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二甲双胍治疗基础上 DPP4 抑制剂与传统口服降糖药用于老年 2 型糖尿病患者的附加治疗的真实世界比较:HYPOCRAS 研究。

Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: the HYPOCRAS study.

机构信息

Department of Endocrinology-Metabolism and Diabetology-Nutrition, Jean-Minjoz Hospital, EA 3920, University of Franche-Comté, Besançon, France.

出版信息

Diabetes Metab. 2012 Dec;38(6):550-7. doi: 10.1016/j.diabet.2012.08.003. Epub 2012 Sep 18.

Abstract

AIM

Despite half of all type 2 diabetes mellitus (T2DM) patients being over 65 and treatment being complicated by an elevated risk of iatrogenic hypoglycaemia, information about antidiabetic treatment is scarce in this age group. This prospective observational study compares DPP4-inhibitors (DPP4-i) with conventional oral antidiabetic drugs (COAD) in the real-life treatment of elderly patients with T2DM uncontrolled on metformin alone.

METHODS

Two treatment cohorts (DPP4-i and COAD, constituted on the basis of the GP decision of add-on therapy at the 1st visit) were compared after 6months. The primary objective was to assess the incidence of hypoglycaemic episodes in relationship with glycaemic control assessed by HbA(1c) level.

RESULTS

Demographics and disease history were comparable between the two cohorts (DPP4-i, n=931 and COAD, n=257) at baseline. The incidence of hypoglycaemia/severe hypoglycaemia was significantly higher over 6months in the COAD cohort (20.1%/2.4% vs. 6.4%/0.1%; P<0.001) whereas similar improvements were observed in glycaemic control with HbA(1c) down from 7.9% to 7.0% (COAD) and 6.9% (DPP4-i). The 7% target was reached without hypoglycaemia in more patients in the DPP4-i than in COAD cohort (59.7% vs. 45.5%; P<0.001). Patients in both cohorts who experienced hypoglycaemia more frequently had a pre-existing diabetic complication. The COAD was more likely to be discontinued (6.6% vs. 1.6%; P<0.001).

CONCLUSION

This large cohort study of elderly T2DM patients in France shows that the incidence of hypoglycaemia was three times higher in patients prescribed a COAD versus a DPP4-i after 6months while both treatments induced satisfactory glycaemic control.

摘要

目的

尽管一半的 2 型糖尿病(T2DM)患者年龄超过 65 岁,并且由于医源性低血糖的风险增加,治疗变得复杂,但在这个年龄段,关于抗糖尿病治疗的信息很少。这项前瞻性观察性研究比较了 DPP4 抑制剂(DPP4-i)与单独使用二甲双胍控制不佳的老年 T2DM 患者的常规口服降糖药物(COAD)的真实治疗效果。

方法

根据 GP 在第一次就诊时决定添加治疗的基础上,将两个治疗队列(DPP4-i 和 COAD)在 6 个月后进行比较。主要目的是评估低血糖发作的发生率与糖化血红蛋白(HbA1c)水平评估的血糖控制之间的关系。

结果

两组患者的人口统计学和疾病史在基线时相似(DPP4-i 组,n=931;COAD 组,n=257)。COAD 组在 6 个月内低血糖/严重低血糖的发生率明显更高(20.1%/2.4% vs. 6.4%/0.1%;P<0.001),而血糖控制也有类似的改善,HbA1c 从 7.9%降至 7.0%(COAD)和 6.9%(DPP4-i)。在 DPP4-i 组中,更多患者达到 7%的目标而无低血糖(59.7% vs. 45.5%;P<0.001)。在两组中,经历低血糖的患者更有可能有糖尿病并发症。COAD 组更有可能被停用(6.6% vs. 1.6%;P<0.001)。

结论

这项法国老年 2 型糖尿病患者的大型队列研究表明,在 6 个月后,与 DPP4-i 相比,使用 COAD 的患者低血糖发生率高 3 倍,而两种治疗均能满意地控制血糖。

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