5 research outputs found

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

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    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

    The issue of stress in neoplastic disease

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    Stres według Seylego jest odpowiedzią organizmu na bodziec. Współczesna psychologia definiuje stres jako dynamiczną relację adaptacyjnąmiędzy możliwościami jednostki a wymogami sytuacji (stresorem), charakteryzującą się brakiem równowagi. Stresory są wszechobecnei nieuniknione, nie wywołują jednak jednoznacznie negatywnych skutków dla jednostki. Rezultaty ich działań zależą od posiadanychzasobów przydatnych w radzeniu sobie.Choroba nowotworowa stanowi szczególny rodzaj sytuacji stresowej, bowiem działa jako stresor biologiczny, wpływając na czynnośćorganizmu, oraz stresor psychiczny; wpływa zatem w sposób pośredni na stan psychiczny i funkcjonowanie człowieka. Wpływa na jednostkęw sposób wielostronny, pociąga za sobą poważne konsekwencje poznawcze, emocjonalne i behawioralne. Stres związany z chorobąnowotworową znajduje swoje źródło w dolegliwościach somatycznych, zagrożeniu życia, niepewności rokowania, uciążliwym procesieterapeutycznym, a także w zmianie sytuacji osobistej i zawodowej. Reakcje emocjonalne na chorobę nowotworową zmieniają się podwpływem nowych informacji, nasilających się dolegliwości, stosowanych metod leczenia i przebiegają etapowo. Można wśród nich wyróżnićreakcje prawidłowe, będące w efekcie końcową adaptacją do choroby nowotworowej i reakcje patologiczne, wyrażające nieprzystosowaniedo rozpoznanej u siebie choroby.Problemy Pielęgniarstwa 2013; 21 (1): 128–136According to Selye stress is a body’s response to stimuli. Modern psychology defines stress as an adaptive and dynamic relationship betweenthe abilities of individuals and the requirements of the situation (stress factors); characterized by a lack of balance. Stressors are ubiquitousand unavoidable, but do not cause clearly negative effects on individuals. The results of people activities depend on the availableresources useful to cope with stress.Neoplastic disease exemplifies a special type of stressful situation; it acts as the biological stressor which affects the activity of the body, andthe mental stressor which has an indirect effect on mental health and functioning of human being. It affects the body in a multilateral way,entails serious cognitive, emotional and behavioural consequences. Stress caused by neoplastic disease has its origin in somatic ailments,threat to life, prognostic indicators, troublesome therapeutic process and change in personal and professional situation. Emotional reactionsto neoplastic disease are changing thanks to new information, worsening symptoms, methods of treatment; and they proceed in stages.From among above mentioned reactions the specialists can distinguish: the correct response which is in the final adaptation to neoplasticdisease, and pathological response which emphasizes the inadequacy of one’s recognized disease.Nursing Topics 2013; 21 (1): 128–13

    Cardiac myosin activation with omecamtiv mecarbil in systolic heart failure

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    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.)
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