Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

El bien como finalidad estatal

Para definir el bien común como finalidad clave e inminente en el ejercicio del Estado con diversas herramientas reguladoras y/o coercitivas (por ejemplo el derecho u organismos de control social como en el caso colombiano la policía nacional), se debe, en primera instancia fundamentar el porqué de su importancia y su origen, cuya raíz se asienta en los cimientos de ideas aristotélicas pero que posteriormente se desarrollaron por Santo Tomás de Aquino, quien establece que “el Estado es una institución necesaria que deriva de la naturaleza social del hombre, y cuya finalidad no es sino alcanzar el bien común” (Aristóteles, 1933 como se citó en Aquino, 1956), lo que permite a su vez sostener la postura sobre cómo el bien común es un conjunto de disposiciones estatales que ayuden a generar condiciones sociales aptas para fomentar una buena estabilidad colectiva

Los derechos humanos II

La violencia interna en Colombia tenía una trascendencia fundamental en el camino de la paz, por ende, en el presente documento se narran diversas vicisitudes con respecto a la misma. Inicialmente se plantean los acontecimientos históricos de manera cronológica como lo son: La disputa entre Liberales y Conservadores, el Bogotazo, la toma del Palacio de Justicia, los carteles de Narcotráfico y, por último, la firma del Acuerdo de Paz, en donde se presencian los mayores índices de violación a los DDHH en la Nación. Posteriormente, se hace una aproximación a las afectaciones provocadas por el conflicto armado sobre las comunidades indígenas. Finalmente, por medio de cifras, causas y testimonios se dará a conocer la problemática que ha cobrado la vida de múltiples líderes sociales

Veredicto caso Laura Espinosa

Se revisa y se analiza el fallo adoptado por el juez 58 y 47 Penal del Circuito de Bogotá, en la acción de tutela promovida por Jaime Lombona contra la Clínica Mediport, Seccional Bogotá aduciendo vulneración del derecho a la vida, salud, integridad personal y a la dignidad humana

Cardiac myosin activation with omecamtiv mecarbil in systolic heart failure

BACKGROUND The selective cardiac myosin activator omecamtiv mecarbil has been shown to improve cardiac function in patients with heart failure with a reduced ejection fraction. Its effect on cardiovascular outcomes is unknown. METHODS We randomly assigned 8256 patients (inpatients and outpatients) with symptomatic chronic heart failure and an ejection fraction of 35% or less to receive omecamtiv mecarbil (using pharmacokinetic-guided doses of 25 mg, 37.5 mg, or 50 mg twice daily) or placebo, in addition to standard heart-failure therapy. The primary outcome was a composite of a first heart-failure event (hospitalization or urgent visit for heart failure) or death from cardiovascular causes. RESULTS During a median of 21.8 months, a primary-outcome event occurred in 1523 of 4120 patients (37.0%) in the omecamtiv mecarbil group and in 1607 of 4112 patients (39.1%) in the placebo group (hazard ratio, 0.92; 95% confidence interval [CI], 0.86 to 0.99; P = 0.03). A total of 808 patients (19.6%) and 798 patients (19.4%), respectively, died from cardiovascular causes (hazard ratio, 1.01; 95% CI, 0.92 to 1.11). There was no significant difference between groups in the change from baseline on the Kansas City Cardiomyopathy Questionnaire total symptom score. At week 24, the change from baseline for the median N-terminal pro-B-type natriuretic peptide level was 10% lower in the omecamtiv mecarbil group than in the placebo group; the median cardiac troponin I level was 4 ng per liter higher. The frequency of cardiac ischemic and ventricular arrhythmia events was similar in the two groups. CONCLUSIONS Among patients with heart failure and a reduced ejection, those who received omecamtiv mecarbil had a lower incidence of a composite of a heart-failure event or death from cardiovascular causes than those who received placebo. (Funded by Amgen and others; GALACTIC-HF ClinicalTrials.gov number, NCT02929329; EudraCT number, 2016 -002299-28.)