Jain Akshay B, Kanters Steve, Khurana Reena, Kissock Jagoda, Severin Naomi, Stafford Sara G
Fraser River Endocrinology, Surrey, BC, Canada.
Department of Medicine, Division of Endocrinology at University of British Columbia, Vancouver, BC, Canada.
Diabetes Ther. 2021 Feb;12(2):527-536. doi: 10.1007/s13300-020-00984-x. Epub 2020 Dec 26.
Injectable semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) that was previously shown to be superior to liraglutide and dulaglutide in head-to-head comparisons in GLP-1 RA-naïve individuals. It is hypothesized that semaglutide will cause further reductions in glycated hemoglobin A1c (HbA1c) and weight in type 2 diabetes mellitus (T2DM) patients previously treated with liraglutide or dulaglutide. The REALISE-DM study provides the first real-world evidence of the effectiveness and tolerability of semaglutide in patients switching from another GLP-1 RA.
This retrospective real-world effectiveness analysis included T2DM adults who were on a stable dose of liraglutide or dulaglutide prior to switching to semaglutide. The primary outcome was change in HbA1c. Secondary outcomes were the changes in weight and body mass index (BMI), the occurrence of gastrointestinal side effects (GSEs), and discontinuations. Linear mixed models were used to estimate changes in HbA1c, weight, and BMI, and logistic regression was employed to analyze GSEs and discontinuations.
Six months after the 164 patients in this study had switched to semaglutide, their mean HbA1c had decreased by 0.65% (7.1 mmol/mol) (95% prediction interval [PI]: 0.48, 0.81% [5.2, 8.9 mmol/mol]) from a baseline of 7.9% (interquartile range [IQR]: 7.3, 8.8) (62.8 mmol/mol [IQR: 56.3, 72.7]), while their weight and BMI had reduced by 1.69 kg (95% PI: 1.01, 2.37) and 0.59 kg/m (95% PI: 0.34, 0.84), respectively. Nineteen patients (11.6%) developed GSEs after switching.
This study supports switching T2DM patients on liraglutide or dulaglutide to injectable semaglutide to achieve further reductions in HbA1c and weight. Although a small number of GSEs occurred, semaglutide was well tolerated by the majority of the patients.
注射用司美格鲁肽是一种胰高血糖素样肽-1受体激动剂(GLP-1 RA),先前在未使用过GLP-1 RA的个体的头对头比较中显示优于利拉鲁肽和度拉糖肽。据推测,司美格鲁肽将使先前接受利拉鲁肽或度拉糖肽治疗的2型糖尿病(T2DM)患者的糖化血红蛋白A1c(HbA1c)和体重进一步降低。REALISE-DM研究提供了司美格鲁肽在从另一种GLP-1 RA转换的患者中的有效性和耐受性的首个真实世界证据。
这项回顾性真实世界有效性分析纳入了在转换为司美格鲁肽之前稳定使用利拉鲁肽或度拉糖肽的T2DM成年人。主要结局是HbA1c的变化。次要结局是体重和体重指数(BMI)的变化、胃肠道副作用(GSEs)的发生情况以及停药情况。使用线性混合模型估计HbA1c、体重和BMI的变化,并采用逻辑回归分析GSEs和停药情况。
本研究中的164例患者转换为司美格鲁肽6个月后,其平均HbA1c从基线的7.9%(四分位间距[IQR]:7.3,8.8)(62.8 mmol/mol [IQR:56.3,72.7])下降了0.65%(7.1 mmol/mol)(95%预测区间[PI]:0.48,0.81% [5.2,8.9 mmol/mol]),而体重和BMI分别下降了1.69 kg(95% PI:1.01,2.37)和0.59 kg/m²(95% PI:0.34,0.84)。19例患者(11.6%)在转换后出现了GSEs。
本研究支持将使用利拉鲁肽或度拉糖肽的T2DM患者转换为注射用司美格鲁肽,以进一步降低HbA1c和体重。尽管出现了少量GSEs,但大多数患者对司美格鲁肽耐受性良好。