Clinical Research, Steno Diabetes Centre Copenhagen, Herlev, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Diabetes Obes Metab. 2023 Jun;25(6):1740-1749. doi: 10.1111/dom.15031. Epub 2023 Mar 9.
To investigate the impact of treatment with once-weekly subcutaneous semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), for up to 2 years in people with type 2 diabetes (T2D) managed in routine clinical practice.
The study was based on data from national registries. People who redeemed at least one prescription of semaglutide and had 2 years of follow-up were included. Data were collected at baseline and after 180, 360, 540 and 720 days of treatment (all timepoints ± 90 days).
In total, 9284 people redeemed at least one semaglutide prescription (intention-to-treat) and 4132 people redeemed semaglutide continuously (on-treatment). For the on-treatment cohort, the median (interquartile range) age was 62.0 (16.0) years, diabetes duration was 10.8 (8.7) years, and glycated haemoglobin (HbA1c) level was 62.0 (18.0) mmol/mol at baseline. A subset of the on-treatment cohort, comprising 2676 people, had HbA1c measurements at baseline and at least once during 720 days. The mean (95% confidence interval) changes in HbA1c after 720 days were -12.6 (-13.6; -11.6) mmol/mol (P < 0.001) for GLP-1RA-naïve people, and -5.6 (-6.2; -5.0) mmol/mol (P < 0.001) for GLP-1RA-experienced people. Similarly, 55% of GLP-1RA-naïve people and 43% of GLP-1RA-experienced people reached a HbA1c target of ≤53 mmol/mol after 2 years.
People treated with semaglutide in routine clinical practice experienced clinically relevant and sustained improvements in glycaemic control after 180, 360, 540 and 720 days, irrespective of former GLP-1RA exposure, effects which were comparable with those observed in clinical studies. These results support the use of semaglutide in routine clinical practice for the long-term management of T2D.
在常规临床实践中,研究每周皮下注射一次司美格鲁肽(一种胰高血糖素样肽-1 受体激动剂(GLP-1RA))治疗长达 2 年对 2 型糖尿病(T2D)患者的影响。
本研究基于国家登记处的数据。纳入至少开具一次司美格鲁肽处方且有 2 年随访的患者。数据在治疗前和治疗后 180、360、540 和 720 天(所有时间点±90 天)采集。
共有 9284 人至少开具了一次司美格鲁肽处方(意向治疗),4132 人连续开具司美格鲁肽处方(治疗组)。对于治疗组,中位(四分位距)年龄为 62.0(16.0)岁,糖尿病病程为 10.8(8.7)年,基线时糖化血红蛋白(HbA1c)水平为 62.0(18.0)mmol/mol。在治疗组的一个亚组中,包括 2676 人,在 720 天内有基线和至少一次 HbA1c 测量值。在 720 天后,GLP-1RA 初治人群的 HbA1c 均值(95%置信区间)变化为-12.6(-13.6;-11.6)mmol/mol(P<0.001),GLP-1RA 经治人群的变化为-5.6(-6.2;-5.0)mmol/mol(P<0.001)。同样,2 年后,55%的 GLP-1RA 初治人群和 43%的 GLP-1RA 经治人群达到 HbA1c 目标值≤53mmol/mol。
在常规临床实践中,接受司美格鲁肽治疗的患者在 180、360、540 和 720 天后血糖控制得到了临床相关且持续的改善,无论以前是否使用过 GLP-1RA,其效果与临床研究观察到的效果相当。这些结果支持在常规临床实践中使用司美格鲁肽长期治疗 T2D。