Abstract：
To present the final results of the TROPHIES study (The real-world observational prospective study of health outcomes with dulaglutide and liraglutide in patients with type 2 diabetes).
The prospective, real-world TROPHIES study included patients with type 2 diabetes initiating their first injectable glucose-lowering medication (GLM), dulaglutide or liraglutide, in France, Germany and Italy. The primary endpoint was the time spent on dulaglutide or liraglutide until a significant treatment change over 24 months. Other endpoints measured persistence with treatment, clinical outcomes (glycated haemoglobin [HbA1c] and weight) and treatment patterns. Kaplan-Meier estimates of time to first significant treatment change and persistence with treatment were generated. Propensity-score-based inverse probability of treatment weighting (IPTW) was used to adjust for baseline imbalances in the comparison between cohorts.
The 286 of 1014 patients (28.2%) in the dulaglutide cohort and 448 of 991 patients (45.2%) in the liraglutide cohort had a significant treatment change over 24 months. By IPTW analysis, dulaglutide-initiating patients were less likely to have a significant treatment change (hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.46-0.63) and more likely to be persistent with treatment (HR 0.69, 95% CI 0.56-0.86) over 24 months than liraglutide-initiating patients. Dulaglutide and liraglutide yielded similar HbA1c (-11.80 mmol/mol [1.08%] and -11.91 mmol/mol [1.09%]) and weight (-3.5 kg and -3.3 kg) reductions from baseline to 24 months. Few changes in patterns of treatment with other GLMs were observed in the two cohorts.
Dulaglutide-initiating patients had a longer time spent without any significant treatment change and higher persistence than those initiating liraglutide. Treatment with either glucagon-like peptide-1 receptor agonist yielded similar and clinically meaningful reductions in HbA1c and body weight.
The prospective, real-world TROPHIES study included patients with type 2 diabetes initiating their first injectable glucose-lowering medication (GLM), dulaglutide or liraglutide, in France, Germany and Italy. The primary endpoint was the time spent on dulaglutide or liraglutide until a significant treatment change over 24 months. Other endpoints measured persistence with treatment, clinical outcomes (glycated haemoglobin [HbA1c] and weight) and treatment patterns. Kaplan-Meier estimates of time to first significant treatment change and persistence with treatment were generated. Propensity-score-based inverse probability of treatment weighting (IPTW) was used to adjust for baseline imbalances in the comparison between cohorts.
The 286 of 1014 patients (28.2%) in the dulaglutide cohort and 448 of 991 patients (45.2%) in the liraglutide cohort had a significant treatment change over 24 months. By IPTW analysis, dulaglutide-initiating patients were less likely to have a significant treatment change (hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.46-0.63) and more likely to be persistent with treatment (HR 0.69, 95% CI 0.56-0.86) over 24 months than liraglutide-initiating patients. Dulaglutide and liraglutide yielded similar HbA1c (-11.80 mmol/mol [1.08%] and -11.91 mmol/mol [1.09%]) and weight (-3.5 kg and -3.3 kg) reductions from baseline to 24 months. Few changes in patterns of treatment with other GLMs were observed in the two cohorts.
Dulaglutide-initiating patients had a longer time spent without any significant treatment change and higher persistence than those initiating liraglutide. Treatment with either glucagon-like peptide-1 receptor agonist yielded similar and clinically meaningful reductions in HbA1c and body weight.
摘要：
目的：介绍TROPHIES研究（杜拉鲁肽和利拉鲁肽对2型糖尿病患者健康结局的真实世界观察性前瞻性研究）的最终结果。
方法：前瞻性，现实世界的TROPHIES研究包括2型糖尿病患者开始他们的第一个注射降糖药物（GLM），杜拉鲁肽或利拉鲁肽，在法国,德国和意大利。主要终点是在24个月内使用杜拉鲁肽或利拉鲁肽直至显著治疗改变的时间。其他终点测量了治疗的持久性，临床结果（糖化血红蛋白[HbA1c]和体重）和治疗模式。产生了对首次显著治疗改变的时间的Kaplan-Meier估计和治疗的持久性。使用基于倾向评分的治疗加权逆概率(IPTW)来调整队列之间比较中的基线不平衡。
结果：杜拉鲁肽队列中1014例患者中的286例（28.2%）和利拉鲁肽队列中991例患者中的448例（45.2%）在24个月内发生了显著的治疗变化。通过IPTW分析，与使用利拉鲁肽的患者相比,使用杜拉鲁肽的患者在24个月内发生显著治疗改变的可能性较小(风险比[HR]0.54,95%置信区间[CI]0.46~0.63),并且在治疗后持续(HR0.69,95%CI0.56~0.86)的可能性更大.从基线到24个月，杜拉鲁肽和利拉鲁肽产生了相似的HbA1c（-11.80mmol/mol[1.08%]和-11.91mmol/mol[1.09%]）和体重（-3.5kg和-3.3kg）减少。在两个队列中观察到其他GLM的治疗模式几乎没有变化。
结论：与使用利拉鲁肽的患者相比，使用达拉鲁肽的患者花费的时间更长，没有任何明显的治疗改变，并且持续的时间更高。使用任一胰高血糖素样肽-1受体激动剂的治疗在HbA1c和体重方面产生了相似且临床上有意义的降低。
方法：前瞻性，现实世界的TROPHIES研究包括2型糖尿病患者开始他们的第一个注射降糖药物（GLM），杜拉鲁肽或利拉鲁肽，在法国,德国和意大利。主要终点是在24个月内使用杜拉鲁肽或利拉鲁肽直至显著治疗改变的时间。其他终点测量了治疗的持久性，临床结果（糖化血红蛋白[HbA1c]和体重）和治疗模式。产生了对首次显著治疗改变的时间的Kaplan-Meier估计和治疗的持久性。使用基于倾向评分的治疗加权逆概率(IPTW)来调整队列之间比较中的基线不平衡。
结果：杜拉鲁肽队列中1014例患者中的286例（28.2%）和利拉鲁肽队列中991例患者中的448例（45.2%）在24个月内发生了显著的治疗变化。通过IPTW分析，与使用利拉鲁肽的患者相比,使用杜拉鲁肽的患者在24个月内发生显著治疗改变的可能性较小(风险比[HR]0.54,95%置信区间[CI]0.46~0.63),并且在治疗后持续(HR0.69,95%CI0.56~0.86)的可能性更大.从基线到24个月，杜拉鲁肽和利拉鲁肽产生了相似的HbA1c（-11.80mmol/mol[1.08%]和-11.91mmol/mol[1.09%]）和体重（-3.5kg和-3.3kg）减少。在两个队列中观察到其他GLM的治疗模式几乎没有变化。
结论：与使用利拉鲁肽的患者相比，使用达拉鲁肽的患者花费的时间更长，没有任何明显的治疗改变，并且持续的时间更高。使用任一胰高血糖素样肽-1受体激动剂的治疗在HbA1c和体重方面产生了相似且临床上有意义的降低。
