Latest news with #MarcP.Bonaca
Associated Press
30-03-2025
- Health
- Associated Press
CPC Announces Semaglutide Significantly Improves Walking Distance, Symptoms and Quality of Life for People with PAD and Diabetes
Study underscores the direct vascular effects of this class of drugs, researchers say AURORA, CO / ACCESS Newswire / March 29, 2025 / A novel study of a semaglutide, a glucagon-like peptide-1 (GLP-1) agonist used to treat type 2 diabetes, obesity and cardiovascular disease, semaglutide was found to significantly improve maximal walking distance in people with symptomatic peripheral artery disease (PAD) and type 2 diabetes, meeting the study's primary endpoint. The STRIDE Trial, presented at the American College of Cardiology's Annual Scientific Session (ACC.25), is the first to evaluate any GLP-1 agonist in PAD for this outcome. In addition to improvements in walking ability and function, people taking semaglutide also saw significant improvements in both symptoms and quality of life compared with those taking a placebo. People taking semaglutide also saw significant improvements in both symptoms and quality of life compared with those taking a placebo. Dr. Marc Bonaca, Executive Director of CPC presented the results and concluded, 'We have the first new treatment for PAD symptoms in 25 years.' PAD affects an estimated 12 million U.S. adults and over 200 million people worldwide. PAD happens when there is a build-up of fat and cholesterol, most commonly in the arteries of the legs. It's often associated with difficulty walking and poor circulation that can lead to non-healing wounds and a high rate of limb loss. People with PAD are at very high risk for serious complications, including acute limb ischemia - similar to a heart attack or stroke of the leg - that can lead to limb amputation or death if not treated quickly. 'Even at very early stages of PAD, people can't walk well, but they often don't know it's PAD. They may say, 'I've just slowed down,' 'I'm getting older,' or 'I have arthritis,' but they're actually severely functionally impaired and they often will self-limit what they are doing,' said Marc P. Bonaca, MD, MPH, professor of medicine and director of vascular research at the University of Colorado School of Medicine in Aurora, Colorado, and the study's lead author, adding that the last drug approved by the FDA for improving functional outcomes in PAD was cilostazol in 2000, so there is a huge unmet need. 'The only drug we have available is contraindicated in people with heart failure, has no benefits beyond improvement in symptoms, and causes a lot of side effects and, so overall it's used in less than 10% of people and so we really have limited options to improve function in PAD,' he said. 'The [issue] is that as PAD progresses, patients go on to get revascularization procedures to open arteries, and become at high risk for adverse cardiovascular and limb events.' For this randomized, placebo-controlled, double-blind trial, called STRIDE, 792 people with type 2 diabetes and early-stage symptomatic PAD were enrolled at 112 medical centers in 20 countries. Patients (67 years old on average, about 25% women, 67% white) were randomized to receive semaglutide (1 mg) or placebo for one year (52 weeks). Researchers assessed maximal walking distance - the maximum distance that patients were able to walk on a treadmill at 2 miles per hour at a 12% grade (similar to walking up a moderate hill). Function was assessed at baseline (median maximal walk distance was 186 meters), week 26, week 52 (primary endpoint), and week 57 (5 weeks after stopping treatment). The Colorado Prevention Center (CPC), affiliated with the University of Colorado School of Medicine, supported the treadmill endpoint through its core lab services. 'Despite the fact that people were recruited on the basis of reporting early-stage PAD observed that they were actually severely impaired and could only walk about one-tenth of a mile with symptom onset significantly earlier,' Bonaca said. 'We saw that the drug clearly worked. There was a clear early benefit at six months that continued to increase at one year.' Overall, patients in the semaglutide arm had median and mean improvements in walking distance compared to placebo of 26 meters and 39.9 meters respectively, giving a statistically significant improvement in the ratio of change from baseline to week 52 of 1.13 (p=0.0004). 'To put that into context, we usually think an increase in walking distance of 10 to 20 meters is clinically important in PAD, so this exceeded those expectations,' he said. The results were further supported by confirmatory secondary endpoints showing significant improvements in quality of life (as measured by the Vascular Quality of Life Questionnaire-6 score), symptoms represented by pain-free walking distance, and sustained improvement in maximal walking distance 5 weeks after stopping therapy. Safety was shown to be similar to what was seen in earlier trials with semaglutide, with non-serious gastrointestinal side effects the most commonly reported side effects. Patients' ankle brachial index, a measure of blood flow in the legs, was also significantly improved among those taking semaglutide compared with placebo. A post-hoc analysis looking at time to rescue treatment (the need for revascularization due to worsening symptoms) or death was also lower with semaglutide. Within one-year of treatment, patients taking semaglutide had a 54% reduction in their risk of dying or needing a medication or procedure to open blocked arteries in their legs due to worsening symptoms compared with those receiving a placebo (14 vs 30 patients). 'Taken together, the data support semaglutide for people with PAD and type 2 diabetes mellitus as a therapy that has cardiometabolic, cardiovascular and kidney benefits and improves function, symptoms, and quality of life.,' said Bonaca, 'There is more work to be done to understand the mechanism of benefit as the population had a median BMI of 28.6 and the relationship between the outcome and weight loss was very weak. This coupled with the increase in ABI really suggests a direct vascular effect. This also raises the question of whether patients with PAD and without type 2 diabetes mellitus could benefit and that should be investigated in future studies.' The study was limited in that it was only in patients who also had diabetes. In addition, there were fewer U.S. patients because revascularization is so common and that patients who had these procedures were excluded. As a result, there was also less diversity and very few Black patients. This study was funded by Novo Nordisk. It was simultaneously published online in The Lancet at the time of presentation. Dr. Marc P. Bonaca can be reached by media at [email protected] or 303-860-9900. Dr. Marc Bonaca will present the study, 'The Effect Of Once-weekly Subcutaneous Semaglutide On Functional Capacity In People With Type 2 Diabetes And Peripheral Artery Disease: Primary Results From The Phase 3b, Randomized, Placebo-controlled, Double Blind Stride Trial,' on March 29, 2025, at 9:30 a.m. CT in Chicago at the American College of Cardiology Meeting. CPC Clinical Research, an ARO affiliated with the University of Colorado, is conducting the study in collaboration with Novo Nordisk. 2115 N. Scranton St., Suite 2040
Yahoo
29-03-2025
- Health
- Yahoo
Ozempic® (semaglutide) injection 1 mg showed improved functional outcomes and health-related quality of life in Phase 3 STRIDE trial in adults with type 2 diabetes and peripheral artery disease (PAD) presented at ACC 2025
Semaglutide 1 mg demonstrated statistically significant and superior improvement in maximum walking distance by 13% over placebo in adults with type 2 diabetes and symptomatic PAD1 Based on STRIDE trial data, presented at the American College of Cardiology's (ACC) Annual Scientific Session and Expo while simultaneously published today in The Lancet, Novo Nordisk submitted a label extension application accepted for review by the FDA Approximately 12 million people in the United States are impacted by PAD, a form of atherosclerotic disease, and one in four also have type 2 diabetes2,3 PLAINSBORO, N.J., March 29, 2025 /PRNewswire/ -- Novo Nordisk today presented results from STRIDE, its phase 3b trial investigating the effects of once-weekly Ozempic® (semaglutide) injection 1 mg in adults with type 2 diabetes and early-stage symptomatic PAD1, at the American College of Cardiology's (ACC) Annual Scientific Session and Expo. The results were presented during a late-breaking clinical trial session and highlighted at an official ACC press conference. In addition, the analysis was also simultaneously published today in The Lancet. The double-blind, randomized, placebo-controlled STRIDE trial, which enrolled 792 adults with type 2 diabetes and symptomatic PAD, achieved its primary endpoint, with semaglutide 1 mg demonstrating a 13% superior improvement in maximum walking distance (estimated treatment ratio [ETR] vs placebo, 1.13; 95% confidence interval [CI], 1.06 to 1.21; p=0.0004) and a clinically meaningful median treatment difference of 26.4 meters (95% CI, 11.8 to 40.9; approximately 87 feet, or about a third the length of an American football field) on a 12% incline, compared to placebo at 52 weeks. The trial also demonstrated superiority to placebo for all confirmatory secondary outcomes assessed, including pain-free walking distance (ETR vs placebo 1.11; 95% CI, 1.03 to 1.20; p=0.0046) and Vascular Quality of Life Questionnaire-6 (VascuQoL-6) (estimated treatment difference vs placebo 1.00; 95% CI, 0.48 to 1.52; p=0.011) at 52 weeks.1,4 "Peripheral artery disease (PAD) may cause severe symptoms, physical limitations, and a diminished quality of life, often making even short walks—such as retrieving the mail—challenging. 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. Semaglutide 1 mg is the first medication in over two decades to show 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," said Marc P. Bonaca, MD, Director of Vascular Research, University of Colorado School of Medicine, Lead Investigator of the STRIDE trial. "The significant improvements in walking distance and patient-reported quality of life observed with semaglutide 1 mg in the STRIDE trial are promising and represent an important step forward on the path to advancing treatment options for this patient population." PAD is a form of atherosclerotic cardiovascular disease that is under screened, under diagnosed, and is associated with limited walking ability and poor health-related quality of life (QoL).2,3 Approximately 12 million people in the United States are impacted by PAD, and one in four also have type 2 diabetes.2,3 The presence of type 2 diabetes increases the incidence of PAD and accelerates disease progression and severity.3 There are limited therapies to specifically improve functional outcomes in people living with PAD and type 2 diabetes, representing a critical need.2 "The results from STRIDE, the first and only dedicated PAD functional outcomes trial with a GLP-1 RA treatment, provide important clinical insights that help further our understanding and approach to cardiometabolic diseases like type 2 diabetes and peripheral artery disease," said Michael Radin, MD, Executive Medical Director, Diabetes Medical Affairs at Novo Nordisk, Inc. "By studying the potential of semaglutide to impact everyday living through improvements in walking and quality of life, Novo Nordisk continues to demonstrate its commitment to advancing cardiometabolic science and to improving clinical outcomes for patients." Serious adverse events (SAEs) were reported in 74 (19%) participants in the semaglutide arm and 78 (20%) participants in the placebo arm, and SAEs that were possibly/probably treatment-related occurred in 5 (1%) and 6 (2%) participants, respectively. The most frequent SAE across both groups was serious gastrointestinal events (2 [1%] vs 3 [1%]). SAEs leading to permanent treatment discontinuation of semaglutide or placebo were reported in 11 (2.8%) and 13 (3.3%) participants in the semaglutide and placebo groups, respectively. SAEs led to the death of 3 (1%) and 8 (2%) participants in the semaglutide and placebo arms, respectively; however, no SAEs leading to death were treatment-related.1,4 Based on data from the STRIDE clinical trial, Novo Nordisk submitted a label extension application for Ozempic® to the US Food & Drug Administration (FDA). A decision is anticipated in 2025.4 About STRIDE STRIDE is a double-blind, randomized, placebo-controlled phase 3b clinical trial assessing the effect of once-weekly injectable semaglutide 1 mg, marketed as Ozempic®, on functional capacity versus placebo, when both were added to standard of care. It enrolled 792 adults with type 2 diabetes and symptomatic peripheral artery disease (PAD) with walking-induced leg pain. The primary endpoint was maximum walking distance on a constant load treadmill for people treated with semaglutide compared to placebo at week 52. STRIDE is the only dedicated PAD functional outcomes trial with a glucagon-like peptide-1 (GLP-1) receptor agonist.4 About PADLower extremity peripheral artery disease (PAD) is a form of atherosclerotic cardiovascular disease. The classical symptom is intermittent claudication (IC), associated with limited walking ability and poor health-related quality of life (QoL).2,5 Approximately 12 million people in the United States are impacted by PAD, and one in four also have type 2 diabetes.2,3 There are limited therapies to specifically improve functional outcomes in people living with PAD and type 2 diabetes, representing a critical need.2 About Ozempic®Ozempic® (semaglutide) injection 0.5 mg, 1 mg or 2 mg is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve blood sugar (glucose), along with diet and exercise, in adults with type 2 diabetes, to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease, and to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to cardiovascular disease in adults with type 2 diabetes and chronic kidney disease.6 Only Novo Nordisk manufactures FDA-approved semaglutide medicines, like Ozempic®. Given the vast amount of information on knock-off or compounded semaglutide being shared in the media, it is important for healthcare professionals and patients to have the clarity and confidence in knowing what they are using has undergone rigorous review for safety, effectiveness and quality. If the label doesn't say Ozempic®, it's not FDA-approved. Learn more about the responsible use of semaglutide-containing medicines and the significant safety and health risks associated with compounded or knock-off "semaglutide" at About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With U.S. headquarters in New Jersey and over ten manufacturing, R&D and business locations in eight states plus Washington DC, Novo Nordisk employs approximately 10,000 people throughout the country. For more information, visit Facebook, Instagram, and X. Contacts for further information: Media: Liz Skrbkova (US) +1 609 917 0632 lzsk@ Ambre James-Brown (Global)+45 3079 9289 abmo@ US Media Relations NNIMediaTeam@ Investors: Frederik Taylor Pitter (US) +1 609 613 0568 fptr@ Jacob Martin Wiborg Rode +45 3075 5956 jrde@ Sina Meyer +45 3079 6656 azey@ Ida Schaap Melvold +45 3077 5649 idmg@ Max Ung +45 3077 6414 mxun@ References Bonaca M, Catarig AM, Houlind K, et al. The Effect of Once-weekly Subcutaneous Semaglutide on Functional Capacity in People with Type 2 Diabetes and Peripheral Artery Disease: Primary Results from the Phase 3b, Randomized, Placebo-Controlled, Double-Blind STRIDE Trial. Oral presentation presented at the American College of Cardiology Congress Scientific Session & Expo 2025; 29-31 March 2025; McCormick Place Convention Center, Chicago, US. Presentation 102-09. Gornik, H. L., Aronow, H. D., Goodney, P. P., et al. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease. Journal of the American College of Cardiology, 83(24), 2497–2604. Barnes, J. A., Eid, M. A., Creager, M. A., & Goodney, P. P. (2020). Epidemiology and risk of amputation in patients with diabetes mellitus and peripheral artery disease. Arteriosclerosis Thrombosis and Vascular Biology, 40(8), 1808–1817. Data on file. Novo Nordisk, Inc.; Plainsboro, NJ. Firnhaber, J. M., & Powell, C. (2019b, March 15). Lower extremity Peripheral artery Disease: Diagnosis and treatment. AAFP. Ozempic® (semaglutide) injection [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2024. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2025 Novo Nordisk All rights reserved. US25OZM00368 March 2025 View original content: SOURCE Novo Nordisk, Inc. Sign in to access your portfolio
Yahoo
29-03-2025
- Health
- Yahoo
Ozempic® (once-weekly semaglutide 1.0 mg) shown to improve walking distance and quality of life in adults with type 2 diabetes and peripheral artery disease (PAD) at ACC 2025
Ozempic® improved maximum walking distance by 13% vs placebo in adults with type 2 diabetes and peripheral artery disease (PAD) in the phase 3 STRIDE trial1. Data were presented at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US, while simultaneously published today in The Lancet2. Approximately 230 million people globally have PAD, a severe form of atherosclerotic cardiovascular disease3, and nearly one in three people with PAD have type 2 diabetes4. Bagsværd, Denmark, 29 March 2025 – Novo Nordisk today presented the full results from STRIDE, a phase 3b peripheral artery disease (PAD) outcomes trial investigating the effects of once-weekly injectable Ozempic® (semaglutide 1.0 mg) in adults with type 2 diabetes and PAD, at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US1. These new data from the phase 3 trial were featured during a late-breaking clinical trial session at the ACC and simultaneously published today in The Lancet2. The double-blind, randomised, placebo-controlled STRIDE trial achieved its primary endpoint, with semaglutide 1.0 mg demonstrating a superior and clinically meaningful improvement of 13% in maximum walking distance and a mean treatment difference of 39.9 meters on a steep incline, compared to placebo at week 52. The trial also demonstrated superiority to placebo for all confirmatory secondary outcomes assessed, including pain-free walking distance at week 52, health-related quality of life (Vascular Quality of Life Questionnaire-6) at week 52, and maximum walking distance at week 571. 'Peripheral artery disease (PAD) may cause severe symptoms, physical limitations, and a diminished quality of life, often making even short walks, such as retrieving the mail challenging. 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. Semaglutide 1.0 mg 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," said Marc P. Bonaca, MD, Director of Vascular Research, University of Colorado School of Medicine, Lead Investigator of the STRIDE trial. 'The significant improvements in walking distance and patient-reported quality of life observed with semaglutide 1.0 mg in the STRIDE trial are promising and represent an important step forward on the path to advancing treatment options for this patient population.' PAD is a severe form of atherosclerotic cardiovascular disease that is under-screened and underdiagnosed and impacts approximately 230 million people globally3. Type 2 diabetes is one of the leading risk factors for PAD, and nearly one in three people with PAD have type 2 diabetes4. There are limited therapies available to specifically improve functional limitations in PAD, representing a significant unmet need in this population5. 'Novo Nordisk continues to evolve its focus beyond diabetes and obesity towards a broader spectrum of metabolic and cardiovascular health,' said Martin Holst Lange, executive vice president for Development at Novo Nordisk. 'These data, alongside other data being presented at ACC, reinforce the comprehensive set of health benefits of semaglutide, making it a strong option for healthcare professionals addressing the spectrum of metabolic and cardiovascular health – and our continued leadership in the space.' The safety results from the STRIDE trial are consistent with the well-established safety and tolerability profile of once-weekly semaglutide1, supported by long-term safety data with more than 33 million patient-years of exposure6. Serious adverse events (SAEs) were reported in fewer participants in the semaglutide group than in the placebo group (74 [19%] vs 78 [20%]). SAE probably related to treatment occurred in 2 participants (1%) in the semaglutide group and in 2 participants (1%) in the placebo group. SAE possibly related to treatment occurred in 3 (1%) and 4 (1%) participants, respectively. SAEs leading to permanent treatment discontinuation of semaglutide or placebo were less common in the semaglutide group than in the placebo group (11 [3%] vs 13 [3%]). SAEs led to the death of 3 (1%) and 8 (2%) participants in the semaglutide and placebo arms, respectively; however, no SAEs leading to death were treatment-related1. Based on data from the STRIDE clinical trial, Novo Nordisk submitted a label extension application for Ozempic® to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). A decision is anticipated in 2025. About STRIDE STRIDE is a double-blind, randomised, placebo-controlled phase 3b clinical trial assessing the benefit of once-weekly injectable semaglutide 1.0 mg, marketed as Ozempic®, on functional capacity. It enrolled 792 participants with type 2 diabetes and symptomatic PAD with walking-induced leg pain. The primary endpoint was maximum walking distance on a constant load treadmill for people treated with semaglutide compared to placebo at week 52. STRIDE is the only dedicated PAD functional outcomes trial with a GLP-1 RA. About PADLower extremity PAD is a severe form of atherosclerotic cardiovascular disease. The classical symptom is intermittent claudication, associated with limited walking ability and poor health-related quality of life7. Type 2 diabetes is one of the leading risk factors for PAD; nearly one in three people with PAD have type 2 diabetes4. While anti-atherosclerotic therapies and lifestyle changes are recommended, there are no effective therapies to specifically improve functional outcomes in PAD and type 2 diabetes8. About Ozempic®Ozempic® (semaglutide) injection 0.25, 0.5 mg, 1.0 mg or 2.0 mg is a once-weekly GLP-1 RA indicated, along with diet and exercise, to improve blood sugar (glucose) in adults with type 2 diabetes mellitus and to reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease9,10. Ozempic® is currently marketed in 75 countries and 7 million people with type 2 diabetes are currently being treated with Ozempic® worldwide11. About Novo NordiskNovo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure disease. Novo Nordisk employs about 76,300 people in 80 countries and markets its products in around 170 countries. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649 idmg@ Sina Meyer +45 3079 6656 azey@ Max Ung+45 3077 6414mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ _______________________References1. Bonaca M, et al. Oral presentation presented at the American College of Cardiology Congress Scientific Session & Expo 2025; 29–31 March 2025. Presentation 102-09.2. The Lancet: Gornik HL, et al. Circulation. 2024;149:e1313–e1410.4. Thiruvoipati T, et al. World J Diabetes. 2015;6:961–969.5. Aronow WS. Arch Med Sci. 2012;8:375–388.6. Bonaca MP, et al. Eur Heart J Cardiovasc Pharmacother. 2025;10:728–737.7. Novo Nordisk Data on File.8. Sillesen H, et al. European Heart Journal. 2021;42:ehab724.2027.9. Ozempic® (semaglutide): SmPC. 2025 [online] Available at: Last accessed: March 2025.10. Ozempic® (semaglutide) US PI. 2025 [online] Available at: Last accessed: March 2025.11. Novo Nordisk Data on File. IQVIA Ozempic and Rybelsus patient numbers March 2025. Attachment PR250329-1530-ACC2025-STRIDESign in to access your portfolio
