Candido Riccardo, Modugno Monica, Larosa Monica, Rossi Maria Chiara, Nicolucci Antonio, Gabellieri Enrico
Diabetes Center District 4, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy.
ASLBA-DSS10 Poliambulatorio, Triggiano, BA, Italy.
Diabetes Ther. 2023 Jan;14(1):77-92. doi: 10.1007/s13300-022-01328-7. Epub 2022 Nov 14.
Pivotal trials documented glycemic benefits of fixed-ratio combination of insulin glargine 100 U/mL and lixisenatide (iGlarLixi), with no weight gain and low hypoglycemia risk in type 2 diabetes (T2D). This study aimed at assessing effectiveness and patterns of use of iGlarLixi in a real-world setting.
This was a retrospective, multicenter, study, based on electronic medical records. All patients initiating iGlarLixi from May 2018 to July 2020 were considered.
Overall, 25 centers provided data on 675 patients initiating iGlarLixi with the following characteristics: age 66.4 ± 10.1 years, 54.2% men, T2D duration 15.5 ± 11.5 years, HbA1c 8.6 ± 1.4%, body mass index (BMI) 30.8 ± 5.3 kg/m, 45.1% already treated with basal insulin, and 21.9% with basal bolus (± oral hypoglycemic agents). Metformin and sodium-glucose cotransporter-2 inhibitors were used in 76.0% and 0.9% of patients, respectively. Combinations of iGlarLixi with other glucose-lowering drugs such as sulfonylureas or short-acting insulin were found in 32.4% of patients. Effectiveness of iGlarLixi (N = 184) showed that HbA1c declined by 0.77% [95% confidence interval (CI) -1.00, -0.54] after 6 months. In combination with metformin and/or SGLT-2i (N = 117), HbA1c declined by -0.92% (95% CI -1.22, -0.62) and weight significantly decreased by 1.21 kg. iGlarLixi dose was suboptimally titrated. Safety data (N = 171) showed incidence rates of blood glucose ≤ 70 and < 54 mg/mL of 0.26 and 0.05 events per person-month during 6 months, respectively, with a risk reduction of about 75% with respect the 6 months before iGlarLixi initiation. No severe hypoglycemia was reported.
In adults with T2D, effectiveness and safety of iGlarLixi were documented in a real-world setting; appropriateness of use and adequate titration should be urgently improved so that clinical practice outcomes become more comparable to clinical trials results. Further real-world studies on the effect of iGlarLixi therapy are warranted.
关键试验证明了甘精胰岛素100 U/mL与利司那肽（iGlarLixi）固定比例联合使用对血糖的益处，在2型糖尿病（T2D）患者中无体重增加且低血糖风险低。本研究旨在评估iGlarLixi在真实世界中的有效性和使用模式。
这是一项基于电子病历的回顾性多中心研究。纳入了2018年5月至2020年7月开始使用iGlarLixi的所有患者。
总体而言，25个中心提供了675例开始使用iGlarLixi患者的数据，其特征如下：年龄66.4±10.1岁，男性占54.2%，T2D病程15.5±11.5年，糖化血红蛋白（HbA1c）8.6±1.4%，体重指数（BMI）30.8±5.3 kg/m²，45.1%的患者已接受基础胰岛素治疗，21.9%的患者接受基础加餐时胰岛素治疗（±口服降糖药）。分别有76.0%和0.9%的患者使用二甲双胍和钠-葡萄糖协同转运蛋白2抑制剂。32.4%的患者将iGlarLixi与其他降糖药物如磺脲类或短效胰岛素联合使用。iGlarLixi（N = 184）的有效性显示，6个月后HbA1c下降了0.77%[95%置信区间（CI）-1.00，-0.54]。与二甲双胍和/或SGLT-2抑制剂联合使用时（N = 117），HbA1c下降了-0.92%（95% CI -1.22，-0.62），体重显著下降1.21 kg。iGlarLixi剂量滴定未达最佳。安全性数据（N = 171）显示，在6个月期间，血糖≤70和<54 mg/mL的发生率分别为每人每月0.26和0.05次事件，与开始使用iGlarLixi前6个月相比，风险降低约75%。未报告严重低血糖事件。
在成年T2D患者中，iGlarLixi在真实世界中的有效性和安全性得到了证实；应迫切改善其使用的合理性和充分滴定，以使临床实践结果更接近临床试验结果。有必要对iGlarLixi治疗效果进行进一步的真实世界研究。
