起始使用速效门冬胰岛素治疗的糖尿病患者的血糖控制:一项美国数据库研究

Glycaemic Control in People with Diabetes Starting Treatment with Fast-Acting Insulin Aspart: a US Database Study.

作者信息

Lane Wendy, Faurby Mads, Husemoen Lise Lotte N, Markovich Dmitriy L, Rathor Naveen, De Block Christophe

机构信息

Mountain Diabetes and Endocrine Center, Asheville, NC, USA.

Novo Nordisk A/S, Søborg, Denmark.

出版信息

Diabetes Ther. 2021 Dec;12(12):3067-3077. doi: 10.1007/s13300-021-01165-0. Epub 2021 Oct 12.

Abstract

INTRODUCTION

This study investigated glycaemic control in individuals with type 1 (T1D) or type 2 diabetes (T2D) 6 months after initiating fast-acting insulin aspart (faster aspart) in a real-world setting.

METHODS

This was a single-arm, observational study using extracted patient data from the IBM Explorys database (USA) for individuals with T1D or T2D initiating faster aspart (at least one prescription of faster aspart) in the study period 1 January 2018 to 27 October 2020. Clinical characteristics, including age, body mass index, and baseline HbA1c, were extracted, as well as recorded events of hypoglycaemia. The primary endpoint was the change in HbA1c from baseline to 6 months.

RESULTS

A total of 787 individuals were included; 36.6% of these individuals had T1D and 63.4% had T2D (of whom 46.9% were new users of rapid-acting insulin when initiating faster aspart [T2D new users] and 53.1% were switching from another rapid-acting insulin to faster aspart [T2D switchers]). For individuals with T1D, T2D new users, or T2D switchers, estimated mean change in HbA1c from baseline to 6 months was - 0.20% (95% CI - 0.53, 0.14; p  =  0.252), - 1.00% (95% CI -  1.34, -  0.67; p < 0.0001), and - 0.70% (95% CI - 1.06,  - 0.35; p = 0.0001), respectively. In the baseline HbA1c > 8.5% subgroup, there was a significant estimated decrease in HbA1c from baseline to 6 months in individuals with T1D (-  1.2% [95% CI - 1.80,  -  0.60]; p = 0.0001) or T2D (- 0.6% [95% CI - 0.92, -  0.35]; p <  0.0001). Event rates of hypoglycaemia after 12 months were 0.68, 0.38, and 0.59 events/year for individuals with T1D, T2D new users, and T2D switchers, respectively.

CONCLUSION

US IBM Explorys data demonstrated a clinically relevant reduction in HbA1c 6 months after initiating faster aspart treatment for individuals with T2D, but not T1D overall, although patients with baseline HbA1c > 8.5% had significant HbA1c reductions regardless of diabetes type.

摘要

引言

本研究调查了在现实环境中启动速效胰岛素门冬氨酸(更快速起效的门冬氨酸)6个月后,1型糖尿病(T1D)或2型糖尿病(T2D)患者的血糖控制情况。

方法

这是一项单臂观察性研究,使用从美国IBM Explorys数据库中提取的患者数据,研究对象为2018年1月1日至2020年10月27日期间开始使用更快速起效的门冬氨酸(至少开具过一次更快速起效的门冬氨酸处方)的T1D或T2D患者。提取了临床特征,包括年龄、体重指数和基线糖化血红蛋白(HbA1c),以及记录的低血糖事件。主要终点是从基线到6个月时HbA1c的变化。

结果

共纳入787例患者;其中36.6%为T1D患者,63.4%为T2D患者(其中46.9%在开始使用更快速起效的门冬氨酸时为速效胰岛素新使用者[T2D新使用者],53.1%是从另一种速效胰岛素转换为更快速起效的门冬氨酸[T2D转换者])。对于T1D患者、T2D新使用者或T2D转换者,从基线到6个月时HbA1c的估计平均变化分别为-0.20%(95%置信区间[-0.53, 0.14];p = 0.252)、-1.00%(95%置信区间[-1.34, -0.67];p < 0.0001)和-0.70%(95%置信区间[-1.06, -0.35];p = 0.0001)。在基线HbA1c>8.5%的亚组中,T1D患者(-1.2%[95%置信区间[-1.80, -0.60];p = 0.0001])或T2D患者(-0.6%[95%置信区间[-0.92, -0.35];p < 0.0001])从基线到6个月时HbA1c有显著的估计下降。12个月后,T1D患者、T2D新使用者和T2D转换者的低血糖事件发生率分别为0.68、0.38和0.59次/年。

结论

美国IBM Explorys数据表明,对于T2D患者,在开始使用更快速起效的门冬氨酸治疗6个月后,HbA1c有临床相关的降低,但总体上T1D患者没有,尽管基线HbA1c>8.5%的患者无论糖尿病类型如何,HbA1c都有显著降低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2397/8586136/029b407f0621/13300_2021_1165_Fig1_HTML.jpg

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