Basal Insulinotherapy in Patients Living with Diabetes in France: The EF-BI Study

IF 3.8 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2024-04-20 DOI:10.1007/s13300-024-01577-8

Pierre Gourdy, Patrice Darmon, Isabelle Borget, Corinne Emery, Isabelle Bureau, Bruno Detournay, Amar Bahloul, Noemie Allali, Aymeric Mahieu, Alfred Penfornis

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Abstract

Introduction

Second-generation basal insulins like glargine 300 U/mL (Gla-300) have a longer duration of action and less daily fluctuation and interday variability than first-generation ones, such as glargine 100 U/mL (Gla-100). The EF-BI study, a nationwide observational, retrospective study, was designed to compare persistence, acute care complications, and healthcare costs associated with the initiation of such basal insulins (BI) in a real-life setting in France.

Methods

This study was conducted using the French healthcare claims database (SNDS). Adult patients living with type 1 or type 2 diabetes mellitus (T1DM or T2DM) initiating Gla-300 or Gla-100 ± other hypoglycemic medications between January 1, 2016 and December 31, 2020, and without any insulin therapy over the previous 6 months were included. Persistence was defined as remaining on the same insulin therapy until discontinuation defined by a 6 month period without insulin reimbursement. Hospitalized acute complications were identified using ICD-10 codes. Total collective costs were established for patients treated continuously with each basal insulin over 1–3 years. All comparisons were adjusted using a propensity score based on initial patient/treatment characteristics.

Results

A total of 235,894 patients with T2DM and 6672 patients with T1DM were included. Patients treated with Gla-300 were 83% (T1DM) and 44% (T2DM) less likely to discontinue their treatment than those treated with Gla-100 after 24 months (p < 0.0001). The annual incidence of acute hospitalized events in patients with T2DM treated with Gla-300 was 12% lower than with Gla-100 (p < 0.0001) but similar in patients with T1DM. Comparison of overall costs showed moderate but statistically significant differences in favor of Gla-300 versus Gla-100 for all patients over the first year, and in T2DM only over a 3-year follow-up.

Conclusion

Use of Gla-300 resulted in a better persistence, less acute hospitalized events at least in T2DM, and reduced healthcare expenditure. These real-life results confirmed the potential interest of using Gla-300 rather than Gla-100.

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法国糖尿病患者的基础胰岛素疗法：EF-BI 研究

导言格列酮 300 U/mL（Gla-300）等第二代基础胰岛素与格列酮 100 U/mL（Gla-100）等第一代基础胰岛素相比，作用时间更长，每日波动和日间变化更小。EF-BI 研究是一项全国性的观察性、回顾性研究，旨在比较在法国实际生活环境中使用此类基础胰岛素（BI）的持续性、急性并发症和医疗费用。研究对象包括在 2016 年 1 月 1 日至 2020 年 12 月 31 日期间开始使用 Gla-300 或 Gla-100 以及其他降糖药物，且在此前 6 个月内未接受过任何胰岛素治疗的 1 型或 2 型糖尿病（T1DM 或 T2DM）成年患者。持续治疗的定义是，在停用胰岛素之前一直使用相同的胰岛素治疗，停用胰岛素的定义是在 6 个月内没有报销胰岛素费用。住院急性并发症使用 ICD-10 编码进行识别。为持续使用每种基础胰岛素治疗 1-3 年的患者确定总费用。所有比较均根据患者/治疗的初始特征使用倾向评分进行调整。结果共纳入 235894 名 T2DM 患者和 6672 名 T1DM 患者。与接受 Gla-100 治疗的患者相比，接受 Gla-300 治疗的患者在 24 个月后中断治疗的可能性分别降低了 83% （T1DM）和 44% （T2DM）（p < 0.0001）。接受 Gla-300 治疗的 T2DM 患者的急性住院事件年发生率比接受 Gla-100 治疗的患者低 12%（p < 0.0001），但与接受 Gla-100 治疗的 T1DM 患者相似。对总费用的比较显示，Gla-300 与 Gla-100 相比，所有患者在第一年的费用差异不大，但在统计学上有显著差异，仅 T2DM 患者在 3 年随访期间的费用有显著差异。这些实际结果证实了使用 Gla-300 而不是 Gla-100 的潜在好处。

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

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes 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 areas of diabetes. 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. Diabetes 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.