Đekić Danijel, Bojić Mirjana, Janež Andrej, Klobučar Sanja, Hadžimušović Iris Grčić, Ković Tijana, Mihalevska Svetla
University Clinical Centre of the Republic Srpska, Banja Luka, Bosnia and Herzegovina.
University Medical Center Ljubljana, Ljubljana, Slovenia.
Diabetes Ther. 2023 Jul;14(7):1217-1229. doi: 10.1007/s13300-023-01407-3. Epub 2023 May 21.
The efficacy of iGlarLixi, a fixed-ratio combination of basal insulin glargine 100 units/mL (iGlar) and the short-acting GLP-1 RA lixisenatide (Lixi), was established in people with type 2 diabetes (T2D) who were advancing therapy from oral antidiabetic drugs (OADs) and basal insulin (BI). This retrospective study aimed to evaluate the effectiveness and safety of iGlarLixi using real-world data from people with T2D in the Adriatic region countries.
This was a non-interventional, retrospective, multicenter, cohort study with the collection of pre-existing data at iGlarLixi initiation and after 6 months of treatment in real-world clinical and ambulatory settings. The primary outcome was the change in glycated hemoglobin (HbA) at 6 months after iGlarLixi initiation. Key secondary outcomes included the proportion of people achieving HbA < 7.0%, the effect of iGlarLixi on fasting plasma glucose (FPG), body weight and body mass index (BMI).
In this study, 262 participants (130 in Bosnia and Herzegovina, 72 in Croatia and 60 in Slovenia) initiated treatment with iGlarLixi. The participants had a mean ± SD age of 66.2 ± 7.9 years and the majority were women (58.0%). The mean baseline HbA was 8.9 ± 1.7% and the mean body weight was 94.3 ± 18.0 kg. After 6 months of treatment, the reduction in the mean HbA was statistically significant (1.11 ± 1.61%, 95% confidence internal [CI] 0.92, 1.31; p < 0.001), and the proportion of participants who achieved HbA < 7.0% had significantly increased from baseline (8.0-26.0%, p < 0.001). The change in mean FPG (mmol/L) levels was significant (2.7 ± 4.4 [95% CI 2.1, 3.2; p < 0.001]). The mean ± SD body weight and BMI were significantly reduced by 2.9 ± 4.3 kg (95% CI 2.3, 3.4; p < 0.001) and 1.3 ± 4.4 kg/m (95% CI 0.7, 1.8; p < 0.001), respectively. Two serious hypoglycemia episodes and one adverse gastrointestinal effect (nausea) were registered.
This real-world study demonstrated the effectiveness of iGlarLixi for improving glycemic control and decreasing body weight in people with T2D who need to advance therapy from OADs or insulin.
甘精胰岛素100单位/毫升（iGlar）与短效胰高血糖素样肽-1受体激动剂（GLP-1 RA）利司那肽（Lixi）的固定比例复方制剂iGlarLixi，在从口服抗糖尿病药物（OAD）和基础胰岛素（BI）转换治疗方案的2型糖尿病（T2D）患者中已证实其疗效。这项回顾性研究旨在利用亚得里亚海地区国家T2D患者的真实世界数据，评估iGlarLixi的有效性和安全性。
这是一项非干预性、回顾性、多中心队列研究，收集了在真实世界临床和门诊环境中开始使用iGlarLixi时以及治疗6个月后的已有数据。主要结局是开始使用iGlarLixi后6个月糖化血红蛋白（HbA）的变化。关键次要结局包括HbA＜7.0%的患者比例、iGlarLixi对空腹血糖（FPG）、体重和体重指数（BMI）的影响。
在本研究中，262名参与者（波斯尼亚和黑塞哥维那130名、克罗地亚72名、斯洛文尼亚60名）开始使用iGlarLixi治疗。参与者的平均年龄±标准差为66.2±7.9岁，大多数为女性（58.0%）。平均基线HbA为8.9±1.7%，平均体重为94.3±18.0千克。治疗6个月后，平均HbA的降低具有统计学意义（1.11±1.61%，95%置信区间[CI]0.92，1.31；p＜0.001），且HbA＜7.0%的参与者比例较基线显著增加（8.0 - 26.0%，p＜0.001）。平均FPG（mmol/L）水平的变化具有显著性（2.7±4.4[95%CI 2.1，3.2；p＜0.001]）。平均体重±标准差和BMI分别显著降低2.9±4.3千克（95%CI 2.3，3.4；p＜0.001）和1.3±4.4千克/米²（95%CI 0.7，1.8；p＜0.001）。记录到2次严重低血糖事件和1例胃肠道不良反应（恶心）。
这项真实世界研究证明了iGlarLixi在改善需要从OAD或胰岛素转换治疗方案的T2D患者血糖控制及减轻体重方面的有效性。
