Department for Internal Medicine III, Jena University Hospital, Jena, Germany.
Center for Clinical Studies, Jena University Hospital, Jena, Germany.
Diabet Med. 2017 Sep;34(9):1212-1218. doi: 10.1111/dme.13397. Epub 2017 Jul 12.
To evaluate the use of new anti-hyperglycaemic agents that offer effective glycaemic control while reducing risk of hypoglycaemia, by analysing the incidence rates of severe hypoglycaemia in 2006 vs 2011 in relation to the medication.
This cross-sectional, population-based study used German health insurance data. All adults diagnosed with Type 2 diabetes mellitus (extrapolated to the German population: 6.35 million in 2006 and 7.52 million in 2011) were screened for severe hypoglycaemia. Anti-hyperglycaemic agents were identified by their Anatomical Therapeutic Chemical code, and defined daily doses of each medication were calculated.
The severe hypoglycaemic event rate was 460 per 100,000 people/year in 2006 and 490 per 100,000 people/year in 2011. In 2006 and 2011, 10.9% and 7.3%, respectively, of all people with severe hypoglycaemia were on sulfonylureas, while 12.7% and 9.3%, respectively, were on a combination therapy of metformin and sulfonylureas. Among those with severe hypoglycaemia, there were no prescriptions of dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 receptor agonists in 2006, but in 2011, 1.55% and 0.17%, of those with severe hypoglycaemia were receiving the respective treatments. In 2006 vs 2011, human insulin was prescribed for 11.3% vs 10.3% of people with severe hypoglycaemia, while insulin analogues were prescribed for 5.4% vs 8.1%, and mixed human insulins for 19.7% vs 14.0% of patients with severe hypoglycaemia. People receiving insulin analogue therapy had a higher risk of severe hypoglycaemia than those receiving metformin, after adjusting for age, gender, nephropathy diagnosis and year of survey (odds ratio 14.6; CI 13.3-15.9).
The incidence of severe hypoglycaemic events in Germany increased between 2006 and 2011, despite increased use of newer anti-hyperglycaemic agents and decreased use of insulins.
通过分析 2006 年与 2011 年与药物相关的严重低血糖发生率，评估新的降血糖药物在控制血糖的同时降低低血糖风险的效果。
本横断面、基于人群的研究使用了德国健康保险数据。所有被诊断为 2 型糖尿病的成年人（推断德国人口：2006 年为 635 万，2011 年为 752 万）均筛查严重低血糖。通过其解剖治疗化学代码识别降血糖药物，并计算每种药物的定义日剂量。
2006 年严重低血糖事件发生率为每 100000 人/年 460 例，2011 年为每 100000 人/年 490 例。2006 年和 2011 年，分别有 10.9%和 7.3%的所有严重低血糖患者使用磺酰脲类药物，分别有 12.7%和 9.3%的患者使用二甲双胍和磺酰脲类药物的联合治疗。在严重低血糖患者中，2006 年没有使用二肽基肽酶-4 抑制剂或胰高血糖素样肽-1 受体激动剂的处方，但 2011 年，分别有 1.55%和 0.17%的严重低血糖患者接受了相应的治疗。2006 年和 2011 年，分别有 11.3%和 10.3%的严重低血糖患者使用人胰岛素，5.4%和 8.1%的患者使用胰岛素类似物，19.7%和 14.0%的患者使用混合人胰岛素。在调整年龄、性别、肾病诊断和调查年份后，接受胰岛素类似物治疗的患者发生严重低血糖的风险高于接受二甲双胍治疗的患者（比值比 14.6；95%置信区间 13.3-15.9）。
尽管新型降血糖药物的使用增加，胰岛素的使用减少，但 2006 年至 2011 年期间，德国严重低血糖事件的发生率仍有所上升。
