Royal Victoria Hospital, McGill University Health Centre, Montreal, Quebec, Canada
Kastruplægerne, Kastrup, Denmark.
BMJ Open Diabetes Res Care. 2022 Apr;10(2). doi: 10.1136/bmjdrc-2021-002619.
This post hoc pooled analysis of four real-world studies (SURE Canada, Denmark/Sweden, Switzerland and UK) aimed to characterize the use of once-weekly (OW) semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), in patients with type 2 diabetes (T2D).
The Semaglutide Real-world Evidence (SURE) studies had a duration of ~30 weeks. Changes in glycated hemoglobin (HbA) and body weight (BW) were analyzed for the overall population and the following baseline subgroups: GLP-1RA-naïve/GLP-1RA switchers; body mass index <25/≥25-<30/≥30-<35/≥35 kg/m; age <65/≥65 years; HbA <7%/≥7-≤8%/>8-≤9%/>9%; T2D duration <5/≥5-<10/≥10 years. Data for patients achieving treatment targets were analyzed in the overall population and the baseline HbA ≥7% subgroup.
Of 1212 patients, 960 were GLP-1RA-naïve and 252 had switched to semaglutide from another GLP-1RA. In the overall population, HbA was reduced from baseline to end of study (EOS) by -1.1% point and BW by -4.7 kg; changes were significant for all subgroups. There were significantly larger reductions of HbA and BW in GLP-1RA-naïve versus GLP-1RA switchers and larger reductions in HbA for patients with higher versus lower baseline HbA. At EOS, 52.6% of patients in the overall population achieved HbA <7%. No new safety concerns were identified in any of the completed SURE studies.
In this pooled analysis, patients with T2D initiating OW semaglutide showed significant improvements from baseline to EOS in HbA and BW across various baseline subgroups, including patients previously treated with a GLP-1RA other than semaglutide, supporting OW semaglutide use in clinical practice.
NCT03457012; NCT03631186; NCT03648281; NCT03876015.
本事后分析纳入了四项真实世界研究(SURE 加拿大、丹麦/瑞典、瑞士和英国),旨在描述每周一次(OW)司美格鲁肽(一种胰高血糖素样肽-1 受体激动剂 [GLP-1RA])在 2 型糖尿病(T2D)患者中的应用。
SURE 研究的持续时间约为 30 周。分析了总体人群和以下基线亚组的糖化血红蛋白(HbA)和体重(BW)变化:GLP-1RA 初治/GLP-1RA 转换者;体重指数(BMI)<25/≥25-<30/≥30-<35/≥35kg/m²;年龄<65/≥65 岁;HbA<7%/≥7-≤8%/>8-≤9%/>9%;T2D 病程<5/≥5-<10/≥10 年。在总体人群和基线 HbA≥7%亚组中,分析了达到治疗目标患者的数据。
在 1212 名患者中,960 名患者为 GLP-1RA 初治,252 名患者从其他 GLP-1RA 转换为司美格鲁肽。在总体人群中,HbA 从基线下降至研究结束(EOS)-1.1 个百分点,BW 下降-4.7kg;所有亚组均有显著变化。GLP-1RA 初治患者的 HbA 和 BW 降幅明显大于 GLP-1RA 转换者,基线 HbA 较高的患者的 HbA 降幅更大。在 EOS,总体人群中有 52.6%的患者 HbA<7%。在任何一项已完成的 SURE 研究中,均未发现新的安全性问题。
在这项汇总分析中,开始接受 OW 司美格鲁肽治疗的 T2D 患者在 HbA 和 BW 方面均有显著改善,在包括之前接受过非司美格鲁肽 GLP-1RA 治疗的患者在内的各种基线亚组中均如此,支持 OW 司美格鲁肽在临床实践中的应用。
NCT03457012;NCT03631186;NCT03648281;NCT03876015。