Expert opinion on drug safety · 2025
Impact of sodium glucose cotransporter 2 inhibitors on bladder cancer and breast cancer: a pharmacovigilance analysis and Mendelian randomization study.
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Xu Bo, Zhang Tianqiao, He Yechuan, Jiang Aihua, Liu Yinglan, He Zunbo, Zhou Jiecan
Аннотация
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 (IC025). 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; IC025 = 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.
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 (IC025). 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; IC025 = 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.