评估长效GLP-1受体激动剂治疗T1DM患者的疗效和安全性

Deene Mohandas, Jamie Calma, Catherine Gao, M. Basina
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引用次数: 2

摘要

(1) 背景:胰高血糖素样肽1受体激动剂(GLP-1 RA)是一类模拟内源性肠促生长素GLP-1的治疗剂。虽然由于担心糖尿病酮症酸中毒(DKA)风险增加,这类药物未被批准用于1型糖尿病(T1DM),但在临床实践中,长效GLP-1药物通常是针对T1DM的标示外处方。几项研究探讨了短效GLP-1激动剂治疗T1DM患者的疗效和安全性,但缺乏长效药物的数据。在我们的研究中,我们旨在填补这一空白,并帮助医疗保健提供者在T1DM患者使用这些药物的临床决策中。(2) 方法:我们对服用长效GLP-1至少六个月的T1DM患者进行了回顾性图表审查。我们的回顾性图表审查包括开始GLP-1前两年和开始GLP-1后六个月或更长时间的信息。收集的参数包括HbA1c、14天连续血糖监测(CGM)和血糖(BG)数据,以及代谢数据(体重、收缩压和舒张压以及胆固醇水平)。在R和Excel上使用配对t检验进行统计分析,α为0.05。(3) 结果:我们的队列由54名服用长效GLP-1(赛马鲁肽、杜拉鲁肽、艾塞那肽缓释[ER]、阿比鲁肽)的T1DM参与者组成。GLP-1的平均治疗时间为23.85±15.46个月。与GLP-1治疗相比,治疗前HbA1c值平均下降0.71%(%-点,p=0.002)。类似地,对于治疗前与GLP-1治疗值相比,CGM结果显著增加了12.15%的时间(p=0.0009),显示高血糖(BG>180 mg/dL)的平均时间减少了11.97%的平均差异(p=0.006),14天平均BG减少了19 mg/dL(p=0.01),DKA住院率降低,体重减轻3.16kg(p=0.007)。(4)结论:随着更多关于长效GLP-1对2型糖尿病心血管和肾脏益处的数据出现,T1DM的结果尚未报告。我们的研究首次证明了这类药物作为胰岛素辅助治疗T1DM的血糖和代谢益处,以及在平均1.5-2年内使用的安全性。这项研究代表了真实的生活经历,数据值得进一步的前瞻性研究证实。
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Evaluating the Efficacy and Safety of Long-Acting GLP-1 Receptor Agonists in T1DM Patients
(1) Background: Glucagon-like peptide 1 receptor agonists (GLP-1 RA) are a class of therapeutic agents that mimic the endogenous incretin hormone GLP-1. While this class of agents is not approved for Type 1 Diabetes (T1DM) due to concern of increased diabetic ketoacidosis (DKA) risk, long-acting GLP-1 medications are being commonly prescribed off label for T1DM in clinical practice. Several studies addressed the efficacy and safety of short-acting GLP-1 agonists therapy in patients with T1DM, but the data on long-acting agents are lacking. In our study, we aim to fill in this gap and help healthcare providers in their clinical decision making on the use of these agents for T1DM patients. (2) Methods: We conducted a retrospective chart review of T1DM patients on a long-acting GLP-1 for at least six months. Our retrospective chart review included information starting two years prior to starting GLP-1, and six or more months after starting GLP-1. Parameters collected included HbA1c, 14-day Continuous Glucose Monitor (CGM) and blood glucose (BG) data, and metabolic data (weight, systolic and diastolic blood pressure, and cholesterol levels). Statistical analysis was conducted using paired t-tests on R and Excel with α of 0.05. (3) Results: Our cohort consisted of 54 participants with T1DM on a long-acting GLP-1 (semaglutide, dulaglutide, exenatide extended-release [ER], albiglutide). Mean GLP-1 treatment duration was 23.85 ± 15.46 months. HbA1c values decreased significantly by an average of 0.71% percentage points (%-points, p = 0.002) comparing pre-therapy vs. on GLP-1 treatment. Similarly, for pre-therapy vs. on GLP-1 treatment values, CGM results were significant for increased time in range by 12.15%-points (p = 0.0009) showing a decreased average time in hyperglycemia (BG > 180 mg/dL) by a mean difference of 11.97%-points (p = 0.006), decreased 14-day mean BG by 19 mg/dl (p = 0.01), decreased 14-day BG standard deviation by 8.45 mg/dl (p = 0.01), decreased incidence of DKA hospitalization, and a decrease in weight by 3.16 kg (p = 0.007). (4) Conclusions: As more data emerges on cardiovascular and renal benefits of long acting GLP-1 in type 2 diabetes, there have been no reported outcomes in T1DM. Our study is the first to demonstrate glycemic and metabolic benefits of this class of medication as an adjunct therapy to insulin in T1DM, and safety of its use over an average of 1.5–2 years’ time. This study represents real life experience and the data warrants confirmation by additional prospective studies.
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