使用门冬胰岛素的 2 型糖尿病患者记录的心血管转归发生率低于使用人常规胰岛素者：来自普通诊所的观察性证据。

Lower incidence of recorded cardiovascular outcomes in patients with type 2 diabetes using insulin aspart vs. those on human regular insulin: observational evidence from general practices.

机构信息

German Diabetes Center, Institute of Biometrics and Epidemiology, Düsseldorf, Germany.

出版信息

Diabetes Obes Metab. 2013 Apr;15(4):358-63. doi: 10.1111/dom.12035. Epub 2012 Nov 28.

DOI:10.1111/dom.12035

PMID:23137345

Abstract

AIMS

Insulin aspart has a higher ability to treat postprandial glucose than regular human insulin, which may have favourable cardiovascular effects. The aim was to collect and compare the incidence of recorded macro- and microvascular events in patients with type 2 diabetes with insulin aspart or regular human insulin in general practices.

METHODS

Computerized data from 3154 aspart and 3154 regular insulin users throughout Germany (Disease Analyzer, January 2000 to July 2011) were analysed after matching for age (60 ± 10 years), sex (men: 57%), health insurance (private: 5.8%) and diabetes treatment period in practice (2.2 ± 2.5 years). Hazard ratios (HR; Cox regression) for macro- or microvascular outcomes (follow-up: 3.5 years) were further adjusted for diabetologist care, practice region, hypertension, hyperlipidaemia, co-medication (basal insulin, oral antidiabetics, antihypertensives, lipid-lowering agents and antithrombotic drugs), previous treatment with rapid-acting insulins, hypoglycaemia and the Charlson co-morbidity score. Furthermore, adjustment was carried out for baseline microvascular complications when analysing macrovascular outcomes and vice versa.

RESULTS

Overall, the risk of combined macrovascular outcomes was 15% lower for insulin aspart users (p = 0.01). For insulin aspart there was also a decreased risk incident stroke [HR: 0.58; 95% confidence interval (CI): 0.45-0.74], myocardial infarction (HR: 0.69; 95% CI: 0.54-0.88) and peripheral vascular disease (HR: 0.80; 95% CI: 0.69-0.93). For microvascular complications (retinopathy, neuropathy and nephropathy), no significant differences were observed (HR: 0.96; 95% CI: 0.87-1.06).

CONCLUSION

Use of the rapid-acting insulin analogue aspart was associated with a reduced incidence of macrovascular outcomes in type 2 diabetes in general practices. It is important to confirm this finding in a randomized controlled trial.

摘要

目的

门冬胰岛素治疗餐后血糖的能力优于人胰岛素，这可能对心血管有有利影响。本研究旨在收集并比较 2 型糖尿病患者使用门冬胰岛素或人胰岛素的普通诊所中记录的大血管和微血管事件的发生率。

方法

对德国 3154 名门冬胰岛素使用者和 3154 名人胰岛素使用者（使用 Disease Analyzer，2000 年 1 月至 2011 年 7 月）的计算机数据进行分析，年龄（60±10 岁）、性别（男性：57%）、医疗保险（私人：5.8%）和诊所中糖尿病治疗时间（2.2±2.5 年）匹配。大血管或微血管结局（随访：3.5 年）的风险比（HR；Cox 回归）进一步根据糖尿病专家治疗、诊所区域、高血压、高血脂、合并用药（基础胰岛素、口服降糖药、降压药、降脂药和抗血栓药物）、之前使用速效胰岛素、低血糖和 Charlson 合并症评分进行调整。此外，在分析大血管结局时，对微血管并发症进行了基线调整，反之亦然。

结果

总体而言，门冬胰岛素使用者的联合大血管结局风险降低 15%（p=0.01）。门冬胰岛素使用者发生中风[HR：0.58；95%置信区间（CI）：0.45-0.74]、心肌梗死（HR：0.69；95% CI：0.54-0.88）和外周血管疾病（HR：0.80；95% CI：0.69-0.93）的风险也降低。对于微血管并发症（视网膜病变、神经病变和肾病），没有观察到显著差异（HR：0.96；95% CI：0.87-1.06）。