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在2型糖尿病患者中,达格列净疗法联合胰高血糖素样肽-1(GLP1)受体激动剂的真实世界有效性和安全性。

Real-world effectiveness and safety of dapagliflozin therapy added to a GLP1 receptor agonist in patients with type 2 diabetes.

作者信息

Gorgojo-Martínez J J, Serrano-Moreno C, Sanz-Velasco A, Feo-Ortega G, Almodóvar-Ruiz F

机构信息

Unit of Endocrinology and Nutrition, Hospital Universitario Fundación Alcorcón, Madrid, Spain.

出版信息

Nutr Metab Cardiovasc Dis. 2017 Feb;27(2):129-137. doi: 10.1016/j.numecd.2016.11.007. Epub 2016 Nov 23.

DOI:10.1016/j.numecd.2016.11.007
PMID:28077257
Abstract

BACKGROUND AND AIM

To evaluate the effectiveness and safety of a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, dapagliflozin, in patients with type 2 diabetes mellitus (T2DM) and background glucagon-like peptide-1 receptor agonist (GLP1-RA) therapy.

METHODS AND RESULTS

This is a 12-month, real-world observational study, which assessed the effectiveness and safety of dapagliflozin in patients with T2DM and background GLP1-RA therapy. The main outcome measures were changes in A1C and weight at 6 and 12 months from baseline. Secondary outcomes were differences in A1C and weight reduction between this cohort and another group of patients with T2DM treated with dapagliflozin but without background GLP1-RA therapy. In total, 109 patients with GLP1-RA and 104 patients without GLP1-RA were included. Baseline mean A1C and weight in the GLP1-RA and non-GLP1-RA groups were 7.4% vs. 7.3% and 96.2 kg vs. 95.1 kg, respectively. A significant reduction in A1C was seen with dapagliflozin in both cohorts at 6 and 12 months (GLP1-RA: -0.51% and -0.34%, non-GLP1-RA: -0.69% and -0.62%, respectively, p < 0.0001 in all analyses). Weight was significantly reduced in both groups at 6 and 12 months (GLP1-RA: -2.3 kg and -2.4 kg, non-GLP1-RA: -3.9 kg and -4.8 kg, respectively, p < 0.0001 in all analyses). A1C reduction and weight loss were significantly lower in patients with GLP1-RA than in patients without GLP1-RAs. Drug discontinuation rates were similar in both cohorts.

CONCLUSIONS

Dapagliflozin, when added in real life to patients with T2DM treated with GLP1-RAs, induced a further significant, albeit modest improvement in A1C and a further weight loss.

摘要

背景与目的

评估钠-葡萄糖协同转运蛋白2(SGLT-2)抑制剂达格列净在接受胰高血糖素样肽-1受体激动剂(GLP1-RA)基础治疗的2型糖尿病(T2DM)患者中的有效性和安全性。

方法与结果

这是一项为期12个月的真实世界观察性研究,评估了达格列净在接受GLP1-RA基础治疗的T2DM患者中的有效性和安全性。主要观察指标为自基线起6个月和12个月时糖化血红蛋白(A1C)和体重的变化。次要观察指标为该队列与另一组接受达格列净治疗但未接受GLP1-RA基础治疗的T2DM患者在A1C和体重减轻方面的差异。总共纳入了109例接受GLP1-RA治疗的患者和104例未接受GLP1-RA治疗的患者。GLP1-RA组和非GLP1-RA组的基线平均A1C分别为7.4%和7.3%,基线平均体重分别为96.2 kg和95.1 kg。在6个月和12个月时,两组患者使用达格列净后A1C均显著降低(GLP1-RA组:分别降低-0.51%和-0.34%;非GLP1-RA组:分别降低-0.69%和-0.62%,所有分析中p<0.0001)。在6个月和12个月时,两组患者体重均显著减轻(GLP1-RA组:分别减轻-2.3 kg和-2.4 kg;非GLP1-RA组:分别减轻-3.9 kg和-4.8 kg,所有分析中p<0.0001)。接受GLP1-RA治疗的患者A1C降低幅度和体重减轻幅度显著低于未接受GLP1-RA治疗的患者。两组的停药率相似。

结论

在现实生活中,对于接受GLP1-RA治疗的T2DM患者,加用达格列净可使A1C进一步显著改善(尽管改善程度较小),并使体重进一步减轻。

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