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CHICAGO, June 21, 2025 ~ A new analysis presented at the 85th Scientific Sessions of the American Diabetes Association® (ADA) in Chicago and published in Diabetes Care® has demonstrated the potential vascular benefits of semaglutide for patients with peripheral artery disease (PAD) and type 2 diabetes. The analysis, which was based on data from the STRIDE trial, showed that semaglutide can improve symptoms, quality of life, and disease progression in these patients.
PAD is a serious condition that affects approximately 230 million individuals worldwide and up to 30% of people with diabetes. It is characterized by narrowed arteries and reduced blood flow to the legs, leading to significant disability, decreased quality of life, and an increased risk of severe complications such as amputations and death. Currently, treatment options for PAD are limited and there have been few advancements in its treatment over the past 25 years.
The STRIDE trial is a phase 3 clinical trial conducted at 112 outpatient sites in 20 countries across North America, Asia, and Europe. It involved 792 patients aged 18 years or older with type 2 diabetes and PAD with intermittent claudication (a symptom of PAD that causes leg pain or cramping during physical activity) and reduced ankle-brachial or toe-brachial index (indicators of restricted blood flow to the legs). These patients were randomly assigned to receive either semaglutide or a placebo over a period of 52 weeks to assess its impact on walking capacity, symptoms, and quality of life. The median age of participants was 68 years old, with 195 (25%) being female and 597 (75%) being male.
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The sub-analysis presented at the ADA conference builds on previous results published in The Lancet which showed that semaglutide significantly improved walking outcomes in people with PAD and diabetes. It also demonstrated enhanced quality of life and a reduced risk of disease progression by 54%. At the end of the 52-week period, the estimated median ratio to baseline in maximum walking distance was 1.21 in the semaglutide group compared to 1.08 in the placebo group. The drug was well tolerated, with no treatment-related deaths and a low rate of serious adverse events (1%), consistent with its known safety profile. The analysis also showed that these benefits were observed regardless of baseline levels of A1C (a measure of blood sugar control), duration of diabetes, or intensity of diabetes treatment. Additionally, the benefits were seen across all body mass index (BMI) categories and regardless of whether patients were also taking SGLT2 inhibitors, another type of medication commonly used to treat diabetes.
According to Professor Subodh Verma, MD, PhD, FRCSC, FAHA, FCAHS, cardiovascular surgeon at the University of Toronto and senior author of the STRIDE trial, these findings suggest that semaglutide can be recognized as a vascular protective medication with benefits that go beyond just lowering weight or A1C levels. He stated that "the totality of data now suggest that in people with diabetes, semaglutide favorably affects the pipes [atherosclerosis], pump [heart failure], filter [kidney outcomes]. And in patients with PAD, these new data provide robust evidence that semaglutide is a therapy to improve their function, quality of life, and progression of disease." However, further research is needed to determine if these benefits extend to individuals with PAD who do not have diabetes.
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The study's findings were presented by Dr. Verma at a symposium titled "Diabetes and Peripheral Artery Disease - Evolving Role of GLP-1 RA and New Insights from the STRIDE Trial" on Saturday June 21 at 1:30 p.m. CT. This presentation highlights the potential for semaglutide to be a beneficial treatment option for patients with PAD and type 2 diabetes.
PAD is a serious condition that affects approximately 230 million individuals worldwide and up to 30% of people with diabetes. It is characterized by narrowed arteries and reduced blood flow to the legs, leading to significant disability, decreased quality of life, and an increased risk of severe complications such as amputations and death. Currently, treatment options for PAD are limited and there have been few advancements in its treatment over the past 25 years.
The STRIDE trial is a phase 3 clinical trial conducted at 112 outpatient sites in 20 countries across North America, Asia, and Europe. It involved 792 patients aged 18 years or older with type 2 diabetes and PAD with intermittent claudication (a symptom of PAD that causes leg pain or cramping during physical activity) and reduced ankle-brachial or toe-brachial index (indicators of restricted blood flow to the legs). These patients were randomly assigned to receive either semaglutide or a placebo over a period of 52 weeks to assess its impact on walking capacity, symptoms, and quality of life. The median age of participants was 68 years old, with 195 (25%) being female and 597 (75%) being male.
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The sub-analysis presented at the ADA conference builds on previous results published in The Lancet which showed that semaglutide significantly improved walking outcomes in people with PAD and diabetes. It also demonstrated enhanced quality of life and a reduced risk of disease progression by 54%. At the end of the 52-week period, the estimated median ratio to baseline in maximum walking distance was 1.21 in the semaglutide group compared to 1.08 in the placebo group. The drug was well tolerated, with no treatment-related deaths and a low rate of serious adverse events (1%), consistent with its known safety profile. The analysis also showed that these benefits were observed regardless of baseline levels of A1C (a measure of blood sugar control), duration of diabetes, or intensity of diabetes treatment. Additionally, the benefits were seen across all body mass index (BMI) categories and regardless of whether patients were also taking SGLT2 inhibitors, another type of medication commonly used to treat diabetes.
According to Professor Subodh Verma, MD, PhD, FRCSC, FAHA, FCAHS, cardiovascular surgeon at the University of Toronto and senior author of the STRIDE trial, these findings suggest that semaglutide can be recognized as a vascular protective medication with benefits that go beyond just lowering weight or A1C levels. He stated that "the totality of data now suggest that in people with diabetes, semaglutide favorably affects the pipes [atherosclerosis], pump [heart failure], filter [kidney outcomes]. And in patients with PAD, these new data provide robust evidence that semaglutide is a therapy to improve their function, quality of life, and progression of disease." However, further research is needed to determine if these benefits extend to individuals with PAD who do not have diabetes.
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The study's findings were presented by Dr. Verma at a symposium titled "Diabetes and Peripheral Artery Disease - Evolving Role of GLP-1 RA and New Insights from the STRIDE Trial" on Saturday June 21 at 1:30 p.m. CT. This presentation highlights the potential for semaglutide to be a beneficial treatment option for patients with PAD and type 2 diabetes.
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