Amylin Pharmaceuticals Inc., San Diego, CA 92121, USA.
Diabet Med. 2009 Jul;26(7):722-8. doi: 10.1111/j.1464-5491.2009.02752.x.
To assess treatment satisfaction and weight-related quality of life (QOL) in subjects with Type 2 diabetes treated with exenatide once weekly (QW) or twice daily (BID).
In this 52-week randomized, multi-centre, open-label study, 295 subjects managed with diet and exercise and/or oral glucose-lowering medications received either exenatide QW or BID during weeks 1-30; thereafter, subjects receiving exenatide BID were switched to exenatide QW, with 258 total subjects receiving exenatide QW during weeks 30-52. Diabetes Treatment Satisfaction Questionnaire-status (DTSQ-s) and Impact of Weight on Quality of Life-Lite (IWQOL-Lite) were assessed at baseline and weeks 30 and 52. Mean group changes from baseline to week 30 were estimated by ancova; changes from week 30 to week 52 were assessed by Student's t-test.
Statistically significant improvements from baseline to week 30 were observed in both treatment groups for DTSQ-s and IWQOL-Lite measures, with significantly greater reduction in perceived frequency of hyperglycaemia and greater satisfaction with continuing treatment in the QW group compared with the BID group. Effect sizes for change in DTSQ-s total scores were 0.84 QW, 0.64 BID; for IWQOL-Lite: 0.96 QW, 0.82 BID. Treatment satisfaction and QOL improved significantly between weeks 30 and 52 for those switching from BID to QW. Occurrence of adverse events did not affect patients' improvements in treatment satisfaction and QOL.
Patients treated with exenatide QW or BID experienced significant and clinically meaningful improvements in treatment satisfaction and QOL. Patients who switched from exenatide BID to exenatide QW administration reported further significant improvements.
评估每周一次(QW)或每日两次(BID)给予艾塞那肽治疗 2 型糖尿病患者的治疗满意度和与体重相关的生活质量(QOL)。
在这项为期 52 周的随机、多中心、开放性研究中,295 例饮食和运动以及/或口服降糖药物控制不佳的患者在第 1-30 周接受 QW 或 BID 治疗;此后,接受 BID 治疗的患者转换为 QW 治疗,共有 258 例患者在第 30-52 周接受 QW 治疗。分别于基线和第 30、52 周评估糖尿病治疗满意度问卷状态(DTSQ-s)和体重对生活质量的影响简表(IWQOL-Lite)。通过协方差分析估计从基线到第 30 周的平均组间变化;通过学生 t 检验评估从第 30 周到第 52 周的变化。
QW 和 BID 两组患者的 DTSQ-s 和 IWQOL-Lite 测量值均从基线到第 30 周有统计学显著改善,QW 组与 BID 组相比,感知高血糖频率降低和继续治疗满意度提高更显著。DTSQ-s 总分变化的效应大小为 0.84 QW、0.64 BID;IWQOL-Lite:0.96 QW、0.82 BID。从第 30 周到第 52 周,从 BID 转换为 QW 的患者的治疗满意度和 QOL 显著改善。不良事件的发生并未影响患者治疗满意度和 QOL 的改善。
QW 或 BID 治疗的患者在治疗满意度和 QOL 方面均有显著且具有临床意义的改善。从 BID 转换为 QW 治疗的患者报告了进一步的显著改善。