MSD K.K. Market Access, Tokyo, Japan.
MSD K.K. Medical Affairs, Tokyo, Japan.
J Diabetes Investig. 2018 Jul;9(4):925-936. doi: 10.1111/jdi.12778. Epub 2018 Jan 16.
AIMS/INTRODUCTION: To evaluate the incidence rate of and identify factors associated with severe hypoglycemic episodes in patients with treated type 2 diabetes mellitus.
Using Diagnosis Procedure Combination hospital-based medical database, we carried out a retrospective cohort study to assess the incidence rate of severe hypoglycemia in treated type 2 diabetes mellitus patients. We evaluated the associations between severe hypoglycemia and age, sex, complications, and current use of insulin or sulfonylurea (SU) in a nested case-control study.
Of 166,806 eligible patients, 1,242 had episodes of severe hypoglycemia during the observational period. The incidence rate of the first hypoglycemic events was 3.70/1,000 patient years. Based on the nested case-control analysis, age was associated with hypoglycemic events with adjusted odds ratios (ORs) of 1.64 or 65-74-year-old patients and 3.79 for ≥75-year-old patients in comparison with 20-64-year-old patients. Comorbidities, such as cognitive impairment, cancer, macrovascular disease and diabetic complications (retinopathy, nephropathy and neuropathy), were associated with severe hypoglycemia, with adjusted ORs ranging from 1.25 to 3.80. Severe hypoglycemic events also increased in patients with current use of both SU and insulin, either SU or insulin, with adjusted ORs of 18.36, 6.31 or 14.07, respectively, compared with patients with other antihyperglycemic agents. In patients with an SU glimepiride, adjusted ORs increased dose-dependently from 3.65 (≤1 mg) to 13.34 (>2 mg).
The incidence rate of severe hypoglycemia in this cohort was 3.70/1,000 patient years. Age, cognitive impairment, cancer, diabetic complications, current use of insulin + SU and SU dosage were identified as risk factors for severe hypoglycemia.
目的/引言:评估已治疗 2 型糖尿病患者中严重低血糖发作的发生率,并确定与严重低血糖发作相关的因素。
我们使用诊断程序组合医院基础医疗数据库,开展了一项回顾性队列研究,以评估已治疗 2 型糖尿病患者中严重低血糖的发生率。我们在嵌套病例对照研究中评估了严重低血糖与年龄、性别、并发症以及胰岛素或磺酰脲(SU)当前使用之间的关系。
在 166806 名合格患者中,有 1242 名患者在观察期间发生严重低血糖发作。首次低血糖事件的发生率为 3.70/1000 患者年。基于嵌套病例对照分析,年龄与低血糖事件相关,调整后的优势比(OR)为 65-74 岁患者为 1.64,≥75 岁患者为 3.79,与 20-64 岁患者相比。认知障碍、癌症、大血管疾病和糖尿病并发症(视网膜病变、肾病和神经病变)等合并症与严重低血糖相关,调整后的 OR 范围为 1.25 至 3.80。当前同时使用 SU 和胰岛素、SU 或胰岛素的患者严重低血糖事件也增加,调整后的 OR 分别为 18.36、6.31 或 14.07,与其他抗高血糖药物相比。在使用 SU 格列美脲的患者中,调整后的 OR 呈剂量依赖性增加,从 3.65(≤1mg)增加到 13.34(>2mg)。
本队列中严重低血糖的发生率为 3.70/1000 患者年。年龄、认知障碍、癌症、糖尿病并发症、当前使用胰岛素+SU 和 SU 剂量被确定为严重低血糖的危险因素。