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利拉鲁肽与格列美脲单药治疗对2型糖尿病患者骨密度的长期影响比较

COMPARISON OF THE LONG-TERM EFFECTS OF LIRAGLUTIDE AND GLIMEPIRIDE MONOTHERAPY ON BONE MINERAL DENSITY IN PATIENTS WITH TYPE 2 DIABETES.

作者信息

Gilbert Matthew P, Marre Michel, Holst Jens Juul, Garber Alan, Baeres Florian M M, Thomsen Henrik, Pratley Richard E

出版信息

Endocr Pract. 2016 Apr;22(4):406-11. doi: 10.4158/EP15758.OR. Epub 2015 Nov 17.

Abstract

OBJECTIVE

Patients with type 2 diabetes have an increased risk of fragility fractures; the cause is unclear but is likely multifactorial. Some diabetes treatments induce bone loss, accentuating underlying skeletal fragility and increasing fracture risk. This subgroup analysis aimed to compare long-term effects of liraglutide and glimepiride on bone mineral density (BMD) in patients with type 2 diabetes.

METHODS

LEAD-3, a 52-week, double-blind, active-control, phase III, multicenter trial, investigated the efficacy of liraglutide (1.2 and 1.8 mg/day) versus glimepiride monotherapy in type 2 diabetes. A 52-week, open-label extension followed, in which participants remained on randomized therapy. A subgroup of participants underwent BMD measurement by dual-energy X-ray absorptiometry at baseline, 52, and 104 weeks. The main outcome measure was change from baseline in total body BMD at 52 and 104 weeks, assessed by analysis of covariance.

RESULTS

A total of 746 patients with type 2 diabetes aged 19 to 79 years were randomized into the main trial. Of these, 61 patients (20 assigned to liraglutide 1.8 mg/day, 23 to liraglutide 1.2 mg/day, 18 to glimepiride 8 mg/day) had BMD measurements. Baseline age, body mass index, diabetes duration, glycated hemoglobin, and total BMD were similar across treatment groups. There was no apparent difference in mean total BMD change from baseline in patients receiving liraglutide 1.8 or 1.2 mg/day or glimepiride 8 mg/day at 52 or 104 weeks.

CONCLUSION

In this small subgroup analysis, liraglutide monotherapy did not negatively affect total BMD in a 2-year prospective study, suggesting it may not exacerbate the consequences of bone fragility.

摘要

目的

2型糖尿病患者发生脆性骨折的风险增加;其病因尚不清楚,但可能是多因素的。一些糖尿病治疗会导致骨质流失,加剧潜在的骨骼脆弱性并增加骨折风险。这项亚组分析旨在比较利拉鲁肽和格列美脲对2型糖尿病患者骨密度(BMD)的长期影响。

方法

LEAD-3是一项为期52周的双盲、活性对照、III期多中心试验,研究了利拉鲁肽(1.2和1.8毫克/天)与格列美脲单药治疗2型糖尿病的疗效。随后进行了为期52周的开放标签扩展试验,参与者继续接受随机治疗。一组参与者在基线、52周和104周时通过双能X线吸收法进行骨密度测量。主要结局指标是通过协方差分析评估的52周和104周时全身骨密度相对于基线的变化。

结果

共有746例年龄在19至79岁之间的2型糖尿病患者被随机纳入主要试验。其中,61例患者(20例分配至利拉鲁肽1.8毫克/天,23例至利拉鲁肽1.2毫克/天,18例至格列美脲8毫克/天)进行了骨密度测量。各治疗组的基线年龄、体重指数、糖尿病病程、糖化血红蛋白和总骨密度相似。在52周或104周时,接受利拉鲁肽1.8或1.2毫克/天或格列美脲8毫克/天治疗的患者,其平均总骨密度相对于基线的变化无明显差异。

结论

在这项小型亚组分析中,在一项为期2年的前瞻性研究中,利拉鲁肽单药治疗对总骨密度没有负面影响,这表明它可能不会加剧骨骼脆弱的后果。

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