Analysis of Ketoacidosis Induced by Dapagliflozin Tablets

doi:10.19803/j.1672-8629.2020.03.06

Abstract

Abstract: Objective To explore the safety of dapagliflozin tablets in clinical application. Methods This article summarizes two cases which have been diagnosed with ketoacidosis after using dapagliflozin tablets from Shanghai General Hospital in November 2018. In addition, relevant literatures at home and abroad are reviewed. Results The two diabetic patients began to show symptoms of tolerance, nausea and vomiting without obvious inducement on the 6th and 1st day after taking dapagliflozin tablets respectively. On the 7th and 6th day after taking the tablets, they were diagnosed with ketoacidosis through laboratory examination. Their symptoms improved after drug withdrawal, fluid rehydration, low-dose insulin intravenous drip, electrolyte correction and other treatments. Conclusion Dapagliflozin tablets may cause ketoacidosis. Medical personnel should pay attention and use carefully in high-risk groups.

Key words: dapagliflozin tablets, sodium-dependent glucose transporters 2 (SGLT-2) inhibitor, ketoacidosis, diabetes mellitus

CLC Number:

R977.15

YUAN Menghu, QIAN Fengdan. Analysis of Ketoacidosis Induced by Dapagliflozin Tablets[J]. Chinese Journal of Pharmacovigilance, 2020, 17(3): 157-160.

References

[1] 刘玉萍, 刘烨, 邱小玉. 新型降糖药达格列净的临床研究进展[J]. 中国医院药学杂志, 2019, 39(18): 1896-1899.
[2] 中华医学会糖尿病学分会. 中国2型糖尿病防治指南(2017年版)[J]. 中华糖尿病杂志, 2018, 10(1): 4-67.
[3] 涂威, 陈静, 李亚玲. 钠-葡萄糖共转运蛋白2抑制剂导致正常血糖酮症酸中毒2例报道[J]. 华中科技大学学报(医学版), 2018, 47(4): 496-498.
[4] FDA. Drug safety communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections[EB/OL]. (2015- 12-04)[2019-02-14]. http://www.fda.gov/Drugs/DrugSafety/ ucm475463.htm.
[5] 段蓉, 李正翔. 基于openFDA对达格列净上市后不良反应的分析研究[J]. 中国医院药学杂志, 2018, 38(22): 2360-2362.
[6] 芦志伟, 赵振宇, 李继彬. 22例钠-葡萄糖协同转运蛋白2抑制剂致酮症酸中毒的文献分析[J]. 中国医院药学杂志, 2019, 39(3): 69-73.
[7] Puchalska P, Crawford P A.Multi-dimensional Roles of Ketone Bodies in Fuel Metabolism, Signaling, and Therapeutics[J]. Cell Metabolism, 2017, 25(2): 262-284.
[8] Akram M.A Focused Review of the Role of Ketone Bodies in Health and Disease[J]. Journal of Medicinal Food, 2013, 16(11): 965-967.
[9] Handelsman Y, Henry RR, Bloomgarden ZT, et al.American Association of Clinical Endocrinologists and American College of Endocrinology position statement on the association of SGLT-2 inhibitors and diabetic ketoacidosis[J]. Endocr Pract, 2016, 22(6): 753-762.
[10] 邢影, 姬秋和. 钠-葡萄糖共转运蛋白2抑制剂与酮体或酮症酸中毒的关系[J]. 中华糖尿病杂志, 2018, 10(2): 107-110.
[11] 严颐丹, 施芳红. SGLT2抑制剂引起酮症酸中毒的机制及处理[J]. 中国医院药学杂志, 2018, 38(14): 1563-1565.
[12] 刘敏, 苏娜, 徐珽. 钠-葡萄糖共转运蛋白2抑制剂引发糖尿病酮症酸中毒机制的研究进展[J]. 中国医院药学杂志, 2018, 38(3): 330-333.
[13] Goldenberg RM, Berard LD, Cheng AYY, et al. SGLT2 Inhibitor- associated Diabetic Ketoacidosis: Clinical Review and Recom- mendations for Prevention and Diagnosis[J]. Clinical Therapeu- tics, 2016, 38(12): 2654-2664.e1.
[14] Peters AL, Buschur EO, Buse JB, et al.Euglycemic Diabetic Ketoacidosis: A Potential Complication of Treatment With Sodium- Glucose Cotransporter 2 Inhibition[J]. Diabetes care, 2015, 38(9): 1687-1693.
[15] Blau JE, Tella SH, Taylor SI, et al.Ketoacidosis associated with SGLT2 inhibitor treatment: Analysis of FAERS data[J]. Diabetes Metab Res Rev, 2017,33(8): e2924.
[16] EMA. EMA confirms recommendations to minimise ketoacidosis risk with SGLT2 inhibitors for diabetes[EB/OL]. (2016-02-26) [2019-02-19] https://www.ema.europa.eu/en/news/ema-confirms- recommendations-minimise-ketoacidosis-risk-sglt2-inhibitors- diabetes.