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当开始使用伊格列净时,磺酰脲类药物是否应该停用或维持最低剂量?日本 2 型糖尿病患者的多中心观察性研究。

Should sulfonylurea be discontinued or maintained at the lowest dose when starting ipragliflozin? A multicenter observational study in Japanese patients with type 2 diabetes.

机构信息

Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.

Kushiro Red Cross Hospital, Kushiro, Japan.

出版信息

J Diabetes Investig. 2019 Mar;10(2):429-438. doi: 10.1111/jdi.12913. Epub 2018 Sep 26.

DOI:10.1111/jdi.12913
PMID:30136403
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6400155/
Abstract

AIMS/INTRODUCTION: We investigated the difference in efficacy and safety between discontinuation and maintaining of sulfonylurea when adding a sodium-glucose cotransporter 2 inhibitor.

MATERIALS AND METHODS

In the present multicenter, prospective observational study, 200 patients with type 2 diabetes treated with sulfonylurea and with a need to add ipragliflozin were enrolled and divided into two groups: discontinued sulfonylurea (Discontinuation group) or maintained sulfonylurea, but at the lowest dose (Low-dose group) when adding ipragliflozin. We compared the two groups after 24 weeks using propensity score matching to adjust for differences between the groups.

RESULTS

In the matched cohort (58 patients in each group), baseline characteristics of both groups were balanced. The primary outcome of the proportion of patients with non-exacerbation in glycated hemoglobin after 24 weeks was 91.4% in the Low-dose group and 75.9% in the Discontinuation group, a significant difference (P = 0.024). However, bodyweight was significantly decreased in the Discontinuation group compared with the Low-dose group (-4.4 ± 2.1 kg vs -2.9 ± 1.9 kg, P < 0.01). Similarly, liver enzyme improvement was more predominant in the Discontinuation group. A logistic regression analysis showed that high-density lipoprotein cholesterol, age and sulfonylurea dose were independent factors associated with non-exacerbation of glycated hemoglobin in the Discontinuation group.

CONCLUSIONS

The purpose of using ipragliflozin should be considered when making the decision to discontinue or maintain sulfonylurea at the lowest dose. Furthermore, low high-density lipoprotein cholesterol level, low dose of sulfonylurea and younger age were possible markers to not show worsening of glycemic control by discontinuing sulfonylurea.

摘要

目的/引言:我们研究了当添加钠-葡萄糖共转运蛋白 2 抑制剂时,停止使用磺酰脲类药物和维持磺酰脲类药物的疗效和安全性差异。

材料和方法

在这项多中心、前瞻性观察性研究中,纳入了 200 名接受磺酰脲类药物治疗且需要添加吡格列酮的 2 型糖尿病患者,并将其分为两组:停止使用磺酰脲类药物(停药组)或在添加吡格列酮时维持磺酰脲类药物,但剂量最低(低剂量组)。我们在 24 周后使用倾向评分匹配来比较两组,以调整组间差异。

结果

在匹配队列中(每组 58 例患者),两组的基线特征平衡。24 周后糖化血红蛋白无恶化的患者比例是低剂量组为 91.4%,停药组为 75.9%,差异有统计学意义(P=0.024)。然而,与低剂量组相比,停药组的体重明显下降(-4.4±2.1kg 比-2.9±1.9kg,P<0.01)。同样,停药组的肝酶改善更为明显。Logistic 回归分析显示,高密度脂蛋白胆固醇、年龄和磺酰脲类药物剂量是与停药组糖化血红蛋白无恶化相关的独立因素。

结论

在决定停止或维持磺酰脲类药物的最低剂量时,应考虑使用吡格列酮的目的。此外,低水平的高密度脂蛋白胆固醇、低剂量的磺酰脲类药物和年轻的年龄可能是停止磺酰脲类药物不会导致血糖控制恶化的标志物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/883b/6400155/714f063693d3/JDI-10-429-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/883b/6400155/e270ed2c1dbe/JDI-10-429-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/883b/6400155/89d640d13c51/JDI-10-429-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/883b/6400155/714f063693d3/JDI-10-429-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/883b/6400155/e270ed2c1dbe/JDI-10-429-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/883b/6400155/89d640d13c51/JDI-10-429-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/883b/6400155/714f063693d3/JDI-10-429-g003.jpg

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Real-world evidence for the safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): final results of a post-marketing surveillance study.依帕列净在老年日本2型糖尿病患者中的安全性真实世界证据(STELLA-ELDER):一项上市后监测研究的最终结果
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