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在已经服用肠促胰岛素药物的 2 型糖尿病患者中,缓释纳曲酮/安非他酮安全有效:LIGHT 试验的事后分析。

Extended-release naltrexone/bupropion is safe and effective among subjects with type 2 diabetes already taking incretin agents: a post-hoc analysis of the LIGHT trial.

机构信息

The Wharton Medical Clinic, Toronto, ON, Canada.

Bausch Health, Laval, QC, Canada.

出版信息

Int J Obes (Lond). 2021 Aug;45(8):1687-1695. doi: 10.1038/s41366-021-00831-4. Epub 2021 Jun 3.

DOI:10.1038/s41366-021-00831-4
PMID:34083744
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8310797/
Abstract

BACKGROUND

Extended-release naltrexone/bupropion (NB) is indicated for chronic weight management. Incretin agents are recommended for patients with type 2 diabetes. This analysis looked at the add-on of NB to incretins to see if weight loss could occur in patients already stabilized on incretin agents.

METHODS

This was a post-hoc analysis of NB vs. placebo (PL) among subjects with type 2 diabetes stable on an incretin agent prior to randomization in a double-blind, PL-controlled cardiovascular outcome trial (N = 1317).

RESULTS

Over 1 year, mean weight loss was significantly greater among NB patients vs. PL among those taking DPP-4i (mean absolute difference 4.6% [p < 0.0001]) and those taking GLP-1RAs (mean absolute difference 5.2%, p < 0.0001). Proportions of subjects achieving 5% weight loss were significantly greater for NB vs. PL at weeks 26 and 52 among those taking DPP-4is or GLP-1RAs. There were no significant differences in effectiveness observed between NB + DPP-4i and NB + GLP-1RA or between PL + DPP-4i and PL + GLP-1RA in any of the analyses. Serious adverse events were reported by 9.1% and 11.1% for PL + DPP-4i and PL + GLP-1RA, respectively, and 13.3% and 12.4% of NB + DPP-4i and NB + GLP-1RA, respectively.

CONCLUSION

NB appears to be effective in reducing weight in patients with T2DM and obesity/overweight who are taking DPP-4ihibitors or GLP-1RA. The SAE rates in all arms of this analysis were lower than have been reported in other cardiovascular outcome trials in type 2 diabetes.

摘要

背景

纳曲酮/丁丙诺啡(NB)缓释片适用于慢性体重管理。对于 2 型糖尿病患者,推荐使用肠促胰岛素。本分析旨在研究 NB 联合肠促胰岛素是否能在已使用肠促胰岛素稳定的 2 型糖尿病患者中实现体重减轻。

方法

这是一项在双盲、安慰剂对照的心血管结局试验中,在随机分组前已使用肠促胰岛素稳定的 2 型糖尿病患者中,NB 与安慰剂(PL)相比的事后分析(N=1317)。

结果

在 1 年期间,与 PL 相比,在接受 DPP-4i 治疗的患者中(平均绝对差异 4.6%[p<0.0001])和接受 GLP-1RA 治疗的患者中(平均绝对差异 5.2%,p<0.0001),NB 患者的体重减轻更显著。在接受 DPP-4i 或 GLP-1RA 的患者中,NB 组在第 26 周和第 52 周时达到 5%体重减轻的患者比例明显高于 PL 组。在任何分析中,NB+DPP-4i 与 NB+GLP-1RA 之间或 PL+DPP-4i 与 PL+GLP-1RA 之间,均未观察到疗效有显著差异。PL+DPP-4i 和 PL+GLP-1RA 分别有 9.1%和 11.1%的患者报告严重不良事件,NB+DPP-4i 和 NB+GLP-1RA 分别有 13.3%和 12.4%的患者报告严重不良事件。

结论

NB 似乎可有效降低正在接受 DPP-4i 抑制剂或 GLP-1RA 治疗的 2 型糖尿病和肥胖/超重患者的体重。本分析中所有治疗组的 SAE 发生率均低于其他 2 型糖尿病心血管结局试验中的报道。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f83/8310797/5ec93d9d70ed/41366_2021_831_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f83/8310797/3d52617b9f0e/41366_2021_831_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f83/8310797/26b32eab780a/41366_2021_831_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f83/8310797/5ec93d9d70ed/41366_2021_831_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f83/8310797/3d52617b9f0e/41366_2021_831_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f83/8310797/26b32eab780a/41366_2021_831_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1f83/8310797/5ec93d9d70ed/41366_2021_831_Fig3_HTML.jpg

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