Aims
Pulmonary hypertension (PH) associated with left heart disease is an increasingly prevalent problem, orphan of targeted therapies, and related to a poor prognosis, particularly when pre‐ and ...post‐capillary PH combine. The current study aimed to determine whether treatment with the selective β3 adrenoreceptor agonist mirabegron improves outcomes in patients with combined pre‐ and post‐capillary PH (CpcPH).
Methods and results
The β3 Adrenergic Agonist Treatment in Chronic Pulmonary Hypertension Secondary to Heart Failure (SPHERE‐HF) trial is a multicentre, randomized, parallel, placebo‐controlled clinical trial that enrolled stable patients with CpcPH associated with symptomatic heart failure. A total of 80 patients were assigned to receive mirabegron (50 mg daily, titrated till 200 mg daily, n = 39) or placebo (n = 41) for 16 weeks. Of them, 66 patients successfully completed the study protocol and were valid for the main analysis. The primary endpoint was the change in pulmonary vascular resistance (PVR) on right heart catheterization. Secondary outcomes included the change in right ventricular (RV) ejection fraction by cardiac magnetic resonance or computed tomography, other haemodynamic variables, functional class, and quality of life. The trial was negative for the primary outcome (placebo‐corrected mean difference of 0.62 Wood units, 95% confidence interval CI −0.38, 1.61, p = 0.218). Patients receiving mirabegron presented a significant improvement in RV ejection fraction as compared to placebo (placebo‐corrected mean difference of 3.0%, 95% CI 0.4, 5.7%, p = 0.026), without significant differences in other pre‐specified secondary outcomes.
Conclusions
SPHERE‐HF is the first clinical trial to assess the potential benefit of β3 adrenergic agonists in PH. The trial was negative since mirabegron did not reduce PVR, the primary endpoint, in patients with CpcPH. On pre‐specified secondary outcomes, a significant improvement in RV ejection fraction assessed by advanced cardiac imaging was found, without differences in functional class or quality of life.
Summary of the study outline, flowchart, and results of the primary and secondary outcomes. The β3 selective agonist mirabegron did not improve pulmonary haemodynamics in adult patients with combined pre‐ and post‐capillary pulmonary hypertension associated with symptomatic heart failure. On secondary outcomes, a significant improvement in right ventricular ejection fraction assessed by advanced cardiac imaging was found, without differences in functional class or quality of life. PP, per protocol population.
There is clinically relevant molecular heterogeneity in prostate cancer (PCa), but this biological diversity has had only a minimal impact on clinical practice. Treatment outcomes in patients with ...localised PCa are often highly variable, even among patients stratified to the same risk group or disease state based on standard clinical and pathological parameters. In recent years, the development of gene panels has provided valuable data on the differential expression of genes in patients with PCa. Nevertheless, there is an urgent need to identify and validate prognostic and predictive biomarkers that can be applied across clinical scenarios, ranging from localised disease to metastatic castration-resistant PCa. The availability of such tools would allow for precision medicine to finally reach PCa patients. In this review, we evaluate current data on molecular biomarkers for PCa, with an emphasis on the biomarkers and gene panels with the most robust evidence to support their application in routine clinical practice.
The aim of this study has been to categorize, analyze and integrate, in different scenarios, the results of research on the social skills of young people at risk of social exclusion. A systematic ...review is carried out including papers selected from 8 international databases, with relevance and sufficiency criteria, in the period between January 2016 and March 2021. It consists of 19 quantitative, qualitative and mixed research from 10 countries, whose main source of information is the young people themselves. The association of social skills with psycho-emotional development, training and employability and the establishment of support networks stands out. The results indicate how, through participatory, interactive and digital environments, the development of social skills that favor teamwork, conflict resolution and emotional control is promoted. Based on the scarcity of research carried out from this conceptual approach, the contributions of this study stand out in terms of knowledge about social skills linked to the configuration of personality, social competence, training, employability and socio-educational intervention with young people in social difficulty
El objetivo de este estudio ha sido categorizar, analizar e integrar, en diferentes escenarios, los resultados de investigaciones sobre las habilidades sociales de las personas jóvenes en riesgo de exclusión social. Se realiza una revisión sistemática que incluye artículos seleccionados a partir de 8 bases de datos internacionales, con criterios de pertinencia y suficiencia, en el periodo comprendido entre enero de 2016 y marzo de 2021. Se trata de 19 investigaciones de 10 países, de tipo cuantitativo, cualitativo y mixto, cuya principal fuente de información son los propios jóvenes. Sobresale la asociación de las habilidades sociales con el desarrollo psicoemocional, la formación y empleabilidad y el establecimiento de redes de apoyo. Se encuentran resultados que indican cómo a través de entornos participativos, interactivos y digitales se potencia el desarrollo de habilidades sociales que favorecen el trabajo en equipo, la resolución de conflictos y el control emocional. Partiendo de la escasez de investigaciones realizadas desde este enfoque conceptual, destacan las aportaciones de este estudio en cuanto al conocimiento sobre las habilidades sociales vinculadas a la configuración de la personalidad, competencia social, formación, empleabilidad y la intervención socioeducativa con personas jóvenes en dificultad social