19,6%; p < 0,001). No hubo diferencias en la eficacia del fármaco al comparar las distintas poblaciones analizadas. A lo largo del estudio no se modificaron los niveles de calcio, PTHi, ferritina, índice de saturación de la transferrina ni hemoglobina, aunque se manifestó una tendencia al aumento de los 2 últimos. Doce pacientes (14%) abandonaron el seguimiento, 10 por efectos adversos gastrointestinales (diarrea fundamentalmente) y 2 por pérdida de seguimiento (trasplante renal). La dosis media del fármaco que recibieron los pacientes se incrementó a lo largo del tiempo hasta alcanzar los 1.147 ± 371 mg/día. CONCLUSIONES: OSF es una opción eficaz para el tratamiento de la hiperfosforemia en pacientes con ERC tanto en fases avanzadas de la enfermedad como en diálisis. Encontramos una eficacia similar en los 3 grupos analizados. A mayor nivel basal de fósforo, mayor descenso de sus niveles séricos. Con dosis de alrededor de 1.000 g/día se puede conseguir un notable descenso de los niveles de fósforo. La diarrea fue el efecto secundario más frecuente, aunque tuvo poca importancia generalmente

INTRODUCTION: Alterations in bone and mineral metabolism are very common in chronic kidney disease (CKD). The increase in phosphate levels leads to bone disease, risk of calcification and greater mortality, so any strategy aimed at reducing them should be welcomed. The latest drug incorporated into the therapeutic arsenal to treat hyperphosphataemia in CKD is sucroferric oxyhydroxide (SFO). OBJECTIVE: To analyse the efficacy and safety of SFO in 3 cohorts of patients, one with advanced CKD not on dialysis, another on peritoneal dialysis and the last on haemodialysis, followed for 6 months. METHODS: A prospective, observational, multicentre study in clinical practice. Clinical and epidemiological variables were analysed. The evolution of parameters relating to alterations in bone and mineral metabolism and anaemia was analysed. RESULTS: Eighty-five patients were included in the study (62 ± 12 years, 64% male, 34% diabetic), 25 with advanced CKD not on dialysis, 25 on peritoneal dialysis and lastly, 35 on haemodialysis. In 66 patients (78%), SFO was the first phosphate binder; in the other 19, SFO replaced a previous phosphate binder due to poor tolerance or efficacy. The initial dose of SFO was 964 ± 323 mg/day. Overall, serum phosphate levels saw a significant reduction at 3 months of treatment (19.6%; P < .001). There were no differences in the efficacy of the drug when the different populations analysed were compared. Over the course of the study, there were no changes to levels of calcium, PTHi, ferritin, transferrin saturation index or haemoglobin, although there was a tendency for the last 2 to increase. Twelve patients (14%) withdrew from follow-up, 10 due to gastrointestinal adverse effects (primarily diarrhoea) and 2 were lost to follow-up (kidney transplant). The mean dose of the drug that the patients received increased over time, up to 1,147 ± 371 mg/day. CONCLUSIONS: SFO is an effective option for the treatment of hyperphosphataemia in patients with CKD both in the advanced phases of the disease and on dialysis. We found similar efficacy across the 3 groups analysed. The higher their baseline phosphate level, the greater the reduction in the serum levels. A notable reduction in phosphate levels can be achieved with doses of around 1,000 mg/day. Diarrhoea was the most common side effect, although it generally was not significant

Efficacy and safety of sucroferric oxyhydroxide in the treatment of hyperphosphataemia in chronic kidney disease in Asturias. FOSFASTUR study.

Alterations in bone and mineral metabolism are very common in chronic kidney disease (CKD). The increase in phosphate levels leads to bone disease, risk of calcification and greater mortality, so any strategy aimed at reducing them should be welcomed. The latest drug incorporated into the therapeutic arsenal to treat hyperphosphataemia in CKD is Sucroferric Oxyhydroxide (SFO). OBJECTIVE: To analyse the efficacy and safety of OSF in three cohorts of patients, one with advanced chronic kidney disease not on dialysis (CKD-NoD), another on peritoneal dialysis (PD) and the last on haemodialysis (HD), followed for six months. METHODS: A prospective, observational, multicentre study in clinical practice. Clinical and epidemiological variables were analysed. The evolution of parameters relating to alterations in bone and mineral metabolism and anaemia was analysed. RESULTS: Eighty-five patients were included in the study (62 ±â€¯12 years, 64% male, 34% diabetic), 25 with CKD-NoD, 25 on PD and lastly, 35 on HD. In 66 patients (78%), SFO was the first phosphate binder; in the other 19, SFO replaced a previous phosphate binder due to poor tolerance or efficacy. The initial dose of SFO was 964 ±â€¯323 mg/day. Overall, serum phosphate levels saw a significant reduction at three months of treatment (19.6%, P < 0.001). There were no differences in the efficacy of the drug when the different populations analysed were compared. Over the course of the study, there were no changes to levels of calcium, PTHi, ferritin, or the transferrin and haemoglobin saturation indices, although there was a tendency for the last two to increase. Twelve patients (14%) withdrew from follow-up, ten due to gastrointestinal adverse effects (primarily diarrhoea) and two were lost to follow-up (kidney transplant). The mean dose of the drug that the patients received increased over time, up to 1147 ±â€¯371 mg/day. CONCLUSIONS: SFO is an effective option for the treatment of hyperphosphataemia in patients with CKD both in the advanced phases of the disease and on dialysis. We found similar efficacy across the three groups analysed. The higher their baseline phosphate level, the greater the reduction in the serum levels. A notable reduction in phosphate levels can be achieved with doses of around 1000 mg/day. Diarrhoea was the most common side effect, although it generally was not significant.

Efficacy and safety of sucroferric oxyhydroxide in the treatment of hyperphosphataemia in chronic kidney disease. FOSFASTUR study. / Eficacia y seguridad de oxihidróxido sucroférrico en el tratamiento de la hiperfosforemia en la enfermedad renal crónica. Estudio FOSFASTUR.

INTRODUCTION: Alterations in bone and mineral metabolism are very common in chronic kidney disease (CKD). The increase in phosphate levels leads to bone disease, risk of calcification and greater mortality, so any strategy aimed at reducing them should be welcomed. The latest drug incorporated into the therapeutic arsenal to treat hyperphosphataemia in CKD is sucroferric oxyhydroxide (SFO). OBJECTIVE: To analyse the efficacy and safety of SFO in 3 cohorts of patients, one with advanced CKD not on dialysis, another on peritoneal dialysis and the last on haemodialysis, followed for 6 months. METHODS: A prospective, observational, multicentre study in clinical practice. Clinical and epidemiological variables were analysed. The evolution of parameters relating to alterations in bone and mineral metabolism and anaemia was analysed. RESULTS: Eighty-five patients were included in the study (62±12 years, 64% male, 34% diabetic), 25 with advanced CKD not on dialysis, 25 on peritoneal dialysis and lastly, 35 on haemodialysis. In 66 patients (78%), SFO was the first phosphate binder; in the other 19, SFO replaced a previous phosphate binder due to poor tolerance or efficacy. The initial dose of SFO was 964±323mg/day. Overall, serum phosphate levels saw a significant reduction at 3 months of treatment (19.6%; P<.001). There were no differences in the efficacy of the drug when the different populations analysed were compared. Over the course of the study, there were no changes to levels of calcium, PTHi, ferritin, transferrin saturation index or haemoglobin, although there was a tendency for the last 2 to increase. Twelve patients (14%) withdrew from follow-up, 10 due to gastrointestinal adverse effects (primarily diarrhoea) and 2 were lost to follow-up (kidney transplant). The mean dose of the drug that the patients received increased over time, up to 1,147±371mg/day. CONCLUSIONS: SFO is an effective option for the treatment of hyperphosphataemia in patients with CKD both in the advanced phases of the disease and on dialysis. We found similar efficacy across the 3 groups analysed. The higher their baseline phosphate level, the greater the reduction in the serum levels. A notable reduction in phosphate levels can be achieved with doses of around 1,000mg/day. Diarrhoea was the most common side effect, although it generally was not significant.

Estudio de la deficiencia de hierro en pacientes con insuficiencia cardiaca congestiva: una práctica clínica que precisa mayor atención / Investigation of iron deficiency in patients with congestive heart failure: A medical practice that requires greater attention

Introducción: La deficiencia de hierro en la insuficiencia cardiaca crónica (ICC), con o sin anemia concomitante, se halla asociada a la calidad de vida relacionada con la salud, clase funcional NYHA, y a la capacidad de realización de ejercicio. Estudios prospectivos aleatorizados han demostrado que la corrección de la deficiencia de hierro mejora la calidad de vida y el estadio funcional de estos pacientes con ICC, incluidos aquellos que no presentaban anemia. Objetivo: El objetivo de este estudio es analizar la frecuencia de determinaciones de estos parámetros de hierro y, por consiguiente, conocer la implementación de esta herramienta de mejoría de la calidad en pacientes que ingresan por ICC. Métodos: Estudio observacional retrospectivo sobre pacientes de un hospital universitario, que fueron diagnosticados al ingreso de ICC, entre el 1/1/2012 y el 11/6/2013. Resultados: El número de pacientes analizados fue de 824, de los que a un 39% (324) les fueron evaluados los parámetros de hierro. Entre los pacientes no evaluados y sí evaluados de hierro, no se observó diferencia significativa en la edad, aunque sí en el género, (p=0,007). Los valores del filtrado glomerular y de hemoglobina fueron significativamente inferiores en el grupo de pacientes analizados de hierro (p<0,001). La proporción de pacientes con anemia, insuficiencia renal y de aquellos que presentaban conjuntamente ambas comorbilidades fue significativamente superior en el grupo de pacientes analizados de hierro (p<0,001). Entre los 324 pacientes evaluados de parámetros férricos, 164 pacientes (51%) mostraban deficiencia de hierro. Entre los no deficientes y sí deficientes en hierro, no se observaron diferencias significativas en edad, ni en género. Los parámetros férricos de ambos grupos, ferritina e índice de saturación de la transferrina fueron significativamente inferiores entre los deficientes de hierro, (p<0,001). Los valores de filtrado glomerular fueron significativamente inferiores en aquellos que no mostraban deficiencia de hierro, (p<0,001). Se observaron igualmente diferencias significativas en la proporción de pacientes con insuficiencia renal, entre no deficientes y sí deficientes de hierro, (79 vs. 66%; p=0,013), aunque no en los valores de hemoglobina. Conclusión: La ICC se asocia con alta frecuencia a anemia, deficiencia de hierro e insuficiencia renal. El estudio de los parámetros férricos en los pacientes que ingresan con ICC, pese a que la corrección de la deficiencia de hierro se asocia a mejoría de la sintomatología, no se realiza con la frecuencia necesaria (AU)

Introduction: Iron deficiency in congestive heart failure (CHF), with or without concomitant anaemia, is associated with health-related quality of life, NYHA functional class, and exercise capacity. Prospective, randomised studies have demonstrated that correcting iron deficiency improves the quality of life and functional status of patients with CHF, including those who do not have anaemia. Objective: The aim of this study was to analyse how frequently these iron parameters are tested and thus determine the extent to which this quality improvement tool has been implemented in patients admitted with CHF. Methods: Retrospective observational study of patients from a university hospital diagnosed with CHF on admission between 01/01/2012 and 11/06/2013. Results: Iron parameters were tested in 39% (324) of the 824 patients analysed. There was no significant difference in age between the patients whose iron was tested and those whose iron was not tested, but the difference in terms of gender was significant (P=.007). Glomerular filtration rate and haemoglobin, were significantly lower in the group of patients whose iron was tested (P<.001). The proportion of patients with anaemia, renal failure or both was significantly higher in the group of patients who had iron tests (P<.001). Of the 324 patients whose iron parameters were tested, 164 (51%) had iron deficiency. There were no differences between patients with and without iron deficiency in terms of age or gender. The iron parameters in both groups, ferritin and transferrin saturation index were significantly lower among the patients with iron deficiency (P<.001). The glomerular filtration rate values were significantly lower in patients with no iron deficiency (P<.001). Significant differences were also observed between those with and without iron deficiency in the proportion of patients with renal failure (79 vs. 66%, respectively, P=.013), but not in terms of haemoglobin concentration. Conclusion: Congestive heart failure is very frequently associated with anaemia, iron deficiency and renal failure. Despite the fact that correcting iron deficiency is known to improve symptoms, testing of iron parameters in patients admitted with CHF is not performed as often as it should be (AU)

Investigation of iron deficiency in patients with congestive heart failure: A medical practice that requires greater attention. / Estudio de la deficiencia de hierro en pacientes con insuficiencia cardiaca congestiva: una práctica clínica que precisa mayor atención.

INTRODUCTION: Iron deficiency in congestive heart failure (CHF), with or without concomitant anaemia, is associated with health-related quality of life, NYHA functional class, and exercise capacity. Prospective, randomised studies have demonstrated that correcting iron deficiency improves the quality of life and functional status of patients with CHF, including those who do not have anaemia. OBJECTIVE: The aim of this study was to analyse how frequently these iron parameters are tested and thus determine the extent to which this quality improvement tool has been implemented in patients admitted with CHF. METHODS: Retrospective observational study of patients from a university hospital diagnosed with CHF on admission between 01/01/2012 and 11/06/2013. RESULTS: Iron parameters were tested in 39% (324) of the 824 patients analysed. There was no significant difference in age between the patients whose iron was tested and those whose iron was not tested, but the difference in terms of gender was significant (P=.007). Glomerular filtration rate and haemoglobin, were significantly lower in the group of patients whose iron was tested (P<.001). The proportion of patients with anaemia, renal failure or both was significantly higher in the group of patients who had iron tests (P<.001). Of the 324 patients whose iron parameters were tested, 164 (51%) had iron deficiency. There were no differences between patients with and without iron deficiency in terms of age or gender. The iron parameters in both groups, ferritin and transferrin saturation index were significantly lower among the patients with iron deficiency (P<.001). The glomerular filtration rate values were significantly lower in patients with no iron deficiency (P<.001). Significant differences were also observed between those with and without iron deficiency in the proportion of patients with renal failure (79 vs. 66%, respectively, P=.013), but not in terms of haemoglobin concentration. CONCLUSION: Congestive heart failure is very frequently associated with anaemia, iron deficiency and renal failure. Despite the fact that correcting iron deficiency is known to improve symptoms, testing of iron parameters in patients admitted with CHF is not performed as often as it should be.