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比较每周胰高血糖素样肽-1 受体激动剂度拉鲁肽和司美格鲁肽在日本 2 型糖尿病患者中的临床疗效和安全性:一项随机、平行分组、多中心、开放性标签试验(COMING 研究)。

Comparison of clinical efficacy and safety of weekly glucagon-like peptide-1 receptor agonists dulaglutide and semaglutide in Japanese patients with type 2 diabetes: Randomized, parallel-group, multicentre, open-label trial (COMING study).

机构信息

Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, Kurashiki, Japan.

Department of Internal Medicine, Osugki Hospital, Takahashi, Japan.

出版信息

Diabetes Obes Metab. 2023 Dec;25(12):3632-3647. doi: 10.1111/dom.15258. Epub 2023 Aug 30.

Abstract

AIM

To compare the clinical usefulness of once-weekly glucagon-like peptide-1 receptor agonists dulaglutide and semaglutide at the doses approved for use in Japanese patients with type 2 diabetes.

METHODS

In total, 120 patients with glycated haemoglobin (HbA1c) ≥7% were randomly assigned to dulaglutide (n = 59) or semaglutide group (n = 61), and 107 participants (dulaglutide/semaglutide = 53/54) completed the 24-week trial. The primary endpoint was the difference of HbA1c level between the two groups at 24 weeks.

RESULTS

HbA1c level at 24 weeks was significantly lower in the semaglutide group (7.9 ± 0.5%-6.7 ± 0.5%) compared with the dulaglutide group (8.1 ± 0.6%-7.4 ± 0.8%) (p < .0001). Reduction in body mass index and visceral fat area were also more significant in the semaglutide group (p < .05, respectively). The achievement rate of HbA1c <7% was higher in the semaglutide group (p < .0001). The parameters such as low-density lipoprotein cholesterol, alanine aminotransferase and γ-glutamyl transpeptidase were decreased in the semaglutide group. Surprisingly, only semaglutide group significantly improved the apolipoprotein B/A1 ratio, which is considered a useful myocardial infarction risk index. Using computed tomography, the liver to spleen ratio was significantly elevated only in the semaglutide group. In contrast, gastrointestinal symptoms were observed in 13.2% of dulaglutide and 46.3% of semaglutide group (p < .01). The Diabetes Treatment-Related Quality of Life scores related to pain and gastrointestinal symptoms were also superior in the dulaglutide group.

CONCLUSIONS

This prospective trial showed that semaglutide has more pronounced glucose- and body mass index-lowering effects and reduces liver fat percentage and visceral fat area and that dulaglutide has less gastrointestinal symptoms and superior Diabetes Treatment-Related Quality of Life scores related to pain and gastrointestinal symptoms.

摘要

目的

比较每周一次给予胰高血糖素样肽-1 受体激动剂度拉鲁肽和司美格鲁肽在日本 2 型糖尿病患者中的临床应用剂量。

方法

共纳入 120 例糖化血红蛋白(HbA1c)≥7%的患者,随机分为度拉鲁肽组(n=59)和司美格鲁肽组(n=61),107 例(度拉鲁肽/司美格鲁肽=53/54)参与者完成了 24 周的试验。主要终点为两组 24 周时 HbA1c 水平的差异。

结果

司美格鲁肽组 24 周时 HbA1c 水平显著低于度拉鲁肽组(7.9±0.5% vs 8.1±0.6%)(p<.0001)。司美格鲁肽组体重指数和内脏脂肪面积的降低也更为显著(p<.05)。司美格鲁肽组 HbA1c<7%的达标率更高(p<.0001)。司美格鲁肽组低密度脂蛋白胆固醇、丙氨酸氨基转移酶和γ-谷氨酰转肽酶等参数降低。令人惊讶的是,只有司美格鲁肽组显著改善了载脂蛋白 B/A1 比值,这被认为是一种有用的心肌梗死风险指标。使用计算机断层扫描,仅司美格鲁肽组的肝脾比值显著升高。相比之下,度拉鲁肽组有 13.2%的患者和司美格鲁肽组 46.3%的患者出现胃肠道症状(p<.01)。度拉鲁肽组与疼痛和胃肠道症状相关的糖尿病治疗相关生活质量评分也更高。

结论

本前瞻性试验表明,司美格鲁肽具有更显著的降糖和减重效果,降低肝脂肪百分比和内脏脂肪面积,而度拉鲁肽胃肠道症状较少,与疼痛和胃肠道症状相关的糖尿病治疗相关生活质量评分更高。

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