Wilke Thomas, Picker Nils, Mueller Sabrina, Geier Silke, Foersch Johannes, Aberle Jens, Martin Stephan, Riedl Matthias, Gabler Maximilian
IPAM, University of Wismar 23966 Wismar, Germany.
Real-World Evidence and Health Economics, Ingress-Health HWM GmbH, Wismar 23966, Germany.
Diabetes Metab Syndr Obes. 2019 Jul 24;12:1225-1237. doi: 10.2147/DMSO.S214288. eCollection 2019.
A substantial share of type 2 diabetes mellitus (T2DM) patients receive insulin. However, little is known about the real-world treatment patterns around insulin initiation.
This was a retrospective claims data analysis. T2DM patients who initiated an insulin therapy between 01/01/2013 and 31/12/2015 were identified in the German AOK PLUS dataset. For validation of results, additional data on a similar T2DM patient population were collected in a Germany-wide medical chart review.
A total of 284,878 T2DM patients were identified. Of these, 27,340 (9.6%) initiated an insulin treatment during the inclusion period (mean age: 72.2 years; 51.4% female). Mean/median weight and BMI of patients with available clinical data was 85.8/84.0 kg (SD:18.9) and 30.6/29.8 kg/m (SD:6.1), respectively at baseline. Mean/median HbA1c-value at baseline was 8.4/8.0% (SD: 1.8). Most commonly prescribed antidiabetic drugs (AD) within 6 months before insulin initiation were metformin (MET; 54.0%), DPP-4 inhibitors (DPP-4i; 37.6%), and sulfonylureas (SU; 29.5%). As high as 23.2% of the patients did not receive any AD prescription within 6 months before insulin initiation. A total of 10,953 of above 27,340 insulin starters (40.1%) initiated their insulin therapy without concomitant ADs (insulin monotherapy); 43% of these patients did not receive any AD before insulin initiation. Of the remaining 16,387 patients (59.9%), 4070 patients (14.9%) received MET only as concomitant AD, 6385 (23.4%) received MET plus at least one further AD, and 5932 (21.7%) received at least one further AD excluding MET. Throughout the first year of treatment, prescribed insulin dosage increased over time, resulting in approximately 43.3-77.9 IUs per observed patient day after 12 months of insulin treatment.
Characteristics of German T2DM patients initiating insulin deviate substantially from the average German population, especially in terms of weight. We identified an unexpectedly high number of patients without previous AD therapy receiving insulin monotherapy, which is not in line with the clinical guidelines.
相当一部分2型糖尿病（T2DM）患者接受胰岛素治疗。然而，对于胰岛素起始治疗的真实世界治疗模式知之甚少。
这是一项回顾性索赔数据分析。在德国AOK PLUS数据集中识别出2013年1月1日至2015年12月31日期间开始胰岛素治疗的T2DM患者。为了验证结果，在全德国范围内的病历审查中收集了类似T2DM患者群体的额外数据。
共识别出284,878例T2DM患者。其中，27,340例（9.6%）在纳入期间开始胰岛素治疗（平均年龄：72.2岁；51.4%为女性）。有可用临床数据的患者在基线时的平均/中位数体重和BMI分别为85.8/84.0 kg（标准差：18.9）和30.6/29.8 kg/m²（标准差：6.1）。基线时的平均/中位数糖化血红蛋白（HbA1c）值为8.4/8.0%（标准差：1.8）。胰岛素起始治疗前6个月内最常处方的抗糖尿病药物（AD）是二甲双胍（MET；54.0%）、二肽基肽酶-4抑制剂（DPP-4i；37.6%）和磺脲类药物（SU；29.5%）。高达23.2%的患者在胰岛素起始治疗前6个月内未接受任何AD处方。在上述27,340例胰岛素起始治疗患者中，共有10,953例（40.1%）在不联用AD的情况下开始胰岛素治疗（胰岛素单药治疗）；这些患者中有43%在胰岛素起始治疗前未接受任何AD。在其余16,387例患者（59.9%）中，4070例患者（14.9%）仅接受MET作为联用AD，6385例（23.4%）接受MET加至少一种其他AD，5932例（21.7%）接受至少一种不包括MET的其他AD。在整个治疗的第一年，处方胰岛素剂量随时间增加，胰岛素治疗12个月后，每位观察患者每天的剂量约为43.3 - 77.9国际单位。
开始胰岛素治疗的德国T2DM患者的特征与德国普通人群有很大差异，尤其是在体重方面。我们发现有出乎意料数量的患者在未接受过AD治疗的情况下接受胰岛素单药治疗，这不符合临床指南。
