Core Viewpoint - Novo Nordisk's semaglutide injection (brand name: Ozempic) has received approval from China's National Medical Products Administration (NMPA) for a new indication to treat chronic kidney disease (CKD) in adults with type 2 diabetes, marking it as the first and only GLP-1 receptor agonist approved for this purpose in China [2] Group 1: Clinical Trial Results - The FLOW clinical trial, a randomized, double-blind, placebo-controlled study, involved 3,533 patients with type 2 diabetes and CKD to evaluate the efficacy of 1.0 mg semaglutide in preventing kidney damage progression and reducing cardiovascular and kidney mortality risks [4] - Results indicated a significant 24% reduction in the risk of kidney disease progression and cardiovascular and kidney mortality for patients receiving 1.0 mg semaglutide compared to placebo, achieving the primary endpoint of the trial [5] Group 2: Meta-Analysis Findings - A meta-analysis published in The Lancet Diabetes & Endocrinology, involving 85,373 participants, demonstrated that GLP-1 receptor agonists, including semaglutide, reduced the risk of kidney failure by 16% and the risk of kidney function deterioration by 22% compared to placebo [6][7] - The overall risk of kidney failure, kidney function deterioration, and death due to kidney disease was reduced by 19% with the use of GLP-1 receptor agonists [7] Group 3: Broader Implications - The findings suggest that GLP-1 receptor agonists not only benefit patients with type 2 diabetes but also provide significant renal and cardiovascular protection for those with CKD, indicating a potential shift in clinical guidelines for managing these conditions [10] - The research emphasizes the need for further work to integrate these findings into clinical practice and improve access to GLP-1 receptor agonists for patients who could benefit from them [10]
速递|司美格鲁肽注射液,新肾病适应症国内获批上市!