新型降糖药物贝格列净的临床研究进展

doi:10.3969/j.issn.1006-5725.2023.22.028

Abstract

Abstract:

Several drugs have been developed for the treatment of diabetes， but many patients still fail to achieve ideal glycemic control. In January 2023， the U.S. Food and Drug Administration （FDA） approved the marketing of the sodium-glucose cotransporter 2 inhibitor， bexagliflozin， for use to improve glycemic control in adults with type 2 diabetes as an adjunctive therapy to diet and exercise. The drug has been shown to be effective and safe in the treatment of diabetes mellitus. Several clinical studies have demonstrated its efficacy and safety in type 2 diabetes， and it also has potential applications in the treatment of obesity， cardiovascular disease， and chronic kidney disease. This article summarizes the mechanism of action， clinical studies， efficacy and safety of bexagliflozin to provide reference for its clinical application in China.

Key words: type 2 diabetes mellitus, bexagliflozin, SGLT-2, review

CLC Number:

R587.1

Yan YANG,Zhen WANG,Defeng. WANG. Clinical research progress of bexagliflozin： A new hypoglycemic drug[J]. The Journal of Practical Medicine, 2023, 39(22): 3015-3020.

Figures/Tables 1

References 28

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作者	年	类型	患者类型	入组例数	干预组	对照组	干预时间	主要结局
HALVORSEN^［15］	2019	多国、双盲、平行、随机对照试验	T2DM	288	贝格列净（20 mg）	安慰剂	96周	HbA_1c、体质量和血压降低，不良事件的发生率并未增加
HALVORSEN^［18］	2019	双盲、随机对照试验	T2DM	386	贝格列净（20 mg） +二甲双胍	西格列汀（100 mg） +二甲双胍	24周	贝格列净在降低FPG和体质量方面具有优势
ALLEGRETTI^［8］	2019	3期，双盲，多中心，多国，随机对照试验	T2DM+CKD	312	贝格列净（20 mg）	安慰剂	24周	体质量减轻、SBP下降、FPG水平降低和白蛋白尿水平减少
HALVORSEN^［9］	2020	双盲、随机对照试验	T2DM	292	贝格列净（5、10、20 mg）	安慰剂	12周	HbA_1c、FPG和体质量下降，服用20 mg效果更显
HALVORSEN^［16］	2023	双盲、随机对照试验	二甲双胍控制欠佳的T2DM	426	贝格列净（20 mg） +二甲双胍	格列美脲+ 二甲双胍	96周	与格列美脲相比，贝格列净在降低体质量和SBP方面更为有效，且低血糖事件发生率低
HALVORSEN^［17］	2023	双盲、随机对照试验	T2DM	317	贝格列净（20 mg）. +二甲双胍	二甲双胍+安慰剂	24周	FPG、HbA_1c改善，降低收缩压
JOHN^［19］	2020	双盲、随机对照试验	T2DM合并心血管疾病	1 700	贝格列净	安慰剂	24周	HbA_1c及FPG下降

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Clinical research progress of bexagliflozin： A new hypoglycemic drug

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