ACC25: Ozempic shows its value in PAD
Novo Nordisk's Ozempic has been shown to improve waking distance and quality of life in people with type 2 diabetes (T2D) and peripheral artery disease (PAD), potentially adding yet another indication for the blockbuster GLP-1 agonist.
In the 792-subject STRIDE study reported at the American College of Cardiology (ACC) annual meeting, Ozempic (semaglutide) achieved its main objective with a 13% improvement in maximum walking distance compared to placebo at week 52, translating to an average difference between the groups of almost 40 metres on a steep incline.
That result was backed up by significant improvements on secondary endpoints, including pain-free walking distance and health-related quality of life scores at week 52, as well as maximum walking distance at week 57, according to lead investigator Marc Bonaca of the University of Colorado, who presented the data at the meeting.
Notably, there wasn't a strong association between efficacy readouts in the study and the weight loss achieved with the GLP-1 drug, suggesting that some direct vascular effect of the drug in these patients may be at play. The data has also been published in The Lancet.
"Semaglutide […] is the first medication in over two decades to show improvements in cardiometabolic and cardiovascular outcomes, as well as meaningful improvements in functional capacity and quality of life, which could address a critical unmet need for those with both PAD and type 2 diabetes," he said.
"There is more work to be done to understand the mechanism of benefit," continued Bonaca, who also noted that the study "raises the question of whether patients with PAD and without [T2D] could benefit and that should be investigated in future studies."
PAD is a severe form of atherosclerotic cardiovascular disease that is under-screened and underdiagnosed and impacts approximately 230 million people globally, with T2D a major risk factor. Novo Nordisk said it has already filed for approval in the US and Europe to extend the label for Ozempic to include the STRIDE data and is expecting a decision from regulators later this year.
Ozempic is already approved to treat T2D, for cardiovascular risk reduction in T2D patients, and to prevent worsening kidney disease and cardiovascular death in people with T2D and CKD.
…as Rybelsus cuts MACE in type 2 diabetics
Meanwhile, semaglutide has become the first drug in the GLP-1 class to show that it can lower the risk of major adverse cardiovascular events (MACE) in patients with T2Ds when given as an oral therapy.
The results of the SOUL trial reveal that the Danish pharma's Rybelsus formulation of semaglutide reduced the risk of MACE (cardiovascular death, non-fatal myocardial infarction (MI), or stroke) by 13.8% compared to placebo over four years of follow-up in a population of 9,650 people with T2D, persistently elevated blood glucose, and atherosclerotic cardiovascular disease and/or chronic kidney disease.
The data was presented at ACC by Darren McGuire at UT Southwestern, who said: "This study gives us confidence that people who are resistant or reluctant to take injections can still have an option for clinical benefit with [semaglutide] in the form of a tablet." It has also been published in the New England Journal of Medicine.
