A Randomized Controlled Trial on the Effect of Luseogliflozin on Bone Microarchitecture Evaluated Using HR-pQCT in Elderly Type 2 Diabetes.

IF 3.8 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2024-10-01 Epub Date: 2024-08-17 DOI:10.1007/s13300-024-01634-2

Riyoko Shigeno, Ichiro Horie, Ai Haraguchi, Ryuji Niimi, Ko Chiba, Shigeki Tashiro, Yurika Kawazoe, Shuntaro Sato, Makoto Osaki, Atsushi Kawakami, Norio Abiru

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Abstract

Introduction: Bone fragility is a critical issue in the treatment of elderly people with type 2 diabetes (T2D). In the Canagliflozin Cardiovascular Assessment Study, the subjects with T2D who were treated with canagliflozin showed a significant increase in fracture events compared to a placebo group as early as 12 weeks post-initiation. In addition, it has been unclear whether sodium-glucose co-transporter 2 (SGLT2) inhibitors promote bone fragility. We used high-resolution peripheral quantitative computed tomography (HR-pQCT) to prospectively evaluate the short-term effect of the SGLT2 inhibitor luseogliflozin on bone strength and microarchitecture in elderly people with T2D.

Methods: This was a single-center, randomized, open-label, active-controlled pilot trial for ≥ 60-year-old Japanese individuals with T2D without osteoporosis. A total of 22 subjects (seven women and 15 men) were randomly assigned to a Lusefi group (added luseogliflozin 2.5 mg) or a control group (added metformin 500 mg) and treated for 48 weeks. We used the second-generation HR-pQCT (Xtreme CT II®, Scanco Medical, Brüttisellen, Switzerland) before and 48 weeks after the treatment to evaluate the subjects' bone microarchitecture and estimate their bone strength.

Results: Twenty subjects (Lusefi group, n = 9; control group, n = 11) completed the study, with no fracture events. As the primary outcome, the 48-week changes in the bone strength (stiffness and failure load) estimated by micro-finite element analysis were not significantly different between the groups. As the secondary outcome, the changes in all of the cortical/trabecular microarchitectural parameters at the radius and tibia from baseline to 48 weeks were not significantly different between the groups.

Conclusions: In the pilot trial, we observed no negative effect of 48-week luseogliflozin treatment on bone microarchitecture or bone strength in elderly people with T2D.

Trial registration: UMIN-CTR no. 000036202 and jRCT 071180061.

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使用 HR-pQCT 评估卢塞格列净对老年 2 型糖尿病患者骨微结构影响的随机对照试验。

简介骨质脆弱是治疗老年 2 型糖尿病（T2D）患者的一个关键问题。在 "卡格列净心血管评估研究"（Canagliflozin Cardiovascular Assessment Study）中，与安慰剂组相比，接受卡格列净治疗的 2 型糖尿病患者在开始治疗后 12 周内的骨折事件明显增加。此外，钠-葡萄糖协同转运体 2（SGLT2）抑制剂是否会促进骨脆性，目前尚不清楚。我们采用高分辨率外周定量计算机断层扫描（HR-pQCT）前瞻性地评估了SGLT2抑制剂鲁塞格列净对T2D老年人骨强度和微结构的短期影响：这是一项单中心、随机、开放标签、主动对照试验，对象是年龄≥ 60 岁、患有 T2D 但无骨质疏松症的日本人。共有22名受试者（7名女性和15名男性）被随机分配到鲁赛非组（添加鲁赛格列净2.5毫克）或对照组（添加二甲双胍500毫克），治疗48周。在治疗前和治疗48周后，我们使用第二代HR-pQCT（Xtreme CT II®，Scanco Medical，Brüttisellen，Switzerland）评估受试者的骨微结构并估算骨强度：20名受试者（卢赛菲组，n = 9；对照组，n = 11）完成了研究，没有发生骨折事件。作为主要结果，通过微有限元分析估算的骨强度（刚度和破坏载荷）在 48 周内的变化在两组间无显著差异。作为次要结果，桡骨和胫骨的所有皮质/蝶骨微结构参数从基线到48周的变化在各组间无明显差异：在该试验中，我们观察到在T2D老年人中，48周的鲁塞格列净治疗对骨微结构和骨强度没有负面影响：UMIN-CTR no.000036202 和 jRCT 071180061。

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.