Introduction

A dedicated Humulin R U-500 (U-500R) prefilled disposable insulin pen (KwikPen) became available in 2016, yet limited evidence exists on treatment patterns and outcomes of U-500R via KwikPen (U500-KP).

Methods

This is a retrospective observational study among adults with ≥2 claims for type 2 diabetes initiating U500-KP (index date: first claim) identified in Veterans Health Administration database. Treatment patterns and outcomes were evaluated in 9-month pre- and post-index periods, including dispensed total daily insulin dosage derived from claims expressed in units (dTDD) and units/kg, HbA1c, symptomatic hypoglycemia, and body weight. Multivariable modeling was used to confirm the associations between U500-KP initiation and outcomes.

Results

A total of 647 U500-KP initiators were identified. The mean age was 64 years, and mean Quan-Charlson Comorbidity-index score was 3.8. Before U500-KP initiation, 62% of patients had dTDD ≤ 200 units with mean A1c 9.5%. Mean dTDD increased from 188.2 to 269.9 units after U500-KP initiation with mean A1c decreased by 0.83% (SD = 1.67) and mean weight gain of 1.5 kg (SD = 6.74). Hypoglycemia events increased from 4.3 to 5.3 (p < 0.05) per person per year.

Conclusions

Initiation of U500-KP brought significant improvement in dispensed insulin dose and glycemic control accompanied by moderate increases in hypoglycemia and weight.

中文翻译：

---

在美国 2 型糖尿病退伍军人中通过 KwikPen® 启动人类常规 U-500 胰岛素之前和之后的治疗模式和结果

介绍

专用的 Humulin R U-500 (U-500R) 预填充一次性胰岛素笔 (KwikPen) 于 2016 年上市，但通过 KwikPen (U500-KP) 对 U-500R 的治疗模式和结果的证据有限。

方法

这是一项回顾性观察研究，在退伍军人健康管理局数据库中确定的 ≥2 项 2 型糖尿病索赔的成年人中发起 U500-KP（索引日期：第一次索赔）。在指标前后的 9 个月内评估治疗模式和结果，包括根据以单位 (dTDD) 和单位/kg、HbA1c、症状性低血糖和体重表示的声明得出的每日总胰岛素剂量。多变量模型用于确认 U500-KP 启动与结果之间的关联。

结果

总共确定了 647 个 U500-KP 发起者。平均年龄为 64 岁，平均 Quan-Charlson 合并症指数评分为 3.8。在开始 U500-KP 之前，62% 的患者 dTDD ≤ 200 单位，平均 A1c 为 9.5%。开始 U500-KP 后，平均 dTDD 从 188.2 增加到 269.9 单位，平均 A1c 下降 0.83% (SD = 1.67)，平均体重增加 1.5 kg (SD = 6.74)。 每人每年的低血糖事件从 4.3 增加到 5.3 ( p < 0.05)。

结论

U500-KP 的启动显着改善了分配的胰岛素剂量和血糖控制，伴随着低血糖和体重的适度增加。