Metabolic Institute of America, 18372 Clark St. Suite 212, Tarzana, CA 91356, USA.
Abington Memorial Hospital, 500 York Rd Suite 108, Jenkintown, PA 19046, USA.
J Diabetes Complications. 2019 Mar;33(3):236-242. doi: 10.1016/j.jdiacomp.2018.11.009. Epub 2018 Nov 30.
This study assessed the efficacy and safety of iGlarLixi (a titratable, fixed-ratio combination of insulin glargine [iGlar] plus lixisenatide) in older patients with type 2 diabetes.
This post hoc analysis used patient-level data from patients aged ≥65 years from the phase III LixiLan-O and LixiLan-L studies, which compared iGlarLixi with iGlar and lixisenatide (LixiLan-O only). Efficacy endpoints were changes in glycated hemoglobin A1C, fasting plasma glucose, postprandial glucose, weight, and achievement of A1C <7.0% (53 mmol/mol). Safety measures included incidence of documented symptomatic hypoglycemia (defined as typical symptoms of hypoglycemia plus self-measured plasma glucose ≤70 mg/dL [3.9 mmol/L]), severe hypoglycemia (requiring assistance of another person), and incidence of gastrointestinal adverse events. Results were compared with those from patients aged <65 years.
In both trials, older patients treated with iGlarLixi achieved significantly greater reductions in A1C at Week 30 than comparators. Treatment with iGlarLixi mitigated insulin-associated weight gain and lixisenatide-associated gastrointestinal events. Results were largely comparable between patients aged ≥65 versus <65 years.
iGlarLixi provides significant improvements in glycemic control in patients aged ≥65 years without increasing hypoglycemia risk. As a once-daily injection, it simplifies treatment regimens and may contribute to improved adherence in this patient population.
本研究评估了可滴定固定比例胰岛素甘精（iGlar）加利西那肽（lixisenatide）合剂（iGlarLixi）在老年 2 型糖尿病患者中的疗效和安全性。
这是一项事后分析，使用了来自 LixiLan-O 和 LixiLan-L 三期研究中年龄≥65 岁患者的个体患者数据，这些研究比较了 iGlarLixi 与 iGlar 和利西那肽（仅 LixiLan-O）的疗效。疗效终点为糖化血红蛋白 A1C、空腹血糖、餐后血糖、体重的变化以及 A1C<7.0%（53mmol/mol）的达标率。安全性措施包括记录到的有症状低血糖（定义为低血糖典型症状加上自我测量的血浆葡萄糖≤70mg/dL[3.9mmol/L]）、严重低血糖（需要他人帮助）以及胃肠道不良事件的发生率。结果与年龄<65 岁的患者进行了比较。
在两项试验中，接受 iGlarLixi 治疗的老年患者在第 30 周时 A1C 降低幅度显著大于对照组。与对照组相比，使用 iGlarLixi 治疗可减轻胰岛素相关的体重增加和利西那肽相关的胃肠道事件。≥65 岁和<65 岁患者之间的结果基本一致。
iGlarLixi 可显著改善≥65 岁患者的血糖控制，且不会增加低血糖风险。作为一种每日一次的注射剂，它简化了治疗方案，可能有助于提高该患者人群的治疗依从性。
