Dalal Mehul R, Kazemi Mahmood R, Ye Fen
a Employee of Sanofi US at the time of the study.
b Millennium Pharmaceuticals Inc. , Cambridge , MA , USA.
Curr Med Res Opin. 2017 Feb;33(2):209-214. doi: 10.1080/03007995.2016.1248911. Epub 2016 Nov 4.
To evaluate the impact of 6 month hypoglycemia on treatment discontinuation and hospitalization of patients initiating basal insulin for type 2 diabetes (T2D) in real-world practice.
This was a retrospective cohort study of patient-level data using electronic medical records (EMRs) in the Predictive Health Intelligence diabetes dataset. Data from adult patients with T2D initiating basal insulin glargine, insulin detemir, or Neutral Protamine Hagedorn insulin between January 2008 and March 2014 was analyzed. The date of first basal insulin prescription in an outpatient setting was the index date. A 12 month baseline prior to the index date was established; follow-up was 6-24 months from the index date. Patients were assigned to cohorts by experience of hypoglycemia (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code or blood glucose test) in the first 6 months following the index date; with hypoglycemia and without hypoglycemia cohorts were compared for basal insulin treatment discontinuation and hospitalization.
Overall, 49,062 patients were included; 5159 (10.5%) experienced hypoglycemia in the 6 months following basal insulin initiation. In the first 12 months, 68.1% of patients in the with hypoglycemia cohort discontinued basal insulin versus 53.9% in the without hypoglycemia cohort (p < .0001); more patients in the with hypoglycemia cohort had at least one hospitalization in the first year of follow-up (50.1% vs. 14.6%; p < .0001).
Patients with hypoglycemia soon after initiating basal insulin are at greater risk of discontinuation of their basal insulin therapy and hospitalization versus those who did not have hypoglycemic events within the first 6 months of basal insulin initiation. A limitation of this study is that it was a retrospective analysis of EMR data and the study may not be representative of all US patients with T2D on basal insulin and it cannot be assumed that every hypoglycemic event was recorded.
评估在实际临床中，6个月内发生低血糖对2型糖尿病（T2D）患者起始基础胰岛素治疗后停药及住院情况的影响。
这是一项利用预测健康智能糖尿病数据集的电子病历（EMR）进行的患者水平数据回顾性队列研究。分析了2008年1月至2014年3月期间开始使用甘精胰岛素、地特胰岛素或中性鱼精蛋白锌胰岛素的成年T2D患者的数据。门诊首次开具基础胰岛素处方的日期为索引日期。在索引日期前建立12个月的基线期；随访时间为索引日期后的6 - 24个月。根据索引日期后前6个月内的低血糖经历（国际疾病分类第九版临床修订本[ICD - 9 - CM]编码或血糖检测结果）将患者分为不同队列；比较有低血糖和无低血糖队列的基础胰岛素治疗停药及住院情况。
总体纳入49062例患者；5159例（10.5%）在起始基础胰岛素后的6个月内发生低血糖。在最初12个月内，有低血糖队列中68.1%的患者停用基础胰岛素，而无低血糖队列中这一比例为53.9%（p <.0001）；有低血糖队列中更多患者在随访的第一年至少有一次住院（50.1%对14.6%；p <.0001）。
与在起始基础胰岛素的前6个月内未发生低血糖事件的患者相比，起始基础胰岛素后不久发生低血糖的患者停用基础胰岛素治疗及住院的风险更高。本研究的一个局限性在于它是对EMR数据的回顾性分析，该研究可能不代表所有使用基础胰岛素的美国T2D患者，且不能假定记录了每一次低血糖事件。
