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从 DPP-4 抑制剂切换至鲁格列净降低伴高血压的 2 型糖尿病患者的血压和脉搏率:一项多中心、前瞻性、随机、开放标签、平行组比较试验(LUNA 研究)。

Lowering of blood pressure and pulse rate by switching from DPP-4 inhibitor to luseogliflozin in patients with type 2 diabetes complicated with hypertension: A multicenter, prospective, randomized, open-label, parallel-group comparison trial (LUNA study).

机构信息

Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan.

Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan; Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Kita 14, Nishi 5, Kita-ku, Sapporo 060-8648, Japan.

出版信息

Diabetes Res Clin Pract. 2021 Oct;180:109069. doi: 10.1016/j.diabres.2021.109069. Epub 2021 Sep 23.

Abstract

AIMS

Sodium-glucose cotransporter-2 inhibitor (SGLT2i) reduces clinic blood pressure (BP), but the effects on BP circadian rhythm remain unclear. The present study aimed to determine the nighttime antihypertensive effect of SGLT2i compared with dipeptidyl peptidase-4 inhibitor (DPP-4i) in patients with type 2 diabetes and hypertension.

MATERIALS AND METHODS

In this randomized, open-label, parallel-group trial, patients treated with DPP-4i were either switched to luseogliflozin 2.5 mg/day (Luseo group;n = 30) or continued DPP-4i (DPP-4i group;n = 26). The patients undertook 24-h ambulatory BP monitoring before and 8 weeks after the group allocation. The primary endpoint was mean change in nighttime systolic BP (SBP).

RESULTS

Nighttime SBP, as well as daytime SBP, was significantly reduced in the Luseo group compared with the DPP-4i group (nighttime, -4.0 ± 11.4 vs. 3.6 ± 10.7 mmHg,P = 0.01; daytime, -4.4 ± 10.9 vs. 3.7 ± 11.9 mmHg,P = 0.01). Similarly, nighttimepulse rate(PR) was significantly reduced in the Luseo group (-2.0 ± 4.8 vs. 0.9 ± 4.8 bpm,P = 0.03). The proportion of patients with abnormal BP circadian rhythms (non-dipper pattern plus riser pattern) was significantly lower in the Luseo group (36.6% vs. 56.7%,P < 0.05).

CONCLUSIONS

Switching from DPP-4i to luseogliflozin decreased nighttime SBP and PR; moreover, BP circadian rhythm was improved.

摘要

目的

钠-葡萄糖协同转运蛋白 2 抑制剂(SGLT2i)可降低临床血压(BP),但其对 BP 昼夜节律的影响尚不清楚。本研究旨在确定 SGLT2i 与二肽基肽酶-4 抑制剂(DPP-4i)相比在 2 型糖尿病合并高血压患者中的降压作用。

材料和方法

在这项随机、开放标签、平行组试验中,接受 DPP-4i 治疗的患者被转换为服用 luseogliflozin 2.5mg/天(Luseo 组;n=30)或继续使用 DPP-4i(DPP-4i 组;n=26)。患者在分组前和分组后 8 周进行 24 小时动态血压监测。主要终点是夜间收缩压(SBP)的平均变化。

结果

与 DPP-4i 组相比,Luseo 组的夜间 SBP 以及日间 SBP 均显著降低(夜间,-4.0±11.4 与 3.6±10.7mmHg,P=0.01;日间,-4.4±10.9 与 3.7±11.9mmHg,P=0.01)。同样,Luseo 组的夜间脉搏率(PR)也显著降低(-2.0±4.8 与 0.9±4.8bpm,P=0.03)。Luseo 组异常血压昼夜节律(非杓型加升型)的患者比例显著降低(36.6%比 56.7%,P<0.05)。

结论

从 DPP-4i 转换为 luseogliflozin 可降低夜间 SBP 和 PR;此外,血压昼夜节律得到改善。

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