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在既往二甲双胍单药治疗未达控制的患者中,磺脲类药物与胰岛素对比基于肠促胰岛素治疗的真实世界比较。

A real world comparison of sulfonylurea and insulin vs. incretin-based treatments in patients not controlled on prior metformin monotherapy.

作者信息

Gitt Anselm K, Bramlage Peter, Schneider Steffen, Tschöpe Diethelm

机构信息

Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg, Bremser Strasse 79, 67063, Ludwigshafen, Germany.

Herzzentrum Ludwigshafen, Medizinische Klinik B, Kardiologie, Ludwigshafen, Germany.

出版信息

Cardiovasc Diabetol. 2015 Feb 3;14:13. doi: 10.1186/s12933-015-0172-9.

Abstract

AIMS

Metformin is the first line drug for patients diagnosed with type-2 diabetes; however, the impact of different treatment escalation strategies after metformin failure has thus far not been investigated in a real world situation. The registry described herein goes some way to clarifying treatment outcomes in such patients.

METHODS

DiaRegis is a multicentre registry including 3,810 patients with type-2 diabetes. For the present analysis we selected patients being treated with metformin monotherapy at baseline (n = 1,373), with the subsequent addition of incretin-based drugs (Met/Incr; n = 783), sulfonylureas (Met/SU; n = 255), or insulin (n = 220).

RESULTS

After two years 1,110 of the initial 1,373 patients had a complete follow-up (80.8%) and 726 of these were still on the initial treatment combination (65.4%). After treatment escalation, compared to Met/Incr (n = 421), Met/SU (n = 154) therapy resulted in a higher HbA1c reduction vs. baseline (-0.6 ± 1.4% vs. -0.5 ± 1.0%; p = 0.039). Insulin (n = 151) resulted in a stronger reduction in HbA1c (-0.9 ± 2.0% vs. -0.5 ± 1.0%; p = 0.003), and fasting plasma glucose (-24 ± 70 mg/dl vs. -19 ± 42 mg/dl; p = 0.001), but was associated with increased bodyweight (0.8 ± 9.0 kg vs. -1.5 ± 5.0 kg; p = 0.028). Hypoglycaemia rates (any with or without help and symptoms) were higher for patients receiving insulin (Odds Ratio [OR] 8.35; 95% Confidence Interval [CI] 4.84-14.4) and Met/SU (OR 2.70; 95% CI 1.48-4.92) versus Met/Incr. While there was little difference in event rates between Met/Incr and Met/SU, insulin was associated with higher rates of death, major cardiac and cerebrovascular events, and microvascular disease.

CONCLUSIONS

Taking the results of DiaRegis into consideration it can be concluded that incretin-based treatment strategies appear to have a favourable balance between glycemic control and treatment emergent adverse effects.

摘要

目的

二甲双胍是确诊为2型糖尿病患者的一线用药;然而,二甲双胍治疗失败后不同治疗升级策略的影响,至今尚未在现实世界的情况下进行研究。本文所述的登记研究在一定程度上阐明了此类患者的治疗结果。

方法

DiaRegis是一项多中心登记研究,纳入了3810例2型糖尿病患者。在本次分析中,我们选择了基线时接受二甲双胍单药治疗的患者(n = 1373),随后添加基于肠促胰岛素的药物(二甲双胍/肠促胰岛素;n = 783)、磺脲类药物(二甲双胍/磺脲类;n = 255)或胰岛素(n = 220)。

结果

两年后,最初的1373例患者中有1110例完成了随访(80.8%),其中726例仍采用初始治疗方案(65.4%)。治疗升级后,与二甲双胍/肠促胰岛素组(n = 421)相比,二甲双胍/磺脲类(n = 154)治疗使糖化血红蛋白(HbA1c)较基线降低更多(-0.6±1.4%对-0.5±1.0%;p = 0.039)。胰岛素组(n = 151)使HbA1c降低更显著(-0.9±2.0%对-0.5±1.0%;p = 0.003),空腹血糖降低也更显著(-24±70mg/dl对-19±42mg/dl;p = 0.001),但与体重增加相关(0.8±9.0kg对-1.5±5.0kg;p = 0.028)。接受胰岛素治疗的患者低血糖发生率(无论有无帮助及症状)高于接受二甲双胍/肠促胰岛素治疗的患者(优势比[OR]8.35;95%置信区间[CI]4.84 - 14.4)和二甲双胍/磺脲类治疗的患者(OR 2.70;95%CI 1.48 - 4.92)。虽然二甲双胍/肠促胰岛素组和二甲双胍/磺脲类组的事件发生率差异不大,但胰岛素治疗与更高的死亡率、主要心血管和脑血管事件以及微血管疾病发生率相关。

结论

考虑到DiaRegis的结果,可以得出结论,基于肠促胰岛素的治疗策略在血糖控制和治疗突发不良反应之间似乎具有良好的平衡。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9e2c/4324641/cf616d42fee5/12933_2015_172_Fig1_HTML.jpg

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