Eli Lilly and Company , Indianapolis, Indiana , USA.
Endocrine Clinic of Southeast Texas , Beaumont, Texas , USA.
BMJ Open Diabetes Res Care. 2015 Apr 30;3(1):e000074. doi: 10.1136/bmjdrc-2014-000074. eCollection 2015.
Describe the characteristics of patients initiating human regular U-500 insulin (U-500R) and their subsequent glycemic control in a real-world setting.
US Humedica electronic health record system data (July 2007-September 2011) were used to identify patients with diabetes aged ≥18 years with ≥1 records for U-500R prescriptions, 6 months of preindex data, 12 months following first use of U-500R, and at least one glycated hemoglobin (HbA1c) value in both preindex and postindex periods. Paired t tests were used to measure the change in HbA1c from preindex to postindex periods (last or most recent values) and hypoglycemia.
Among patients initiating U-500R (N=445), 96.9% had type 2 diabetes with mean age 57 years and mean body mass index 40.4 kg/m(2). Postindex prescriptions were written for U-500R alone (47.0%, group A) and concomitant U-500R/U-100 insulins (53.0%, group B). Concomitant oral antihyperglycemic agents (AHAs) and non-insulin injectable AHAs were used by 43.4% and 14.6% of patients, respectively. Following initiation of U-500R, mean HbA1c improved 0.68% in all patients (p<0.0001 compared with baseline), but the decrease in HbA1c did not differ significantly between groups (A: 0.78%; B: 0.60%). Overall, hypoglycemic events, largely captured in the outpatient setting, increased in incidence from 6.7% to 11.9% (p≤0.0001) and from 0.23 to 0.39 events/patient/year, an increase of 0.16 (p=0.003), from preindex to postindex.
This real-world outcomes analysis demonstrates that U-500R initiation is associated with a clinically meaningful improvement in glycemic control over the subsequent 12-month period with modest increase in incidence and rate of hypoglycemia.
描述在真实环境中使用人用常规 U-500 胰岛素（U-500R）的患者的特征及其随后的血糖控制情况。
使用美国 Humedica 电子健康记录系统的数据（2007 年 7 月至 2011 年 9 月），确定年龄≥18 岁、有≥1 次 U-500R 处方记录、有 6 个月的索引前数据、在首次使用 U-500R 后 12 个月、并且索引前和索引后都至少有 1 次糖化血红蛋白（HbA1c）值的糖尿病患者。采用配对 t 检验测量 HbA1c 从索引前到索引后的变化（最后或最近的值）和低血糖情况。
在开始使用 U-500R 的患者中（N=445），96.9%患有 2 型糖尿病，平均年龄为 57 岁，平均体重指数为 40.4kg/m2。索引后处方仅开 U-500R（47.0%，A 组）和 U-500R/ U-100 胰岛素（53.0%，B 组）。分别有 43.4%和 14.6%的患者同时使用口服抗高血糖药物（AHA）和非胰岛素注射 AHA。在开始使用 U-500R 后，所有患者的 HbA1c 平均改善 0.68%（与基线相比，p<0.0001），但两组之间 HbA1c 的下降没有显著差异（A 组：0.78%；B 组：0.60%）。总体而言，低血糖事件（主要在门诊中发现）的发生率从 6.7%增加到 11.9%（p≤0.0001），从 0.23 增加到 0.39 例/患者/年，增加了 0.16（p=0.003），从索引前到索引后。
这项真实世界的结局分析表明，U-500R 的起始治疗与随后 12 个月内血糖控制的临床显著改善相关，低血糖的发生率和发生率略有增加。
