Safety considerations of semaglutide in the potential treatment of Alzheimer's disease: A pooled analysis of semaglutide in adults aged ≥ 65 years
Abstract INTRODUCTION 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 semaglut...
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| Format: | Article |
| Language: | English |
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Wiley
2025-04-01
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| Series: | Alzheimer’s & Dementia: Translational Research & Clinical Interventions |
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| Online Access: | https://doi.org/10.1002/trc2.70076 |
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| author | Marwan Sabbagh Cristina Boschini Sharon Cohen Magnus Fugger Frank Jessen Sune Dandanell Sue D. Pedersen Luis Rafael Solís Tarazona Vanita R. Aroda |
| author_facet | Marwan Sabbagh Cristina Boschini Sharon Cohen Magnus Fugger Frank Jessen Sune Dandanell Sue D. Pedersen Luis Rafael Solís Tarazona Vanita R. Aroda |
| author_sort | Marwan Sabbagh |
| collection | DOAJ |
| description | Abstract INTRODUCTION 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. METHODS 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. RESULTS 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/m2, respectively, compared to 47.8 to 58.5 years and 31.3 to 36.7 kg/m2 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. DISCUSSION 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. Highlights 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. |
| format | Article |
| id | doaj-art-a95f4ba5a5f241e6a70b80c4d87f5713 |
| institution | Matheson Library |
| issn | 2352-8737 |
| language | English |
| publishDate | 2025-04-01 |
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| series | Alzheimer’s & Dementia: Translational Research & Clinical Interventions |
| spelling | doaj-art-a95f4ba5a5f241e6a70b80c4d87f57132025-06-26T06:30:48ZengWileyAlzheimer’s & Dementia: Translational Research & Clinical Interventions2352-87372025-04-01112n/an/a10.1002/trc2.70076Safety considerations of semaglutide in the potential treatment of Alzheimer's disease: A pooled analysis of semaglutide in adults aged ≥ 65 yearsMarwan Sabbagh0Cristina Boschini1Sharon Cohen2Magnus Fugger3Frank Jessen4Sune Dandanell5Sue D. Pedersen6Luis Rafael Solís Tarazona7Vanita R. Aroda8Department of NeurologyBarrow Neurological InstitutePhoenix Arizona USANovo Nordisk A/S Bagsværd DenmarkToronto Memory Program Toronto Ontario CanadaNovo Nordisk A/S Bagsværd DenmarkDepartment of Psychiatry University Hospital of Cologne Cologne GermanyNovo Nordisk A/S Bagsværd DenmarkC‐endo Diabetes and Endocrinology Clinic Calgary CanadaNovo Nordisk A/S Bagsværd DenmarkBrigham and Women's Hospital, Harvard Medical School Boston Massachusetts USAAbstract INTRODUCTION 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. METHODS 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. RESULTS 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/m2, respectively, compared to 47.8 to 58.5 years and 31.3 to 36.7 kg/m2 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. DISCUSSION 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. Highlights 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.https://doi.org/10.1002/trc2.70076adverse eventAlzheimer's diseaseearlyglucagon‐like peptide‐1 analoguepooled analysissemaglutide |
| spellingShingle | Marwan Sabbagh Cristina Boschini Sharon Cohen Magnus Fugger Frank Jessen Sune Dandanell Sue D. Pedersen Luis Rafael Solís Tarazona Vanita R. Aroda Safety considerations of semaglutide in the potential treatment of Alzheimer's disease: A pooled analysis of semaglutide in adults aged ≥ 65 years Alzheimer’s & Dementia: Translational Research & Clinical Interventions adverse event Alzheimer's disease early glucagon‐like peptide‐1 analogue pooled analysis semaglutide |
| title | Safety considerations of semaglutide in the potential treatment of Alzheimer's disease: A pooled analysis of semaglutide in adults aged ≥ 65 years |
| title_full | Safety considerations of semaglutide in the potential treatment of Alzheimer's disease: A pooled analysis of semaglutide in adults aged ≥ 65 years |
| title_fullStr | Safety considerations of semaglutide in the potential treatment of Alzheimer's disease: A pooled analysis of semaglutide in adults aged ≥ 65 years |
| title_full_unstemmed | Safety considerations of semaglutide in the potential treatment of Alzheimer's disease: A pooled analysis of semaglutide in adults aged ≥ 65 years |
| title_short | Safety considerations of semaglutide in the potential treatment of Alzheimer's disease: A pooled analysis of semaglutide in adults aged ≥ 65 years |
| title_sort | safety considerations of semaglutide in the potential treatment of alzheimer s disease a pooled analysis of semaglutide in adults aged ≥ 65 years |
| topic | adverse event Alzheimer's disease early glucagon‐like peptide‐1 analogue pooled analysis semaglutide |
| url | https://doi.org/10.1002/trc2.70076 |
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