PMID- 33067519 OWN - NLM STAT- MEDLINE DCOM- 20210310 LR - 20210310 IS - 2045-2322 (Electronic) IS - 2045-2322 (Linking) VI - 10 IP - 1 DP - 2020 Oct 16 TI - Gender differences in adverse event reports associated with antidiabetic drugs. PG - 17545 LID - 10.1038/s41598-020-74000-4 [doi] LID - 17545 AB - Little is known about gender-specific reporting of adverse events (AEs) associated with antidiabetic drugs. This study was to assess the gender-related difference in AEs reporting associated with antidiabetic agents. The number of antidiabetic drug-AE pairs associated was identified using the Korea Adverse Event Reporting System database. Prevalence of diabetes was estimated using the Health Insurance Review and Assessment Service-National Patients Sample database. Reporting rate per 10,000 people was calculated by dividing drug-AE pairs with the number of antidiabetic drug users by gender. Gender difference was presented with risk ratio (reporting rate ratio) of women to men. Antidiabetic agent-associated AEs were more frequently reported by women than men throughout body organs and drug classes. 13 out of 17 system organ class level disorders with significant gender differences were reported more often by women than men. By drug class, gender-specific reporting rates were observed in most of the drug classes, especially in newer classes such as glucagon-like peptide-1 analog (GLP1-RA), sodium glucose co-transporter-2 inhibitor (SGLT2i), and thiazolidinedione (TZD). Looking into preferred term level for each drug class, women dominated the reports of class-specific AEs of newer antidiabetic drugs such as urinary tract/genital infection (all reported by women) in SGLT2i, edema in TZD (risk ratio (RR) 12.56), and hyperglycemia in insulin users (RR 15.35). Gender differences in antidiabetic-associated AE reporting often attributed to women. Explanations for these different report levels by gender should be further investigated. FAU - Joung, Kyung-In AU - Joung KI AD - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon, Gyeong gi-do, South Korea. FAU - Jung, Gyu-Won AU - Jung GW AD - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon, Gyeong gi-do, South Korea. FAU - Park, Han-Heui AU - Park HH AD - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon, Gyeong gi-do, South Korea. FAU - Lee, Hyesung AU - Lee H AD - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon, Gyeong gi-do, South Korea. FAU - Park, So-Hee AU - Park SH AD - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon, Gyeong gi-do, South Korea. FAU - Shin, Ju-Young AU - Shin JY AD - School of Pharmacy, Sungkyunkwan University, 2066 Seobu-ro, Jangan-gu, Suwon, Gyeong gi-do, South Korea. shin.jy@skku.edu. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20201016 PL - England TA - Sci Rep JT - Scientific reports JID - 101563288 RN - 0 (GLP1R protein, human) RN - 0 (Glucagon-Like Peptide-1 Receptor) RN - 0 (Hypoglycemic Agents) RN - 0 (Insulin) RN - 0 (Sodium-Glucose Transporter 2 Inhibitors) RN - 0 (Thiazolidinediones) RN - AA68LXK93C (2,4-thiazolidinedione) SB - IM MH - Adult MH - *Adverse Drug Reaction Reporting Systems MH - Aged MH - Aged, 80 and over MH - Databases, Factual MH - Diabetes Mellitus/*drug therapy MH - Female MH - Glucagon-Like Peptide-1 Receptor/metabolism MH - Humans MH - Hypoglycemic Agents/*adverse effects MH - Insulin/metabolism MH - Male MH - Middle Aged MH - Republic of Korea/epidemiology MH - Risk MH - *Sex Factors MH - Sodium-Glucose Transporter 2 Inhibitors/adverse effects MH - Thiazolidinediones/adverse effects PMC - PMC7567832 COIS- The authors declare no competing interests. EDAT- 2020/10/18 06:00 MHDA- 2021/03/11 06:00 PMCR- 2020/10/16 CRDT- 2020/10/17 05:28 PHST- 2020/03/31 00:00 [received] PHST- 2020/09/02 00:00 [accepted] PHST- 2020/10/17 05:28 [entrez] PHST- 2020/10/18 06:00 [pubmed] PHST- 2021/03/11 06:00 [medline] PHST- 2020/10/16 00:00 [pmc-release] AID - 10.1038/s41598-020-74000-4 [pii] AID - 74000 [pii] AID - 10.1038/s41598-020-74000-4 [doi] PST - epublish SO - Sci Rep. 2020 Oct 16;10(1):17545. doi: 10.1038/s41598-020-74000-4.