Latest news with #ASCVD
Time of India
3 days ago
- Health
- Time of India
Heart health is a shared responsibility, says Novartis India head
A recent Beat Bad Cholesterol event by The Times of India group, in collaboration with Novartis, emphasized the need for the right kind of awareness, education and timely intervention in India where cardiovascular diseases are a leading cause of death. Cardiovascular diseases (CVDs) are the leading cause of death and disability in India. Calling it an 'epidemic' a 2023 study published in the medical journal The Lancet* says Indians have a higher relative risk burden of CVDs; an earlier age of onset; higher case fatality; and higher premature deaths. The World Health Organization (WHO) says that over 25% of deaths in India can be attributed to CVDs, and that they occur in an age group which is at least 10 years younger than that in the West. So, what is one to do in this situation? Recently, global pharma major Novartis and The Times of India hosted an event, titled Beat Bad Cholesterol, to spread the word about heart health and the dangers of LDL (low-density lipoprotein) cholesterol. Commonly known as the 'bad' cholesterol, LDL-C is a driver of CVDs, but it is also a modifiable risk. With the right kind of care and treatment, its risk as a primary cause of CVDs can be managed and even reduced. Novartis has a strong legacy of reimagining medicine for over 250 years and has partnered India's healthcare journey since 1947. For over 30 years it has been instrumental in transforming the standards of care for cardiovascular diseases, which is the world's primary cause of death, claiming nearly 18 million lives each year. Sadly, India accounts for one-fifth of these deaths caused by CVDs, worldwide. Elevated LDL-C is the main cause of Atherosclerotic Cardiovascular Disease (ASCVD), and is one of the neglected but important risk factors for CVDs. LDL-C is a critical cardiovascular disease marker to estimate the risk of Acute Coronary Syndrome (ACS), and several studies have shown that a reduction in LDL-C levels prevents cardiovascular outcomes. In a large, case-control INTERHEART study, it was found that among all the modifiable risk factors, abnormal lipid levels were identified to be associated with the highest population attributable risk (PAR 49.2%) for the occurrence of myocardial infarction. The most important risk factor identified across all geographic regions was LDL-C. In her inaugural address Ms Judith Love, President – APMA Region at Novartis, said: 'High LDL-C is a silent threat, often overlooked until it's too late. We believe that with the right awareness, regular screening, timely diagnosis and early treatment, we can change this trajectory. Initiatives like Beat Bad Cholesterol do more than raise awareness; they reinforce a collective commitment. It's encouraging to see a shared purpose across India's healthcare ecosystem, where every stakeholder has a vital role to play in advancing heart health. ' This was reiterated by Mr Rajeev D. Nivatkar, Commissioner of Medical Education and AYUSH. 'One of the most underestimated risk factors for heart attacks is bad cholesterol or LDL-C,' he said. 'It has no visible symptoms, yet it can quietly damage the heart and arteries over time. Many people are unaware of their numbers, and that has to change. We must encourage citizens to know their LDL-C numbers and consult their doctors proactively. ' Most stakeholders emphasised the need for regular lipid profile testing, since elevated levels of LDL-C (even when at dangerous levels) don't present any symptoms. In other words, one may not know about an increase in LDL-C levels until it's too late. The audience was also addressed by Mr Amitabh Dube, Country President and MD, Novartis India; Senior Cardiologist from Apollo Hospitals, Dr Nikhil Parchure; Mr Ram Khandelwal, Founder of Heart Health India Foundation, a patient advocacy group; and Mr Surinder Chawla, President & Head – Response, BCCL. Over 150 members of the audience -- including healthcare professionals, government officials and media leaders – also participated in a workout session conducted by celebrity fitness expert Aanchal Hans. According to Mr Amitabh Dube, 'Cardiovascular diseases continue to be a leading cause of mortality in India, and yet awareness of critical and modifiable risk factors like LDL-C remains low. Through Beat Bad Cholesterol, we aim to raise awareness and encourage people to 'know their LDL-C numbers' and work with their doctors to proactively manage their heart health. Novartis remains committed to advancing science and improving access to innovative therapies to help patients live longer, healthier lives. ' 'Reactions to LDL-C among patients is mixed,' says Mr Ram Khandelwal. 'Most know that they should not have high cholesterol, but only a few fully understand the dangers and the impact on one's heart. The urgency to act promptly to reduce high LDL-C is still missing. However, thanks to initiatives like Beat Bad Cholesterol, awareness is growing. People are getting sensitized and asking their doctors about target goals for LDL-C. In my understanding while engaging with heart patients, only five to 10% of them speak to their doctors about their target LDL-C.' Three key messages emerged from the event. First, that LDL-C is a modifiable, critical yet neglected cardiovascular risk factor. Second, most people only give importance to diabetes and hypertension, and neglect cholesterol management – even though 85% of all heart-related deaths are attributed to elevated LDL-C levels. Therefore, each one of us must talk to our doctor about our individual target LDL-C goals. Third, experts emphasise that heart treatment is not a one-size-fits-all option. As Ms Judith Love concluded: 'Each of us has a personal responsibility — not just to support these efforts, but to role-model healthy choices that protect our own hearts. India's scale, talent, and passion give us a powerful platform to drive lasting impact, and Novartis is proud to be part of this journey.' * One step to a healthier you—join Times Health+ Yoga and feel the change
Yahoo
20-05-2025
- Health
- Yahoo
Ionis reports positive data from study of olezarsen for hypertriglyceridemia
Ionis Pharmaceuticals has reported positive topline outcomes from the randomised, global Phase III Essence study of Tryngolza (olezarsen) in individuals with moderate hypertriglyceridemia and, or at risk for, atherosclerotic cardiovascular disease (ASCVD). This condition is characterised by fasting triglyceride (TG) levels between ≥150mg/dL and <500mg/dL. The multicentre, double-blind, placebo-controlled Essence study was carried out with the TIMI Study Group, the company's research partner. It enrolled 1,478 subjects aged 18 years and above diagnosed with or at risk for ASCVD, and 9% of them had fasting triglycerides of ≥500mg/dL at baseline. Subjects received either 50mg or 80mg of olezarsen or a placebo every four weeks via subcutaneous injection for 12 months. The primary endpoint focused on the percentage change from baseline in fasting TG levels at the six-month mark, compared to the placebo. Key secondary endpoints were changes in TG levels at 12 months, the proportion of subjects achieving fasting TG levels of <150mg/dL, and the percentage variations in other lipid parameters against the placebo over the treatment period. The trial, which included subjects already on standard of care, lipid-lowering medications, achieved its primary endpoint. A significant decrease in TG levels was observed, with a placebo-adjusted 61% decrease at the 80mg monthly dose and a 58% decrease at the 50mg dose over a six-month period, compared to the placebo. In addition, the therapy met all key secondary endpoints, with the majority of subjects achieving normal TG levels of <150mg/dL. Olezarsen also demonstrated a favourable tolerability and safety profile in the trial. Ionis Pharmaceuticals global cardiovascular development senior vice-president Sam Tsimikas said: 'Following the Food and Drug Administration (FDA) approval and encouraging launch of Tryngolza (olezarsen) for people living with familial chylomicronaemia syndrome (FCS), a rare, genetic form of severely elevated TGs, these data support olezarsen's potential tobenefit the much broader population of people living with severe hypertriglyceridemia (sHTG).' The investigational RNA-targeted medicine is designed to decrease the body's apolipoprotein C III (apoC-III) production, a protein for regulating the metabolism of triglyceride in the blood. Last November, Ionis announced the design for a pivotal Phase III trial of ION582, an investigational treatment for Angelman syndrome (AS), following discussions with the US FDA. "Ionis reports positive data from study of olezarsen for hypertriglyceridemia" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
19-05-2025
- Health
- Yahoo
The National Lipid Association (NLA) and Foundation of the National Lipid Association (FNLA) Urge CMS and Administrator Oz to Include Low-Density Lipoprotein Cholesterol (LDL-C) Measurement in CMS Quality Measurement Programs
JACKSONVILLE, Fla., May 19, 2025 /PRNewswire/ -- The National Lipid Association (NLA) and Foundation of the National Lipid Association (Foundation) urge the Centers for Medicare & Medicaid Services (CMS) and recently confirmed CMS Administrator, Dr. Mehmet C. Oz, to help increase measurement and management of low-density lipoprotein cholesterol (LDL-C) through CMS quality measurement programs. Effective LDL-C management is essential to addressing atherosclerotic cardiovascular disease (ASCVD) — the United States' leading cause of death. Following more than 40 years of decline, death related to ASCVD has been on the rise for over a decade, accompanied by decreased rates of LDL-C measurement and accompanying CMS incentives. To address the ASCVD chronic disease crisis, Christie M. Ballantyne, MD, President of the NLA stated: There is overwhelming evidence that lowering LDL-C leads to a proportional decrease in ASCVD risk and that LDL-C is a reliable and established measure of atherogenic lipoproteins; however, there is also irrefutable evidence that clinicians are not measuring or managing LDL-C as recommended by the American Heart Association, American College of Cardiology, multisociety guidelines. Existing guidelines from the American Heart Association, American College of Cardiology, and other leading organizations provide the highest level of evidence support for measuring LDL-C in patients with ASCVD, including: Adherence to changes in lifestyle and effects of LDL-C lowering medications should be assessed by measurement of fasting lipids and appropriate safety indicators 4 to 12 weeks after statin initiation or dose adjustment and every 3 to 12 months thereafter based on need to assess adherence or safety.[i],[ii] Recent data shows that only 29.9% of Medicare beneficiaries had LDL-C measured within 90 days of hospital discharge for myocardial infarction,[iii] only 49.9% of patients with ASCVD are on any statin therapy.[iv] With LDL-C a well-established causal risk factor for ASCVD progression and clear guidance from the leading organizations in the United States, CMS quality measures could play a greater role in increasing LDL-C measurement and management. "Existing measures that consider whether a patient received a prescription for a statin or was dispensed a statin are not consistent with the standard of care, as those measures fail to assess whether the patient is taking their medication or if the medication is working as intended," continued Ballantyne. "Quality measures can incentivize and prioritize care for many clinicians and patients. Improving existing quality measures to focus on measuring lipids, including LDL-C, will provide the necessary information to clinicians to improve prevention of cardiovascular events and empower patients to make informed decisions about their health," stated James A. Underberg, MD, MNLA, President of the Foundation. The NLA and Foundation of the NLA welcome any opportunity to work with CMS and Dr. Oz toward helping develop evidence-based updates, quality measures, or other interventions to help stem the ASCVD crisis – with a focus on effective LDL-C measurement and management. For media inquiries, please contact Brian Hart, Executive Director of the National Lipid Association, at exec@ About the National Lipid Association:The National Lipid Association (NLA) is a nonprofit, multidisciplinary medical society focused on enhancing the science and practice of lipidology and promote optimal cardiometabolic health, representing more than 2,200 members throughout the United States. The NLA is the leader in this field, having published numerous clinical recommendations for lipid management, served as a co-author of the 2018 American Heart Association/American College of Cardiology/Multisociety cholesterol guidelines and 2023 American Heart Association/American College of Cardiology/Multisociety chronic coronary disease guidelines, and serves as the primary educator and advocate for clinical lipidology. Website: About the Foundation of the National Lipid AssociationThe Foundation of the National Lipid Association is a 501(c)(3) nonprofit organization focused on improving the welfare of patients and families affected by cholesterol and triglyceride problems. The Foundation of the National Lipid Association develops and maintains resources for patients, families, and caregivers for common and rare cholesterol and triglyceride disorders to support management of lipid-related health problems that may put patients at risk for a heart attack or stroke. Website: i Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/ APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139: Virani SS, Newby LK, Arnold SV, Bittner V, Brewer LC, Demeter SH, Dixon DL, Fearon WF, HessB, Johnson HM, Kazi DS, Kolte D, Kumbhani DJ, LoFaso J, Mahtta D, Mark DB, Minissian M, Navar AM, Patel AR, Piano MR, Rodriguez F, Talbot AW, Taqueti VR, Thomas RJ, vanDiepen S, Wiggins B, Williams MS. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA guideline for the management of patients with chronic coronary disease: a report of the AmericanHeart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2023;148:e9–e119. doi: 10.1161/ Nelson, A, Haynes, K, Shambhu, S. et al. High-Intensity Statin Use Among Patients With Atherosclerosis in the U.S. JACC. 2022 May, 79 (18) 1802– Colantonio, L, Wang, Z, Jones, J. et al. Low-Density Lipoprotein Cholesterol Testing Following Myocardial Infarction Hospitalization Among Medicare Beneficiaries. JACC Adv. 2024 Jan, 3 (1). View original content to download multimedia: SOURCE National Lipid Association
Yahoo
30-03-2025
- Health
- Yahoo
Novo Nordisk A/S: Rybelsus® (oral semaglutide 14 mg) demonstrates superior reduction in cardiovascular events in the SOUL trial at ACC 2025
Rybelsus® reduced major adverse cardiovascular events by 14% vs placebo in adults with type 2 diabetes and cardiovascular and/or chronic kidney disease in the SOUL cardiovascular outcomes 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 New England Journal of Medicine2. Rybelsus®, the only approved oral GLP-1 medicine, demonstrated this risk reduction on top of standards of cardiovascular and diabetes care. Based on SOUL findings, Novo Nordisk submitted a label extension application for Rybelsus® for CV event risk reduction to the US FDA and EMA. Bagsværd, Denmark, 29 March 2025 – Novo Nordisk today presented the full results from the SOUL cardiovascular outcomes trial, demonstrating that Rybelsus® (oral semaglutide) significantly reduced the risk of major adverse cardiovascular events in adults with type 2 diabetes and cardiovascular disease (CVD) and/or chronic kidney disease (CKD)1. These new data from the phase 3b trial were featured during a late-breaking clinical trial session at the American College of Cardiology's (ACC) Annual Scientific Session and Expo in Chicago, US and simultaneously published today in New England Journal of Medicine2. The SOUL trial achieved its primary endpoint, demonstrating a 14% reduction in risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and CVD and/or CKD when treated with Rybelsus® compared to placebo. Each component of MACE, being CV death, nonfatal myocardial infarction and nonfatal stroke, contributed to the risk reduction1. 'Heart attacks and strokes are the leading causes of disability and death for people with type 2 diabetes, and there is a need for new, patient-centric treatments to help manage this risk,' said Darren McGuire, MD, Distinguished Chair in Cardiovascular Science and Teaching Professor of Medicine at UT Southwestern, US, and SOUL steering committee co-chair. 'The SOUL trial in adults with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or CKD demonstrated significant reductions in the risk of major cardiovascular events including heart attack, stroke and CV death in those treated with oral semaglutide vs placebo. The proven cardiovascular benefit reflects a profound clinical impact for our patients who now have an oral option to improve health outcomes.' Cardiometabolic diseases span a wide range of conditions, including cardiovascular and peripheral artery disease, type 2 diabetes and chronic kidney disease3. When combined, these conditions represent the leading cause of death globally4. Having type 2 diabetes directly increases the risk of developing interconnected cardiometabolic diseases, while also contributing to the progression of other cardiovascular risk factors5. Nearly one in three adults with type 2 diabetes have CVD6. '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 our 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 overall safety profile of oral semaglutide in SOUL was consistent with that seen in previous semaglutide trials, and no new safety signals were observed. The incidence of serious adverse events (SAEs) was lower in participants receiving Rybelsus® than those receiving placebo, mostly due to the higher rate of cardiovascular events and infections in the placebo group. The most common SAEs were cardiac disorders (17.8% and 19.8%, respectively) and infections/infestations (15.0% and 16.5%, respectively) in the Rybelsus® and placebo arms1. In a key secondary analysis from SOUL published simultaneously, oral semaglutide reduced risk of MACE independently of baseline use of SGLT2i and suggests similar benefits in participants with and without concomitant SGLT2i use during trial7. SOUL confirmed the well-established safety and tolerability profile of semaglutide supported by long-term safety data with more than 33 million patient years8. Based on data from the SOUL clinical trial, Novo Nordisk submitted a label extension application for Rybelsus®, which has been accepted for review by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA. A decision is anticipated in 2025. About SOUL SOUL was a multicentre, international, randomised, double-blind, parallel-group, placebo-controlled, phase 3 cardiovascular outcomes trial with 9,650 people enrolled. It was conducted to assess the effect of oral semaglutide vs placebo on cardiovascular outcomes in people with type 2 diabetes and established CVD and/or CKD. The SOUL trial was initiated in 2019. The key objective of SOUL was to demonstrate that oral semaglutide lowers the risk of major adverse cardiovascular events (a composite endpoint consisting of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke) compared to placebo, both added to standard of care in patients with type 2 diabetes and established CVD and/or CKD9,10. About Rybelsus®Rybelsus® (oral semaglutide) is a GLP-1 receptor agonist indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise11,12. Rybelsus® is administered once daily and is approved for use in three therapeutic dosages: 3 mg, 7 mg and 14 mg13,14. Rybelsus® offers superior blood glucose lowering vs Januvia® and Jardiance®13,14, together with consistent weight reduction13-15 and reduction in cardiometabolic risk factors15. Rybelsus® is currently commercially marketed in 45 countries. More than 2.1 million people with type 2 diabetes are currently being treated with Rybelsus® worldwide16. 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. McGuire DK, et al. Oral presentation presented at the American College of Cardiology Congress Scientific Session & Expo 2025; 29–31 March 2025. Presentation 104-07.2. McGuire DK., et al. N Engl J Med. 2025, New England Journal of Medicine: 3. Reiter-Brennan C, et al. Curr Cardiol Rep. 2021;23:22.4. World Health Organization [online]. Available at: Last accessed: February 2025.5. Chakraborty S, et al. Clin Med Insights Endocrinol Diabetes. 2023;16:11795514231220780.6. Mosenzon O, et al. Cardiovasc Diabetol. 2021;20:1547. Marx N., et al. Circulation 2025: Novo Nordisk data on file.9. NCT03914326. Available at: Last accessed: February 2025.10. McGuire DK, et al. Diabetes Obes Metab. 2023;25:1932–1941.11. Rybelsus® (semaglutide) US PI. 2024 [online]. Available at: Last accessed: March 2025.12. Rybelsus® (semaglutide) SmPC. 2025 [online]. Available at: Last accessed: March 2025.13. Rodbard HW, et al. Diabetes Care. 2019;42:2272–2281.14. Rosenstock J, et al. JAMA. 2019;321:1466–1480.15. Husain M, et al. N Engl J Med. 2019;381:841–851.16. Novo Nordisk Data on File. IQVIA Ozempic and Rybelsus patient numbers March 2025. Attachment PR250329-1930-ACC2025-SOULSign in to access your portfolio
Yahoo
30-03-2025
- Health
- Yahoo
Oral semaglutide 14 mg demonstrated superior reduction in risk of cardiovascular events in late-breaking SOUL trial presented at the American College of Cardiology
SOUL study showed Rybelsus® (semaglutide) tablets 14 mg reduced the risk of major adverse cardiovascular events (MACE) by 14% (ARR 2% absolute risk reduction at 3 years) vs placebo in adults with type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD)1 Oral semaglutide 14 mg demonstrated this reduction of risk on top of standards of cardiovascular (CV) and diabetes care Data simultaneously published today in The New England Journal of Medicine, and based on SOUL findings, Novo Nordisk submitted a label extension application for Rybelsus® (semaglutide) tablets 14 mg for CV event risk reduction to the FDA PLAINSBORO, N.J., March 29, 2025 /PRNewswire/ -- Novo Nordisk today presented the full results from the SOUL cardiovascular outcomes trial investigating the effects of Rybelsus® (semaglutide) tablets 14 mg on reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes and ASCVD and/or CKD.1 These new data from the phase 3 trial were featured during a Late-Breaking Clinical Trial session at the American College of Cardiology's (ACC) Annual Scientific Session and Expo and simultaneously published today in The New England Journal of Medicine. The randomized, double-blind, parallel-group, placebo-controlled, event-driven CV outcomes trial which enrolled 9,650 adults with type 2 diabetes and ASCVD and/or CKD, achieved its primary endpoint, with oral semaglutide 14 mg demonstrating a 14% reduction in risk of MACE (2% absolute risk reduction at 3 years) compared to placebo (579 vs 668 events; hazard ratio: 0.86 [0.77; 0.96]; P=0.0055). The primary endpoint was time from randomization to first occurrence of a major adverse CV event (a composite of CV death, nonfatal myocardial infarction or nonfatal stroke).1,2 "The significant reduction in risk of composite endpoint of heart attack, stroke, or death seen in the SOUL trial in adults with type 2 diabetes highlights the cardiovascular impact of oral semaglutide in adult patients with cardiometabolic conditions such as type 2 diabetes and atherosclerotic cardiovascular disease and/or chronic kidney disease," said John B. Buse, MD, PhD, Distinguished Professor of Medicine, Director of UNC Diabetes Care Center, Steering Committee Co-Chair of the SOUL trial. "Given the cardiovascular outcomes seen in SOUL, the trial represents important data for a community who may need options that also address common and serious comorbidities of type 2 diabetes, like cardiovascular disease." Cardiometabolic diseases span a wide range of conditions, including type 2 diabetes and cardiovascular disease.3 Overall, cardiovascular disease represents the leading cause of death globally.4 Having type 2 diabetes directly increases the risk of developing interconnected cardiometabolic diseases, while also contributing to the progression of other cardiovascular risk factors.5,6 Nearly one in three adults with type 2 diabetes have cardiovascular disease (CVD).7 "Novo Nordisk continues to evolve its leadership beyond any one therapy area, toward a broader spectrum of cardiometabolic diseases that explores the interconnectivity of these conditions to create better outcomes for patients," said Michael Radin, MD, Executive Medical Director, Diabetes Medical Affairs at Novo Nordisk, Inc. "The SOUL data reinforce the importance of looking beyond glycemic control to explore cardiovascular disease in patients with type 2 diabetes." The overall safety profile of oral semaglutide 14 mg in SOUL was consistent with that seen in previous trials, and no new safety signals were observed. The incidence of serious adverse events (SAEs) was lower in participants receiving oral semaglutide 14 mg than those receiving placebo, mostly due to the higher rate of cardiovascular events and infections in the placebo group. The most common SAEs were cardiac disorders (17.8% and 19.8%, respectively) and infections/infestations (15.0% and 16.5%, respectively).1 Serious adverse events were less common with oral semaglutide 14 mg (47.9%) than with placebo (50.3%), although there was a higher incidence of gastrointestinal disorders with oral semaglutide 14 mg (5.0% versus 4.4%). Adverse events leading to permanent treatment discontinuation were more common for oral semaglutide 14 mg than placebo (749 [15.5%] and 559 [11.6%], respectively), comprising mainly gastrointestinal disorders in both arms (310 [6.4%] and 98 [2.0%], respectively). Additionally, the placebo group had 96 cases (2.0%) of infections and infestations leading to treatment discontinuation (versus 63 [1.3%] with oral semaglutide 14 mg).1,2 Based on data from the SOUL clinical trial, Novo Nordisk submitted a label extension application for Rybelsus® (semaglutide) tablets 14 mg which has been accepted for review by the US Food & Drug Administration (FDA). A decision is anticipated in 2025.2 About SOUL SOUL was a multicenter, international, randomized, double-blind, parallel-group, placebo-controlled, event-driven phase 3 cardiovascular outcomes trial with 9,650 people enrolled. It was conducted to assess the effect of oral semaglutide 14 mg vs placebo on cardiovascular outcomes in adults with type 2 diabetes and ASCVD and/or CKD. SOUL included adults aged ≥50 years with type 2 diabetes and evidence of ASCVD (coronary artery disease [CAD], cerebrovascular disease, symptomatic peripheral arterial disease [PAD]) and/or CKD (estimated glomerular filtration rate <60 mL/min/1.73 m2). The SOUL trial was initiated in 2019 with a total duration of 5 years and 2 months. The key objective of the SOUL trial was to demonstrate that oral semaglutide 14 mg helps lower the risk of major adverse cardiovascular events (a composite endpoint consisting of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke) compared to placebo, both added to standard of care in patients with type 2 diabetes and ASCVD and/or CKD.8 About Rybelsus® Rybelsus® (semaglutide) tablets 7 mg and 14 mg is a once daily glucagon-like peptide-1 (GLP-1) receptor agonist indicated for adults with type 2 diabetes along with diet and exercise to improve glycemic control.9 Only Novo Nordisk manufactures FDA-approved semaglutide medicines, like Rybelsus®. 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 Rybelsus®, 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 McGuire DK, Poulter NR, Pop-Busui R, et al. Oral Semaglutide Reduces Cardiovascular Events in People with Type 2 Diabetes with Atherosclerotic Cardiovascular and/or Chronic Kidney Disease: Primary Results From the SOUL Randomized 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 104-07. Data on file. Novo Nordisk, Inc.; Plainsboro, NJ. Reiter-Brennan C, Dzaye O, Davis D, et al. Comprehensive care models for cardiometabolic disease. Curr Cardiol Rep. 2021;23(3):22. Published 2021 Feb 24. doi:10.1007/s11886-021-01450-1. World Health Organization. Cardiovascular diseases (cvds). Accessed February 28, 2025. Feng X (Snow), Farej R, Dean BB, et al. CKD prevalence among patients with and without type 2 diabetes: regional differences in the United States. Kidney Medicine. 2022;4(1):100385. doi: Jankowski J, Floege J, Fliser D, Böhm M, Marx N: Cardiovascular disease in chronic kidney disease: pathophysiological insights and therapeutic options. Circulation. 2021, 143:1157-72. 10.1161/CIRCULATIONAHA.120.050686. Mosenzon O, Alguwaihes A, Leon JLA, et al. CAPTURE: a multinational, cross-sectional study of cardiovascular disease prevalence in adults with type 2 diabetes across 13 countries. Cardiovasc Diabetol. 2021;20:154. A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (SOUL). Available at: Last accessed: February 2025. Rybelsus® (semaglutide) tablets [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. US25RYB00225 March 2025 View original content: SOURCE Novo Nordisk, Inc. Sign in to access your portfolio
