Novo Nordisk(US:NVO) GLP1减重宝典·2025-10-18 10:55Core Viewpoint - The FDA has approved Rybelsus® as the only oral GLP-1 medication for reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes, regardless of prior cardiovascular events, highlighting the need for treatment options beyond blood sugar control [2][3][5]. Group 1: FDA Approval and Clinical Evidence - Rybelsus® is now recognized as the only oral GLP-1 drug approved for both primary and secondary prevention of MACE in high-risk type 2 diabetes patients [5]. - The SOUL study aimed to evaluate the effectiveness of oral semaglutide 14mg combined with standard treatment in reducing MACE risk, with MACE defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke [5][6]. - In the study, 12.0% of patients receiving semaglutide experienced MACE events compared to 13.8% in the placebo group, demonstrating a hazard ratio of 0.86, indicating a 14% relative risk reduction over four years [6]. Group 2: Safety and Side Effects - The overall safety profile of oral semaglutide 14mg was consistent with previous studies, with serious adverse events (SAEs) occurring in 47.9% of the semaglutide group compared to 50.3% in the placebo group [8]. - The most common SAEs included heart disease and infections, with gastrointestinal issues being slightly more prevalent in the semaglutide group (5.0% vs. 4.4%) [8]. - Discontinuation due to adverse events occurred in 15.5% of the semaglutide group versus 11.6% in the placebo group, primarily due to gastrointestinal disorders and infections [8]. Group 3: Future Developments - The company has submitted a supplemental application to the FDA for a daily oral semaglutide formulation, Wegovy®, aimed at treating obesity, with results expected later this year [9].