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DEXBASU 研究中,达格列净联合艾塞那肽治疗接受减重手术的 2 型糖尿病患者。

Dapagliflozin plus exenatide on patients with type 2 diabetes awaiting bariatric surgery in the DEXBASU study.

机构信息

Endocrinology and Nutrition Department, University Hospital Arnau de Vilanova de Lleida, Obesity, Diabetes and Metabolism Research Group (ODIM), Institut de Recerca Biomèdica de Lleida (IRBLleida), University of Lleida, Avda. Rovira Roure 80, 25198, Lleida, Spain.

Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM), Instituto de Salud Carlos III (ISCIII), Madrid, Spain.

出版信息

Sci Rep. 2022 Feb 25;12(1):3236. doi: 10.1038/s41598-022-07250-z.

Abstract

The glucagon-like peptide-1 receptor agonist family together with the renal sodium/glucose cotransporter-2 inhibitors have garnered interest as potential therapeutic agents for subjects with type 2 diabetes and obesity. In these patients, bariatric surgery is indicated based in a BMI ≥ 35 kg/m. A 24-week non-blinded, randomized pilot study to assess the efficacy of subcutaneous exenatide 2.0 mg once weekly plus oral dapagliflozin 10 mg once daily (Group A) compared to a control group (Group B) in 56 patients with type 2 diabetes awaiting bariatric surgery was conducted (EudraCTid.: 2017-001,454-33). Both groups received an energy-deficit low-fat diet. The primary endpoint was the proportion of patients running off the criteria for bariatric surgery at the end of the follow-up period (BMI ≤ 35.0 kg/m or a BMI ≤ 40.0 kg/m plus an HbA1c ≤ 6.0%). Changes in the BMI were also of interest. The proportion of patients who ran off the criteria for bariatric surgery was larger in Group A than in the control group (45.8% vs. 12.0%, p = 0.010). Participants in Group A exhibited an absolute decrease in body weight and BMI of 8.1 kg (95%IC: - 11.0 to - 5.2) and 3.3 kg/m (95%IC: - 4.5 to - 2.2), respectively (p < 0.001 for both in comparison with Group B). A higher percentage of participants in Group A reached a BMI < 35 kg/m (45.8 vs 12.0%) and lost > 10% of their initial body weight (20.8 vs 0%) compared to Group B. The combination of exenatide plus dapagliflozin appears as a strategic option to reduce the waiting list for bariatric surgery, especially in those patients with type 2 diabetes.

摘要

胰高血糖素样肽-1 受体激动剂家族与肾脏钠/葡萄糖协同转运蛋白-2 抑制剂一起,作为 2 型糖尿病和肥胖患者的潜在治疗药物引起了关注。在这些患者中,根据 BMI≥35kg/m2,指示进行减肥手术。进行了一项为期 24 周的非盲、随机试点研究,以评估每周一次皮下给予艾塞那肽 2.0mg 加每日一次口服达格列净 10mg(A 组)与对照组(B 组)在 56 例等待减肥手术的 2 型糖尿病患者中的疗效(EudraCTid.:2017-001,454-33)。两组均接受能量不足的低脂饮食。主要终点是在随访结束时符合减肥手术标准的患者比例(BMI≤35.0kg/m2或 BMI≤40.0kg/m2 加 HbA1c≤6.0%)。BMI 的变化也很重要。A 组符合减肥手术标准的患者比例大于对照组(45.8%比 12.0%,p=0.010)。A 组参与者的体重和 BMI 绝对值分别下降 8.1kg(95%CI:-11.0 至-5.2)和 3.3kg/m(95%CI:-4.5 至-2.2)(与 B 组相比,均 p<0.001)。与 B 组相比,A 组更多的参与者达到 BMI<35kg/m(45.8%比 12.0%),体重减轻超过 10%(20.8%比 0%)。艾塞那肽加达格列净联合应用似乎是减少减肥手术等候名单的一种策略选择,尤其是在那些 2 型糖尿病患者中。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4676/8881618/7e6bcd3eb17d/41598_2022_7250_Fig1_HTML.jpg

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