Results from AstraZeneca’s Deliver phase-III trial showed that the company’s Dapagliflozin significantly reduced the composite of cardiovascular death or worsening heart failure in patients with health failure and mildly reduced or preserved ejection fraction, compared to placebo. The results were presented at the European Society of Cardiology Congress 2022 in Barcelona, Spain, and simultaneously published in The New England Journal of Medicine, according to a statement from AstraZeneca.
The statement notified that Dapagliflozin reduced the composite outcome of cardiovascular death or worsening of heart failure by 18 per cent (p<0.001, 16.4 per cent in the Dapagliflozin group and 19.5 per cent in the placebo group over a median follow-up of 2.3 years). All individual components contributed to the superiority of the primary endpoint. The findings were consistent across key subgroups examined and extend the benefits of Dapagliflozin to the full spectrum of patients with heart failure, irrespective of Left Ventricular Ejection Fraction (LVEF) status. The trial results also showed a symptom benefit in patient-reported outcomes measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score.
The updated 2022 joint heart failure guidelines issued by the American College of Cardiology, the American Heart Association and the Heart Failure Society of America, now recommend sodium-glucose cotransporter 2 (SGLT2) inhibitors such as Dapagliflozin for heart failure with mildly reduced ejection fraction and heart failure with preserved ejection fraction. This expands upon previous recommendations supporting the use of SGLT2 inhibitors in heart failure with reduced ejection fraction.
In addition to it, the statement said that the safety and tolerability profile of Dapagliflozin in the Deliver phase-III trial was consistent with the well-established safety profile of the medicine.
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