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利拉鲁肽对高血压合并 2 型糖尿病患者动态血压的影响:一项随机、双盲、安慰剂对照试验。

Effect of liraglutide on ambulatory blood pressure in patients with hypertension and type 2 diabetes: A randomized, double-blind, placebo-controlled trial.

机构信息

Second Medical Department, Aristotle University Thessaloniki, Thessaloniki, Greece.

Research Institute and Diabetes Center, Second Department of Internal Medicine, National and Kapodistrian University of Athens, Athens, Greece.

出版信息

Diabetes Obes Metab. 2019 Mar;21(3):517-524. doi: 10.1111/dom.13541. Epub 2018 Oct 23.

Abstract

AIMS

To assess the effect of liraglutide on 24-hour ambulatory blood pressure and heart rate in patients with hypertension (pre- and stage 1 hypertension) and inadequately controlled Type 2 diabetes (glycated haemoglobin 7%-10% [53-86 mmol/mol]).

MATERIALS AND METHODS

Eligible patients for this investigator-initiated, parallel-group, randomized, double-blind trial were on stable background antihyperglycaemic therapy excluding insulin, glucagon-like peptide-1 receptor agonists and dipeptidyl-peptidase-4 inhibitors. Participants were centrally randomized in a 1:1 ratio to daily liraglutide 0.6 mg, titrated to 1.2 mg after the first week, or placebo for 5 weeks. The primary outcome was change in 24-hour ambulatory systolic blood pressure (SBP), and secondary outcomes included change in ambulatory diastolic blood pressure (DBP) and heart rate. We also assessed renal sodium handling.

RESULTS

Of 87 patients assessed for eligibility, 62 (66.1% men) with a mean age of 60.2 years were randomized to liraglutide (n = 31) or placebo (n = 31). All participants received background therapy with metformin, whilst 35.5% were treated concomitantly with sulphonylureas and 14.5% with pioglitazone. Compared with placebo, liraglutide reduced 24-hour SBP by -5.73 mm Hg (95% confidence interval [CI] -9.81 to -1.65) and had a neutral effect on 24-hour DBP (mean difference - 1.42 mm Hg; 95% CI -4.25 to 1.40), whilst increasing 24-hour heart rate by 6.16 beats/min (95% CI 3.25 to 9.07). Findings were consistent for daytime and night-time measurements. Liraglutide did not increase urine sodium excretion.

CONCLUSION

Based on 24-hour ambulatory measurements, short-term treatment with liraglutide had a favourable effect on SBP whilst increasing heart rate.

摘要

目的

评估利拉鲁肽对高血压(前期和 1 期高血压)和血糖控制不佳的 2 型糖尿病(糖化血红蛋白 7%-10%[53-86mmol/mol])患者的 24 小时动态血压和心率的影响。

材料和方法

这项由研究者发起的、平行组、随机、双盲试验纳入了正在接受稳定的、不包含胰岛素、胰高血糖素样肽-1 受体激动剂和二肽基肽酶-4 抑制剂的背景降糖治疗的患者。参与者以 1:1 的比例接受每日利拉鲁肽 0.6mg 或安慰剂治疗 5 周,利拉鲁肽在第一周后滴定至 1.2mg。主要结局是 24 小时动态收缩压(SBP)的变化,次要结局包括动态舒张压(DBP)和心率的变化。我们还评估了肾脏钠处理。

结果

在 87 名评估合格性的患者中,有 62 名(66.1%为男性)年龄平均为 60.2 岁的患者被随机分配至利拉鲁肽组(n=31)或安慰剂组(n=31)。所有患者均接受二甲双胍的背景治疗,同时 35.5%的患者同时接受磺脲类药物治疗,14.5%的患者接受吡格列酮治疗。与安慰剂相比,利拉鲁肽降低了 24 小时 SBP-5.73mmHg(95%置信区间[CI]-9.81 至-1.65),对 24 小时 DBP 无明显影响(平均差值-1.42mmHg;95%CI-4.25 至 1.40),同时增加了 24 小时心率 6.16 次/分钟(95%CI 3.25 至 9.07)。日间和夜间测量结果一致。利拉鲁肽并未增加尿钠排泄。

结论

根据 24 小时动态测量,短期利拉鲁肽治疗对 SBP 有有利影响,同时增加了心率。

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