Fracture events associated with GLP-1 receptor agonists in FDA adverse events reporting system

Nov 18, 2024Acta diabetologica

Fractures linked to GLP-1 receptor agonist use in FDA safety reports

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Abstract

GLP-1 receptor agonists (GLP-1RAs) were associated with a 44% lower reporting of fracture-related adverse events compared to other diabetes medications.

Among diabetes medications, GLP-1RAs had the lowest reporting of fracture-related adverse events.
The adjusted reporting odds ratio for any fracture-related adverse events with GLP-1RAs was 0.44.
GLP-1RAs showed a reduced risk for osteoporotic fractures with an adjusted reporting odds ratio of 0.39.
For hip fractures, GLP-1RAs had an adjusted reporting odds ratio of 0.34.
Albiglutide, a specific GLP-1RA, was linked to the lowest adjusted reporting odds ratio of 0.11 for any fracture-related adverse events.
Even after excluding insulin reports, GLP-1RAs maintained a significantly lower adjusted reporting odds ratio for fractures.

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AIMS: Diabetes patients are at a higher risk of fractures, and glucagon-like peptide-1 receptor agonists (GLP-1RAs) have been suggested to positively impact on bone metabolism. We aim to provide a comprehensive assessment of fracture events associated with GLP-1RAs based on pharmacovigilance data.

METHODS: In this study, fracture-related adverse events (AEs) associated with GLP-1RAs and other commonly used glucose-lowering drugs were identified from Food and Drug Administration Adverse Event Reporting System (FAERS) database (2004-2022). The reporting odds ratio (ROR) and adjusted ROR (adj. ROR) were used to compare the reporting of fracture-related AEs associated with insulin, GLP-1RAs, and Non GLP-1RAs, in patients with diabetes through two scenarios. This involved separately comparing each glucose-lowering drug to all other medications used in diabetic patients and reiterating after excluding insulin cases.

RESULTS: A total of 490,107 AE reports for patients with diabetes were identified and 98, 625 of them were for GLP-1RAs. Among all diabetes drugs, GLP-1RAs had the lowest reporting of any fracture-related AEs [adj. ROR = 0.44 (0.40-0.47)], consistent across osteoporotic fracture [adj. ROR = 0.39 (0.34-0.45)] and hip fracture [adj. ROR = 0.34 (0.28-0.41)]. Among GLP-1RA agents, albiglutide was associated with the lowest adj. ROR [0.11 (0.05-0.21)] for any fracture-related AEs. After excluded all insulin reports, GLP-1RAs retained a significantly lower adj. ROR towards any fracture [adj. ROR = 0.45 (0.40-0.50)], osteoporotic fracture [adj. ROR = 0.44 (0.37-0.52)], and hip fracture [adj. ROR = 0.43 (0.33-0.54)].

CONCLUSION: In a real-world pharmacovigilance setting, GLP-1RAs were associated with lower reporting of fracture-related AEs, indicating the protective effect of GLP-1RAs against fractures.

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Fracture events associated with GLP-1 receptor agonists in FDA adverse events reporting system

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