García-Pérez Luis-Emilio, Boye Kristina S, Rosilio Myriam, Jung Heike, Heitmann Elke, Norrbacka Kirsi, Federici Marco Orsini, Gentilella Raffaella, Guerci Bruno, Giorgino Francesco, Aigner Ulrich, Sapin Hélène
Lilly, S.A., Avenida de La Industria, 30, 28108, Alcobendas, Spain.
Eli Lilly and Company, Indianapolis, IN, USA.
Diabetes Ther. 2021 Jul;12(7):1929-1946. doi: 10.1007/s13300-021-01076-0. Epub 2021 Jun 7.
The TROPHIES observational study enrolled patients with type 2 diabetes mellitus (T2DM) initiating their first injectable treatment with the glucagon-like peptide 1 receptor agonists (GLP-1 RAs) dulaglutide or liraglutide. This manuscript focuses on the study design, baseline characteristics of the enrolled population, and factors associated with GLP-1 RA choice.
TROPHIES is a prospective, observational, 24-month study conducted in France, Germany, and Italy. Inclusion criteria include adult patients with T2DM, naïve to injectable antihyperglycemic treatments, initiating dulaglutide or liraglutide per routine clinical practice. The primary outcome is the duration of treatment on dulaglutide or liraglutide without a significant treatment change.
The analysis included 2181 patients (dulaglutide, 1130; liraglutide, 1051) (cutoff date May 15, 2019). The population was 56% male with mean [standard deviation (SD)] patient characteristics at baseline as follows: age, 59.2 (11.0) years; body mass index (BMI), 33.9 (6.6) kg/m; T2DM duration, 8.5 (6.9) years; and glycated hemoglobin (HbA1c), 8.2 (1.3)%. Between-cohort demographic and clinical characteristics were balanced. The mean (SD) HbA1c and BMI values for French, German, and Italian patients were, respectively, 8.6 (1.4)%, 8.2 (1.4)%, 8.0 (0.8)%; 33.3 (6.1) kg/m, 36.0 (7.2) kg/m, and 32.6 (5.9) kg/m.
This study analysis at baseline provides an opportunity to evaluate between-country differences in baseline HbA1c, weight, macrovascular complications, and factors driving GLP-1 RA selection for patients with T2DM in daily practice.
TROPHIES观察性研究纳入了开始首次使用胰高血糖素样肽-1受体激动剂（GLP-1 RAs）度拉糖肽或利拉鲁肽进行注射治疗的2型糖尿病（T2DM）患者。本手稿重点关注研究设计、纳入人群的基线特征以及与GLP-1 RA选择相关的因素。
TROPHIES是一项在法国、德国和意大利进行的为期24个月的前瞻性观察性研究。纳入标准包括成年T2DM患者，既往未接受过注射用降糖治疗，按照常规临床实践开始使用度拉糖肽或利拉鲁肽。主要结局是在度拉糖肽或利拉鲁肽治疗且治疗无显著变化的持续时间。
分析纳入了2181例患者（度拉糖肽组1130例；利拉鲁肽组1051例）（截止日期为2019年5月15日）。该人群中男性占56%，基线时患者的平均[标准差（SD）]特征如下：年龄59.2（11.0）岁；体重指数（BMI）33.9（6.6）kg/m²；T2DM病程8.5（6.9）年；糖化血红蛋白（HbA1c）8.2（1.3）%。队列间的人口统计学和临床特征均衡。法国、德国和意大利患者的平均（SD）HbA1c和BMI值分别为8.6（1.4）%、8.2（1.4）%、8.0（0.8）%；33.3（6.1）kg/m²、36.0（7.2）kg/m²和32.6（5.9）kg/m²。
这项基线研究分析为评估日常实践中T2DM患者基线HbA1c、体重、大血管并发症的国家间差异以及驱动GLP-1 RA选择的因素提供了机会。
