从临床角度看 2 型糖尿病基础胰岛素类似物治疗到目标随机对照试验中的低血糖频率:叙述性综述

IF 3.7 2区 医学 Q2 ENDOCRINOLOGY & METABOLISM
Julio Rosenstock, Harpreet S Bajaj, Ildiko Lingvay, Simon R Heller
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引用次数: 0

摘要

本综述旨在全面介绍和总结每天使用一次或两次基础胰岛素类似物的 2 型糖尿病患者低血糖发生率的报告趋势,以帮助解决新出现的每周使用一次基础胰岛素会增加低血糖风险的理论担忧,并使之符合实际情况。低血糖数据提取自 2000-2022 年间进行的治疗到目标随机临床试验。在 PubMed 或美国食品和药物管理局提交的文件中找到了已发表的文章。共鉴定出 57 篇文章:其中 44 篇评估了接受纯基础治疗的参与者(33 篇评估了胰岛素免疫参与者;11 篇评估了胰岛素经验参与者)、4 篇评估了混合人群(胰岛素免疫参与者和胰岛素经验参与者)以及 9 篇评估了接受基础-加量疗法的参与者的降糖结果。分析的重点是 2 级(血糖 <3.0 mmol/L (<54 mg/dL))和 3 级(或严重)低血糖。总体而言,在大多数研究中,接受纯基础胰岛素治疗方案的参与者发生 2 级或 3 级低血糖的事件发生率为 0.06 至 7.10 次/人-年;基础-胰岛素治疗方案的发生率为 2.4 至 13.6 次/人-年。第二代基础胰岛素(德格列奈胰岛素或格列宁胰岛素 U300)的发病率普遍低于中性原研胰岛素或第一代基础胰岛素(地特米胰岛素或格列宁胰岛素 U100)。根据磺脲类药物的使用情况、治疗结束时的胰岛素剂量或糖化血红蛋白的降低情况对亚组进行分类,并未显示出总体低血糖发生率的一致趋势。迄今为止,每周一次基础胰岛素的低血糖发生率与每日给药基础胰岛素类似物的低血糖发生率一致或更低。与该研究相关的所有数据均包含在文章中或作为补充信息上传。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical perspectives on the frequency of hypoglycemia in treat-to-target randomized controlled trials comparing basal insulin analogs in type 2 diabetes: a narrative review
The objective of this review was to comprehensively present and summarize trends in reported rates of hypoglycemia with one or two times per day basal insulin analogs in individuals with type 2 diabetes to help address and contextualize the emerging theoretical concern of increased hypoglycemic risk with once-weekly basal insulins. Hypoglycemia data were extracted from treat-to-target randomized clinical trials conducted during 2000–2022. Published articles were identified on PubMed or within the US Food and Drug Administration submission documents. Overall, 57 articles were identified: 44 assessed hypoglycemic outcomes in participants receiving basal-only therapy (33 in insulin-naive participants; 11 in insulin-experienced participants), 4 in a mixed population (insulin-naive and insulin-experienced participants) and 9 in participants receiving basal-bolus therapy. For the analysis, emphasis was placed on level 2 (blood glucose <3.0 mmol/L (<54 mg/dL)) and level 3 (or severe) hypoglycemia. Overall, event rates for level 2 or level 3 hypoglycemia across most studies ranged from 0.06 to 7.10 events/person-year of exposure (PYE) for participants receiving a basal-only insulin regimen; the rate for basal-bolus regimens ranged from 2.4 to 13.6 events/PYE. Rates were generally lower with second-generation basal insulins (insulin degludec or insulin glargine U300) than with neutral protamine Hagedorn insulin or first-generation basal insulins (insulin detemir or insulin glargine U100). Subgroup categorization by sulfonylurea usage, end-of-treatment insulin dose or glycated hemoglobin reduction did not show consistent trends on overall hypoglycemia rates. Hypoglycemia rates reported so far for once-weekly basal insulins are consistent with or lower than those reported for daily-administered basal insulin analogs. All data relevant to the study are included in the article or uploaded as supplemental information.
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来源期刊
BMJ Open Diabetes Research & Care
BMJ Open Diabetes Research & Care Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
9.30
自引率
2.40%
发文量
123
审稿时长
18 weeks
期刊介绍: BMJ Open Diabetes Research & Care is an open access journal committed to publishing high-quality, basic and clinical research articles regarding type 1 and type 2 diabetes, and associated complications. Only original content will be accepted, and submissions are subject to rigorous peer review to ensure the publication of high-quality — and evidence-based — original research articles.
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