Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database
Autor(a) principal: | |
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Data de Publicação: | 2023 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10400.6/13301 |
Resumo: | 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. |
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Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance DatabaseSemaglutideType 2 diabetesAdverse drug reactionsEudravigilanceGlucagon-like peptide-1Background: 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.uBibliorumLopes, António CabralRoque, Maria de Fátima dos Santos MarquesLourenço, OlgaHerdeiro, Maria TeresaMorgado, Manuel Augusto Nunes Vicente Passos2023-04-21T15:15:38Z20232023-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.6/13301engAntónio 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: 10.1080/14740338.2023.217215910.1080/14740338.2023.2172159info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-12-15T09:56:48Zoai:ubibliorum.ubi.pt:10400.6/13301Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T00:52:45.763300Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database |
title |
Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database |
spellingShingle |
Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database Lopes, António Cabral Semaglutide Type 2 diabetes Adverse drug reactions Eudravigilance Glucagon-like peptide-1 |
title_short |
Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database |
title_full |
Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database |
title_fullStr |
Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database |
title_full_unstemmed |
Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database |
title_sort |
Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database |
author |
Lopes, António Cabral |
author_facet |
Lopes, António Cabral Roque, Maria de Fátima dos Santos Marques Lourenço, Olga Herdeiro, Maria Teresa Morgado, Manuel Augusto Nunes Vicente Passos |
author_role |
author |
author2 |
Roque, Maria de Fátima dos Santos Marques Lourenço, Olga Herdeiro, Maria Teresa Morgado, Manuel Augusto Nunes Vicente Passos |
author2_role |
author author author author |
dc.contributor.none.fl_str_mv |
uBibliorum |
dc.contributor.author.fl_str_mv |
Lopes, António Cabral Roque, Maria de Fátima dos Santos Marques Lourenço, Olga Herdeiro, Maria Teresa Morgado, Manuel Augusto Nunes Vicente Passos |
dc.subject.por.fl_str_mv |
Semaglutide Type 2 diabetes Adverse drug reactions Eudravigilance Glucagon-like peptide-1 |
topic |
Semaglutide Type 2 diabetes Adverse drug reactions Eudravigilance Glucagon-like peptide-1 |
description |
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. |
publishDate |
2023 |
dc.date.none.fl_str_mv |
2023-04-21T15:15:38Z 2023 2023-01-01T00:00:00Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10400.6/13301 |
url |
http://hdl.handle.net/10400.6/13301 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
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 10.1080/14740338.2023.2172159 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.source.none.fl_str_mv |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
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RCAAP |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
repository.name.fl_str_mv |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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