Improved Control of Secondary Hyperparathyroidism in Hemodialysis Patients Switching from Oral Cinacalcet to Intravenous Etelcalcetide, Especially in Nonadherent Patients.

BACKGROUND: Etelcalcetide is a novel second-generation calcimimetic that, because of its intravenous administration, could improve treatment adherence in secondary hyperparathyroidism (SHPT). The aim of this study was to evaluate the effectiveness of etelcalcetide compared with that of cinacalcet in controlling SHPT in patients under hemodialysis. METHODS: A prospective observational study was performed in 29 patients with SHPT under hemodialysis who switched from cinacalcet to etelcalcetide with a follow-up of 6 months. A survey was conducted of adherence to the oral calcimimetic. The primary end-point of the study was to assess whether etelcalcetide was more effective than cinacalcet in controlling SHPT. RESULTS: After the switch of treatment, none of the patients developed clinical intolerance or new adverse effects. Etelcalcetide was more effective than cinacalcet in controlling intact parathyroid hormone (iPTH), with an overall decrease in iPTH levels that was significant from the second month. Average calcium levels remained within the normal range, with a higher percentage of hypocalcemia with etelcalcetide (6.9 vs. 13.8%), which was asymptomatic in all cases. Patients who were nonadherent to cinacalcet (38%) showed a significant reduction in calcium and iPTH during follow-up with etelcalcetide. The adherent group (62%) also showed a trend to lower iPTH levels reaching statistical significance after 5 months of follow-up. The dose conversion factor for the switch from cinacalcet to etelcalcetide was etelcalcetide/session = 0.111*mg cinacalcet/day + 0.96, R2 = 0.57. CONCLUSIONS: Etelcalcetide was more effective than cinacalcet in this patient population, especially in the nonadherent subgroup, leading to better SHPT control without adverse effects.

[Are inhaled corticosteroids effective in asthma exacerbations? Evidentia praxis]. / ¿Son eficaces los corticoides inhalados en las exacerbaciones asmáticas? Evidentia praxis.

A clinical scenario is presented, from which a structured clinical question arises: In asthmatic children or adolescents with exacerbation symptoms, does the use of inhaled corticosteroids (newly instituted or base dose increased) reduce the risk of exacerbations that require systemic steroids and/or hospitalization? To answer it, we carried out a bibliographic search, with selection, evaluation and graduation of the evidence, following GRADE criteria. We did not find sufficient evidence to consider intermittent inhaled steroids as an alternative to maintenance inhaled steroids to avoid exacerbations that require the use of systemic steroids. The use of a combination of inhaled steroids with formoterol, as a rescue treatment at the onset of symptoms, is only effective when used by patients with this maintenance treatment, compared to those who only have inhaled steroids and rescue with beta2-agonists of short action; when patients already take maintenance combined therapy, combined rescue does not reduce the risk. In patients with asthma attacks attended in the emergency department, inhaled steroids compared to placebo reduce the risk of admission, but not when compared to systemic corticosteroids.

Survival and quality of life in elderly patients in conservative management. / Supervivencia y calidad de vida en pacientes ancianos en tratamiento renal conservador.

INTRODUCTION: Conservative Management (CM) has become a therapeutic option in Advanced Chronic Kidney Disease in the elderly. However, there is a lack of evidence about prognosis of these patients in terms of survival and health related quality of life (HRQoL). OBJECTIVE: Establish predictive variables associated with mortality and analyse HRQoL in CM patients. PATIENTS AND METHODS: Prospective cohort study. An assessment of renal function parameters and a comprehensive geriatric assessment were made, including: analysis of comorbidity, functional, cognitive, fragility, nutritional, social and HRQoL status. RESULTS: 82 patients with a mean age of 84 years and significant pluripathology were studied: 56% had history of vascular event and Charlson >8. The mortality rate was 23/1,000 patients per month, with a homogeneous mortality rate after 6 months. Survival differed significantly depending on whether they presented with a previous vascular event (36.7 vs. 14.8; p=0.028), Charlson score ≥10 (42 vs. 17; p=0.002), functional status (48.4 vs. 19; p=0.002) and fragility (27 vs. 10; p=0.05). Mortality predictors included eGFR and proteinuria, the presence of previous vascular events, Charlson comorbidity score, malnutrition-inflammation parameters (albumin and MNA score), degree of dependency, physical HRQoL and increase of PTH level. The presence of previous vascular event, comorbidity, decreased albumin and elevated PTH were independent predictors of mortality. HRQoL remained stable over time and no significant worsening occurred during treatment. CONCLUSIONS: Having knowledge of the factors associated with mortality and HRQoL assessment can be a useful tool to helping decision making during CM. Previous vascular events, comorbidity, decreased albumin and increased PTH were independent predictors of mortality.

¿Son eficaces los corticoides inhalados en las exacerbaciones asmáticas? Evidentia praxis / Are inhaled corticosteroids effective in asthma exacerbations? Evidentia praxis

Se presenta un escenario clínico del que surge una pregunta clínica estructurada: en niños o adolescentes asmáticos con síntomas de exacerbación, ¿el uso de corticoides inhalados (de nueva instauración o aumento de dosis habitual) reduce el riesgo de exacerbaciones que requieran corticoides sistémicos y/o ingreso? Para contestarla realizamos una búsqueda bibliográfica con selección, valoración y jerarquización de la evidencia, siguiendo criterios GRADE. No encontramos evidencia suficiente como para considerar los corticoides inhalados intermitentes una alternativa a los corticoides inhalados de mantenimiento para evitar exacerbaciones que requieran el uso de corticoides sistémicos. El uso de una combinación de corticoides inhalados con formoterol, como tratamiento de rescate al inicio de síntomas, solo es eficaz en los pacientes con dicho tratamiento de base, en comparación con los que solo tienen corticoides inhalados y hacen rescate con beta2-agonistas de acción corta; cuando los pacientes ya toman tratamiento combinado de base, el rescate combinado no mejora el riesgo. En pacientes con crisis asmáticas atendidas en urgencias, los corticoides inhalados en comparación con placebo reducen el riesgo de ingreso, pero no si se compara con corticoides sistémicos

A clinical scenario is presented, from which a structured clinical question arises: In asthmatic children or adolescents with exacerbation symptoms, does the use of inhaled corticosteroids (newly instituted or base dose increased) reduce the risk of exacerbations that require systemic steroids and/or hospitalization? To answer it, we carried out a bibliographic search, with selection, evaluation and graduation of the evidence, following GRADE criteria. We did not find sufficient evidence to consider intermittent inhaled steroids as an alternative to maintenance inhaled steroids to avoid exacerbations that require the use of systemic steroids. The use of a combination of inhaled steroids with formoterol, as a rescue treatment at the onset of symptoms, is only effective when used by patients with this maintenance treatment, compared to those who only have inhaled steroids and rescue with beta2-agonists of short action; when patients already take maintenance combined therapy, combined rescue does not reduce the risk. In patients with asthma attacks attended in the emergency department, inhaled steroids compared to placebo reduce the risk of admission, but not when compared to systemic corticosteroids

Enfermedad renal crónica avanzada en ancianos en tratamiento renal sustitutivo y tratamiento conservador. Estudio comparativo de supervivencia y síntomas / Advanced chronic kidney disease in elderly under renal replacement therapy and conservative treatment. Comparative survival and symptoms study

Resumen Introducción: A pesar de la elevada prevalencia de la enfermedad renal crónica avanzada en ancianos, sigue siendo incierto el beneficio en términos de supervivencia y control de los síntomas del tratamiento renal sustitutivo frente al tratamiento renal conservador en esta población. Analizamos estos dos objetivos en ambas modalidades de tratamiento. Material y métodos: Estudio de cohortes prospectivo de pacientes mayores de 75 años en tratamiento renal sustitutivo y tratamiento renal conservador. Se realizaron un análisis de supervivencia y una valoración de la sintomatología utilizando la escala POS-S Renal en consulta multidisciplinar de tratamiento renal sustitutivo y en unidades de tratamiento renal sustitutivo. Resultados: Analizamos 82 pacientes en tratamiento renal sustitutivo y 37 pacientes en TRS. Los pacientes en tratamiento renal sustitutivo tuvieron mayor comorbilidad (Charlson) y peor situación funcional (Karnofsky). La mediana de supervivencia en el grupo de tratamiento renal sustitutivo fue de 26,9 meses (IC95% 19,6-34,2) frente a una media de 30,5 meses (IC95% 27,46-33,67) en el grupo tratamiento renal sustitutivo (p=0,014 a favor de diálisis). Los dos grupos presentaron gran variedad de síntomas, siendo la debilidad el más prevalente e intenso en ambos (97% tratamiento renal sustitutivo y 98% tratamiento renal conservador). La valoración a los 0,12 y 24 meses mostró que el número e intensidad de los síntomas se mantuvo estable en ambas terapias, sin diferencias clínicas. Conclusiones: El tratamiento renal sustitutivo se asocia a mayor supervivencia que el tratamiento renal conservador, sin embargo, los síntomas percibidos en enfermedad renal crónica avanzada son muy prevalentes y no apreciamos diferencias al comparar ambos tratamientos. La evaluación regular de los síntomas mediante un equipo multidisciplinar es útil en el manejo clínico de pacientes en ambas terapias.

Abstract Introduction: Despite the high prevalence of advanced chronic kidney disease for elderly, survival and symptom burden are uncertain for patients commencing renal replacement therapy versus patients managed with supportive care without dialysis (RSC-NFD). We examined these outcomes in both treatment modalities. Methods: Prospective cohort study of RSC-NFD and renal replacement therapy patients older than 75-years-old. A survival analysis and Symptoms were measured using POS-S Renal Scale in a multidisciplinary RSC-NFD clinic and in renal replacement therapy units. Results: 82 RSC-NFD patients and 37 renal replacement therapy patients were included in the study. RSC-NFD patients presented significant comorbidity (Charlson) and worse functional situation (Karnofsky). Median survival in the RSC-NFD treatment was 26.9 months (95%CI 19.6-34.2) vs mean 30.5 months (95% CI 27.46-33.67) in renal replacement therapy group (p 0.014 in favour of dialysis). Both treatments presented a wide variety of symptoms, being weakness the most prevalent and intense in both groups (97% renal replacement therapy and 98% RSC-NFD). The evaluation at 0,12 and 24 months showed that the number and intensity of symptoms remained stable in both therapies and there were no clinical differences. Conclusions: Dialysis is associated with a survival advantage from RSC-NFD. However, the perceived symptoms in advanced chronic kidney disease are highly prevalent and we didn`t appreciate differences comparing both treatments. Routine symptom assessment by a multidisciplinary team can be useful in clinical practice of patients in renal replacement therapy and RSC-NFD.

Tratamiento renal conservador en ancianos con enfermedad renal crónica avanzada / Conservative management in elderly patients with advanced chronic kidney disease

FUNDAMENTO: Los resultados en salud del tratamiento renal sustitutivo (TRS) en el anciano han hecho que el tratamiento renal conservador (TRC) sea una opción terapéutica en la enfermedad renal crónica avanzada. Sin embargo, se sabe poco sobre la evolución de estos pacientes, por lo que el objetivo fue analizar la supervivencia de los pacientes ancianos en TRS y TRC y evaluar el efecto de las variables relacionadas con el inicio de ambos tratamientos. MÉTODO: Estudio de cohortes prospectivo de pacientes >75 años en TRS y TRC. Se realizó un análisis de supervivencia incluyendo la valoración de la función renal y variables demográficas y clínicas, comorbilidad, fragilidad y situación funcional, cognitiva, nutricional y social. RESULTADOS: Cohorte de 37 pacientes en TRS y 82 en TRC. Los pacientes en TRC eran significativamente más ancianos, con mayor frecuencia de evento vascular, mayor comorbilidad (Charlson>8), peor situación funcional (Barthel), mayor riesgo de deterioro cognitivo (Pfeiffer) y malnutrición (MNA-SF), y mayor fragilidad y deterioro sociofamiliar. La tasa de mortalidad fue inferior en pacientes en TRS (8,7 vs 23/1.000 pacientes-mes; HR= 0,37; p = 0,018) pero el ajuste por los diferentes síndromes geriátricos analizados redujo considerablemente esta ventaja de supervivencia. CONCLUSIONES: La comorbilidad medida por el índice de Charlson fue predictor independiente de mortalidad en pacientes ancianos con enfermedad renal crónica avanzada. En aquellos pacientes ancianos con Charlson mayor de 8 puntos el TRS no mejoró la supervivencia respecto del TRC

BACKGROUND: The poor health outcomes of Renal Replacement Therapy (RRT) in the elderly has promoted Conservative Management (CM) as a therapeutic option in advanced chronic kidney disease. However, there is still a lack of evidence about prognosis of these patients; thus, the aim was to analyze the survival rate of elderly patients under CM and RRT and evaluate the variables related to the initiation of such treatments in clinical practice. METHODS: Prospective cohort study of RRT and CM patients >75años. Renal function parameters and geriatric assessments were carried out. This evaluation included: analysis of comorbidity, functional, cognitive, frailty, nutritional and socio-family status. RESULTS: Cohort of 37 RRT and 82 CM patients. CM patients were significantly older, with more frequency of history of vascular event, more comorbility (Charlson), worse functional situation (Barthel), higher risks of cognitive impairment (Pfeiffer) and malnutrition (MNA-SF), and higher frailty and socio-familiar impairment. Mortality rate was lower in RRT patients (8.72 vs. 3/1,000 patients/month; HR= 0.37, p = 0.018), but survival advantage reduced drastically after adjustment for the different geriatric syndromes analyzed. CONCLUSIONS: Charlson's comorbidity was found to be an independent mortality predictor in elderly patients with advanced chronic kidney disease. Dialysis did not improve survival with respect to conservative treatment in patients with Charlson higher than 8 points

Supervivencia y calidad de vida en pacientes ancianos en tratamiento renal conservador / Survival and quality of life in elderly patients in conservative management

Introducción: El tratamiento renal conservador (TRC) se ha convertido en una opción terapéutica en la enfermedad renal crónica avanzada en ancianos. Se sabe poco sobre la evolución pronóstica de estos pacientes en términos de supervivencia y calidad de vida relacionada con la salud (CVRS). Objetivo: Establecer variables predictivas de mortalidad y analizar la CVRS en los pacientes en TRC. Pacientes y métodos: Estudio de cohortes prospectivo. Se realizó una valoración de parámetros de función renal y evaluación geriátrica integral: análisis de comorbilidad, situación funcional, cognitiva, fragilidad, nutricional, social y CVRS. Resultados: Se evaluaron 82 pacientes, con una edad media de 84 años e importante pluripatología: el 56% tenía antecedentes de evento vascular y Charlson > 8. La tasa de mortalidad fue de 23/1.000 pacientes-mes, con un ritmo de mortalidad homogéneo a partir de los 6 meses. La supervivencia difirió significativamente si presentaban evento vascular previo (36,7 vs. 14,8; p = 0,028), Charlson ≥10 (42 vs. 17; p = 0,002), grado de dependencia (48,4 vs. 19; p = 0,002) y fragilidad (27 vs. 10; p = 0,05). Fueron predictores de mortalidad: eFG y proteinuria, presencia de evento vascular previo, comorbilidad de Charlson, parámetros de malnutrición-inflamación (albúmina y puntuación MNA), grado de dependencia, CVRS física y aumento de PTH. La presencia de evento vascular previo, comorbilidad, albúmina descendida y elevación de PTH fueron predictores independientes de mortalidad. La CVRS se mantuvo estable y no se produjo empeoramiento significativo durante el tratamiento. Conclusiones: El conocimiento de los factores asociados con mortalidad y la evaluación de la CVRS puede ser útil como herramienta en la toma de decisiones en TRC. La presencia de evento vascular previo, comorbilidad, albúmina disminuida y el aumento de PTH fueron predictores independientes de mortalidad

Introduction: Conservative Management (CM) has become a therapeutic option in Advanced Chronic Kidney Disease in the elderly. However, there is a lack of evidence about prognosis of these patients in terms of survival and health related quality of life (HRQoL). Objective: Establish predictive variables associated with mortality and analyse HRQoL in CM patients. Patients and methods: Prospective cohort study. An assessment of renal function parameters and a comprehensive geriatric assessment were made, including: analysis of comorbidity, functional, cognitive, fragility, nutritional, social and HRQoL status. Results: 82 patients with a mean age of 84 years and significant pluripathology were studied: 56% had history of vascular event and Charlson > 8. The mortality rate was 23/1,000 patients per month, with a homogeneous mortality rate after 6 months. Survival differed significantly depending on whether they presented with a previous vascular event (36.7 vs. 14.8; p = 0.028), Charlson score ≥10 (42 vs. 17; p = 0.002), functional status (48.4 vs. 19; p = 0.002) and fragility (27 vs. 10; p = 0.05). Mortality predictors included eGFR and proteinuria, the presence of previous vascular events, Charlson comorbidity score, malnutrition-inflammation parameters (albumin and MNA score), degree of dependency, physical HRQoL and increase of PTH level. The presence of previous vascular event, comorbidity, decreased albumin and elevated PTH were independent predictors of mortality. HRQoL remained stable over time and no significant worsening occurred during treatment. Conclusions: Having knowledge of the factors associated with mortality and HRQoL assessment can be a useful tool to helping decision making during CM. Previous vascular events, comorbidity, decreased albumin and increased PTH were independent predictors of mortality