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在使用二肽基肽酶-4 抑制剂和磺脲类药物治疗 2 型糖尿病患者中,治疗的持久性、低血糖和临床结局:初级保健数据库分析。

Treatment persistence, hypoglycaemia and clinical outcomes in type 2 diabetes patients with dipeptidyl peptidase-4 inhibitors and sulphonylureas: a primary care database analysis.

机构信息

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

出版信息

Diabetes Obes Metab. 2013 Jan;15(1):55-61. doi: 10.1111/j.1463-1326.2012.01674.x. Epub 2012 Sep 9.

Abstract

AIMS

To investigate therapy persistence, frequency of hypoglycaemia and macrovascular outcomes among type 2 diabetes patients with dipeptidyl peptidase-4 (DPP-4) inhibitors (DPP-4) and sulphonylureas (SU).

METHODS

Data from 19,184 DPP-4 (mean age: 64 years; 56% males) and 31,110 SU users (69 years; 51%) with new prescriptions (index date), without additional antidiabetics except metformin, in 1201 general practises in Germany were analysed. Therapy discontinuation (prescription gap >90 days), hypoglycaemia [International Classification of Diseases (ICD-10)] and macrovascular outcomes (ICD-10) (2-year follow-up) were compared adjusting for age, sex, diabetes duration, metformin, previous hypoglycaemia, health insurance, hypertension, hyperlipidaemia, antihypertensives, lipid-lowering and antithrombotic drugs, microvascular complications and Charlson co-morbidity score using logistic or Cox regression models.

RESULTS

Two years after index date, DDP-4 (non-persistence: 39%) were associated with a lower risk of discontinuation compared to SU (49%) [adjusted hazard ratio (HR): 0.74; 95% confidence interval (CI): 0.71-0.76]. Hypoglycaemias (≥1) were documented in 0.18% patients with DPP-4 and in 1.00% with SU [odds ratio (OR): 0.21; 95%CI: 0.08-0.57]. Hypoglycaemias were significantly associated with incident macrovascular complications (HR: 1.6; 95% CI: 1.1-2.2). Risk of macrovascular events was 26% lower in DPP-4 than in SU users.

CONCLUSIONS

Lack of persistence with antidiabetic therapy is frequently found in primary care patients. DPP-4 was associated with lower therapy discontinuation and a fivefold reduced frequency of patients with hypoglycaemia compared to SU. The low absolute numbers of hypoglycaemias are most likely due to the fact that only severe events were documented. DPP-4 treatment was associated with reduced incidence of macrovascular events relative to SU in type 2 diabetes patients in primary care practises.

摘要

目的

调查二肽基肽酶-4(DPP-4)抑制剂(DPP-4)和磺酰脲类药物(SU)治疗 2 型糖尿病患者的治疗持续时间、低血糖频率和大血管结局。

方法

对德国 1201 家普通诊所中 19184 例新处方(索引日期)DPP-4(平均年龄:64 岁;56%为男性)和 31110 例 SU 使用者(69 岁;51%)的患者数据进行了分析。在没有二甲双胍以外的其他抗糖尿病药物的情况下,根据年龄、性别、糖尿病持续时间、二甲双胍、既往低血糖、健康保险、高血压、血脂异常、降压药、降脂药和抗血栓药物、微血管并发症和 Charlson 合并症评分,使用逻辑或 Cox 回归模型比较了治疗中断(处方间隙>90 天)、低血糖[国际疾病分类(ICD-10)]和大血管结局(ICD-10)(2 年随访)。

结果

在索引日期后 2 年,与 SU(49%)相比,DDP-4(非持续性:39%)的停药风险较低[调整后的危险比(HR):0.74;95%置信区间(CI):0.71-0.76]。DPP-4 组有 0.18%的患者发生≥1 次低血糖,SU 组有 1.00%的患者发生低血糖[比值比(OR):0.21;95%CI:0.08-0.57]。低血糖与大血管并发症的发生显著相关(HR:1.6;95%CI:1.1-2.2)。与 SU 使用者相比,DPP-4 使用者发生大血管事件的风险降低了 26%。

结论

初级保健患者中经常发现抗糖尿病治疗的持续性不足。与 SU 相比,DPP-4 与较低的治疗中断率和低血糖发生率降低五倍相关。低血糖的绝对数量较低很可能是因为仅记录了严重事件。在初级保健实践中,与 SU 相比,DPP-4 治疗与 2 型糖尿病患者大血管事件的发生率降低相关。

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