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2型糖尿病患者中使用钠-葡萄糖协同转运蛋白2抑制剂与二肽基肽酶-4抑制剂起始胰岛素治疗的风险:一项日本真实世界索赔数据库研究

Risk of insulin initiation with sodium-glucose cotransporter-2 inhibitors versus dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes mellitus: A real-world claims database study in Japan.

作者信息

Suzuki Ryo, Shoji Shingo, Yoshinaga Yoko, Kosakai Yoshinori, Shintani-Tachi Mami

机构信息

Department of Diabetes, Metabolism, and Endocrinology, Tokyo Medical University, Tokyo, Japan.

Medical Affairs, Astellas Pharma Inc, Tokyo, Japan.

出版信息

Diabetes Obes Metab. 2025 Apr;27(4):1960-1971. doi: 10.1111/dom.16188. Epub 2025 Jan 13.

DOI:10.1111/dom.16188
PMID:39806567
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11885076/
Abstract

AIMS

Insulin therapy is a cornerstone in type 2 diabetes mellitus (T2DM) management, but its use is associated with several barriers, including hypoglycaemia, fear of injections and high costs. We compared the risk of insulin initiation and other treatment intensification between patients with T2DM newly treated with a sodium-glucose cotransporter-2 inhibitor (SGLT2i) versus those newly treated with a dipeptidyl peptidase-4 inhibitor (DPP4i).

MATERIALS AND METHODS

This Japanese retrospective cohort study was conducted between 1 January 2015 and 31 March 2023 using the JMDC Claims Database. Patients with T2DM newly treated with an SGLT2i or a DPP4i were matched 1:1 using propensity score (n = 18 488 each). Incidence rates (IR) of insulin initiation, other antidiabetic drugs (OAD) and antihypertensive drugs added onto baseline treatment were calculated for each treatment group. Hazard ratios (HR) and 95% confidence intervals (CI) were calculated using a Cox proportional hazards model.

RESULTS

The IR of insulin initiation was 0.95 and 2.12 per 1000 person-years in the SGLT2i and DPP4i groups, respectively, with significantly lower risk in the SGLT2i group than in the DPP4i group (HR 0.46, 95% CI: 0.28-0.74, p = 0.001). The risks of OAD (HR 0.66, 95% CI: 0.64-0.69, p < 0.001) and antihypertensive drugs (HR 0.90, 95% CI: 0.85-0.95, p < 0.001) added onto baseline treatment were lower in the SGLT2i group than in the DPP4i group.

CONCLUSIONS

The risk of insulin initiation was lower in patients with T2DM newly treated with an SGLT2i than in those newly treated with a DPP4i. SGLT2i may reduce or delay the need for insulin therapy.

摘要

目的

胰岛素治疗是2型糖尿病(T2DM)管理的基石,但其使用存在若干障碍,包括低血糖、害怕注射和成本高昂。我们比较了新接受钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)治疗的T2DM患者与新接受二肽基肽酶4抑制剂(DPP4i)治疗的患者开始使用胰岛素及其他治疗强化的风险。

材料与方法

本日本回顾性队列研究于2015年1月1日至2023年3月31日期间使用JMDC理赔数据库进行。新接受SGLT2i或DPP4i治疗的T2DM患者使用倾向评分进行1:1匹配(每组n = 18488)。计算每个治疗组开始使用胰岛素、在基线治疗基础上加用其他抗糖尿病药物(OAD)和抗高血压药物的发病率(IR)。使用Cox比例风险模型计算风险比(HR)和95%置信区间(CI)。

结果

SGLT2i组和DPP4i组开始使用胰岛素的IR分别为每1000人年0.95和2.12,SGLT2i组的风险显著低于DPP4i组(HR 0.46,95% CI:0.28 - 0.74,p = 0.001)。SGLT2i组在基线治疗基础上加用OAD(HR 0.66,95% CI:0.64 - 0.69,p < 0.001)和抗高血压药物(HR 0.90,95% CI:0.85 - 0.95,p < 0.001)的风险低于DPP4i组。

结论

新接受SGLT2i治疗的T2DM患者开始使用胰岛素的风险低于新接受DPP4i治疗的患者。SGLT2i可能会降低或延迟胰岛素治疗的需求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc92/11885076/791bae867a91/DOM-27-1960-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc92/11885076/64bd7fe4ccd7/DOM-27-1960-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc92/11885076/ac2eb0e18544/DOM-27-1960-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc92/11885076/791bae867a91/DOM-27-1960-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc92/11885076/64bd7fe4ccd7/DOM-27-1960-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc92/11885076/ac2eb0e18544/DOM-27-1960-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc92/11885076/791bae867a91/DOM-27-1960-g002.jpg

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