Safety of benzodiazepines in patients with acute heart failure: A propensity score-matching study.

AIM: Benzodiazepines (BZDs) are one of the most used drugs to control symptoms in patients with acute heart failure (HF). However, the evidence on its safety is inconclusive. The objective was to describe the characteristics of patients admitted for HF and treated with BZDs and to assess the relationship of this treatment and mortality. PATIENTS AND METHODS: We performed a cross-sectional, multicentre (74 Spanish hospitals), cohort study. Patients admitted for HF were divided depending on whether they were treated with BZDs or not. Propensity score analysis matched patients in both groups in a 1:1 manner according to different factors. The primary outcome was mortality at day 7. Secondary outcomes were mortality at days 30 and 180, as well as readmissions and emergency room visits at 180 days. RESULTS: We included 1855 patients: 639 (34.4%) had prescribed BZDs treatment versus 1216 (65.6%) who had not been treated. Patients receiving BZDs had advanced heart disease, severe symptoms, need more HF intensive treatment and higher mortality. After propensity matching 381 balanced paired cases were included in each group. Treatment with BZDs was not associated with greater risk of mortality at day 7 of index hospitalization (7.6% vs 5.2%, adjusted OR 1.49, 95% CI 0.83-2.68, p = 0.186). There were also no differences between groups in terms of mortality at day 30 and 180, readmissions or visits to the emergency room. CONCLUSIONS: Our data support that benzodiazepines could be safely used for improving symptoms. in patients admitted for acute HF in terms of short-medium term mortality.

Evolocumab como tratamiento de la dislipemia secundaria a lorlatinib / Evolocumab as treatment in lorlatinib-related hyperlipidemia

Los anticuerpos monoclonales anti-PCSK9 han demostrado reducción de eventos cardiovasculares en pacientes con enfermedad vascular ateroesclerótica1. Sin embargo, no está descrito su uso en el tratamiento de la dislipemia secundaria a lorlatinib, un inhibidor competitivo de la quinasa del linfoma anaplásico de tercera generación, indicado en cáncer de pulmón no microcítico avanzado ALK+.(AU)

Anti-PCSK9 monoclonal antibodies have reduced the risk of cardiovascular events in patients with atheroesclerosis cardiovascular disease. However, its use has not been described in hyperlipidemia associated with lorlatinib, a third-generation ALK tyrosin kinasa inhibitor approved as treatment for ALK-positive non-small cell lung cancer.(AU)

Evolocumab as treatment in lorlatinib-related hyperlipidemia. / Evolocumab como tratamiento de la dislipemia secundaria a lorlatinib.

Anti-PCSK9 monoclonal antibodies have reduced the risk of cardiovascular events in patients with atheroesclerosis cardiovascular disease. However, its use has not been described in hyperlipidemia associated with lorlatinib, a third-generation ALK tyrosin kinasa inhibitor approved as treatment for ALK-positive non-small cell lung cancer.

Efectividad de los glucocorticoides en pacientes hospitalizados por neumonía grave por SARS-CoV-2 / Effectiveness of glucocorticoids in patients hospitalized for severe SARS-CoV-2 pneumonia

Introducción: Se han comunicado varios trabajos donde se ha demostrado un efecto beneficioso de los glucocorticoides como tratamiento de la tormenta de citocinas que se asocia a los cuadros graves por SARS-CoV-2, plateándose diferentes pautas de glucocorticoides.MétodosEstudio observacional retrospectivo que incluye pacientes con neumonía grave por SARS-CoV-2 y compara el ingreso en una unidad de cuidados intensivos (UCI) o fallecimiento durante la hospitalización en 3 grupos de pacientes: sin tratamiento con glucocorticoides, uso de dosis diarias de glucocorticoides equivalentes menores a 250mg de prednisona y dosis diarias equivalentes mayores o iguales a 250mg de prednisona. Se realizó un análisis multivariante mediante regresión logística, utilizando el índice de propensión como covariante.ResultadosDe los 259 pacientes incorporados al estudio 67 (25,9%) tuvieron una evolución desfavorable, falleciendo o precisando ingreso en UCI. Los análisis comparativos entre diferentes tratamientos con glucocorticoides, y la asociación con ingreso en UCI o fallecimiento fueron: tratamiento con glucocorticoides (cualquier dosis) versus sin tratamiento con glucocorticoides (OR: 0,71 [0,30-1,66]), tratamiento con glucocorticoides (≥250mg de prednisona al día) versus sin tratamiento con glucocorticoides (OR: 0,35 [0,11-1,08]) y tratamiento con glucocorticoides (≥250mg de prednisona al día) versus pacientes con dosis de glucocorticoides<250mg de prednisona o sin tratamiento con glucocorticoides (OR: 0,30 [0,10-0,88]).ConclusiónLos resultados de este estudio muestran que los paciente con neumonía grave por SARS-CoV-2 tratados con pulsos con glucocorticoides con dosis equivalentes de prednisona mayor o igual de 250mg tienen una evolución más favorable (menos mortalidad e ingreso en UCI). (AU)

Introduction: Several studies have reported the beneficial effect of glucocorticoids in the treatment of cytokine storm that occurs in patients with severe COVID-19. Various glucocorticoids regimens have been proposed.MethodsRetrospective observational study that includes patients with severe SARS-CoV-2 pneumonia and compares admission to an Intensive Care Unit (ICU) or death during hospitalization in three groups of patients: no glucocorticoids treatment, use of glucocorticoids doses equivalent to less than 250mg of prednisone daily and use of equivalent doses greater than or equal to 250mg of prednisone daily. Multivariate analysis was performed using logistic regression, using the propensity index as a covariant.ResultsOf the 259 patients enrolled in the study, 67 (25.9%) had an unfavorable evolution, dying or requiring ICU admission. Comparative analyzes between different glucocorticoids treatments and the association with ICU admission or death were: glucocorticoids treatment (any dose) versus no glucocorticoids treatment (OR: 0.71 [0.30-1.66]), treatment with glucocorticoids (≥250mg prednisone daily) versus no glucocorticoids treatment (OR: 0.35 [0.11-1.08]) and glucocorticoids treatment (≥250mg prednisone daily) versus patients with glucocorticoids doses <250mg prednisone daily or without glucocorticoids treatment (OR: 0.30 [0.10-0.88]).ConclusionThe results of this study show that patients with severe SARS-CoV-2 pneumonia treated with glucocorticoids pulses with equivalent doses of prednisone greater than or equal to 250mg have a more favorable evolution (less mortality and less admission to ICU). (AU)

Effectiveness of glucocorticoids in patients hospitalized for severe SARS-CoV-2 pneumonia.

BACKGROUND: Several studies have reported the beneficial effect of glucocorticoids in the treatment of cytokine storm that occurs in patients with severe COVID-19. Various glucocorticoids regimens have been proposed. METHODS: Retrospective observational study that includes patients with severe SARS-CoV-2 pneumonia and compares admission to an Intensive Care Unit (ICU) or death during hospitalization in three groups of patients: no glucocorticoids treatment, use of glucocorticoids doses equivalent to less than 250 mg of prednisone daily and use of equivalent doses greater than or equal to 250 mg of prednisone daily. Multivariate analysis was performed using logistic regression, using the propensity index as a covariant. RESULTS: Of the 259 patients enrolled in the study, 67 (25.9%) had an unfavorable evolution, dying or requiring ICU admission. Comparative analyzes between different glucocorticoids treatments and the association with ICU admission or death were: glucocorticoids treatment (any dose) versus no glucocorticoids treatment (OR: 0.71 [0.30-1.66]), treatment with glucocorticoids (≥250 mg prednisone daily) versus no glucocorticoids treatment (OR: 0.35 [0.11-1.08]) and glucocorticoids treatment (≥250 mg prednisone daily) versus patients with glucocorticoids doses <250 mg prednisone daily or without glucocorticoids treatment (OR: 0.30 [0.10-0.88]). CONCLUSION: The results of this study show that patients with severe SARS-CoV-2 pneumonia treated with glucocorticoids pulses with equivalent doses of prednisone greater than or equal to 250 mg have a more favorable evolution (less mortality and less admission to ICU).

INTRODUCCIÓN: Se han comunicado varios trabajos donde se ha demostrado un efecto beneficioso de los glucocorticoides como tratamiento de la tormenta de citocinas que se asocia a los cuadros graves por SARS-CoV-2, plateándose diferentes pautas de glucocorticoides. MÉTODOS: Estudio observacional retrospectivo que incluye pacientes con neumonía grave por SARS-CoV-2 y compara el ingreso en una unidad de cuidados intensivos (UCI) o fallecimiento durante la hospitalización en 3 grupos de pacientes: sin tratamiento con glucocorticoides, uso de dosis diarias de glucocorticoides equivalentes menores a 250 mg de prednisona y dosis diarias equivalentes mayores o iguales a 250 mg de prednisona. Se realizó un análisis multivariante mediante regresión logística, utilizando el índice de propensión como covariante. RESULTADOS: De los 259 pacientes incorporados al estudio 67 (25,9%) tuvieron una evolución desfavorable, falleciendo o precisando ingreso en UCI. Los análisis comparativos entre diferentes tratamientos con glucocorticoides, y la asociación con ingreso en UCI o fallecimiento fueron: tratamiento con glucocorticoides (cualquier dosis) versus sin tratamiento con glucocorticoides (OR: 0,71 [0,30­1,66]), tratamiento con glucocorticoides (≥250 mg de prednisona al día) versus sin tratamiento con glucocorticoides (OR: 0,35 [0,11­1,08]) y tratamiento con glucocorticoides (≥250 mg de prednisona al día) versus pacientes con dosis de glucocorticoides < 250 mg de prednisona o sin tratamiento con glucocorticoides (OR: 0,30 [0,10­0,88]). CONCLUSIÓN: Los resultados de este estudio muestran que los paciente con neumonía grave por SARS-CoV-2 tratados con pulsos con glucocorticoides con dosis equivalentes de prednisona mayor o igual de 250 mg tienen una evolución más favorable (menos mortalidad e ingreso en UCI).

[Effectiveness of glucocorticoids in patients hospitalized for severe SARS-CoV-2 pneumonia]. / Efectividad de los glucocorticoides en pacientes hospitalizados por neumonía grave por SARS-CoV-2.

INTRODUCTION: Several studies have reported the beneficial effect of glucocorticoids in the treatment of cytokine storm that occurs in patients with severe COVID-19. Various glucocorticoids regimens have been proposed. METHODS: Retrospective observational study that includes patients with severe SARS-CoV-2 pneumonia and compares admission to an Intensive Care Unit (ICU) or death during hospitalization in three groups of patients: no glucocorticoids treatment, use of glucocorticoids doses equivalent to less than 250mg of prednisone daily and use of equivalent doses greater than or equal to 250mg of prednisone daily. Multivariate analysis was performed using logistic regression, using the propensity index as a covariant. RESULTS: Of the 259 patients enrolled in the study, 67 (25.9%) had an unfavorable evolution, dying or requiring ICU admission. Comparative analyzes between different glucocorticoids treatments and the association with ICU admission or death were: glucocorticoids treatment (any dose) versus no glucocorticoids treatment (OR: 0.71 [0.30-1.66]), treatment with glucocorticoids (≥250mg prednisone daily) versus no glucocorticoids treatment (OR: 0.35 [0.11-1.08]) and glucocorticoids treatment (≥250mg prednisone daily) versus patients with glucocorticoids doses <250mg prednisone daily or without glucocorticoids treatment (OR: 0.30 [0.10-0.88]). CONCLUSION: The results of this study show that patients with severe SARS-CoV-2 pneumonia treated with glucocorticoids pulses with equivalent doses of prednisone greater than or equal to 250mg have a more favorable evolution (less mortality and less admission to ICU).

[Cardiovascular morbimortality reduction after an acute cardiovascular event through multifactorial and intensive cardiovascular risk factors management (MIRVAS project)]. / Reducción de la morbimortalidad cardiovascular tras un episodio cardiovascular agudo mediante el tratamiento intensivo de los factores de riesgo (proyecto MIRVAS).

BACKGROUND AND OBJECTIVE: In spite of publication of many guidelines, management of patients on secondary prevention of cardiovascular disease is still not appropriated. We design a randomized trial, in usual clinical practice conditions, to compare the results in cardiovascular morbimortality of intensive and integral management of cardiovascular risk factors (CVRF) management versus conventional care. PATIENTS AND METHOD: We selected patients discharged between October 2002 and January 2004 who suffered an acute coronary syndrome with or without ST-segment elevation or a stroke, 247 patients that met inclusions criteria were randomized to intensive care of CVRF in a specific Internal Medicine outpatient clinic (n = 121) or usual care according to National Health Service recommendations (n = 126). A year after randomization, the percentage of patients who met CVRF control, treatment received and the number of cardiovascular events (cardiovascular death, acute coronary syndrome with or without ST-segment elevation, stroke, transient ischemic attack, revascularization, lower limb amputation, heart failure admission and sudden death) were revised. RESULTS: CVRF control was greater in patients assigned to intensive care. 74.1% of hypertensive patients assigned to this treatment were controlled vs 41.7% in the usual care group (relative risk [RR] = 1.78; 95% confidence interval [CI], 1.27-2-49); 70.2% of patients had low-densi-tiy lipoprotein cholesterol lower than 100 mg/dl vs 55.8% (RR = 1.26; 95% CI, 1.00-1.58) of patients in usual care group; 93.1% of diabetic patients had glycosylated haemoglobin lower than 7% vs. 57.1% (RR = 1.63; 95% CI, 1.11-2.39) in the usual care group. There were 12 cardiovascular events in the intensive care group vs 35 in the usual care group. CONCLUSIONS: Intensive management of CVRF leads to a better control of them and a reduction of the morbimortality one year after an acute cardiovascular event.

Reducción de la morbimortalidad cardiovascular tras un episodio cardiovascular agudo mediante el tratamiento intensivo de los factores de riesgo (proyecto MIRVAS) / Cardiovascular morbimortality reduction after an acute cardiovascular event through multifactorial and intensive cardiovascular risk factors management (MIRVAS project)

Fundamento y objetivo: A pesar de la publicación de numerosas guías de tratamiento, el seguimiento de los pacientes en prevención secundaria de enfermedad cardiovascular todavía no es el adecuado. Hemos diseñado un ensayo aleatorizado en situación de práctica clínica habitual para evaluar los resultados de un programa de tratamiento integral e intensivo de los factores de riesgo cardiovascular (FRCV) frente al tratamiento convencional en la morbimortalidad cardiovascular. Pacientes y método: Entre octubre de 2002 y enero de 2004 se seleccionó a todos los pacientes dados de alta que habían presentado un síndrome coronario agudo, con o sin elevación del segmento ST, o un ictus. Cumplían los criterios de inclusión un total de 247, que se asignaron aleatoriamente a un tratamiento integral e intensivo de los FRCV en una consulta monográfica atendida por un médico internista (n = 121) o al seguimiento habitual según las recomendaciones del Sistema Nacional de Salud (n = 126). Un año después de la inclusión se comprobó el porcentaje de pacientes que habían alcanzado el control óptimo de cada factor de riesgo, así como el tratamiento recibido y el número de episodios cardiovasculares sucesivos (muerte por causa cardiovascular, síndrome coronario agudo con o sin elevación del segmento ST, ictus, accidente isquémico transitorio, revascularización en cualquier territorio, amputación de extremidades inferiores, ingreso por insuficiencia cardíaca y muerte súbita). Resultados: El control de los FRCV fue superior en el grupo de tratamiento intensivo. Un 74,1% de los pacientes hipertensos asignados a este tratamiento estaban controlados, frente al 41,7% del grupo de tratamiento habitual (riesgo relativo [RR] = 1,78; intervalo de confianza [IC] del 95%, 1,27-2,49); un 70,2% presentaba cifras de colesterol unido a lipoproteínas de baja densidad menores de 100 mg/dl, frente a un 55,8% (RR = 1,26; IC del 95%, 1,00-1,58) del grupo de tratamiento habitual; un 93,1% de los diabéticos presentaba valores de hemoglobina glucosilada inferiores al 7%, frente a un 57,1% (RR = 1,63; IC del 95%, 1,11-2,39) del grupo de tratamiento habitual. Se produjeron 12 episodios cardiovasculares en el grupo de intervención, frente a 35 en el grupo de tratamiento habitual. Conclusiones: El tratamiento intensivo aumenta la proporción de pacientes que alcanzan un control óptimo de los FRCV y reduce la morbimortalidad durante el año siguiente a un episodio cardiovascular

Background and objective: In spite of publication of many guidelines, management of patients on secondary prevention of cardiovascular disease is still not appropriated. We design a randomized trial, in usual clinical practice conditions, to compare the results in cardiovascular morbimortality of intensive and integral management of cardiovascular risk factors (CVRF) management versus conventional care. Patients and method: We selected patients discharged between October 2002 and January 2004 who suffered an acute coronary syndrome with or without ST-segment elevation or a stroke, 247 patients that met inclusions criteria were randomized to intensive care of CVRF in a specific Internal Medicine outpatient clinic (n = 121) or usual care according to National Health Service recommendations (n = 126). A year after randomization, the percentage of patients who met CVRF control, treatment received and the number of cardiovascular events (cardiovascular death, acute coronary syndrome with or without ST-segment elevation, stroke, transient ischemic attack, revascularization, lower limb amputation, heart failure admission and sudden death) were revised. Results: CVRF control was greater in patients assigned to intensive care. 74.1% of hypertensive patients assigned to this treatment were controlled vs 41.7% in the usual care group (relative risk [RR] = 1.78; 95% confidence interval [CI], 1.27-2-49); 70.2% of patients had low-densitiy lipoprotein cholesterol lower than 100 mg/dl vs 55.8% (RR = 1.26; 95% CI, 1.00-1.58) of patients in usual care group; 93.1% of diabetic patients had glycosylated haemoglobin lower than 7% vs. 57.1% (RR = 1.63; 95% CI, 1.11-2.39) in the usual care group. There were 12 cardiovascular events in the intensive care group vs 35 in the usual care group. Conclusions: Intensive management of CVRF leads to a better control of them and a reduction of the morbimortality one year after an acute cardiovascular event