从基础胰岛素治疗进展而来的2型糖尿病成人患者中，甘精胰岛素利司那肽起始治疗对比基础-餐时胰岛素治疗：SoliComplex真实世界研究
Initiation of iGlarLixi Versus Basal-Bolus Insulin in Adults With Type 2 Diabetes Advancing From Basal Insulin Therapy: The SoliComplex Real-World Study.
作者信息
Pantalone Kevin M, Heller Caroline, Lajara Rosemarie, Lew Elisheva, Li Xuan, Dex Terry, Kilpatrick C Rachel
机构信息
Cleveland Clinic, Cleveland, OH.
Aetion, New York, NY.
出版信息
Diabetes Spectr. 2023 Summer;36(3):253-263. doi: 10.2337/ds22-0064. Epub 2023 Mar 7.
BACKGROUND
When type 2 diabetes is suboptimally controlled with basal insulin, prandial insulin injections are commonly added (i.e., a basal-bolus insulin regimen), which can increase treatment burden and hypoglycemia risk. The once-daily injectable iGlarLixi is an alternative treatment.
METHODS
This retrospective analysis of the U.S. Optum Clinformatics database compared outcomes in adults (≥18 years of age) with type 2 diabetes who previously received basal insulin and were newly initiated on iGlarLixi or basal-bolus insulin therapy. Cohorts were propensity score-matched in a 1:1 ratio on baseline characteristics, and imbalances were adjusted in multivariate analyses. Subgroup analyses were performed for people ≥65 years of age and those with a baseline A1C ≥9%. The primary end point was persistence with therapy at 12 months in the overall population. Secondary end points were treatment adherence, health care resource utilization (HCRU), costs, any hypoglycemia, and A1C change at 12 months.
RESULTS
Cohorts each comprised 1,070 participants. Treatment persistence at 12 months was statistically significantly higher for iGlarLixi versus basal-bolus insulin therapy (43.7 vs. 22.3%, hazard ratio 0.51, 95% CI 0.46-0.57, adjusted <0.001). Adherence was numerically higher for iGlarLixi, and hypoglycemia events, HCRU, and costs were numerically lower for iGlarLixi. A1C reduction from baseline was slightly greater for basal-bolus insulin. Results for both subgroups (≥65 years of age and baseline A1C ≥9%) were similar to those of the overall population.
CONCLUSION
In this observational study, initiation of once-daily iGlarLixi versus basal-bolus insulin was associated with higher persistence, lower hypoglycemia, and similar A1C reduction without increasing HCRU or costs regardless of age or A1C. iGlarLixi could be an alternative to basal-bolus insulin, particularly for older adults with type 2 diabetes who require treatment simplification with lower hypoglycemia risk.
背景
当基础胰岛素治疗未能使2型糖尿病得到充分控制时，通常会加用餐时胰岛素注射（即基础-餐时胰岛素方案），这会增加治疗负担和低血糖风险。每日一次注射用的iGlarLixi是一种替代治疗方法。
方法
这项对美国Optum临床信息数据库的回顾性分析比较了成年（≥18岁）2型糖尿病患者的治疗结果，这些患者之前接受基础胰岛素治疗，新近开始使用iGlarLixi或基础-餐时胰岛素治疗。队列根据基线特征以1:1的比例进行倾向评分匹配，并在多变量分析中对不均衡因素进行调整。对年龄≥65岁和基线糖化血红蛋白（A1C）≥9%的患者进行亚组分析。主要终点是总体人群中12个月时的治疗持续率。次要终点包括治疗依从性、医疗资源利用（HCRU）、成本、任何低血糖事件以及12个月时的A1C变化。
结果
每个队列各有1070名参与者。与基础-餐时胰岛素治疗相比，iGlarLixi在12个月时的治疗持续率在统计学上显著更高（43.7%对22.3%，风险比0.51，95%置信区间0.46 - 0.57，校正后<0.001）。iGlarLixi的依从性在数值上更高，而低血糖事件、HCRU和成本在数值上更低。基础-餐时胰岛素从基线的A1C降低幅度略大。两个亚组（年龄≥65岁和基线A1C≥9%）的结果与总体人群相似。
结论
在这项观察性研究中，起始每日一次的iGlarLixi与基础-餐时胰岛素相比，具有更高的治疗持续率、更低的低血糖发生率以及相似的A1C降低幅度，且不增加HCRU或成本，无论年龄或A1C如何。iGlarLixi可能是基础-餐时胰岛素的一种替代选择，尤其适用于需要简化治疗且低血糖风险较低的老年2型糖尿病患者。
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