ArticleCureus2024
Mortality and Serious Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists: A Pharmacovigilance Study Using the FDA Adverse Event Reporting System.
Article in Cureus, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Ranking the Diabetes-related Safety Profile of Different Statin Drugs.Current pharmaceutical design · 2026Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are an increasingly prevalent class of drugs for managing overweight/obesity and type 2 diabetes mellitus. Postmarket surveillance is essential for characterizing their risk profiles in real-world patient populations as clinical use increases. This study investigated the association of GLP-1RAs with mortality and serious adverse events (AEs) reported to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Methods A disproportionality analysis was conducted utilizing FAERS data from Q2 2005 to Q1 2024 to identify AEs listing an approved GLP-1RA as the primary suspect drug. The reporting odds ratio (ROR) was calculated for mortality and serious AEs associated with each GLP-1RA compared to the combined group of all other GLP-1RAs. A signal of disproportionate reporting indicating a potential safety concern was defined as a lower bound of the 95% CI for the ROR exceeding 1.0. Results The analysis identified 287,201 AEs associated with GLP-1RAs during the study period. Disproportionality analyses revealed statistically significant elevated signals for mortality with the earliest approved GLP-1RAs: Byetta (ROR = 2.20, 95% CI: 2.06-2.34) and Victoza (ROR = 2.12, 95% CI: 1.98-2.28). Significant elevated signals for serious AEs were identified with the semaglutide products Ozempic (ROR = 2.77, 95% CI: 2.69-2.85), Rybelsus (ROR = 2.42, 95% CI: 2.26-2.60), and Wegovy (ROR = 1.30, 95% CI: 1.22-1.39); the liraglutide products Victoza (ROR = 2.10, 95% CI: 2.04-2.15) and Saxenda (ROR = 2.21, 95% CI: 2.09-2.33); and Byetta (ROR = 1.11, 95% CI: 1.08-1.14) compared to other GLP-1RAs. The newer GLP-1RAs were associated with a higher proportion of serious AEs reported in younger patients (p < 0.001) and females (p < 0.001). Conclusion This pharmacovigilance study utilizing the FAERS database identified potential safety signals of increased mortality and serious AE reporting associated with certain GLP-1RAs, particularly the earlier approved liraglutide agents Byetta and Victoza. These findings highlight the importance of proactive postmarket surveillance to characterize the real-world safety profiles of individual GLP-1RA drugs.
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