先锋真实世界日本研究:一项针对日本临床实践中成年2型糖尿病患者使用口服司美格鲁肽的多中心、前瞻性、真实世界研究的基线特征

PIONEER REAL Japan: Baseline characteristics of a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in clinical practice in Japan.

作者信息

Suzuki Ryo, Amadid Hanan, Major-Pedersen Atheline, Yabe Daisuke

机构信息

Department of Diabetes, Metabolism, and Endocrinology, Tokyo Medical University, Tokyo, Japan.

Global Clinical Drug Development, Novo Nordisk A/S, Søborg, Denmark.

出版信息

J Diabetes Investig. 2024 Aug;15(8):1047-1056. doi: 10.1111/jdi.14219. Epub 2024 May 6.

Abstract

AIMS/INTRODUCTION: PIONEER REAL Japan was a non-interventional, multicenter, prospective study investigating oral semaglutide in adults with type 2 diabetes in routine clinical practice. We report baseline characteristics of participants enrolled in this study.

MATERIALS AND METHODS

Adults aged ≥20 years with type 2 diabetes but no previous treatment with injectable glucose-lowering medication were enrolled. Participants initiated oral semaglutide at their treating physician's discretion and were followed for 34-44 weeks. Participants were stratified into <75-year-old and ≥75-year-old subgroups.

RESULTS

A total of 624 participants initiated the study. The mean (standard deviation) age was 64.1 years (14.1), the mean (standard deviation) body weight was 72.4 kg (16.1), and the mean (standard deviation) body mass index was 27.5 kg/m (5.0). Participants had a median (interquartile range) type 2 diabetes duration of 9.3 years (4.2, 15.2) and mean (standard deviation) glycated hemoglobin 7.7% (1.1). Most (75.6%) participants were taking glucose-lowering medications at baseline; the most common was metformin (51.9%). The main reasons for initiating oral semaglutide were glycemic control and weight loss. Most (86.0%) participants had an individualized target for glycemic control of glycated hemoglobin ≤7%. The <75-year-old subgroup was heavier (mean [standard deviation] body mass index 28.6 kg/m [5.2] vs 25.1 kg/m [3.4]) but had comparable glycated hemoglobin levels (mean [standard deviation] 7.7% [1.2] vs 7.8% [1.0]) to the ≥75-year-old subgroup.

CONCLUSIONS

PIONEER REAL Japan describes the characteristics of individuals with type 2 diabetes prescribed oral semaglutide. The baseline characteristics provide insights into Japanese individuals with type 2 diabetes prescribed oral semaglutide in clinical practice.

摘要

目的/引言:“先锋真实日本”研究是一项非干预性、多中心、前瞻性研究,旨在调查在常规临床实践中口服司美格鲁肽治疗2型糖尿病成人患者的情况。我们报告了参与本研究的受试者的基线特征。

材料与方法

纳入年龄≥20岁、患有2型糖尿病但既往未接受过注射用降糖药物治疗的成年人。受试者由治疗医生酌情决定开始口服司美格鲁肽,并随访34 - 44周。受试者被分为<75岁和≥75岁两个亚组。

结果

共有624名受试者开始本研究。平均(标准差)年龄为64.1岁(14.1),平均(标准差)体重为72.4千克(16.1),平均(标准差)体重指数为27.5千克/米²(5.0)。受试者2型糖尿病病程的中位数(四分位间距)为9.3年(4.2,15.2),糖化血红蛋白平均(标准差)为7.7%(1.1)。大多数(75.6%)受试者在基线时正在服用降糖药物;最常用的是二甲双胍(51.9%)。开始口服司美格鲁肽的主要原因是血糖控制和体重减轻。大多数(86.0%)受试者有糖化血红蛋白≤7%的个体化血糖控制目标。<75岁亚组体重更重(平均[标准差]体重指数28.6千克/米²[5.2] vs 25.1千克/米²[3.4]),但糖化血红蛋白水平与≥75岁亚组相当(平均[标准差]7.7%[1.2] vs 7.8%[1.0])。

结论

“先锋真实日本”研究描述了接受口服司美格鲁肽治疗的2型糖尿病患者的特征。这些基线特征为临床实践中接受口服司美格鲁肽治疗的日本2型糖尿病患者提供了见解。

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