Department of Endocrinology, Diabetology and Nutrition, University Hospital of Nancy, Vandoeuvre-lès-Nancy, France.
Department of Emergency and Organ Transplantation, Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy.
Diabetes Obes Metab. 2022 Dec;24(12):2373-2382. doi: 10.1111/dom.14823. Epub 2022 Aug 31.
The primary objective of the TROPHIES observational study is to estimate the duration of treatment on dulaglutide or liraglutide without a significant treatment change by 24 months in patients with type 2 diabetes (T2D) initiating their first injectable treatment with these glucagon-like peptide-1 receptor agonists (GLP-1 RAs). This manuscript presents 12-month interim data.
TROPHIES is a prospective, non-comparative, observational study of patients with T2D in Europe, naïve to injectable antihyperglycaemic treatments and initiating dulaglutide or liraglutide. Data on clinical characteristics, GLP-1 RA persistence and treatment patterns of glucose-lowering medication were collected at initiation of first injectable therapy and by 12 months.
By 12 months, 1014 dulaglutide and 991 liraglutide patients were eligible across France, Germany and Italy. Both cohorts presented a high probability [95% confidence interval (CI)] of GLP-1 RA persistence [dulaglutide, 0.88 (0.86 to 0.90); liraglutide, 0.83 (0.80 to 0.85)] and reduction in mean glycated haemoglobin percentage (95% CI) from baseline [dulaglutide, -1.18 (-1.27 to -1.08); liraglutide, -1.15 (-1.26 to -1.05)] with 48.2% of dulaglutide and 41.2% of liraglutide patients reaching their individualized glycated haemoglobin percentage target set by the physician at baseline. Mean weight (95% CI) change from baseline was -3.2 kg (-3.6 to -2.8) for dulaglutide and -3.4 kg (-3.9 to -3.0) for liraglutide. Slight changes in concomitant medications were observed compared with baseline.
In the real-world setting, dulaglutide and liraglutide cohorts achieved good persistence with similarly improved glycaemic control that was accompanied by weight loss at 12 months, consistent with previous clinical trial results.
TROPHIES 观察性研究的主要目的是估计在开始使用这些胰高血糖素样肽-1 受体激动剂（GLP-1 RAs）的 24 个月内，2 型糖尿病（T2D）患者接受度拉鲁肽或利拉鲁肽治疗而不进行重大治疗改变的治疗持续时间。本文介绍了 12 个月的中期数据。
TROPHIES 是一项在欧洲进行的前瞻性、非对照、观察性研究，纳入了初治注射用抗高血糖药物的 T2D 患者。在开始首次注射治疗时和 12 个月时收集了临床特征、GLP-1 RA 持久性和降糖药物治疗模式的数据。
在法国、德国和意大利，12 个月时共有 1014 例度拉鲁肽和 991 例利拉鲁肽患者符合条件。两个队列均显示出 GLP-1 RA 持久性的高可能性[95%置信区间（CI）] [度拉鲁肽，0.88（0.86 至 0.90）；利拉鲁肽，0.83（0.80 至 0.85）]和平均糖化血红蛋白百分比从基线下降[度拉鲁肽，-1.18（-1.27 至-1.08）；利拉鲁肽，-1.15（-1.26 至-1.05）]，48.2%的度拉鲁肽和 41.2%的利拉鲁肽患者达到了医生在基线时设定的个体化糖化血红蛋白百分比目标。与基线相比，度拉鲁肽的平均体重（95%CI）变化为-3.2kg（-3.6 至-2.8），利拉鲁肽为-3.4kg（-3.9 至-3.0）。与基线相比，伴随药物的轻微变化。
在真实世界环境中，度拉鲁肽和利拉鲁肽队列在 12 个月时实现了良好的持久性，同时改善了血糖控制，伴随着体重减轻，这与先前的临床试验结果一致。
