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2型糖尿病患者使用胰高血糖素样肽-1受体激动剂治疗后的强化治疗:RESTORE-G真实世界研究。

Treatment intensification following glucagon-like peptide-1 receptor agonist treatment in type 2 diabetes: The RESTORE-G real-world study.

作者信息

Candido Riccardo, Nicolucci Antonio, Larosa Monica, Rossi Maria Chiara, Napoli Raffaele

机构信息

Diabetes Centre District 4, Azienda Sanitaria Universitaria Integrata, Trieste, Italy.

CORESEARCH, Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy.

出版信息

Nutr Metab Cardiovasc Dis. 2023 Nov;33(11):2294-2305. doi: 10.1016/j.numecd.2023.07.025. Epub 2023 Jul 22.

Abstract

BACKGROUND AND AIMS

To assess intensification approaches with basal insulin (BI) following glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment in type 2 diabetes (T2D).

METHODS AND RESULTS

Real-world data were collected in electronic medical records by 32 Italian diabetes clinics between 2011 and 2021. Primary endpoint was the proportion of insulin-naïve T2D patients treated with GLP-1 RA who initiated (add-on or switch) BI. Secondary endpoints were: treatment approaches, mean time to BI start, effectiveness and safety. Among 7,962 eligible patients, BI was prescribed to 3,164 (39.7%; 95%CI 38.7; 40.8): 67.6% switched to BI (22.1% also starting 1-3 injections of short-acting insulin), 22.7% added BI while maintaining GLP-1 RA, and 9.7% switched to a fixed-ratio combination of GLP-1 RA and BI (FRC). Median time since the first GLP-1 RA to BI/FRC prescription was 27.4 (IQ range 11.8-53.5) months. In this study 60.3% of patients did not start BI/FRC, among whom 15.2% intensified GLP-1 RA therapy with other oral agents. Effectiveness and safety were documented in all intensification approaches with BI/FRC, but HbA1c level at intensification time of ≥9.0% and suboptimal BI titration suggested clinical inertia. Use of second generation BI and add-on to GLP-1 RA schemes increased over time and effectiveness improved.

CONCLUSION

Clinical inertia should be overcome using innovative insulin options. Timely combination therapy of BI and GLP-1 RA is a valuable choice.

摘要

背景与目的

评估2型糖尿病(T2D)患者在接受胰高血糖素样肽-1受体激动剂(GLP-1 RA)治疗后使用基础胰岛素(BI)的强化治疗方法。

方法与结果

2011年至2021年间,32家意大利糖尿病诊所通过电子病历收集了真实世界数据。主要终点是接受GLP-1 RA治疗的初治T2D患者启动(加用或转换)BI的比例。次要终点包括:治疗方法、开始使用BI的平均时间、有效性和安全性。在7962例符合条件的患者中,3164例(39.7%;95%CI 38.7;40.8)接受了BI治疗:67.6%转换为BI治疗(22.1%同时开始注射1-3次短效胰岛素),22.7%在维持GLP-1 RA治疗的同时加用BI,9.7%转换为GLP-1 RA与BI的固定比例联合治疗(FRC)。从首次使用GLP-1 RA到开具BI/FRC处方的中位时间为27.4(四分位间距11.8-53.5)个月。在本研究中,60.3%的患者未开始使用BI/FRC,其中15.2%使用其他口服药物强化GLP-1 RA治疗。所有使用BI/FRC的强化治疗方法均记录了有效性和安全性,但强化时糖化血红蛋白(HbA1c)水平≥9.0%以及BI滴定未达最佳提示存在临床惰性。第二代BI的使用以及在GLP-1 RA方案上加用BI的情况随时间增加,有效性有所改善。

结论

应使用创新的胰岛素方案克服临床惰性。BI与GLP-1 RA的及时联合治疗是一种有价值的选择。

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