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治疗 2 型糖尿病二甲双胍和西格列汀双联疗法的维持时间:ODYSSEE 观察性研究。

Treatment maintenance duration of dual therapy with metformin and sitagliptin in type 2 diabetes: The ODYSSEE observational study.

机构信息

Department of Endocrinology-Diabetology-Nutrition, Jean-Verdier Hospital, AP-HP, Paris Nord University, CRNH-IdF, CINFO, Bondy, France.

ESSEC, Cergy-Pontoise, France.

出版信息

Diabetes Metab. 2015 Jun;41(3):231-8. doi: 10.1016/j.diabet.2015.03.007. Epub 2015 May 12.

Abstract

AIM

The study compared the duration of maintenance of treatment in patients with type 2 diabetes (T2D) using dual therapy with either metformin and sitagliptin (M-Sita) or metformin and a sulphonylurea (M-SU).

MATERIALS AND METHODS

This observational study included adult patients with T2D who had responded inadequately to metformin monotherapy and therefore had started de-novo treatment with Met-Sita or Met-SU within the previous eight weeks. Patient follow-up and changes to treatment were performed according to their general practitioner's usual clinical practice. The primary outcome was time to change in treatment for whatever cause. HbA1c and symptomatic hypoglycaemia were also documented.

RESULTS

The median treatment duration for patients in the M-Sita group (43.2 months) was significantly longer (P < 0.0001) than in the M-SU group (20.2 months). This difference persisted after adjusting for baseline differences and confounders. A similar reduction in HbA1c was noted in both arms (-0.6%), and the incidence of hypoglycaemia prior to treatment modification was lower with M-Sita (9.7%) than with M-SU (21.0%). Adverse events potentially related to treatment were reported in 2.8% (n = 52) and 2.7% (n = 20) of patients in the M-Sita and M-SU arms, respectively.

CONCLUSION

Under everyday conditions of primary diabetes care, dual therapy with M-Sita can be maintained for longer than M-SU. In addition, while efficacy, as measured by changes in HbA1c, was similar between treatments, the incidence of hypoglycaemia was lower in patients taking M-Sita.

摘要

目的

本研究比较了使用二甲双胍和西他列汀(M-Sita)或二甲双胍和磺酰脲类药物(M-SU)的双重疗法治疗 2 型糖尿病(T2D)患者的治疗维持时间。

材料和方法

本观察性研究纳入了对二甲双胍单药治疗反应不佳的成年 T2D 患者,因此在过去 8 周内开始使用 Met-Sita 或 Met-SU 进行新的治疗。根据其全科医生的常规临床实践对患者进行随访和治疗变更。主要结局是因任何原因改变治疗的时间。还记录了 HbA1c 和有症状的低血糖。

结果

M-Sita 组患者的中位治疗持续时间(43.2 个月)明显长于 M-SU 组(20.2 个月)(P < 0.0001)。调整基线差异和混杂因素后,这种差异仍然存在。在两个治疗组中,HbA1c 均有类似程度的降低(-0.6%),并且在治疗前改变之前,M-Sita(9.7%)的低血糖发生率低于 M-SU(21.0%)。在 M-Sita 和 M-SU 组中,分别有 2.8%(n=52)和 2.7%(n=20)的患者报告了可能与治疗相关的不良事件。

结论

在初级糖尿病护理的日常条件下,M-Sita 的双重疗法维持时间长于 M-SU。此外,虽然两种治疗方法的疗效(以 HbA1c 的变化衡量)相似,但服用 M-Sita 的患者低血糖的发生率较低。

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