Strandberg Arto Y, Khanfir Houssem, Mäkimattila Sari, Saukkonen Tero, Strandberg Timo E, Hoti Fabian
a University of Helsinki, Helsinki, Finland, and Aava Medical Centre , Kerava , Finland.
b EPID Research , Espoo , Finland.
Ann Med. 2017 Jun;49(4):357-364. doi: 10.1080/07853890.2016.1278302. Epub 2017 Feb 10.
The longer acting basal insulin analogs glargine and detemir have shown a lower incidence of hypoglycemia compared to insulin NPH in clinical studies. We evaluated the real-life risk of severe hypoglycemia among new users of insulins in the working-age population in Finland.
All persons aged 18-65 years with diabetes mellitus who were newly prescribed with insulins NPH, glargine, or detemir during 2006-2009, were identified from national registers. Risk of severe hypoglycemia requiring hospital care was compared between insulin types.
A total of 16,985 persons initiated basal insulin treatment (5586, 7499, and 3900 patients started NPH, glargine, and detemir, respectively) during follow-up. Five hundred and thirty-six persons were hospitalized because of severe hypoglycemia. Absolute rate (per 1000 patient-years) was 20.6 (95% CI 17.9, 23.8), 17.8 (15.6, 20.3), and 12.4 (9.9, 15.5) for NPH, glargine, and detemir initiators, respectively. With NPH as reference, the adjusted hazard ratio (HR) was 0.92 (95% CI 0.74, 1.15, p = 0.47) for glargine, and 0.70 (0.51, 0.94, p= 0.018) for detemir. The HR for detemir compared to glargine was 0.76 (0.58, 0.99, p = 0.040).
Initiating insulin treatment with detemir, but not with glargine, was associated with a significantly lower risk of severe hypoglycemia compared to NPH, among working-age adults. KEY MESSAGES The comparative safety of modern basal insulins regarding hypoglycemia among the working-age population is unclear. Large reductions in the incidence of severe hypoglycemia were seen among real-life patients who started insulin detemir, as compared to patients who initiated glargine or especially NPH insulin. Given the large amount of patients using insulin, these findings may have considerable clinical consequences at the population level.
在临床研究中，长效基础胰岛素类似物甘精胰岛素和地特胰岛素与中性鱼精蛋白锌胰岛素相比，低血糖发生率更低。我们评估了芬兰工作年龄人群中胰岛素新使用者发生严重低血糖的实际风险。
从国家登记处识别出2006年至2009年期间新处方使用中性鱼精蛋白锌胰岛素、甘精胰岛素或地特胰岛素的所有18至65岁糖尿病患者。比较不同胰岛素类型之间需要住院治疗的严重低血糖风险。
在随访期间，共有16985人开始基础胰岛素治疗（分别有5586、7499和3900例患者开始使用中性鱼精蛋白锌胰岛素、甘精胰岛素和地特胰岛素）。536人因严重低血糖住院。中性鱼精蛋白锌胰岛素、甘精胰岛素和地特胰岛素起始使用者的绝对发生率（每1000患者年）分别为20.6（95%可信区间17.9, 23.8）、17.8（15.6, 20.3）和12.4（9.9, 15.5）。以中性鱼精蛋白锌胰岛素为参照，甘精胰岛素的调整后风险比（HR）为0.92（95%可信区间0.74, 1.15，p = 0.47），地特胰岛素为0.70（0.51, 0.94，p = 0.018）。地特胰岛素与甘精胰岛素相比的HR为0.76（0.58, 0.99，p = 0.040）。
在工作年龄成年人中，与中性鱼精蛋白锌胰岛素相比，起始使用地特胰岛素而非甘精胰岛素与严重低血糖风险显著降低相关。关键信息工作年龄人群中现代基础胰岛素在低血糖方面的比较安全性尚不清楚。与开始使用甘精胰岛素尤其是中性鱼精蛋白锌胰岛素的患者相比，在实际生活中开始使用地特胰岛素的患者严重低血糖发生率大幅降低。鉴于使用胰岛素的患者数量众多，这些发现可能在人群层面产生相当大的临床影响。
