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利拉鲁肽治疗超越血糖控制:真实世界环境中 2 型糖尿病印度患者的观察性研究。

Liraglutide therapy beyond glycemic control: an observational study in Indian patients with type 2 diabetes in real world setting.

机构信息

Jothydev's Diabetes Research Center, JDC Junction, Trivandrum, Kerala, India 695032.

出版信息

Int J Gen Med. 2012;5:317-22. doi: 10.2147/IJGM.S27886. Epub 2012 Apr 13.

Abstract

BACKGROUND

Liraglutide is an analog of human glucagon-like peptide-1 (GLP-1) and acts as a GLP-1 receptor agonist. Liraglutide is presently used in the treatment of selected patients with type 2 diabetes mellitus (T2DM).

OBJECTIVE

To assess efficacy and safety of liraglutide in, overweight and obese Indian patients with T2DM.

METHODS

A single center, prospective, open-labeled, single-arm, observational study for 24 weeks in a real-world setting. Fourteen overweight and obese patients with T2DM who were clinically suitable for liraglutide therapy received liraglutide injections. The starting dose of liraglutide (Victoza) injection was 0.6 mg/day for 3 days followed by 1.2 mg for next 10 days and finally 1.8 mg/day for 22 weeks. Patients were evaluated at baseline and after 12 and 24 weeks of therapy. Adverse events (AE) noted during course of therapy were recorded. A repeated measure analysis of variance was performed to assess statistical significance.

RESULTS

Fourteen patients were studied for 24 weeks. After 24 weeks of liraglutide therapy, mean fasting and postprandial plasma glucose decreased by 48.5 mg/dL and 66.71 mg/dL, respectively (P = 0.002 and P = 0004 over 24 weeks, respectively). A mean reduction of 2.26% of glycosylated hemoglobin was noted (P < 0.001 over 24 weeks). Mean decrease in body weight of 8.65 kg and mean decrease in body mass index of 3.26 kg/m(2) was noted (P < 0.001 over 24 weeks for each parameter). Systolic blood pressure was reduced by 15.15 mm of Hg (P = 0.004). Significant improvement in total cholesterol, low-density lipoprotein, triglycerides, and serum creatinine was noted. Nine patients reported AEs. The AEs noticed were nausea (n = 6), feeling of satiety (n = 3), and vomiting (n = 1). No serious AE or hypoglycemic episodes were observed.

CONCLUSION

Liraglutide once a day improved overall glycemic control and was well tolerated. Clinically significant reduction in body weight, systolic blood pressure and improvement in lipid profile were noticed with liraglutide therapy in addition to glycemic control.

摘要

背景

利拉鲁肽是一种人胰高血糖素样肽-1(GLP-1)类似物,作为 GLP-1 受体激动剂。利拉鲁肽目前用于治疗某些 2 型糖尿病(T2DM)患者。

目的

评估利拉鲁肽在超重和肥胖的印度 2 型糖尿病患者中的疗效和安全性。

方法

在真实环境中进行的为期 24 周的单中心、前瞻性、开放标签、单臂、观察性研究。14 名符合利拉鲁肽治疗条件的超重和肥胖 T2DM 患者接受了利拉鲁肽注射。利拉鲁肽(诺和力)注射的起始剂量为 0.6mg/天,持续 3 天,然后在接下来的 10 天内增加至 1.2mg,最后在 22 周内增加至 1.8mg/天。在治疗开始时、治疗 12 周和 24 周时对患者进行评估。记录治疗过程中出现的不良事件(AE)。采用重复测量方差分析评估统计学意义。

结果

14 名患者接受了 24 周的研究。利拉鲁肽治疗 24 周后,空腹和餐后血浆葡萄糖分别降低了 48.5mg/dL 和 66.71mg/dL(P=0.002 和 P=0.0004,分别在 24 周时)。糖化血红蛋白平均降低 2.26%(P<0.001,在 24 周时)。体重平均减轻 8.65kg,体重指数平均降低 3.26kg/m²(在 24 周时,每个参数均为 P<0.001)。收缩压降低 15.15mmHg(P=0.004)。总胆固醇、低密度脂蛋白、甘油三酯和血清肌酐显著改善。9 名患者报告了 AEs。观察到的 AEs 是恶心(n=6)、饱腹感(n=3)和呕吐(n=1)。未观察到严重 AEs 或低血糖发作。

结论

利拉鲁肽每天一次可改善整体血糖控制,且耐受性良好。除了血糖控制外,利拉鲁肽治疗还可显著降低体重、收缩压和改善血脂谱。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ef5/3333831/23c39702d999/ijgm-5-317f1.jpg

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