Investigation of Severe Hypoglycemia Risk Among Patients with Diabetes Treated with Ultra-Rapid Lispro in Japan.

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL Advances in Therapy Pub Date : 2024-11-21 DOI:10.1007/s12325-024-03050-1

Seiko Mizuno, Machiko Minatoya, Satoshi Osaga, Rina Chin, Makoto Imori

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Abstract

Introduction: There is no information on the incidence of severe hypoglycemia in real-world patients with diabetes receiving ultra-rapid lispro (URLi). This post-marketing, observational, safety study assessed the incidence proportion and incidence rate of the first severe hypoglycemia event requiring a hospital visit in URLi-treated patients. It also compared the risk of severe hypoglycemia between patients treated with URLi or other rapid-acting insulin analogs (RAIAs).

Methods: Claims data were obtained from a nationwide hospital-based administrative database in Japan (Medical Data Vision). Adults with diabetes who initiated URLi or other RAIA on/after June 01, 2020, were followed up through May 31, 2023. Severe hypoglycemia was identified using a validated algorithm. Incidence proportion and incidence rate of the first severe hypoglycemia event requiring a hospital visit was described in URLi-treated patients (descriptive analysis). These outcomes were also compared against propensity score (PS)-matched other RAIA-treated patients (comparator; comparative analysis). Hazard ratio (HR) and 95% confidence interval (CI) was estimated with a Cox proportional hazards model.

Results: The descriptive analysis' URLi-treated cohort included 17,838 patients [mean (standard deviation, SD) age 65.9 (15.7) years; 58.3% male]. The majority had type 2 diabetes (75.7%). The incidence proportion of the first severe hypoglycemia event requiring a hospital visit was 0.6% (95% CI 0.5, 0.8) and the incidence rate was 1.7 per 100 person-years (95% CI 0.7, 4.3). The comparative analysis included 10,592 URLi-treated and 52,917 comparator-treated patients. The incidence rate of severe hypoglycemia did not significantly differ between these cohorts (HR 0.8; 95% CI 0.5, 1.1; p = 0.132;.

Conclusion: This study did not show a statistically significant increase in the incidence and risk of the first severe hypoglycemia event requiring a hospital visit in real-world URLi-treated patients in Japan, compared with a PS-matched cohort of other RAIA-treated patients.

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日本使用超快速利血平治疗的糖尿病患者严重低血糖风险调查。

简介：目前还没有关于接受超快速利血平（URLi）治疗的糖尿病患者严重低血糖发生率的信息。这项上市后观察性安全性研究评估了接受URLi治疗的患者首次发生需要住院治疗的严重低血糖事件的发生比例和发生率。研究还比较了接受URLi或其他速效胰岛素类似物（RAIAs）治疗的患者发生严重低血糖的风险：方法：索赔数据来自日本全国医院管理数据库（Medical Data Vision）。对 2020 年 6 月 1 日/之后开始使用 URLi 或其他 RAIA 的成人糖尿病患者进行随访，直至 2023 年 5 月 31 日。严重低血糖是通过验证算法确定的。描述了URLi治疗患者首次发生严重低血糖事件并需要到医院就诊的发生比例和发生率（描述性分析）。这些结果还与倾向评分（PS）匹配的其他 RAIA 治疗患者进行了比较（比较分析）。采用考克斯比例危险模型估算危险比（HR）和95%置信区间（CI）：描述性分析的URLi治疗队列包括17838名患者[平均（标准差，SD）年龄65.9（15.7）岁；58.3%为男性]。大多数患者为 2 型糖尿病（75.7%）。首次发生严重低血糖而需要到医院就诊的比例为 0.6%（95% CI 0.5，0.8），发病率为每 100 人年 1.7 例（95% CI 0.7，4.3）。对比分析包括 10,592 名接受过 URLi 治疗的患者和 52,917 名接受过对比治疗的患者。这两组患者的严重低血糖发生率没有显著差异（HR 0.8；95% CI 0.5，1.1；P = 0.132）：这项研究表明，与其他RAIA治疗患者的PS匹配队列相比，在日本真实世界中接受URLi治疗的患者首次发生需要住院治疗的严重低血糖事件的发生率和风险并没有统计学意义上的显著增加。

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.