Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 32 n° 289

Death and the Worsening of Heart Failure

Posted by fidest press agency su martedì, 3 settembre 2019

AstraZeneca today announced detailed results from the landmark Phase III DAPA-HF trial that showed FARXIGA (dapagliflozin) on top of standard of care reduced both the incidence of cardiovascular (CV) death and the worsening of heart failure.DAPA-HF is the first outcomes trial with an SGLT2 inhibitor investigating the treatment of heart failure in patients with reduced ejection fraction (HFrEF), with and without type 2 diabetes (T2D). FARXIGA is currently approved to improve glycemic control in patients with T2D.Top-line results announced in August 2019 showed DAPA-HF met the primary endpoint. The detailed results of the trial presented today at the ESC Congress 2019 in Paris, France, showed FARXIGA reduced the composite of CV death or worsening of heart failure by 26% (p<0.0001) and showed a reduction in each of the individual components of the composite endpoint. In analyzing each of the components of the primary composite endpoint, there was a 30% decrease (p<0.0001) in the risk of experiencing a first episode of worsening heart failure and an 18% decrease (p=0.0294) in the risk of dying from CV causes. The effect of FARXIGA on the primary composite endpoint was generally consistent across the key subgroups examined.The trial results also showed a significant improvement in patient reported outcomes measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score and a nominally significant reduction in all-cause mortality by 17% (7.9 vs 9.5 patients with an event per 100 patient-years) in favor of FARXIGA.The safety profile of FARXIGA in the DAPA-HF trial was consistent with the well-established safety profile of the medicine. The proportion of patients with volume depletion (7.5% vs 6.8%) and renal adverse events (6.5% vs 7.2%), which are commonly of concern when treating heart failure, were comparable to placebo. Major hypoglycemic events (0.2% vs 0.2%) were rare in both treatment groups.

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