アブストラクト | INTRODUCTION: We tested the possible association between sodium glucose cotransporter-2 inhibitor (SGLT-2i) use and urogenital tract infection (UTI) occurrences by assessing the publicly available US Food and Drug Administration Adverse Event Reporting System (FAERS). METHODS: Disproportionality analysis and Bayesian analysis were used to mine FAERS for suspected UTI data for SGLT-2i use from the first quarter of 2004 to the second quarter of 2018. RESULTS: On the basis of 37,100 reports, 1628 reports (4.39% of total adverse drug reactions, ADRs) were associated with UTIs; among them, the number of UTIs reported for the top four was as follows: canagliflozin, 858 (52.74%); dapagliflozin, 324 (19.91%); empagliflozin, 189 (11.62%); and empagliflozin/metformin, 183 (11.25%). Although the number of ADRs reported for these drugs is different, their risk of causing UTIs is determined. Of the reports of SGLT-2i adverse events related to UTIs, 61.73% occurred in women, which was a much higher proportion than that in men (28.50%). CONCLUSION: FAERS data were consistent with clinical studies on a strong association between SGLT-2i use and UTIs. The results strongly suggest that female patients are more likely than male patients to experience UTIs when using SGLT-2i. |
組織名 | Department of Pharmacy, The Third Affiliated Hospital of Anhui Medical;University, No. 390 Huaihe Road, Luyang District, Hefei, 230061, Anhui, People's;Republic of China.;Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of;Medical Science and Peking Union Medical College, No. 1 Shuaifuyuan, Dongcheng;District, Beijing, 100730, People's Republic of China.;Department of Pharmacy, National Cancer Center/Cancer Hospital, Chinese Academy;of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuannanli,;Chaoyang District, Beijing, 100021, People's Republic of China.;District, Beijing, 100730, People's Republic of China. zhaobin@pumch.cn. |