Safety and effectiveness of sucroferric oxyhydroxide in Spanish patients on dialysis: sub-analysis of the VERIFIE study.

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.

Epidemiología de la hiperpotasemia en la enfermedad renal crónica / Epidemiology of hyperkalemia in chronic kidney disease

ANTECEDENTES: La hiperpotasemia constituye un importante desequilibrio electrolítico en la enfermedad renal crónica (ERC). Los inhibidores del sistema renina-angiotensina-aldosterona (iSRAA) tienen propiedades beneficiosas cardiorrenales, aunque son causa importante de hiperpotasemia. OBJETIVO: Examinar la prevalencia de la hiperpotasemia en la ERC, identificar factores asociados a su aparición y la relación entre hiperpotasemia y mortalidad. PACIENTES Y MÉTODOS: Estudio observacional retrospectivo en pacientes con ERC en el período 1971-2017. La población se categorizó en 3 grupos: grupo 1, pacientes con ERC sin tratamiento renal sustitutivo; grupo 2, pacientes en hemodiálisis, y grupo 3, pacientes en diálisis peritoneal continua ambulatoria. RESULTADOS: Se evaluó a 2.629 pacientes. La prevalencia observada en los distintos grupos fue del 9,6, el 16,4 y el 10,6%, respectivamente. Los factores de riesgo relacionados con la aparición de hiperpotasemia en el grupo de ERC fueron la tasa de filtrado glomerular (FG) (p < 0,001), la creatinina plasmática (p < 0,001), el sodio plasmático (p < 0,001), la hemoglobina (p = 0,028), la presión arterial diastólica (p = 0,012), la ingesta de inhibidores de la enzima de conversión de la angiotensina o antagonistas de receptores de angiotensina II (p = 0,008), el tratamiento con metformina (p < 0,001) y la diabetes (p = 0,045). El tratamiento con iSRAA incrementó de forma relevante la hiperpotasemia a medida que disminuía el FG, así como en pacientes con diabetes o insuficiencia cardiaca. CONCLUSIONES: La hiperpotasemia es una alteración metabólica frecuente en pacientes con ERC que aumenta en presencia de fármacos con propiedades beneficiosas cardiorrenales (iSRAA), por lo que en muchos casos los pacientes pierden el beneficio asociado a estos fármacos. Nuevos compuestos no absorbibles de reciente aparición, que se unen al potasio en el tracto gastrointestinal potenciando su excreción fecal, manteniendo el beneficio cardiorrenal de los iSRAA, pudieran ser relevantes en la evolución de los pacientes con ERC

BACKGROUND: Hyperkalaemia is a significant electrolyte imbalance in chronic kidney disease (CKD). Renin-angiotensin-aldosterone system inhibitors (RAASi) have beneficial cardio-renal properties, although they can often cause hyperkalaemia. OBJECTIVE: To examine the prevalence of hyperkalaemia in CKD, identify factors associated with its appearance and the relationship between hyperkalaemia and mortality. PATIENTS AND METHODS: Retrospective observational study on patients with CKD in the period 1971-2017. The population was categorised into 3 groups: Group 1, patients with CKD without renal replacement therapy; Group 2, patients on haemodialysis; and Group 3, patients on continuous ambulatory peritoneal dialysis. RESULTS: A total of 2,629 patients were evaluated. The prevalence observed in the different groups was: 9.6%, 16.4% and 10.6%, respectively. Risk factors related to the appearance of hyperkalaemia in the CKD group were glomerular filtration rate (GFR) (P<.001), plasma creatinine (P<.001), plasma sodium (P<.001), haemoglobin (P=.028), diastolic blood pressure (P=.012), intake of ACE inhibitors and/or angiotensin II receptor blockers (P=.008), treatment with metformin (P<.001) and diabetes (P=.045). Treatment with RAASi significantly increased hyperkalaemia as GFR decreased, as well as in patients with diabetes or heart failure. CONCLUSIONS: Hyperkalaemia is a frequent metabolic alteration in CKD patients that increases in the presence of drugs with beneficial cardio-renal properties (RAASi), which means that patients often lose the benefit associated with these drugs. New, recently-appearing non-absorbable compounds, which bind to potassium in the gastrointestinal tract, enhancing faecal excretion and thus maintaining the cardio-renal benefit of the RAASi, could be relevant in the progress of patients with CKD

Interacciones farmacológicas de los captores del fósforo / Pharmacological interactions of phosphate binders

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Denosumab y enfermedad renal crónica avanzada: hipocalcemia severa con riesgo vital / Denosumab anf cronic kidney disease: Severe life-threatening hypocalcemia

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Glomerulonefritis pauciinmune paraneoplásica en paciente con carcinoma pulmonar / Paraneoplastic pauci-immune glomerulonephritis in a patient with lung carcinoma

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Sesión de hemodiálisis: la tormenta perfecta para la calcificación vascular / Haemodialysis session: The perfect storm for vascular calcification

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Sesión de hemodiálisis: la tormenta perfecta para la calcificación vascular / Haemodialysis session: The perfect storm for vascular calcification

Introducción: La calcificación vascular (CV) asociada a la enfermedad renal crónica (ERC) es un fenómeno estrechamente ligado a las alteraciones en el metabolismo mineral óseo. Existen muchos factores implicados, entre ellos los fármacos empleados en el tratamiento de la ERC. Algunos estudios in vitro señalan que las alteraciones electrolíticas y ácido básicas que tienen lugar durante la sesión de hemodiálisis (HD) pueden jugar un papel clave en el proceso de CV. Métodos: Analizamos las alteraciones electrolíticas y ácido-básicas que tienen lugar durante la sesión de HD en 26 pacientes, empleando de forma aleatorizada concentraciones de calcio en el líquido de diálisis de 1,25 o 1,5 mM. Resultados: En todos los pacientes, independientemente del baño de calcio empleado, se produce una ganancia de calcio. En el grupo de pacientes dializados con baño de calcio 1,5mM, el 100% finaliza la sesión con valores de calcio sérico > 1,3 mM, mientras que en el de 1,25mM, esto solo ocurre en el 15%. Al inicio de la sesión, esta ganancia de calcio coincide con niveles de fósforo aún no controlado. Además, en todos los pacientes se observa una alcalinización progresiva: el 50% finaliza la sesión con cifras de bicarbonato > 30mM y el 23% con pH> 7,5. Conclusiones: Durante la sesión de HD se producen cambios electrolíticos y ácido-básicos inductores de CV: ganancia de calcio y alcalinización en presencia de fósforo sérico inicialmente elevado. Son necesarios estudios con modelos cinéticos de ganancia de calcio y alcalinización diferentes a los actuales (AU)

Introduction: Vascular calcification (VC) associated to chronic kidney disease (CKD) is a complex phenomenon closely related to mineral bone metabolism disorders. Many are the factors implicated, as the drugs used in the treatment of CKD. Some in vitro studies suggest that electrolyte and acid-base disorders induced by hemodialysis (HD) may play a key role in VC. Methods: We analyzed electrolyte and acid-base disorders that occur during an HD session in 26 patients randomly assigned to 1,25 mM or 1,5 mM calcium bath. Results: There is a calcium load in all the patients, independently of calcium bath concentration or basal serum calcium levels. At the end of the session, 100% of the patients dialyzed with 1,5mMcalcium bath have calcium serum levels > 1,3 mM. However, this only occurs in 15% of the patients dialysed with 1,25 mM calcium bath. During this calcium load, phosphorus levels persist uncontrolled. Besides, there is a progressive alkalinization in all the patients. In the end of the session 50% have serum bicarbonate > 30 mM and 23% pH > 7,5. Conclusions: During HD sessions occur electrolyte and acid-base disorders that induce VC: Calcium load and alkalization in presence of elevated phosphorus levels. It is necessary to perform studies with kinetic models of calcium load and alkalinization different from the actual ones (AU)

Haemodialysis session: the perfect storm for vascular calcification.

INTRODUCTION: Vascular calcification (VC) associated to chronic kidney disease (CKD) is a complex phenomenon closely related to mineral bone metabolism disorders. Many are the factors implicated, as the drugs used in the treatment of CKD. Some in vitro studies suggest that electrolyte and acid-base disorders induced by hemodialysis (HD) may play a key role in VC. METHODS: We analyzed electrolyte and acid-base disorders that occur during an HD session in 26 patients randomly assigned to 1,25 mM or 1,5 mM calcium bath. RESULTS: There is a calcium load in all the patients, independently of calcium bath concentration or basal serum calcium levels. At the end of the session, 100% of the patients dialyzed with 1,5 mM calcium bath have calcium serum levels > 1,3 mM. However, this only occurs in 15% of the patients dialysed with 1,25 mM calcium bath. During this calcium load, phosphorus levels persist uncontrolled. Besides, there is a progressive alkalinization in all the patients. In the end of the session 50% have serum bicarbonate > 30 mM and 23% pH > 7,5. CONCLUSIONS: During HD sessions occur electrolyte and acid-base disorders that induce VC: Calcium load and alkalization in presence of elevated phosphorus levels. It is necessary to perform studies with kinetic models of calcium load and alkalinization different from the actual ones.

Enfermedad cardiovascular, enfermedad renal y otras enfermedades crónicas. Es necesaria una intervención más temprana en la enfermedad renal crónica / Cardiovascular disease, renal disease and other chronic diseases. Earlier intervention is needed in chronic renal disease

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Recomendaciones de la Sociedad Española de Nefrología para el manejo de las alteraciones del metabolismo óseo-mineral en los pacientes con enfermedad renal crónica / SEN Guidelines. Recommendations of the Spanish society of nephrology for managing bone-mineral metabolic alterations in chronic renal disease patients

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Association between pulse pressure and cardiovascular disease in renal transplant patients.

Elevated pulse pressure in general population has been shown to be associated with cardiovascular disease, which is the main cause of death in renal transplant patients. We investigated the effect that a wider pulse pressure range may have on cardiovascular disease after renal transplantation in 532 transplant patients with functioning graft for more than 1 year. Patients were classified into two groups depending on 1-year pulse pressure (< or >/=65 mmHg) and we analyzed patient and graft survival, post-transplant cardiovascular disease and main causes of death. Higher pulse pressure was associated with older recipient age (40.8 +/- 10.8 vs. 50 +/- 11.3), higher systolic blood pressure (132.7 +/- 16.1 vs. 164.5 +/- 16), lower blood diastolic pressure (84.5 +/- 11.6 vs. 84.4 +/- 11.2), higher prevalence of diabetes (12% vs. 23%) and total cardiovascular disease (20.9% vs. 33.6%). Five- and 10-year patient survivals were lower in the group with higher pulse pressure, being vascular disease the main cause of death in both groups. In a Cox regression model increased pulse pressure was associated with higher cardiovascular disease (RR = 1.73, 95% CI: 1.13-2.32 p < 0.01). In conclusion, pulse pressure was an independent risk factor for increased cardiovascular morbidity and mortality in renal transplant patients.

[Estimation of glomerular filtration rate using weight/creatinine formula]. / Valoración del filtrado glomerular mediante la fórmula peso/creatinina.

BACKGROUND AND OBJECTIVE: The correct management of patients with chronic renal disease depends on an early diagnosis. The aim of this study was to evaluate the usefulness, in the daily clinical practice, of the weight/creatinine formula as an indirect measurement of glomerular filtration. PATIENTS AND METHOD: 1,025 ambulatory patients were referred to the Nephrology Laboratory for basic blood and urine analysis. Creatinine clearance was calculated with the standard formula. RESULTS: A good correlation between the creatinine clearance adjusted for the corporal surface and that estimated by the weight/creatinine formula was observed, especially when creatinine levels were between 1.5-3 mg/dl and patients were older than 60 years. The mean difference between both methods was 6.3 (14.5) ml/min for males and 2.4 (10.5) ml/min for females. The weight/creatinine formula had a sensitivity of 91% and a specificity of 80% to detect a clearance below 50 ml/min. CONCLUSIONS: The weight/creatinine formula underestimates the clearance for normal creatinine values but fits quite well for creatinine levels between 1.5-3 mg/dl, mainly in patients older than 60 years. Although the estimation of clearance through this formula could be inaccurate, in most cases this is clinically irrelevant. Moreover, such a simple formula could avoid potential mistakes appearing at the time of evaluating renal function only by the serum creatinine.

Valoración del filtrado glomerularmediante la fórmula peso/creatinina / Estimation of glomerular filtration rate using weight/creatinine formula

FUNDAMENTO Y OBJETIVO: El tratamiento adecuado de los pacientes con insuficiencia renal crónica depende de su diagnóstico temprano. El objetivo de este estudio fue evaluar la utilidad, en la práctica clínica diaria, de la fórmula peso/creatinina como medida indirecta del filtrado glomerular analizando el posible error cometido con la valoración exclusiva de la creatinina sérica. PACIENTES Y MÉTODO: Se incluyó a 1.025 pacientes ambulatorios remitidos al laboratorio de nefrología para la realización de una analítica básica en sangre y orina. El aclaramiento de creatinina se calculó mediante la fórmula estándar con recogida de orina de 24 h ajustado a la superficie corporal y por el estimado mediante la fórmula peso/creatinina. RESULTADOS: Se observó una buena correlación entre el aclaramiento de creatinina corregido por superficie corporal y el estimado por la fórmula de peso/creatinina especialmente para valores de creatinina entre 1,5 y 3 mg/dl y para pacientes mayores de 60 años. La diferencia promedio (DE) de ambos métodos fue de 6,3 (14,5) ml/min para varones y 2,4 (10,5) para mujeres. La fórmula peso/creatinina tuvo una sensibilidad del 91 por ciento y una especificidad del 80 por ciento para detectar un aclaramiento inferior a 50 ml/min. CONCLUSIONES: La fórmula peso/creatinina estima muy a la baja el aclaramiento para valores de creatinina considerados normales, pero se aproxima mucho para cifras de creatinina entre 1,5 y 3 mg/dl en sujetos mayores de 60 años. Aunque la estimación del aclaramiento por la fórmula puede ser inexacta, en la mayoría de los casos esto es clínicamente irrelevante y una fórmula tan sencilla permite evitar el error de valorar la función renal únicamente por la creatinina (AU)