| アブストラクト | BACKGROUND: Recent clinical case reports have generated controversy concerning the adverse events (AEs) of amputation linked to sodium-glucose co-transporter 2 inhibitors (SGLT2i). We assessed the risk of osteomyelitis AE reporting linked to SGLT2i or SGLT2i-metformin co-medication. RESEARCH DESIGN AND METHODS: Investigated the FDA Adverse Event Reporting System for osteomyelitis-related AEs associated with SGLT2i or SGLT2i-metformin co-medication from 2013q2 to 2023q1. Comprehensive disproportionality analysis and Bayesian confidence propagation methods were used to detect safe signals. The additive interaction model, multiplicative interaction model, and Omega shrinkage measure were employed to explore the latent interactions between SGLT2i and metformin. A Venn diagram was utilized to estimate the coincidence of related osteomyelitis and amputation. RESULTS: Among 2,569 SGLT2i-associated osteomyelitis reports, we identified 2,509 related to canagliflozin (ROR 104.47; PRR 99.70, chi2 = 214840.90; EBGM05 = 84.38; IC025 = 4.78) and 103 related to the SGLT2i-metformin compound. Drug-drug interaction detection revealed a negative correlation RERI = -21.73, e(beta3) = 0.699, Omega025=-1.370). The coincidence of osteomyelitis and amputation linked to SGLT2i (2,672 vs. 3,548) was 2,150(80%) by Venn diagram. CONCLUSIONS: This study showed an increased risk of SGLT2i-associated osteomyelitis, focusing on canagliflozin, and presented a potential association between amputation and osteomyelitis, providing a reference for the clinical practice of diabetes with SGLT2i medication. |
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| 組織名 | Department of Pharmacy, The First Affiliated Hospital of Chongqing Medical;University, Chongqing, China.;Department of Pharmacy, Qiandongnan Miao and Dong Autonomous Prefecture Peoples;Hospital, Guizhou Kaili, China. |
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