在日本2型糖尿病患者中使用替尔泊肽与度拉糖肽的治疗满意度和生活质量：SURPASS J-单药试验的探索性评估
Treatment Satisfaction and Quality of Life with Tirzepatide Versus Dulaglutide Among Japanese Patients with Type 2 Diabetes: Exploratory Evaluation of the SURPASS J-mono Trial.
作者信息
Ishii Hitoshi, Oura Tomonori, Takeuchi Masakazu
机构信息
Department of Doctor-Patient Relationships, Nara Medical University, Kashihara, Nara, Japan.
Japan Drug Development and Medical Affairs, Eli Lilly Japan K.K., Kobe, Hyogo, Japan.
出版信息
Diabetes Ther. 2023 Dec;14(12):2173-2183. doi: 10.1007/s13300-023-01485-3. Epub 2023 Oct 16.
INTRODUCTION
Treatment satisfaction in diabetes management is vital to achieving long-term clinical outcomes. This analysis evaluated treatment satisfaction among patients with type 2 diabetes (T2D) after 52 weeks of treatment with once-weekly tirzepatide (5, 10, and 15 mg) compared with dulaglutide 0.75 mg.
METHODS
This exploratory analysis of the phase 3 SURPASS J-mono trial assessed treatment satisfaction using the Japanese translation of the Diabetes Treatment Satisfaction Questionnaire status (DTSQs) and change versions (DTSQc). Subgroup analyses were post hoc and conducted for the DTSQc overall treatment satisfaction score based on age (< 65 or ≥ 65 years), sex (male or female), baseline body mass index (BMI; < 25 or ≥ 25 kg/m), and baseline glycated hemoglobin (≤ 8.5% or > 8.5%).
RESULTS
Baseline DTSQs scores were similar among patients across all treatment arms. Overall, trends showed higher satisfaction among patients who received any tirzepatide dose compared with those who received dulaglutide after 52 weeks of treatment. Mean overall DTSQc treatment satisfaction scores at week 52 were significantly higher with tirzepatide 5, 10, and 15 mg versus dulaglutide 0.75 mg (11.5, 12.1, and 12.3, respectively, vs 8.9; P < 0.001). The DTSQc perceived frequency scores for unacceptable hyperglycemia were significantly lower with tirzepatide 5, 10, and 15 mg versus dulaglutide 0.75 mg (- 1.7, - 1.8, and - 2.3, respectively, vs - 0.6; P < 0.001), while scores for unacceptable hypoglycemia were similar across all treatment arms, ranging from - 0.8 to - 1.1. Subgroup analyses showed increased treatment satisfaction with tirzepatide compared with dulaglutide in the < 65 years (P < 0.001) and baseline BMI ≥ 25 kg/m subgroups (P < 0.01 or < 0.001) and similar treatment satisfaction across treatment arms in the ≥ 65 years and BMI < 25 kg/m subgroups.
CONCLUSION
Patients with T2D reported higher treatment satisfaction with once-weekly tirzepatide (5, 10, and 15 mg) compared with dulaglutide 0.75 mg after 52 weeks of treatment.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03861052.
简介
糖尿病管理中的治疗满意度对于实现长期临床疗效至关重要。本分析评估了接受每周一次替尔泊肽（5、10和15毫克）治疗52周的2型糖尿病（T2D）患者与度拉糖肽0.75毫克相比的治疗满意度。
方法
这项3期SURPASS J-单药试验的探索性分析使用糖尿病治疗满意度问卷状态（DTSQs）的日语翻译和变化版本（DTSQc）评估治疗满意度。亚组分析为事后分析，基于年龄（<65岁或≥65岁）、性别（男性或女性）、基线体重指数（BMI；<25或≥25千克/米²）和基线糖化血红蛋白（≤8.5%或>8.5%）对DTSQc总体治疗满意度评分进行分析。
结果
所有治疗组患者的基线DTSQs评分相似。总体而言，趋势显示治疗52周后，接受任何剂量替尔泊肽的患者比接受度拉糖肽的患者满意度更高。与度拉糖肽0.75毫克相比，替尔泊肽5毫克、10毫克和15毫克在第52周时的平均总体DTSQc治疗满意度评分显著更高（分别为11.5、12.1和12.3，对比8.9；P<0.001）。替尔泊肽5毫克、10毫克和15毫克组中不可接受的高血糖的DTSQc感知频率评分显著低于度拉糖肽0.75毫克组（分别为-1.7、-1.8和-2.3，对比-0.6；P<0.001），而所有治疗组中不可接受的低血糖评分相似，范围为-0.8至-1.1。亚组分析显示，在<65岁（P<0.001）和基线BMI≥25千克/米²亚组（P<0.01或<0.001）中，与度拉糖肽相比，替尔泊肽的治疗满意度有所提高，而在≥65岁和BMI<25千克/米²亚组中，各治疗组的治疗满意度相似。
结论
治疗52周后，与度拉糖肽0.75毫克相比，T2D患者对每周一次的替尔泊肽（5、10和15毫克）报告了更高的治疗满意度。
试验注册
ClinicalTrials.gov，NCT03861052。
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