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利拉鲁肽——印度经验

Liraglutide - Indian Experience.

作者信息

Anirban Majumder, Soumyabrata Roy Chaudhri, Debmalya Sanyal, Bhattacharjee Kingshuk

机构信息

Department of Endocrinology, KPC Medical College, Jadavpur, Kolkata, West Bengal, India.

Department of Medical Sciences, JJT University, Rajasthan, India.

出版信息

Indian J Endocrinol Metab. 2018 Nov-Dec;22(6):818-826. doi: 10.4103/ijem.IJEM_187_18.

Abstract

Liraglutide is an effective drug for the treatment of type 2 diabetes mellitus (T2DM). The aim of this review is to collate evidence on the real-world clinical effectiveness of liraglutide from the published Indian studies. A review of publications was conducted to identify observational studies that assessed the effectiveness of liraglutide among Indian T2DM. Total ten publications were retrieved and these observational studies are compared with the results of the liraglutide randomized controlled trial (RCT) program (Liraglutide Effect and Action in Diabetes [LEAD]). Liraglutide therapy demonstrated HbA1c reduction in the Indian population up to 2.26% and 2.54%, over 24 and 52 weeks, respectively. Among the LEAD trials, the HbA1c reduction at 24 weeks was maximum in LEAD-4 with 1.5% reduction at both doses used (1.2 and 1.8 mg) and up to 1.14% in LEAD-3 with a dose of 1.8 mg. The weight loss among Indian subjects was generally around 5 kg or more with maximum weight loss of 8.6 kg over 24 weeks. The maximal weight loss in LEAD studies was less than 3 kg with an exception of 3.24 kg in LEAD-6. In over 52 weeks of liraglutide therapy among Indian subjects, mean weight loss was 7.4 kg, which was 3.5 times more than of LEAD program. Two Indian observational studies also demonstrated significant weight loss among nondiabetic obese subjects at a much lower than that of 3 mg anti-obesity dose. Gastrointestinal (GI) events are the commonly reported adverse events with Indian studies as well as LEAD program. Liraglutide therapy produces better glycemic control and more weight loss among Indian T2DM subjects compared with RCTs conducted in western population with almost similar adverse consequences.

摘要

利拉鲁肽是治疗2型糖尿病(T2DM)的一种有效药物。本综述的目的是整理已发表的印度研究中关于利拉鲁肽真实世界临床疗效的证据。对出版物进行了回顾,以确定评估利拉鲁肽在印度T2DM患者中疗效的观察性研究。共检索到10篇出版物,并将这些观察性研究与利拉鲁肽随机对照试验(RCT)项目(糖尿病中的利拉鲁肽效应与作用[LEAD])的结果进行了比较。在印度人群中,利拉鲁肽治疗在24周和52周时分别使糖化血红蛋白(HbA1c)降低了2.26%和2.54%。在LEAD试验中,LEAD-4在24周时HbA1c降低幅度最大,两种使用剂量(1.2毫克和1.8毫克)均降低了1.5%,LEAD-3使用1.8毫克剂量时HbA1c降低幅度高达1.14%。印度受试者的体重减轻一般约为5千克或更多,24周内最大体重减轻为8.6千克。LEAD研究中的最大体重减轻少于3千克,LEAD-6除外,为3.24千克。在印度受试者中进行的超过52周的利拉鲁肽治疗中,平均体重减轻为7.4千克,是LEAD项目的3.5倍。两项印度观察性研究还表明,非糖尿病肥胖受试者的体重显著减轻,且剂量远低于3毫克抗肥胖剂量。胃肠道(GI)事件是印度研究以及LEAD项目中常见的不良事件报告。与在西方人群中进行的RCT相比,利拉鲁肽治疗在印度T2DM受试者中能产生更好的血糖控制和更多的体重减轻,且不良后果几乎相似。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1442/6330852/6f325f9ca9d3/IJEM-22-818-g009.jpg

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