Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database

ABSTRACT

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.

KEYWORDS:

• Semaglutide
• adverse drug reactions
• Eudravigilance Database
• Glucagon-like peptide-1
• type 2 diabetes

Acknowledgments

Authors would like to thank Inês Ribeiro-Vaz from the Porto Pharmacovigilance Centre for their review.

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One reviewer is a member of the advisory boards for NovoNordisk. The remaining reviewers have no other relevant financial relationships or otherwise to disclose.

Author contributions statement

F Roque, M Morgado and MT Herdeiro were involved in the conception and design, all authors were involved in the analysis and interpretation of the data; AC Lopes wrote the first draft of the paper and all authors revised it critically for intellectual content and approved the final version to be published; all authors agree to be accountable for all aspects of the work.

Additional information

Funding

This paper was not funded