Adverse drug reaction/ event caused by oral antidiabetic drugs

doi:10.19803/j.1672-8629.20230077

Abstract

Abstract: Objective To study the characteristics and regularity of adverse drug reaction / adverse drug event (ADR/ADE) caused by oral antidiabetic drugs, and to provide reference for rational use of these drugs in clinic. Methods A retrospective study was conducted to retrieve all ADR/ADE reports involving 10 types of oral antidiabetic drugs from the database of Wuhan ADR/ADE spontaneous reporting system that were submitted between 2012 and 2022. The demography of the users, usage of drugs, organs and systems involved in ADR/ADE and clinical manifestations were analyzed using the descriptive statistical methods. Results A total of 953 ADR/ADE reports and 1 405 cases related to oral antidiabetic drugs were included in this study. The number of reports trended up. Mild cases and serious ones accounted for 88.67% and 11.33% respectively. The most common ADR/ADE were gastrointestinal, skin, and metabolic disorders while drugs involved most frequently were α-glycosidase inhibitors, thiazolidinediones (TZD) and biguanide combined with TZD. Meanwhile, the ADR/ADE caused by different types of oral antidiabetic drugs varied in terms of system -organ distribution and clinical manifestations. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) were most likely to induce urinary tract damage and genital pruritus, dipeptidyl peptidase-IV inhibitors (DPP4i) tended to lead to skin or skin accessory disorders, glinides were mainly associated with hypoglycemia, and other drugs were mainly linked to gastrointestinal damage. Conclusion The ADR/ADE due to oral antidiabetic drugs involve a wide range of systems and keep increasing each year. The ADR/ADE caused by new oral antidiabetic drugs deserve more attention. In order to ensure the safety of oral antidiabetic drugs in clinical use, potential risks need to be prevented, users need to improve their self-control, and related ADR/ADE have to be detected and handled quickly.

Key words: oral antidiabetic drugs, adverse drug reaction/event, α-glycosidase inhibitors, thiazolidinediones (TZD), biguanide combined, sodium-glucose cotransporter-2 inhibitors (SGLT2i), dipeptidyl peptidase-IV inhibitors (DPP4i), glinides

CLC Number:

WEI Anhua, QI Jianjun, WANG Lu, ZENG Lu, GONG Xuepeng, JIANG Ying. Adverse drug reaction/ event caused by oral antidiabetic drugs[J]. Chinese Journal of Pharmacovigilance, 2023, 20(12): 1415-1420.

References

[1] World Health Organization. Media centre: diabetes[EB/OL].(2020-02-03)[2020-03-23]. http://www.who.int/en/news-room/fact-sheets/detail/diabetes.
[2] XIANG YF, SUN H, CHEN Y, et al.Medication safety and combined medication in patients with type 2 diabetes mellitus[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2022, 19(3): 313-316.
[3] BAKER ML, PERAZELLA MA.SGLT2 inhibitor therapy in patients with type-2 diabetes mellitus: is acute kidney injury a concern?[J]. J Nephrol, 2020, 33(5): 985-994.
[4] KE J, TANG WL.Aanlysis on adverse drug reaction reports of Shanghai oral anti-diabetic drugs from 2006 to 2010[J]. Chinese Journal of Clinical Pharmacy(中国临床药学杂志), 2011, 20(6): 351-356.
[5] ZHAO H, XU HM, YU JY.The clinical analysis on adverse drug reaction of 1447 cases caused by oral antidiabetic drugs[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2012, 12(9): 737-740.
[6] FLAVIA F, ILARIA C, STEFANO O, et al.Sex and gender in adverse drug events, addiction, and placebo[J]. Handb Exp Pharmacol, 2012, 214: 107-126.
[7] IRVING Z, BRIAN JP.Sex differences in pharmacokinetics predict adverse drug reactions in women[J]. Biol Sex Differ, 2020, 11(1): 32.
[8] KAUTZKY-WILLER A, LEUTNER M, HARREITER J.Sex differences in type 2 diabetes[J]. Diabetologia, 2023, 66(6): 986-1002.
[9] HERNANDE AV, USMANI A, RAJAMANIKAM A, et al.Thiazolidinediones and risk of heart failure in patients with or at high risk of type 2 diabetes mellitus: a meta-analysis and meta-regression analysis of placebo-controlled randomized clinical trials[J]. Am J Cardiovasc Drugs, 2011, 11(2): 115-128.
[10] SHERIFALI D, NERENBERG K, PULLENEAYEGUM E, et al.The effect of oral antidiabetic agents on A1C levels: a systematic review and meta-analysis[J]. Diabetes Care, 2010, 33(8): 1859-1864.
[11] LALAU JD, KAJBAF F, ARNOUTS P, et al.Mortality and metformin use in patients with advanced chronic kidney disease[J]. Lancet Diabetes Endocrinol, 2015, 3(9): 680-681.
[12] MARX N, DAVIES MJ, GRANT PJ, et al.Guideline recommendations and the positioning of newer drugs in type 2 diabetes care[J]. Lancet Diabetes Endocrinol, 2021, 9(1): 46-52.
[13] CRADDY P, PALIN HJ, JOHNSON KI.Comparative effectiveness of dipeptidylpeptidase-4 inhibitors in type 2 diabetes: a systematic review and mixed treatment comparison[J]. Diabetes Ther, 2014, 5(1): 1-41.
[14] SCHEEN AJ.Sodium-glucose cotransporter type 2 inhibitors for the treatment of type 2 diabetes mellitus[J]. Nat Rev Endocrinol, 2020, 16(10): 556-577.
[15] ZHANG HJ, JI LW.Analysis of adverse drug reactions induced by SGLT-2 inhibitors[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2021, 18(5): 478-482.