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Advisor(s)
Abstract(s)
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 dis orders, 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.
Description
Keywords
Semaglutide Type 2 diabetes Adverse drug reactions Eudravigilance Glucagon-like peptide-1
Citation
António Cabral Lopes, Fátima Roque, Olga Lourenço, Maria Teresa Herdeiro & Manuel Morgado (2023): Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database, Expert Opinion on Drug Safety, DOI: 10.1080/14740338.2023.2172159