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Ozempic®(司美格鲁肽)
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速递|最大步行距离改善13%!诺和诺德公布司美格鲁肽治疗外周动脉疾病的IIIb期临床结果
GLP1减重宝典· 2025-05-09 08:29
Core Viewpoint - Novo Nordisk's Ozempic® (semaglutide) shows significant improvement in walking distance and quality of life for adults with type 2 diabetes and symptomatic peripheral artery disease (PAD) in the STRIDE trial, marking a breakthrough in treatment options for this patient group [1][3][5]. Group 1: STRIDE Trial Results - The STRIDE trial, a double-blind, randomized, placebo-controlled study, involved 792 adults with type 2 diabetes and symptomatic PAD, achieving its primary endpoint with a 13% improvement in maximum walking distance compared to the placebo group after 52 weeks [3]. - The median treatment difference at a 12% incline was clinically significant, measuring 26.4 meters, approximately one-third the length of a football field [3]. - Semaglutide outperformed placebo in all assessed secondary outcomes, including pain-free walking distance and vascular quality of life [3]. Group 2: Clinical Significance and Expert Commentary - PAD can lead to severe symptoms and reduced quality of life, particularly for those also suffering from diabetes, highlighting the urgent need for effective therapies [5][7]. - Semaglutide is the first drug in over two decades to show significant improvements in function and quality of life for patients with PAD and type 2 diabetes, addressing unmet medical needs [5]. - Experts emphasize the importance of STRIDE's findings in advancing treatment options for heart metabolic diseases [7]. Group 3: Safety and Regulatory Actions - In the STRIDE trial, 19% of participants in the semaglutide group and 20% in the placebo group reported serious adverse events (SAEs), with a small percentage likely related to treatment [8]. - The most common SAEs were severe gastrointestinal events, with a low incidence of treatment-related deaths [8]. - Novo Nordisk has submitted a label extension application for Ozempic® to the FDA, with a decision expected in 2025 [8].