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MEDTECH Dive into how the FDA-approved Farxiga is changing the heart failure treatment landscape.
Colleagues, let’s dive into a remarkable milestone. Farxiga, known as dapagliflozin, now has FDA approval. This is groundbreaking for heart failure treatment. It applies to all patients, regardless of their left ventricular ejection fraction (LVEF) status.
The approval didn’t happen overnight. Let’s talk about the DELIVER trial, a vital part of the process. It involved over 6,000 patients, all over 40. Each had heart failure, LVEF above 40%, and may or may not have had type 2 diabetes. They took either dapagliflozin or a placebo daily, plus their usual therapy.
The trial had a clear goal: time to the first composite event. This included CV death, heart failure hospitalization, or an urgent heart failure visit. The goal applied to everyone, including patients with LVEF less than 60%.
Fast forward about 2.3 years, the results were significant. Dapagliflozin cut the composite outcome by 18% versus the placebo. Both worsening heart failure and CV death rates dropped in the dapagliflozin group. The best part? These findings were consistent, even in patients with lower LVEF or diabetes.
Expanding the picture, let’s consider two trials together: DELIVER and DAPA-HF. Over 22 months, dapagliflozin proved its mettle. It cut CV death risk by 14%. It reduced all-cause mortality by 10%. Heart failure hospitalizations plunged by 29%.
Ruud Dobber of AstraZeneca highlighted the bigger picture. With half of heart failure patients dying within five years, the stakes are high. Treatments like Farxiga aren’t just vital; they are life-changing. They show a committed effort to saving lives, a beacon of hope for heart failure patients everywhere.
