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Reuters
02-04-2025
- Health
- Reuters
Health Rounds: Semaglutide pill Rybelsus matches heart benefits of injectable versions
April 2 (Reuters) - (To receive the full newsletter in your inbox for free sign up here) Novo Nordisk's ( opens new tab diabetes medicine Rybelsus, an oral form of the GLP-1 drug semaglutide, provides similar cardiovascular benefits as the injectable forms of the drug, researchers reported at the American College of Cardiology scientific meeting in Chicago. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. In a trial of 9,650 patients with type 2 diabetes, who had clogged heart arteries and/or chronic kidney disease, those taking Rybelsus were overall 14% less likely to experience heart-related death, heart attack or stroke than those who received a placebo after an average follow-up of four years. The researchers saw a 26% reduction in non-fatal heart attacks with oral semaglutide and a 12% reduction in non-fatal strokes, both of which 'are among the most common and devastating complications of diabetes,' study coauthor Dr. John Buse of the University of North Carolina School of Medicine said in a statement. There was also a 7% lower rate of cardiovascular death with Rybelsus. This level of risk reduction is in line with results from eight previous trials involving injectable GLP-1s, such as Novo's Ozempic and Eli Lilly's (LLY.N), opens new tab Trulicity, said study leader Dr. Darren McGuire of UT Southwestern Medical Center and Parkland Health in Dallas. 'The same cardiovascular benefits can be derived from the tablet that we've seen from the injectables before,' McGuire said in a statement. Although the exact mechanism through which the drugs reduce cardiovascular risk is not known, their anti-inflammatory activity is thought to play a role. The most common side effects reported in the study that was also published in The New England Journal of Medicine, opens new tab were gastrointestinal problems such as nausea, diarrhea, constipation and gas, which are also the most common side effects of injectable semaglutide. 'Semaglutide has been a mainstay of our efforts to reduce heart attack and stroke in people with diabetes,' Buse said. 'Having an oral option to deliver this highly effective therapy is a big advance.' HEART FAILURE PATIENTS CAN STOP LIMITING FLUIDS Heart failure patients do not benefit from restricted fluid intake, according to findings that may contradict current practice. U.S. and European medical guidelines have long advised heart failure patients to limit their daily fluid intake to about six cups (1,500 milliliters), to help reduce fluid buildup in the lungs and extremities, but without much evidence to support this practice, researchers said at the ACC meeting. In the trial of 504 patients with mild to moderate heart failure, there was no difference in health status after three months between individuals with unrestricted fluid intake compared with patients assigned to fluid restriction. Nor were there any differences in safety outcomes, such as swelling or shortness of breath due to congestion from fluid overload in the body that occurs when the heart is too stiff or too weak to effectively pump blood, according to a report of the study published in Nature Medicine, opens new tab. Patients in the fluid restriction group reported more problems with thirst, however. There was a trend toward better health at three months among those with unrestricted fluid intake, but the difference between groups was not statistically significant and so could be due to chance. 'Our conclusion is that in patients with stable heart failure there is no need for fluid restriction,' study leader Dr. Roland van Kimmenade of Radboud University Medical Center in Nijmegen, Netherlands said in a statement. MINIMALLY INVASIVE HEART PROCEDURES IMPROVING IN LOW-RISK PATIENTS Physically fit patients who need heart procedures are traditionally referred for major surgery, but the benefits of minimally invasive procedures are starting to outweigh the disadvantages in these individuals, researchers reported at the ACC meeting. In a trial called FAME 3, 1,500 relatively healthy patients with blockages in three coronary arteries, but not in the left main artery known as the 'widow maker', were recruited between 2014 and 2019. They underwent either a percutaneous coronary intervention via a small incision through the skin, or coronary artery bypass grafting (CABG) surgery, which involves sawing through the breastbone and stopping the heart and requires weeks or months of recovery. None of the patients was at particularly high risk for complications from open-heart surgery. Researchers had earlier reported that one year into the study, the combined rate of death, stroke, heart attack, or need for a repeat procedure to reopen the arteries was higher in the minimally invasive group, suggesting the major surgery was still the best option for these patients. But now, five years out, there is no significant difference in the composite of death, stroke, or heart attack between the two groups, the researchers say. 'This is the only study to compare CABG and PCI as they are currently used in cardiology – incorporating recent advances in surgical and minimally invasive techniques as well as in medical therapy – in patients with triple-vessel disease,' study leader Dr. William Fearon of Stanford University School of Medicine in California said in a statement. Looking at the endpoints individually, rates of death and stroke were similar in the two groups, but PCI patients had higher risks for heart attack (8% vs 5%) and repeat revascularization (16% vs 8%) than the CABG group. The narrowing of the outcomes difference between the two approaches is likely due to improved stent technology, the routine use of new techniques for selecting which arteries to treat with PCI, and greater patient adherence to medical therapy, Fearon's team said in The Lancet, opens new tab. In a separate trial involving 1,478 relatively healthy patients who needed aortic valve replacement, rates of death or disabling stroke at five years were similar whether the valve was replaced through a small incision in the arm or via standard open-heart surgery, Dr. Michael Reardon of Houston Methodist Hospital and colleagues reported at the meeting and in the Journal of the American College of Cardiology, opens new tab. However, in a third study of 1,618 patients who were at intermediate or high risk for surgical complications – also reported at the meeting and in the Journal of the American College of Cardiology, opens new tab - five-year outcomes were significantly better after minimally invasive procedures than after surgery, Reardon's team said.
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. 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