| アブストラクト | BACKGROUND: Semaglutide is a Glucagon-like peptide-1 receptor agonist used in the second-line treatment of poorly controlled type 2 diabetes and can be used in monotherapy or associated with other oral antidiabetics or even insulin, increasing the effectiveness of the treatment. This work aims to analyze the profile of adverse drug reactions reported for semaglutide in Eudravigilance. RESEARCH DESIGN AND METHODS: Data on Individual Cases Safety Reports were obtained from the database of the centralized European spontaneous reporting system Eudravigilance by accessing www.adrreports.eu. (1 December 2021). RESULTS: It is possible to observe a high prevalence of gastrointestinal disorders (N = 3502, 53.2%). The most severe reported cases were primarily gastrointestinal disorders, metabolic, and nutritional disorders, eye disorders, renal and urinary disorders and cardiac disorders, with an evident higher prevalence of adverse gastrointestinal events both in oral and injectable dosage form (N = 133, 50.0% vs N = 588, 47.2%, respectively). Through a comparative analysis, semaglutide had a greater number of reported gastrointestinal adverse events compared to sitagliptin and empaglifozin (p < 0.00001). CONCLUSIONS: Semaglutide has a good safety profile, however the definition of subgroups within the type 2 diabetes population who are particularly prone to develop serious adverse event when treated with GLP-1 RAs is crucial. |
|---|
| ジャーナル名 | Expert opinion on drug safety |
|---|
| 投稿日 | 2023/1/26 |
|---|
| 投稿者 | Cabral Lopes, Antonio; Roque, Fatima; Lourenco, Olga; Herdeiro, Maria Teresa; Morgado, Manuel |
|---|
| 組織名 | Pharmaceutical Services of Unity Local of Health of Guarda (ULS da Guarda),;Guarda, Portugal.;Health Sciences Faculty, University of Beira Interior (FCS-UBI), Covilha,;Portugal.;Research Unit for Inland Development, Polytechnic Institute of Guarda (UDI-IPG),;Health Sciences Research Centre, University of Beira Interior (CICS-UBI),;Covilha, Portugal.;Institute of Biomedicine, Department of Medical Sciences (iBiMED-UA), University;of Aveiro, Portugal.;Pharmaceutical Services of University Hospital Center of Cova da Beira, Covilha, |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36695099/ |
|---|
