定性访谈：表征口服奥福格利普隆对比口服司美格鲁肽治疗2型糖尿病III期试验中患者积极治疗体验的质性研究。
完整摘要 · 中文译文
背景与目的：对于2型糖尿病的治疗，目前仍存在对有效且耐受性良好的口服胰高血糖素样肽1受体激动剂制剂的未满足需求。Orforglipron和口服司美格鲁肽是ACHIEVE-3临床试验（NCT06045221）中评估的两种口服胰高血糖素样肽1受体激动剂。这些新型治疗方法能够实现具有临床意义的血糖控制和体重减轻，可能为患者的日常生活带来实质性的积极改变。本研究旨在ACHIEVE-3试验结束后开展出组访谈，以描述接受基于口服胰高血糖素样肽1受体激动剂治疗的2型糖尿病患者所报告的、除糖化血红蛋白和体重减轻之外的积极治疗体验和结局。 方法：在美国十个临床中心，对已入组ACHIEVE-3并完成至少3个月治疗的患者进行了定性访谈。访谈以英语或西班牙语进行，并进行录音和转录。对转录文本进行分析，以识别和归类访谈中报告的治疗获益。采用描述性统计对样本特征进行描述。 结果：共有60名患者完成了定性出组访谈。患者平均年龄为59.1岁（标准差[SD] = 10.3），近一半为女性（n = 28，46.7%）。患者确诊2型糖尿病的平均病程为8.5年（SD = 5.7）。至研究结束时，患者的糖化 血红蛋白从基线8.3%下降1.6%（标准差 = 1.3），体重从基线96.0 kg平均下降4.7 kg（标准差 = 6.8）。所有患者均报告对试验药物满意（n = 59/59），可能向其他患者推荐该治疗，且除一人外均愿意继续服药。如预期所料，两个最重要且最常报告的正向变化是糖化血红蛋白得到控制（n = 53，88.3%）和体重减轻（n = 50，83.3%）。其他常见的自发报告的正向概念包括感知到的精力增加（n = 28，46.7%）、食欲和渴求减少（n = 23，38.3%）、运动/活动改善（n = 18，30.0%）以及心理改善（n = 18，30.0%）。其他正向变化包括自信心/自尊增强、饮食和进食习惯改善、睡眠改善以及视力改善或未出现恶化。所有报告的正向变化均被患者认为有意义。 结论：当前研究探讨了ACHIEVE-3试验中接受口服胰高血糖素样肽1受体激动剂的患者超越传统临床获益（如血糖控制和体重减轻）之外的正向体验。所发现的正向变化可能成为未来临床试验临床结局评估终点策略的合适目标，以帮助区分不同治疗方法，并在临床实践中用于对患者体验进行分类。
完整摘要 · 英文原文
BACKGROUND AND OBJECTIVE: There is an unmet need for effective and well-tolerated oral formulations of glucagon-like peptide 1 receptor agonists for the management of type 2 diabetes. Orforglipron and oral semaglutide are two oral glucagon-like peptide 1 receptor agonists evaluated in the ACHIEVE-3 clinical trial (NCT06045221). These novel treatments have the means to achieve clinically meaningful glycemic control and weight reduction, which may result in substantial positive changes in patients' daily lives. The objective of this study was to conduct exit interviews following the ACHIEVE-3 trial to characterize positive treatment experiences and outcomes, beyond glycated hemoglobin and weight reduction, reported by patients living with type 2 diabetes who received oral glucagon-like peptide 1 receptor agonist-based treatments. METHODS: Qualitative interviews were conducted across ten clinical sites within the USA with patients who had enrolled in ACHIEVE-3 and completed at least 3 months of treatment. Interviews were conducted in English or Spanish, audio-recorded, and transcribed. Transcripts were analyzed to identify and categorize positive treatment benefits reported during the interviews. Descriptive statistics were used to characterize the sample. RESULTS: Sixty patients completed the qualitative exit interviews. Patients had a mean age of 59.1 years (standard deviation [SD] = 10.3), and almost half were female (n = 28, 46.7%). Patients had been diagnosed with type 2 diabetes for a mean of 8.5 years (SD = 5.7). By the end of the study, patients reduced their glycated hemoglobin by 1.6% (SD = 1.3) from a baseline of 8.3% and lost a mean of 4.7 kg (SD = 6.8) from a baseline of 96.0 kg. All patients reported being satisfied with the trial medication (n = 59/59), were likely to recommend the treatment to other patients, and all but one were willing to continue taking the medication. As expected, the two most important and most frequently reported positive changes were controlled glycated hemoglobin (n = 53, 88.3%) and weight reduction (n = 50, 83.3%). Other common spontaneously reported positive concepts included increased perceived energy (n = 28, 46.7%), reduced appetite and cravings (n = 23, 38.3%), improved exercise/movement (n = 18, 30.0%), and psychological improvements (n = 18, 30.0%). Additional positive changes included increased confidence/self-esteem, improved diet and eating habits, improved sleep, and improved or a lack of deterioration in vision. All reported positive changes were considered meaningful by patients. CONCLUSIONS: The current study explored the positive experiences of patients taking an oral glucagon-like peptide 1 receptor agonist in the ACHIEVE-3 trial beyond traditional clinical benefits, such as glycemic control and weight reduction. The positive changes identified may be suitable targets for future clinical trial clinical outcome assessment endpoint strategies to help differentiate treatments and in clinical practices to classify patients' experiences.