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无论年龄如何,门冬胰岛素在基础-餐时胰岛素方案中的安全性和有效性:a1chieve 研究结果。

Safety and effectiveness of insulin aspart in Basal-bolus regimens regardless of age: a1chieve study results.

机构信息

Department of Endocrinology, Bangladesh Institute of Research and Rehabilitation for Diabetes, Endocrine and Metabolic Disorders, Dhaka, Bangladesh.

出版信息

Diabetes Ther. 2013 Jun;4(1):103-18. doi: 10.1007/s13300-013-0023-1. Epub 2013 May 14.

DOI:10.1007/s13300-013-0023-1
PMID:23670205
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3687088/
Abstract

INTRODUCTION

Hypoglycemia is a complication in the management of type 2 diabetes, and elderly people are at greater risk of experiencing hypoglycemia events than younger patients. Insulin analogs achieve glycemic control with minimal risk of hypoglycemia and may therefore be a good treatment option for all patients.

METHODS

A1chieve was an international, multicenter, prospective, open-label, non-interventional, 24-week study in people with type 2 diabetes who started/switched to therapy with biphasic insulin aspart 30, insulin detemir or insulin aspart (alone/in combination) in routine clinical practice. This sub-analysis evaluated clinical safety and effectiveness of insulin aspart as part of a basal-bolus regimen (±oral glucose-lowering drugs) in three age-groups (≤40, >40-65, and >65 years) of insulin-experienced and insulin-naive people with type 2 diabetes.

RESULTS

In total, 4,032 patients were included in the sub-analysis. After 24 weeks of insulin aspart treatment, significant improvements versus baseline were observed in all age-groups for: proportion of people with ≥1 hypoglycemia events (18.3-27.1% and 11.0-12.7%, at baseline and 24 weeks, respectively), ≥1 major hypoglycemia events (3.3-6.7% and 0-0.2%), and ≥1 nocturnal hypoglycemia events (9.2-13.7% and 2.9-4.9%); glycated hemoglobin (9.6-9.8% and 7.4%); fasting plasma glucose (change from baseline ranged from -3.6 to -4.4 mmol/l); and post-breakfast post-prandial plasma glucose (change from baseline ranged from -5.5 to -5.9 mmol/l). Fourteen serious adverse drug reactions were reported. Health-related quality of life was significantly improved for all age-groups (all, p < 0.001).

CONCLUSION

All age-groups showed improved glycemic control and reduced risk of hypoglycemia when starting/switching to insulin aspart therapy within a basal-bolus regimen; this may be particularly important for elderly patients given their greater risk of hypoglycemia versus younger patients.

摘要

简介

低血糖是 2 型糖尿病管理中的一种并发症,老年人发生低血糖事件的风险高于年轻患者。胰岛素类似物可实现低血糖风险最小化的血糖控制,因此可能是所有患者的良好治疗选择。

方法

A1chieve 是一项国际性、多中心、前瞻性、开放标签、非干预性、为期 24 周的研究,纳入了在常规临床实践中开始/转换为双相门冬胰岛素 30、地特胰岛素或门冬胰岛素(单独/联合)治疗的 2 型糖尿病患者。这项亚分析评估了在胰岛素经验丰富和胰岛素初治的 2 型糖尿病患者的三个年龄组(≤40 岁、>40-65 岁和>65 岁)中,作为基础-餐时胰岛素方案(±口服降糖药物)的一部分,使用门冬胰岛素的临床安全性和有效性。

结果

共有 4032 名患者纳入亚分析。在接受门冬胰岛素治疗 24 周后,所有年龄组的以下各项与基线相比均有显著改善:≥1 次低血糖事件的患者比例(18.3-27.1%和 11.0-12.7%,分别为基线和 24 周)、≥1 次重度低血糖事件(3.3-6.7%和 0-0.2%)和≥1 次夜间低血糖事件(9.2-13.7%和 2.9-4.9%);糖化血红蛋白(9.6-9.8%和 7.4%);空腹血浆葡萄糖(从基线的变化范围为-3.6 至-4.4mmol/L);和早餐后餐后血浆葡萄糖(从基线的变化范围为-5.5 至-5.9mmol/L)。报告了 14 例严重药物不良反应。所有年龄组的健康相关生活质量均显著改善(均为 p<0.001)。

结论

在基础-餐时胰岛素方案中开始/转换为门冬胰岛素治疗时,所有年龄组的血糖控制均得到改善,低血糖风险降低;对于低血糖风险高于年轻患者的老年患者而言,这可能尤为重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbf0/3687088/ed6ba87982ce/13300_2013_23_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbf0/3687088/47a101af6c86/13300_2013_23_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbf0/3687088/ed6ba87982ce/13300_2013_23_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbf0/3687088/47a101af6c86/13300_2013_23_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbf0/3687088/ed6ba87982ce/13300_2013_23_Fig2_HTML.jpg

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