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使用二肽基肽酶-4 抑制剂与德国 2 型糖尿病患者骨折风险:真实世界数据的回顾性分析。

Use of dipeptidyl peptidase-4 inhibitors and risk of bone fracture in patients with type 2 diabetes in Germany-A retrospective analysis of real-world data.

机构信息

Epidemiology, IMS Health, Darmstädter Landstraße 108, 60598, Frankfurt am Main, Germany.

Faculty of Medicine, University of Paris 5, Paris, France.

出版信息

Osteoporos Int. 2017 Aug;28(8):2421-2428. doi: 10.1007/s00198-017-4051-y. Epub 2017 Apr 29.

DOI:10.1007/s00198-017-4051-y
PMID:28455750
Abstract

UNLABELLED

In type 2 diabetes patients treated in German primary care practices, the use of dipeptidyl peptidase-4 inhibitor (DPP4i) in combination with metformin was associated with a significant decrease in the risk of developing bone fractures compared to metformin monotherapy.

INTRODUCTION

The goal of this study was to analyze the impact of dipeptidyl peptidase-4 inhibitor (DPP4i) use on the risk of bone fracture in patients diagnosed with type 2 diabetes mellitus (T2DM) in Germany.

METHODS

Patients with an initial prescription of metformin between 2008 and 2014 from 1262 German general practitioner practices were selected. We matched 4160 DPP4i ever users to never users (1:1) based on age, sex, diabetes duration, body mass index, index year, and physician type. The primary outcome measure was the rate of bone fractures within five years of the start of metformin or DPP-4i therapy. Time-dependent Cox regression models were used to estimate hazard ratios (HRs) for fractures as a function of the DPP4i therapy.

RESULTS

The mean age among the patients was 61.6 years (SD = 11.1 years), 59.6% were men, and 3.1% were followed in diabetologist practices. The mean diabetes duration was 1.5 years (SD = 2.4 years), HbA1c levels were 7.1% in DPP4i users and 6.6% in non-users, and body mass index was 31.5 kg/m (SD = 5.0 kg/m). Within five years of the index date, 6.4% of users and 8.3% of non-users developed bone fractures (log-rank p-value < 0.001). Within five years of the index date, 7.4% of female and 4.7% of male users and 13.3% of female and 8.8% of male non-users were diagnosed with bone fractures (both log-rank p-values < 0.001). The use of DPP4i was associated with a significant decrease in the risk of developing bone fractures (all patients HR = 0.67, 95% CI 0.54-0.84; women HR = 0.72, 95% CI 0.54-0.97; men HR = 0.62, 95% CI 0.44-0.88).

CONCLUSION

DPP4i use was associated with a decrease in the risk of bone fracture.

摘要

目的

本研究旨在分析德国 2 型糖尿病(T2DM)患者使用二肽基肽酶-4 抑制剂(DPP4i)对骨折风险的影响。

方法

从 1262 家德国全科医生诊所中选择 2008 年至 2014 年期间首次开具二甲双胍处方的患者。我们根据年龄、性别、糖尿病病程、体重指数、索引年和医生类型,将 4160 名 DPP4i 既往使用者与 4160 名从未使用者(1:1)进行匹配。主要结局指标为五年内开始使用二甲双胍或 DPP-4i 治疗后骨折的发生率。使用时间依赖性 Cox 回归模型估计骨折的风险比(HR)作为 DPP4i 治疗的函数。

结果

患者的平均年龄为 61.6 岁(SD=11.1 岁),59.6%为男性,3.1%在糖尿病专家诊所就诊。平均糖尿病病程为 1.5 年(SD=2.4 年),DPP4i 使用者的 HbA1c 水平为 7.1%,非使用者为 6.6%,体重指数为 31.5kg/m(SD=5.0kg/m)。在索引日期后的五年内,6.4%的使用者和 8.3%的非使用者发生了骨折(对数秩检验 p 值<0.001)。在索引日期后的五年内,7.4%的女性和 4.7%的男性使用者以及 13.3%的女性和 8.8%的男性非使用者被诊断出骨折(两者的对数秩检验 p 值均<0.001)。使用 DPP4i 与骨折风险显著降低相关(所有患者 HR=0.67,95%CI 0.54-0.84;女性 HR=0.72,95%CI 0.54-0.97;男性 HR=0.62,95%CI 0.44-0.88)。

结论

DPP4i 的使用与骨折风险的降低相关。

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