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2型糖尿病患者的每周一次度拉鲁肽治疗,来自印度一家三级医疗糖尿病中心的真实世界证据。

Once Weekly Dulaglutide Therapy in Type 2 Diabetic Subjects, Real-world Evidence from a Tertiary Care Diabetes Center in India.

作者信息

Wasir Jasjeet S, Mithal Ambrish, Agarwal Paras, Mittal Apeksha

机构信息

Division of Endocrinology and Diabetes, Medanta, The Medicity, Gurugram, Haryana, India.

出版信息

Indian J Endocrinol Metab. 2018 Nov-Dec;22(6):728-734. doi: 10.4103/ijem.IJEM_424_18.

Abstract

AIMS

To evaluate the real-world efficacy, durability, and side-effect profile of once weekly GLP1RA: dulaglutide in Indian type 2 diabetes mellitus (T2DM) patients.

MATERIALS AND METHODS

A retrospective observational study. Data for efficacy (HbA1c and weight), adherence/discontinuation and patient reported side-effects, of 117 patients who were prescribed dulaglutide were analyzed.

RESULTS

Final analysis was done on complete data of 74 patients (6 months follow-up), this indicated that dulaglutide is effective (mean-reduction at 6 months of: HbA1c; 0.87% and weight; 3.8 kg). Subjects with a poorer glycemic control (greater HbA1c) or greater weight at initiation had a better fall in HbA1c and weight reduction at the end of the study. The most common side-effects were gastrointestinal (15% nausea and 6% loose motions). Also, 25% ( = 19) of our study subjects discontinued dulaglutide because of gastrointestinal side-effects.

CONCLUSION

Our real-world experience is well aligned to systematic data of the randomized controlled trials (RCTs) regarding the efficacy of dulaglutide in the treatment of T2DM (our study vs. RCTs; HbA1c reduction: 0.87% vs. 0.78% to 1.64%, weight reduction: 3.8 vs. 0.3 to 3 kg). The most common side-effects and reason for discontinuation were gastrointestinal side-effects. Finally, by virtue of their observed benefit, we expect a superior cardiovascular risk-reduction with dulaglutide use in our population.

摘要

目的

评估每周一次的胰高血糖素样肽-1受体激动剂(GLP1RA)度拉糖肽在印度2型糖尿病(T2DM)患者中的实际疗效、持久性及副作用情况。

材料与方法

一项回顾性观察研究。分析了117例处方度拉糖肽患者的疗效(糖化血红蛋白和体重)、依从性/停药情况以及患者报告的副作用数据。

结果

对74例患者的完整数据(6个月随访)进行了最终分析,结果表明度拉糖肽有效(6个月时平均降低幅度:糖化血红蛋白0.87%,体重3.8千克)。起始时血糖控制较差(糖化血红蛋白较高)或体重较大的受试者在研究结束时糖化血红蛋白下降幅度更大且体重减轻更多。最常见的副作用是胃肠道反应(15%恶心,6%腹泻)。此外,25%(=19例)的研究对象因胃肠道副作用停用了度拉糖肽。

结论

我们的实际经验与随机对照试验(RCT)关于度拉糖肽治疗T2DM疗效的系统数据高度一致(我们的研究与RCT对比;糖化血红蛋白降低:0.87% vs. 0.78%至1.64%,体重减轻:3.8 vs. 0.3至3千克)。最常见的副作用及停药原因是胃肠道副作用。最后,鉴于观察到的益处,我们预计在我们的人群中使用度拉糖肽可更好地降低心血管风险。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7811/6330857/2a3de468a009/IJEM-22-728-g001.jpg

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