在SELECT研究中,塞马格卢提德与安慰剂的安全性概况:一种随机对照试验
Robert F Kushner1, Donna H Ryan2, John Deanfield3
1Departments of Medicine and Medical Education, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Obesity (Silver Spring, Md.)
|February 14, 2025
概括
在患有心血管疾病和肥胖症的患者中,每周服用一次2.4毫克西马格卢提德的安全性表现良好. 虽然更多的患者因不良事件而停止治疗,但与安慰剂相比,严重不良事件较低.
科学领域:
- 心脏病学 心脏病学
- 内分泌学 在内分泌学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 已确定的心血管疾病 (CVD) 和超重/肥胖是严重的健康问题.
- 作为GLP-1受体激动剂的塞马格卢提德 (Semaglutide) 已证明对心血管有好处.
- 在这个人群中,进一步评估2.4毫克塞马格卢提德的安全性至关重要.
研究的目的:
- 为了评估每周一次皮下注射2.4毫克西马格卢提德与安慰剂的安全性.
- 在已确定的心血管疾病和超重或肥胖患者中评估超出主要不良心血管事件的安全性.
- 为了确定与长期使用西马格卢提德相关的任何新的安全问题.
主要方法:
- 选择试验评估了重点关注严重不良事件 (SAE),导致永久停药的所有不良事件 (AE) 和特别感兴趣的预指定AE的安全性.
- 使用双面p值来评估治疗差异.
- 从已确定的心血管疾病和超重或肥胖的患者收集数据.
主要成果:
- 与安慰剂 (36.4%) 相比,塞马格卢提德的严重不良事件 (SAE) 较低 (33.4%),主要是由于心脏疾病.
- 导致中止治疗的不良事件 (AEs) 在塞马格卢提德 (16.6%) 与安慰剂 (8.2%) 相比较高,主要是胃肠道疾病.
- 与胆囊相关的疾病更频繁地发生在塞马格卢提德 (2.8%) 与安慰剂 (2.3%) 之间,主要是胆病.
结论:
- 在SELECT研究中,每周服用一次2.4毫克西马格卢提德的长期安全性概况与之前的研究结果一致.
- 在已确定的心血管疾病和超重或肥胖的患者中,没有发现semaglutide 2.4 mg的新安全问题.
- 塞马格卢提德2.4毫克在这个高风险人群中显示出普遍有利的安全性.
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