PIONEER REAL Japan: Primary results from a multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in Japanese clinical practice

IF 3.1 3区医学 Q2 ENDOCRINOLOGY & METABOLISM

Journal of Diabetes Investigation Pub Date : 2024-08-22 DOI:10.1111/jdi.14291

Daisuke Yabe, Yoshiyuki Hamamoto, Daiji Kawanami, Rimei Nishimura, Yasuo Terauchi, Hanan Amadid, Uffe Christian Braae, Atheline Major-Pedersen, Ryo Suzuki

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引用次数: 0

Abstract

Aims/Introduction

PIONEER REAL Japan was a non-interventional prospective study of oral semaglutide in adults with type 2 diabetes in Japanese clinical practice.

Materials and Methods

Adults naïve to injectable glucose-lowering therapies initiated oral semaglutide in routine clinical practice and were followed for 34–44 weeks. The primary endpoint was change in glycated hemoglobin (HbA_1c) from baseline to end of study; the co-primary endpoint was number of adverse events (AEs). Secondary endpoints included change in bodyweight from baseline to end of study. Analyses were also carried out for subgroups aged <75 and ≥75 years.

Results

A total of 624 participants initiated oral semaglutide; 578 completed the study. Mean baseline HbA_1c and bodyweight were 7.7% and 72.4 kg, respectively. At end of study, estimated change (95% confidence interval [CI]) in HbA_1c from baseline was −0.7 percentage points (−0.77, −0.61) overall, −0.8 percentage points (−0.86, −0.67) in the <75 years subgroup and −0.5 percentage points (−0.68, −0.41) in the ≥75 years subgroup (all P < 0.0001). Estimated change (95% CI) in bodyweight was −2.8 (−3.19, −2.50) kg overall, −2.9 (−3.38, −2.49) kg in the <75 years subgroup and − 2.7 (−3.18, −2.14) kg in the ≥75 years subgroup (all P < 0.0001). AEs occurred in 161 (25.8%) participants: 99 of 423 (23.4%) and 62 of 201 (30.8%) participants in the <75 and ≥75 years subgroups, respectively. Gastrointestinal AEs were the AEs most frequently leading to oral semaglutide discontinuation.

Conclusions

In routine clinical practice, HbA_1c and bodyweight were significantly reduced from baseline in adults initiating oral semaglutide, including those aged ≥75 years, with no new safety concerns.

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日本 PIONEER REAL：一项针对日本临床实践中 2 型糖尿病成人患者口服塞马鲁肽的多中心、前瞻性、真实世界研究的初步结果。

目的/简介：PIONEER REAL Japan是一项针对日本临床实践中2型糖尿病成人患者口服塞马鲁肽的非干预性前瞻性研究：材料：在常规临床实践中，初次使用注射降糖疗法的成人开始口服塞马鲁肽，并随访 34-44 周。主要终点是糖化血红蛋白（HbA1c）从基线到研究结束的变化；共同主要终点是不良事件（AEs）的数量。次要终点包括从基线到研究结束的体重变化。还对年龄分组进行了分析结果：共有 624 名参与者开始口服塞马鲁肽，其中 578 人完成了研究。平均基线 HbA1c 和体重分别为 7.7% 和 72.4 千克。研究结束时，HbA1c 与基线相比的估计变化（95% 置信区间 [CI]）为总体-0.7 个百分点（-0.77, -0.61），结论为-0.8 个百分点（-0.86, -0.67）：在常规临床实践中，开始口服塞马鲁肽的成年人（包括年龄≥75岁者）的HbA1c和体重与基线相比显著降低，且没有新的安全性问题。

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来源期刊

Journal of Diabetes Investigation ENDOCRINOLOGY & METABOLISM-

CiteScore

6.50

自引率

9.40%

发文量

218

审稿时长

6-12 weeks

期刊介绍： Journal of Diabetes Investigation is your core diabetes journal from Asia; the official journal of the Asian Association for the Study of Diabetes (AASD). The journal publishes original research, country reports, commentaries, reviews, mini-reviews, case reports, letters, as well as editorials and news. Embracing clinical and experimental research in diabetes and related areas, the Journal of Diabetes Investigation includes aspects of prevention, treatment, as well as molecular aspects and pathophysiology. Translational research focused on the exchange of ideas between clinicians and researchers is also welcome. Journal of Diabetes Investigation is indexed by Science Citation Index Expanded (SCIE).