Copenhagen University Hospital

Results from 68-week study of 407 adults with obesity and moderate knee osteoarthritis showed semaglutide 2.4 mg significantly reduced body weight, knee osteoarthritis-related pain, and improved physical function1 Obesity is a major risk factor of knee osteoarthritis development and disease progression2-4 Semaglutide is not approved in the U.S. for the treatment of knee osteoarthritis PLAINSBORO, N.J., Oct. 30, 2024 /PRNewswire/ -- Today, The New England Journal of Medicine published results from Novo Nordisk's STEP 9 phase 3 clinical trial that studied semaglutide 2.4 mg compared to placebo as an adjunct to lifestyle modifications in reducing body weight and knee osteoarthritis-related pain in adults with obesity, and a clinical and radiologic diagnosis of moderate knee osteoarthritis, and pain that is at least moderately severe.1 According to the published trial, semaglutide met the study's primary endpoints and was superior to placebo in significantly reducing body weight and knee osteoarthritis-related pain, as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. In addition, the trial met a key confirmatory secondary endpoint of improving patients' physical function.1 In patients with a mean baseline body weight of 239.5 pounds, semaglutide led to a –13.7% mean change from baseline in body weight at week 68 versus –3.2% with placebo ([95% confidence interval (CI) –12.3, –8.6]; P<0.001). Semaglutide also led to a mean change from baseline (70.9) in the WOMAC pain score of –41.7 at week 68 versus –27.5 with placebo ([95% CI –20.0, –8.3]; P<0.001). WOMAC is a 24-item patient-reported questionnaire that assesses clinically important symptoms of pain, stiffness, and physical function in patients with hip and/or knee osteoarthritis (OA).1,5 A greater improvement in physical functioning scores was also observed from baseline at week 68 among trial participants taking semaglutide versus placebo (mean change: 12.0 versus 6.5 points [95% CI 3.1, 8.0], P<0.001]) as measured by the 36-Item Short Form Survey (SF-36v2).1 Obesity is considered a major risk factor for the development and progression of knee osteoarthritis, a common type of osteoarthritis that can lead to chronic pain and reduced mobility.2-4 Obesity contributes to the development of knee osteoarthritis through increased mechanical stress on weight-bearing joints, metabolic factors, and obesity-related inflammation.2,3 "Obesity-related knee osteoarthritis is a progressive condition that can lead to pain and stiffness of the knee and impair critical daily functions such as walking or moving around. The risk of developing the condition is more than four times higher in people with obesity. Weight reduction along with physical activity is often a recommended approach to managing painful symptoms, but adherence can be challenging," said lead study author Henning Bliddal, MD, M.Sci., The Parker Institute, Copenhagen University Hospital, Denmark. "There is a significant need for non-surgical and sustainable treatment options for those living with obesity-related osteoarthritis. The STEP 9 trial aimed to provide rigorous evidence as to how semaglutide may help these people." The study implemented a targeted approach to safety data collection, with investigators recording only serious adverse events (SAEs), adverse events (AEs) leading to treatment discontinuation, AEs requiring invasive knee procedures, medication error, acute pancreatitis, COVID-19, and pregnancy or pregnancy-related AEs.1 AEs leading to treatment discontinuation occurred in 6.7% of patients in the semaglutide group and 3.0% of patients in the placebo group. The most common AEs leading to treatment discontinuation were gastrointestinal disorders (2.2% of patients in the semaglutide group and 0% of patients in the placebo group) and neoplasms (benign, malignant, and unspecified) (semaglutide, 1.9%; placebo, 1.5%). The incidence of SAEs was similar in both groups (semaglutide, 10.0%; placebo, 8.1%).1 STEP 9 was a randomized, double-blind, placebo-controlled multicenter trial of 407 adults aged ≥18 years with obesity (BMI ≥30 kg/m2) and a clinical diagnosis of knee osteoarthritis per American College of Rheumatology criteria with moderate radiographic changes (Kellgren–Lawrence grade 2 or 3) in the target knee. Participants also had pain due to knee osteoarthritis, with a WOMAC pain score ≥40 out of 100 at randomization.1 "Obesity is a complex metabolic disease associated with multiple co-morbid conditions, including knee osteoarthritis," said Anna Windle, PhD, Senior Vice President, Clinical Development, Medical and Regulatory Affairs, Novo Nordisk. "The STEP 9 results are encouraging and provide important information about the effect of semaglutide, a glucagon-like peptide-1 receptor agonist, on knee osteoarthritis outcomes in people with obesity. We look forward to working with regulatory authorities on next steps based on these findings." About obesity Obesity is a serious chronic, progressive, and misunderstood disease that requires long-term management.6-8 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.6,7 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.9 The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.10,11 In the U.S., about 40% of adults live with obesity.12 About the STEP 9 trial (semaglutide 2.4 mg) STEP 9 was a randomized, double-blind, placebo-controlled multicenter trial designed to evaluate the efficacy of semaglutide 2.4 mg versus placebo as an adjunct to lifestyle modifications (counseling on a reduced-calorie diet and physical activity) in reducing body weight and knee osteoarthritis-related pain in patients with obesity and a clinical and radiologic diagnosis of moderate knee osteoarthritis, and pain that is at least moderately severe.1 Participants were randomized 2:1 to receive once-weekly subcutaneous semaglutide 2.4 mg or placebo for 68 weeks, followed by 7 weeks' off-treatment follow-up. There was a 16-week dose escalation to allow for adjustment to therapy (gastrointestinal adverse reactions). The study randomized participants between October 2021 and March 2022.1 All endpoints were measured from baseline to week 68. The primary endpoints were the percentage change in body weight and change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score.1 The trial enrolled 407 adults and was conducted in 11 countries at 61 investigator sites.1 Semaglutide is not approved for the treatment of knee osteoarthritis. Safety and efficacy are not established, and there is no guarantee that semaglutide will become commercially available for this use under clinical investigation. 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 commercial, production, and research facilities in seven states plus Washington DC, Novo Nordisk employs approximately 8,000 people throughout the country. For more information, visit novonordisk-us.com, Facebook, Instagram, X, LinkedIn, and YouTube. References Bliddal H, Bays H, Czernichow S, et al. Once-Weekly Semaglutide in Persons with Obesity and Knee Osteoarthritis. N Engl J Med. 2024; 391:1573-83. Centers for Disease Control and Prevention. Arthritis risk factors. Last accessed: September 2024. Available at . World Health Organization. Osteoarthritis. Last accessed: October 2024. Available at: . Nedunchezhiyan U, Varughese I, Sun AR, et al. Obesity, inflammation, and immune system in osteoarthritis. Front Immunol. 2022;13:907750. doi:10.3389/fimmu.2022.907750. ClinicalTrials.gov. Research study looking at how well semaglutide works in people suffering from obesity and knee osteoarthritis. Last accessed: October 2024. Available at: . Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61-69. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev. 2017;18(7):715-723. Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1-203. Centers for Disease Control and Prevention. Causes of obesity. Last accessed: October 2024. Available at: . World Obesity Federation. World Obesity Atlas 2023. Last accessed: October 2024. Available at: . Centers for Disease Control and Prevention. Why it matters. Last accessed: October 2024. Available at: . Centers for Disease Control and Prevention. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021–August 2023. Last accessed October 2024. Available at: . © 2024 Novo Nordisk All rights reserved. US24SEMO01198 October 2024 SOURCE NOVO NORDISK INC. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Study will assess the Company's Next-Generation device under Intracardiac Echocardiography (ICE) imaging for Left Atrial Appendage Occlusion (LAAO) procedures. NASHUA, N.H., Oct. 1, 2024 /PRNewswire/ -- Conformal Medical, Inc. today announced the initiation of the GLACE Study. This European study* aims to assess the use of intracardiac echocardiography (ICE) imaging of the left atrial appendage (LAA) during appendage closure procedures with the next-generation CLAAS® AcuFORM™ device in patients with non-valvular atrial fibrillation. The prospective, multicenter, non-randomized, single-arm investigation will enroll approximately 80 patients in Denmark, Italy, and the Czech Republic. Continue Reading "Simplified sizing and ease of use enabled by this device will drive improved workflow in the lab." Post this Conformal CLAAS AcuFORM LAAO Initial patients were treated by the study's co-principal investigators Professor Jens Erik Nielsen-Kudsk, M.D. of Aarhus University Hospital and Professor Ole De Backer, M.D. of Rigshospitalet, Copenhagen University Hospital at their respective institutions in Denmark. Additionally, Shephal Doshi, M.D., from Providence Saint John's Health Center and the Pacific Heart Institute in Santa Monica, California and Principal Investigator of the CONFORM Pivotal Trial was present for the initial cases. "I am excited about the new CLAAS AcuFORM implant and the ability to confirm seal with angiography providing procedural confidence, ensuring the patient has been properly treated," stated Nielsen-Kudsk. "ICE has become our primary imaging platform for LAAO, the GLACE Study allows us to validate the use of ICE with this innovative technology." ICE imaging facilitates real-time visualization of cardiac structures during LAAO closure, enhancing precision while reducing radiation exposure and procedure time. This approach often eliminates the need for general anesthesia, improving patient comfort and operational efficiency."The CLAAS AcuFORM device enhances and simplifies the procedure, with only two sizes, one of which effectively treats over 90% of patients," stated Dr. Doshi. "Simplified sizing and ease of use enabled by this device will drive improved workflow in the lab."Designed to optimize anchor penetration and featuring an improved ePTFE material, and a simplified delivery system, the CLAAS AcuFORM LAAO System builds upon the novel CLAAS device and is engineered to conform to and seal the LAA with its proprietary foam-based architecture. The implant addresses the clinical spectrum of LAA anatomies with only two sizes. The system aims to simplify delivery and eliminate the need for procedural transesophageal echocardiogram (TEE) so that physicians may perform the procedure without general anesthesia, a significant advancement with the potential to shift clinical practice to a same-day, single-operator procedure. Over 350 patients have been successfully implanted with the Conformal CLAAS System as part of early feasibility studies and the ongoing CONFORM Pivotal Trial."The use of ICE imaging in LAAO is growing significantly and will continue," said James Reinstein, President and CEO of Conformal Medical. "Our next-generation LAAO technology conforms to individual anatomies, enabling clinicians to simplify the procedure with 2 sizes, the ability to confirm seal, and eliminate general anesthesia & intubation." About Conformal MedicalConformal Medical, Inc., is a medical device company developing devices to prevent stroke in patients with non-valvular atrial fibrillation. The company's proprietary technology is intended to make left atrial appendage closure a same-day, single-operator procedure. For more information, visit . About Left Atrial Appendage ClosureMore than six million people in the United States suffer from Afib, placing them at an increased risk of stroke.1 Current standard of care for stroke prevention is chronic oral anticoagulants, which are not well accepted by patients due to concern about associated risk of bleeding. Left Atrial Appendage Occlusion (LAAO) is emerging as an important alternative to blood thinners for preventing strokes in patients with non-valvular Afib. First-generation LAAO devices are an estimated $1.4B global market in 2023 and are expected to grow to over $6B by 2030.2,3 CAUTION: Investigational Device. The CLAAS System is limited by Federal (or United States) law to investigational use*Study is designed to comply with EU MDR Chapter VI, Article 62 4(i). Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020 Jun 19;127(1):4-20. Piper Sandler Market Analyst Report, September 2023. Boston Scientific Investor Update, September 2023. SOURCE Conformal Medical, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MONDAY, Sept. 23, 2024 -- Antidepressants have the potential to improve memory and thinking skills, a new study suggests. Some patients experienced a boost on brain tests after taking the SSRI antidepressant escitalopram (Lexapro), researchers report. The drug appeared to affect a serotonin receptor in the brain called the 5HT4 receptor, according to results published recently in the journal Biological Psychiatry . Serotonin is described as a “feel good” hormone, researchers said in background notes. Higher levels of serotonin in the brain contribute to a sense of well-being and have been shown to ease clinical depression. “It seems that the SSRI medication contributes to an improvement on cognitive function, at the same time as helping improve mood,” said lead investigator Vibeke Dam , a senior researcher in neurology and neurobiology with Copenhagen University Hospital in Denmark. “Our work ties the improvement in cognitive function to the specific 5HT4 receptor and suggest that direct serotonin 4 receptor stimulation may be an important pro-cognitive target to consider in optimizing outcomes of antidepressant treatment,” Dam added in a journal news release. “It also reinforces the idea that serotonin is crucial to mood improvement." For the study, researchers scanned the brains of 90 depressed patients to measure 5HT4 receptor function in their brains. The patients also were tested for mood problems and cognitive abilities. Then the patients were given daily escitalopram (Lexapro) for eight weeks. At the end of the study, 40 patients were rescanned and retested. What did they find? The patients’ performance on cognitive tests had improved -- particularly their ability to recall words -- and this performance appeared to be linked to higher activity with the 5HT4 receptor. “This work points to the possibility of stimulating this specific receptor so that we can treat cognitive problems, even aside from whether or not the patient has overcome the core symptoms of depression,” said lead researcher Dr. Vibe Froekjaer , a clinical professor of neuropsychiatry with Copenhagen University Hospital in Denmark. The team’s next step will be to treat patients with drugs that specifically target the 5HT4 receptor, and then assess the effect on their brain function. Serotonin is found in the gut, and there are irritable bowel syndrome drugs that specifically bind to and stimulate 5HT4 receptors, researchers said. Researchers also presented these findings Monday at the European College of Neuropsychopharmacology’s annual meeting in Milan. The study “demonstrates the intimate role of brain 5HT4 receptors in cognitive function,” said Philip Cowen , a professor of psychopharmacology with the University of Oxford. “This confirms recent work from Oxford showing that the 5HT4 receptor stimulant, prucalopride -- a drug licensed for the treatment of constipation -- improves memory in both healthy participants and people at risk of depression,” said Cowen, who was not involved in the study. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.