Ozempic Significantly Improves Walking Distance in Patients with Type 2 Diabetes and Peripheral Artery Disease

Semaglutide查看药品详情 1 mg, marketed as Ozempic查看药品详情 by Novo Nordisk查看公司主页, demonstrated significant improvements in walking distance for patients with type 2 diabetes (搜索)搜索该疾病 and peripheral artery disease (搜索)搜索该疾病 (PAD), according to new data presented at the American College of Cardiology's Annual Scientific Session in Chicago.

The phase 3b STRIDE trial results, simultaneously published in The Lancet, showed that once-weekly semaglutide查看药品详情 1 mg increased maximum walking distance by 13% compared to placebo at 52 weeks, meeting the study's primary endpoint.

Significant Functional Improvements

The double-blind, randomized, placebo-controlled trial enrolled 792 adults (mean age 68 years, 25% women) with type 2 diabetes (搜索)搜索该疾病 and symptomatic PAD. All participants had intermittent claudication (搜索)搜索该疾病 and an ankle-brachial index of 0.9 or less or a toe-brachial index of 0.7 or less.

"Importantly, we selected patients that had Fontan IIa stage disease, which is the earliest manifestation of symptoms," said Dr. Marc P. Bonaca, executive director of CPC Clinical Research and CPC Community Health, and lead investigator of the STRIDE trial. "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 primary endpoint results showed the estimated median ratio to baseline in maximum walking distance on a constant load treadmill at 52 weeks was 1.21 in the semaglutide查看药品详情 group compared with 1.08 in the placebo group (estimated treatment ratio, 1.13; 95% CI, 1.06-1.21; p=0.0004).

Compared with placebo, the semaglutide查看药品详情 group had a median improvement in maximum walking distance from baseline to 52 weeks of 26.4 meters (95% CI, 11.8-40.9), representing a clinically meaningful difference.

"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 meters," Dr. Bonaca explained. "This is double that, and it's on a 12% grade, so it's walking up a hill."

Comprehensive Benefits Beyond Walking Distance

The trial also demonstrated superiority to placebo for all confirmatory secondary outcomes, including pain-free walking distance (estimated treatment ratio vs placebo 1.11; 95% CI, 1.03 to 1.20; p=0.0046) and Vascular Quality of Life Questionnaire-6 (VascuQoL-6) scores (estimated treatment difference vs placebo 1.00; 95% CI, 0.48 to 1.52; p=0.011) at 52 weeks.

Additional metabolic benefits were observed in the semaglutide查看药品详情 group compared to placebo, including greater reductions in body weight (estimated treatment difference, −4.1 kg; p<0.0001), HbA1c (estimated treatment difference, −1 percentage point; p<0.0001), and systolic blood pressure (estimated treatment difference, −3.2 mm Hg; p=0.0042) at 52 weeks.

"Even patients who had a BMI below the median had a consistent benefit with semaglutide查看药品详情," noted Dr. Bonaca, indicating the drug's effects extend beyond weight loss.

Clinical Implications for a Significant Unmet Need

PAD is a form of atherosclerotic cardiovascular disease that affects approximately 12 million people in the United States, with one in four also having type 2 diabetes (搜索)搜索该疾病. The presence of type 2 diabetes increases the incidence of PAD and accelerates disease progression and severity.

"Peripheral artery disease (搜索)搜索该疾病 may cause severe symptoms, physical limitations, and a diminished quality of life, often making even short walks—such as retrieving the mail—challenging," Dr. Bonaca said. "In individuals with PAD and diabetes, the disease can be even more severe, affecting small blood vessels and limiting the effectiveness of revascularization procedures and other treatments."

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查看药品详情 group (HR = 0.46; 95% CI, 0.24-0.84).

Safety Profile

The safety profile of semaglutide查看药品详情 in the STRIDE trial was consistent with previous studies. Serious adverse events were reported in 19% of participants in the semaglutide arm and 20% in the placebo arm. Serious adverse events that were possibly or probably treatment-related occurred in 1% and 2% of participants, respectively.

The most frequent serious adverse event across both groups was gastrointestinal events (1% in both groups). No treatment-related deaths were reported.

Regulatory Implications

Based on the STRIDE trial data, Novo Nordisk查看公司主页 has submitted a label extension application for Ozempic查看药品详情 to the U.S. Food and Drug Administration. A decision is anticipated in 2025.

"We have a new drug for PAD," Dr. Bonaca concluded. "And it adds a new element to our understanding of GLP-1 (搜索)搜索该靶点 receptor agonists."

If approved, semaglutide查看药品详情 would be the first medication in over two decades to show meaningful improvements in functional capacity and quality of life for patients with both PAD and type 2 diabetes (搜索)搜索该疾病, addressing a critical unmet need in this patient population.

"The results from STRIDE, the first and only dedicated PAD functional outcomes trial with a GLP-1 (搜索)搜索该靶点 RA treatment, provide important clinical insights that help further our understanding and approach to cardiometabolic diseases like type 2 diabetes (搜索)搜索该疾病 and peripheral artery disease (搜索)搜索该疾病," said Dr. Michael Radin, Executive Medical Director of Diabetes Medical Affairs at Novo Nordisk查看公司主页, Inc.