| アブストラクト | BACKGROUND: There is conflicting real-world evidence regarding the risk of breast and bladder cancer associated with sodium glucose cotransporter 2 (SGLT2) inhibitors. We conducted a pharmacovigilance study on SGLT2 inhibitors and breast and bladder cancer using the US FDA Adverse Event Reporting System (FAERS) and a Mendelian randomization (MR) study. RESEARCH DESIGN AND METHODS: We used AERSMine to mine adverse events from FAERS. We provided proportional reporting ratio (PRR) with 95% confidence interval (CI), and the lower limit of the 95% credible interval of the information component (IC(025)). A two-sample MR approach was used to investigate the causal relationship between SGLT2 inhibition and breast and bladder cancer. RESULTS: We did not find a disproportionate association between SGLT2 inhibitors (PRR = 1.26; 95%CI 1.05-1.51; p = 0.014; IC(025) = 0.01) and their molecules with breast cancer. SGLT2 inhibitors were associated with a disproportionately higher reporting frequency of bladder cancer events compared to metformin, dipeptidyl peptidase 4 inhibitors, or glucagon-like peptide-1 receptor agonists. MR analysis results showed that SGLT2 inhibition was associated with a higher risk of bladder cancer (odds ratio 1.01; 95%CI 1.00-1.01; p = 0.004). CONCLUSION: Our results suggest that the use of SGLT2 inhibitors is associated with a higher reporting frequency/risk of bladder cancer, rather than breast cancer. |
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| 組織名 | The First Affiliated Hospital, Hunan Provincial Clinical Medical Research Center;for Drug Evaluation of Major Chronic Diseases, School of Pharmaceutical Science,;Hengyang Medical School, University of South China, Hengyang, Hunan, China.;The First Affiliated Hospital, Hengyang Clinical Pharmacology Research Center,;The First Affiliated Hospital, Hengyang Key Laboratory of Clinical Pharmacology,;The First Affiliated Hospital, Pharmacy Department, Hengyang Medical School,;University of South China, Hengyang, Hunan, China.;School of Pharmaceutical Science, Hengyang Medical School, University of South;China, Hengyang, Hunan, China.;MOE Key Laboratory of Pediatric Rare Diseases, University of South China,;Hengyang, Hunan, China.;Department of Pathology, The Sixth Affiliated Hospital, Sun Yat-Sen University,;Guangzhou, Guangdong, P.R. China.;Biomedical Innovation Center, The Sixth Affiliated Hospital, Sun Yat-Sen;University, Guangzhou, Guangdong, P.R. China.;The Second Affiliated Hospital, Hunan Clinical Medical Research Center for;Obesity Related Diseases, Endocrinology Department, Hengyang Medical School, |
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