| アブストラクト | AIMS: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are widely used for type 2 diabetes mellitus and obesity, with once-weekly dosing that supports adherence. However, injection-site reactions (ISRs) and dermatologic events have been recognised, ranging from mild local events to rare systemic hypersensitivity reactions that may cause discontinuation. To evaluate dermatologic and ISR safety of GLP-1 RAs through a meta-analysis of randomised controlled trials (RCTs) and disproportionality analysis of data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS). MATERIALS AND METHODS: PubMed, Embase and Web of Science were searched through December 2024 to identify RCTs reporting ISR or dermatologic outcomes for GLP-1 RAs. Random-effects meta-analysis synthesised trial evidence. A retrospective disproportionality analysis of FAERS data evaluated all approved GLP-1 RAs. Lower bound reporting odds ratios (LB ROR), proportional reporting ratios (PRR) and information components (IC) were calculated. RESULTS: The pooled meta-analysis of 14 RCTs that reported ISRs (4861 patients; 396 ISR events) showed increased ISR risk with GLP-1 RAs versus comparators (risk ratio 3.55; 95% confidence interval, 2.35-5.36; I(2) = 41.4%). Dermatologic events were infrequent and not significantly elevated. FAERS data analysis revealed potential ISR signals for exenatide and dulaglutide. Exenatide was associated with injection-site haemorrhage (PRR: 27.6; LB ROR: 29.4; IC(025): 4.6). Dulaglutide showed disproportionate reporting for injection-site haemorrhage (PRR: 11.5; LB ROR: 11.5; IC(025): 3.4). CONCLUSIONS: GLP-1 RAs are consistently linked to higher ISR risk, especially with exenatide and dulaglutide, while generalised dermatologic events are rare. Clinicians should counsel patients about ISR risk to support adherence and optimise outcomes. |
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| ジャーナル名 | Diabetes, obesity & metabolism |
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| Pubmed追加日 | 2025/12/15 |
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| 投稿者 | Taj, Shifa; Zuber, Mohammed; Rashid, Muhammed; Chhabra, Manik; Undela, Krishna; Rawal, Smita; Villa Zapata, Lorenzo |
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| 組織名 | Clinical and Administrative Pharmacy, College of Pharmacy, University of Georgia,;Athens, Georgia, USA.;Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake;City, Utah, USA.;Department of Epidemiology and Biostatistics, Schulich School of Medicine and;Dentistry, Western University, London, Ontario, Canada.;London Health Sciences Centre Research Institute, London, Ontario, Canada.;Department of Pharmacy Practice, National Institute of Pharmaceutical Education;and Research (NIPER), Guwahati, India. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41395692/ |
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