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二肽基肽酶-4 抑制剂作为更优的口服降糖药,从治疗满意度角度来看:来自日本的一项多中心、12 周、开放标签、随机对照研究(PREFERENCE 4 研究)结果。

Dipeptidyl peptidase-4 inhibitors as preferable oral hypoglycemic agents in terms of treatment satisfaction: Results from a multicenter, 12-week, open label, randomized controlled study in Japan (PREFERENCE 4 study).

机构信息

Department of Diabetology, Nara Medical University, Kashihara, Nara, Japan.

Department of Endocrinology, Tenri Hospital, Tenri, Nara, Japan.

出版信息

J Diabetes Investig. 2018 Jan;9(1):137-145. doi: 10.1111/jdi.12659. Epub 2017 May 2.

Abstract

AIMS/INTRODUCTION: To compare the treatment satisfaction of four classes of oral hypoglycemic agents (OHAs): dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase inhibitors (αGI), biguanides (BG) and sulfonylureas (SU), which are common initial treatments for type 2 diabetes mellitus patients in Japan, and to identify the best oral hypoglycemic agent in terms of treatment satisfaction.

MATERIALS AND METHODS

In this 12-week, randomized, controlled, open-label study, Japanese outpatients with type 2 diabetes mellitus who were naïve to pharmacological treatment were randomly assigned a DPP-4 inhibitor, a BG., an αGI or a SU. The primary end-point was the Oral Hypoglycemic Agent Questionnaire (OHA-Q) total and subscale scores (treatment convenience, somatic symptoms and satisfaction) at week 4. Adherence, glycated hemoglobin (HbA1c) level and safety were also evaluated.

RESULTS

The DPP-4 inhibitor group scored highest in the OHA-Q total and all subscale scores at week 4. The total score was significantly higher in the DPP-4 inhibitor group than in the BG or αGI groups (P = 0.0084 and 0.0147, respectively). The mean total score at week 12 was also highest in the DPP-4 inhibitor group, with a significant difference compared with the αGI group (P = 0.0293). The mean HbA1c decreased from baseline to week 12 in all groups. The DPP-4 inhibitor group had the highest adherence at weeks 4 and 12. A total of 11 patients reported adverse events, including one hypoglycemic event in the SU group.

CONCLUSIONS

The DPP-4 inhibitor was the most preferable option in terms of treatment satisfaction.

摘要

目的/引言:本研究旨在比较日本 2 型糖尿病患者常用的四类口服降糖药(OHA),即二肽基肽酶-4(DPP-4)抑制剂、α-葡萄糖苷酶抑制剂(αGI)、双胍类(BG)和磺酰脲类(SU)的治疗满意度,并确定在治疗满意度方面最理想的口服降糖药。

材料和方法

这是一项为期 12 周、随机、对照、开放标签的研究,纳入初治的日本 2 型糖尿病门诊患者,按 1:1:1:1 比例随机分配至 DPP-4 抑制剂组、BG 组、αGI 组或 SU 组。主要终点为第 4 周时的口服降糖药问卷(OHA-Q)总评分和各亚量表评分(治疗方便性、躯体症状和满意度)。同时评估了依从性、糖化血红蛋白(HbA1c)水平和安全性。

结果

DPP-4 抑制剂组在第 4 周时 OHA-Q 总评分和所有亚量表评分均最高。DPP-4 抑制剂组的总评分显著高于 BG 组(P=0.0084)和 αGI 组(P=0.0147)。DPP-4 抑制剂组的平均总评分在第 12 周时也最高,与 αGI 组相比差异具有统计学意义(P=0.0293)。所有组的 HbA1c 均从基线下降至第 12 周。DPP-4 抑制剂组在第 4 周和第 12 周时的依从性最高。共有 11 例患者报告了不良事件,SU 组发生了 1 例低血糖事件。

结论

就治疗满意度而言,DPP-4 抑制剂是最理想的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a8ae/5754532/fc7c06ab0cc3/JDI-9-137-g001.jpg

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