Safety and Tolerability of Glucagon-Like Peptide-1 Receptor Agonists Utilizing Data from the Exenatide Clinical Trial Development Program
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Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have demonstrated benefits for patients with type 2 diabetes including A1C reduction and weight loss with minimal risk of hypoglycemia. This article provides an evidence-based update of safety and tolerability considerations for the clinical use of GLP-1RAs as a class, with a specific detailed review of data from the exenatide clinical trial development program, which has the longest history and availability of safety and tolerability data as the first-approved GLP-1RA. Specific areas covered include comparative risk of hypoglycemia, as well as pancreatic, thyroid, and cardiovascular safety data; clinical guidance regarding current safety and tolerability data is also reviewed.
KeywordsGLP-1 receptor agonists Incretin Exenatide Safety Pancreatitis Cardiovascular
The authors wish to acknowledge Róisín O’Connor and Amanda Sheldon of inScience Communications, Springer Healthcare, for medical writing assistance, which was funded by AstraZeneca.
Compliance with Ethical Standards
Conflict of Interest
Hui Peng declares that he has no conflict of interest.
Laura L. Want has been involved in clinical research trials for AstraZeneca, Sanofi, NovoNordisk, Hanmi, Halozyme, Calibra, and Janssen.
Vanita R. Aroda has served as a consultant for Janssen, Novo Nordisk, and Sanofi-Aventis on behalf of Medstar Health Research Institute. She has been involved in clinical research trials for AstraZeneca/Bristol-Myers Squibb/Amylin, Boehringer-Ingelheim, Eisai, GI Dynamics, Halozyme, Hanmi, Intarcia, Janssen, Novo Nordisk, Sanofi-Aventis, and Takeda. She is an employee of MedStar Health Research Institute.
Human and Animal Rights and Informed Consent
This review article does not contain any new studies with human or animal subjects performed by any of the authors.
Papers of particular interest, published recently, have been highlighted as: • Of importance,•• Of major importance
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