| アブストラクト | PURPOSE: Despite effectiveness of sodium-glucose cotransporter 2 (SGLT 2) inhibitors, concerns have been raised about the potential side effects of these drugs. Thus, a pharmaco-vigilance study was designed that aims to identify any discrepancies between the reported adverse events & assess the safety profile of SGLT2 inhibitors. METHODS: We studied diabetic ketoacidosis (DKA), euglycemic DKA, amputation, urinary tract infection (UTI), mycotic genital infection & hypotension associated with empagliflozin, dapagliflozin, canagliflozin & ertugliflozin in RCTs and reporting databases. WHO's VigiBase, FAERS, EMA's EudraVigilance & DAEN were thoroughly studied to obtain spontaneously reported real-world adverse events. RESULTS: Different SGLT2 inhibitors exhibit varied side effect profiles. Additionally, the findings suggest that adverse events may be more likely to occur in a broader population in the real world than in a highly inclusive clinical trial subset CONCLUSION: Our study provides comparison of the real world reported adverse events to adverse events reported in the clinical trials studying the efficacy of SGLT 2 inhibitors. |
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| ジャーナル名 | Current problems in cardiology |
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| 投稿日 | 2024/5/25 |
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| 投稿者 | Bhanushali, Karan B; Asnani, Heena K; Nair, Ambica; Ganatra, Sarju; Dani, Sourbha S |
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| 組織名 | Roger Williams Medical Center, RI, USA. Electronic address:;bhanushali.karan@gmail.com.;heenaasnani28@gmail.com.;Ocean University Medical Center, NJ, USA. Electronic address:;ambicavnair@gmail.com.;Lahey Hospital and Medical Center, MA, USA. Electronic address:;sarju.ganatra@lahey.org.;sourbha.s.dani@lahey.org. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38789017/ |
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