Novo Nordisk bolstered its heart disease data for semaglutide on Friday with additional analyses from a handful of trials.
In a pooled analysis of certain heart failure patients from four studies, semaglutide reduced the risk of combined cardiovascular death and heart failure hospitalizations or urgent visits by 31%, according to results published in The Lancet. It’s important to note that the data are from a post-hoc analysis, which can be a tough sell at the FDA.
Patients were selected based on ejection fraction, or how much blood the left ventricle pumps with each contraction. Heart failure with preserved ejection fraction (HFpEF) occurs when the heart can’t fill properly but still pumps out a normal amount of blood. It’s the most common type of heart failure, and it’s driven by obesity.
Across the four trials — SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM — semaglutide led to a 41% lower risk of worsening heart failure in patients with HFpEF or mildly reduced ejection fraction, Novo announced. While there were fewer cardiovascular deaths in the semaglutide arm, the difference wasn’t statistically significant.
Novo Nordisk’s weight loss drug Wegovy was approved in March to reduce cardiovascular risk in overweight or obese patients with cardiovascular disease. The company is currently trying to expand the label to heart failure, after pulling an FDA submission last year to wait for more data.
Novo read out more detailed cardiovascular data from its Phase 3 FLOW study in type 2 diabetes patients with chronic kidney disease on Friday at the European Society of Cardiology annual meeting in London.