Sabbagh Marwan, Boschini Cristina, Cohen Sharon, Fugger Magnus, Jessen Frank, Dandanell Sune, Pedersen Sue D, Tarazona Luis Rafael Solís, Aroda Vanita R
Department of Neurology Barrow Neurological Institute Phoenix Arizona USA.
Novo Nordisk A/S Bagsværd Denmark.
Alzheimers Dement (N Y). 2025 May 6;11(2):e70076. doi: 10.1002/trc2.70076. eCollection 2025 Apr-Jun.
The evoke/evoke+ trials are investigating semaglutide in a population with early Alzheimer's disease (AD). Specific analyses of semaglutide safety data in older adults are limited; therefore, in the current analysis, we aimed to evaluate safety considerations with semaglutide in adults ≥ 65 years.
Adverse event (AE) data from three semaglutide phase 3a programs in participants ≥ 65 years with type 2 diabetes and/or overweight/obesity were pooled. Change in body weight was also assessed in a smaller subset of participants ≥ 65 years.
The analysis included 3529 participants ≥ 65 years. Baseline mean age and body mass index in participants ≥ 65 years were 69.3 to 70.2 years and 29.7 to 35.4 kg/m, respectively, compared to 47.8 to 58.5 years and 31.3 to 36.7 kg/m in the overall population. AEs with semaglutide occurred in 73.6% to 92.4% of participants ≥ 65 years versus 73.2% to 90.8% of the overall population. AEs with semaglutide leading to permanent discontinuation appeared to be more frequent in participants ≥ 65 years (9.3%-12.4%) versus the overall population (5.7%-8.7%). Gastrointestinal disorders were the most frequently reported AEs with semaglutide in participants ≥ 65 years (44.6%-73.8%) and in the overall population (39.1%-73.4%). Participants aged ≥ 65 years receiving semaglutide had an estimated weight loss of 3.8% at week 52 compared to 0.1% with placebo.
Age ≥ 65 years did not appear to affect the safety considerations of semaglutide. The ongoing evoke/evoke+ trials will elucidate the balance of efficacy and safety in the treatment of early AD with semaglutide.
This was a post hoc analysis evaluating adverse event (AE) data of semaglutide in people ≥ 65 years.The most common AE with semaglutide was gastrointestinal (GI).GI event rates were similar in people ≥ 65 years and the overall study populations.
“唤起/唤起加”试验正在对患有早期阿尔茨海默病（AD）的人群使用司美格鲁肽进行研究。针对老年人司美格鲁肽安全性数据的具体分析有限；因此，在当前分析中，我们旨在评估司美格鲁肽在65岁及以上成年人中的安全性考量。
汇总了三项司美格鲁肽3a期试验中65岁及以上2型糖尿病和/或超重/肥胖参与者的不良事件（AE）数据。还对一个较小的65岁及以上参与者亚组的体重变化进行了评估。
该分析纳入了3529名65岁及以上的参与者。65岁及以上参与者的基线平均年龄和体重指数分别为69.3至70.2岁和29.7至35.4kg/m²，而总体人群的这两个数值分别为47.8至58.5岁和31.3至36.7kg/m²。65岁及以上参与者中发生司美格鲁肽相关不良事件的比例为73.6%至92.4%，总体人群中这一比例为73.2%至90.8%。导致永久停药的司美格鲁肽相关不良事件在65岁及以上参与者中似乎更为频繁（9.3%-12.4%），而总体人群中为（5.7%-8.7%）。胃肠道疾病是65岁及以上参与者（44.6%-73.8%）和总体人群（39.1%-73.4%）中报告最频繁的司美格鲁肽相关不良事件。与接受安慰剂的参与者相比，接受司美格鲁肽的65岁及以上参与者在第52周时估计体重减轻了3.8%，而接受安慰剂的参与者体重减轻了0.1%。
65岁及以上的年龄似乎并未影响司美格鲁肽的安全性考量。正在进行的“唤起/唤起加”试验将阐明司美格鲁肽治疗早期AD时疗效与安全性的平衡。
这是一项事后分析，评估了65岁及以上人群中司美格鲁肽的不良事件（AE）数据。司美格鲁肽最常见的不良事件是胃肠道（GI）事件。65岁及以上人群和总体研究人群中的胃肠道事件发生率相似。
