| アブストラクト | BACKGROUND: Dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) have acquired a foothold in managing type 2 diabetes mellitus, but few concerns have arisen regarding their overall safety profile. The aim of this study is to assess the potential risk of DPP-4 inhibitors by analyzing data from the FDA Adverse Event Reporting System (FAERS) database. RESEARCH DESIGN AND METHODS: This is a retrospective study which explored the FAERS database till March 2023 for the collection of safety reports. The disproportionality analysis was performed using signal detection algorithms (SDAs) incorporating frequentist-based data mining approach such as relative reporting ratio (RRR), reporting odds ratio (ROR) and proportional reporting ratio (PRR) with 95% confidence interval (CI). RESULTS: A total of 14,573 adverse event reports were reported in the FAERS public dashboard associated with all the included DPP-4 inhibitors. The computed PRR, ROR, and RRR indicated positive signals for DPP-4 inhibitors with cardiac failure, pancreatitis, pemphigoid, hypoglycemia, acute kidney injury and lactic acidosis. Saxagliptin showed a higher signal score for cardiac failure, while sitagliptin was more associated with pancreatitis. Moreover, alogliptin exhibited an elevated signal score associated with pancreatic carcinoma. CONCLUSION: Several significant disproportionality signals were observed with DPP-4 inhibitors. However, clinicians have to consider the comorbidities and concomitant drugs while prescribing these drugs. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2024/4/16 |
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| 投稿者 | Yoosuf, Beema T; Favas Kt, Muhammed; Dutta, Pinaki; Bansal, Dipika |
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| 組織名 | Department of Pharmacy Practice, National Institute of Pharmaceutical Education;and Research, Mohali, Punjab, India.;Department of Endocrinology, Postgraduate Institute of Medical Education and;Research, Chandigarh, India. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38626310/ |
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