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

Cost of Capital when Dividends are Deductible (Custo de Capital quando os Dividendos são Dedutíveis)

Abstract Tax savings and the discount rate we use to calculate their value are involved in the calculation of cost of capital. Based on previous findings, we derive a general approach to cash flow valuation that take into account any kind of tax shields related to the financing decision of a firm and any date when they are earned. They can be used to introduce any type of externality that creates value through tax savings not captured by neither the cost of debt nor the cost of equity. This paper develops the formulations for the cost of capital when dividends, interest on equity or monetary correction of equity are deductible as it happens in Brazil. It shows that when properly done most known valuation methods are consistent and give identical results. Also, the paper argues that when dividends are tax deductible, optimal leverage is lower and equity value is higher. Keywords: corporate finance; WACC; interest on equity; tax savings; tax shields; cost of equity; discount rate for tax savings. JEL codes: D61; G31; H43. Resumo As economias tributárias e a taxa de desconto que usamos para calcular o seu valor estão envolvidos no cálculo do custo de capital. Com base em resultados anteriores, nós derivamos uma abordagem geral para avaliação de fluxo de caixa que considera qualquer tipo de benefícios fiscais relacionados com a decisão de financiamento de uma empresa e qualquer data em que sejam auferidos. Eles podem ser usados para introduzir qualquer tipo de externalidade que cria valor por meio de economias tributárias não capturadas nem pelo custo da dívida nem pelo custo do capital próprio. Particularmente, nós desenvolvemos as formulações para o custo de capital quando os dividendos, juros sobre capital próprio ou correção monetária de capital próprio são dedutíveis, como acontece no Brasil. Isso mostra que, quando usados corretamente, os métodos de avaliação mais conhecidos são consistentes e dão resultados idênticos. Além disso, o artigo argumenta que quando os dividendos são dedutíveis, a alavancagemótimaé menor e o valor do capital acionárioé maior. Palavras-chave: finanças corporativas; WACC; juros sobre capital próprio; economias tributárias; benefícios tributários; custo do capital próprio; taxa de desconto para economias tributárias