Ozempic boosts walking distance for patients with diabetes, peripheral artery disease
Key takeaways:
- Ozempic improved walking distance in patients with diabetes and peripheral artery disease at 1 year.
- An exploratory analysis suggested Ozempic reduced risk for major limb events and mortality.
CHICAGO — Among patients with diabetes and peripheral artery disease, semaglutide 1 mg increased walking distance vs. placebo, according to data from the STRIDE trial presented at the American College of Cardiology Scientific Session.
Marc P. Bonaca, MD, MPH, executive director of CPC Clinical Research and CPC Community Health, director of vascular research and professor of medicine at the University of Colorado School of Medicine and holder of the William R. Hiatt Endowed Chair in Cardiovascular Research, and colleagues randomly assigned 792 patients with diabetes and PAD (mean age, 68 years; 25% women) to semaglutide 1 mg (Ozempic, Novo Nordisk) or placebo.
All patients had intermittent claudication and an ankle-brachial index of 0.9 or less or a toe-brachial index of 0.7 or less, Bonaca said during a press conference.
“Importantly, we selected patients that had Fontan IIa stage disease, which ... is the earliest manifestation of symptoms,” he said. “Patients were only excluded if they had an unstable cardiovascular condition or were planned for revascularization. Despite that, they were severely disabled. Even patients who have early-stage PAD by clinical classification were limited [at baseline] to 185 m of walking on a treadmill, which is about one-tenth of a mile before they had to stop.”
The results were simultaneously published in The Lancet.
The primary endpoint of estimated median ratio to baseline in maximum walking distance on a constant load treadmill at 52 weeks was 1.21 (interquartile range [IQR], 0.95-1.55) in the semaglutide group compared with 1.08 (IQR, 0.86-1.36; estimated treatment ratio, 1.13; 95% CI, 1.06-1.21; P = .0004) in the placebo group, according to the researchers.
The odds ratio for clinically meaningful improvement with semaglutide was 1.79 (95% CI, 1.32-2.43; P = .0002), Bonaca said during the press conference.
An on-treatment analysis did not change the results.
Compared with placebo, the semaglutide group had a median improvement in maximum walking distance from baseline to 52 weeks of 26.4 m (95% CI, 11.8-40.9); mean improvement was 39.9 m (95% CI, 13.9-66), according to the researchers.
“To put that into context, a change on a flat 6-minute walk test that would be clinically significant for this population would be 20 m,” Bonaca said during the press conference. “This is double that, and it’s on a 12% grade, so it’s walking up a hill.”
The results were consistent across subgroups, Bonaca said.
Compared with placebo, the semaglutide group had greater reductions in body weight (estimated treatment difference, –4.1 kg; P < .0001), HbA1c (estimated treatment difference, –1 percentage point; P < .0001) and systolic BP (estimated treatment difference, –3.2 mm Hg; P = .0042) at 52 weeks, he said.
“Even patients who had a BMI below the median had a consistent benefit with semaglutide,” Bonaca said during the press conference.
The semaglutide group also had greater improvement than the placebo group in functional, quality of life and hemodynamic metrics, he said.
In an exploratory clinical analysis, the outcome of rescue initiation (defined as a new medication or revascularization), major adverse limb events and mortality at 52 weeks favored the semaglutide group (HR = 0.46; 95% CI, 0.24-0.84).
Serious adverse events possibly or probably related to the study drug occurred in 1% of the semaglutide group and 2% of the placebo group. There were no treatment-related deaths, according to the researchers.
“We have ... a new drug for PAD,” Bonaca said during the press conference. “And it adds a new element to our understanding of GLP-1 [receptor agonists].”
Reference:
Perspective
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I do think this trial will be a game changer because of the improvement in quality of life and functional capacity and the decrease in a number of secondary outcomes which are related to cardiovascular health, including HbA1c, weight and blood pressure. There is even the potential for improving hard outcomes such as death, revascularization, heart attack and stroke.
I think the results will lead to increased uptake of semaglutide in this population, mainly because there has not been an agent to improve walking distance, quality of life and pain in patients who are suffering with PAD. Because there is so little on the market, clinicians do not have anything to offer these patients, that should probably lead to a quick uptake. It is also a drug used extensively in patients with or at risk for CVD, so there are safety, efficacy and outcomes data showing positive effects that patients with PAD could benefit from.
Lenox Hill Hospital
System Director, Cardiovascular Prevention
Northwell Health
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Bonaca MP, et al. Joint American College of Cardiology/Journal of the American College of Cardiology late-breaking clinical trials. Presented at: American College of Cardiology Scientific Session; March 29-31, 2025; Chicago (hybrid meeting).