Safety of iGlarLixi in Japanese People with Type 2 Diabetes: A Post-marketing Database Study

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2025-03-08 DOI:10.1007/s12325-025-03135-5

Hideaki Kaneto, Makiko Hatanaka, Yukiko Morimoto, Yoko Takahashi, Yasuo Terauchi

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Abstract

Introduction

In this post-marketing study in Japan, the occurrence of hospital-treated hypoglycaemia and severe hyperglycaemia requiring inpatient treatment was evaluated in various cohorts of people with type 2 diabetes (T2D) newly switched to iGlarLixi, a titratable, once-daily, fixed-ratio combination of long-acting insulin glargine 100 U/mL (iGlar-100) and a glucagon-like peptide-1 receptor agonist (GLP-1 RA, lixisenatide).

Methods

In this retrospective, observational study, acute-care hospital data from adults with T2D were analysed from the Medical Data Vision database. In Cohort 1, the incidence rate of hospital-treated hypoglycaemia following newly prescribed iGlarLixi versus iGlar-100 was assessed. Cohort 2 was subdivided to evaluate the incidence rate of hospital-treated hypoglycaemia and severe hyperglycaemia requiring inpatient treatment in people switched to iGlarLixi from either a GLP-1 RA ± oral antidiabetic drugs (OADs) or OADs alone (Cohort 2A) or from a GLP-1 RA and long-acting insulin ± OADs or long-acting insulin ± OADs (Cohort 2B).

Results

Of the 438 people in the iGlarLixi group and 9295 people in the iGlar-100 group in Cohort 1, who had a median follow-up duration of 52 and 44 days, respectively, there were zero and 0.011 (95% CI 0.006–0.018) events per person-year of hospital-treated hypoglycaemia, respectively. Cohort 2A included 201 people each in the GLP-1 RA ± OADs and OADs alone groups, with a median follow-up duration of 76 and 101 days, respectively, and Cohort 2B included 255 people in the GLP-1 RA and long-acting insulin ± OADs group and 623 people in the long-acting insulin ± OADs group, with a median follow-up duration of 73 and 62 days, respectively; no cases of hospital-treated hypoglycaemia or severe hyperglycaemia requiring inpatient treatment were observed.

Conclusion

Consistent with clinical trials, this post-marketing database study observed that newly prescribed iGlarLixi has a low risk of serious hypoglycaemia or hyperglycaemia in Japanese people with T2D, irrespective of prior antidiabetic drug treatment.

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iGlarLixi在日本2型糖尿病患者中的安全性：上市后数据库研究

在日本的一项上市后研究中，评估了在医院治疗的低血糖和需要住院治疗的严重高血糖的发生，在不同的2型糖尿病（T2D）患者中，新切换到iGlarLixi，这是一种可滴定的，每天一次，固定比例的长效甘精胰岛素100 U/mL （iGlar-100）和胰高血糖素样肽-1受体激动剂（GLP-1 RA，利昔森肽）的组合。方法：在这项回顾性观察性研究中，从医学数据视觉数据库中分析了成人T2D的急性护理医院数据。在队列1中，评估了新处方iGlarLixi与iGlar-100后住院治疗的低血糖发生率。对队列2进行细分，以评估从GLP-1 RA +口服降糖药（OADs）或单独使用OADs（队列2A）或从GLP-1 RA +长效胰岛素±OADs或长效胰岛素±OADs（队列2B）切换到iGlarLixi的患者中住院治疗的低血糖和严重高血糖的发生率。结果：队列1中，iGlarLixi组的438人和iGlar-100组的9295人，随访时间中位数分别为52天和44天，每人年住院治疗低血糖事件分别为0和0.011 （95% CI 0.006-0.018）。队列2A纳入GLP-1 RA±OADs组和单独使用OADs组各201人，中位随访时间分别为76天和101天；队列2B纳入GLP-1 RA联合长效胰岛素±OADs组255人，长效胰岛素±OADs组623人，中位随访时间分别为73天和62天；未观察到住院治疗的低血糖或需要住院治疗的严重高血糖病例。结论：与临床试验一致，这项上市后数据库研究发现，新开处方的iGlarLixi在日本T2D患者中发生严重低血糖或高血糖的风险较低，与先前的降糖药物治疗无关。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.