Medical Development, Amylin Pharmaceuticals, San Diego, California, USA.
Diabetes Care. 2011 Feb;34(2):314-9. doi: 10.2337/dc10-1119.
To assess change in patient-reported outcomes in subjects with type 2 diabetes treated with exenatide once weekly compared with those treated with sitagliptin or pioglitazone.
In this 26-week randomized, multicenter, double-dummy study, 491 subjects received 2 mg of exenatide once weekly or maximum daily doses of sitagliptin (100 mg) or pioglitazone (45 mg) on a background of metformin. Weight-related quality of life, health utility, psychological well-being, and diabetes treatment satisfaction were assessed at baseline and week 26. Mean group changes from baseline to week 26 were estimated by ANCOVA.
Weight-related quality of life total scores improved significantly in the exenatide once weekly and sitagliptin arms only; the exenatide once weekly group experienced significantly greater improvement than the pioglitazone group in weight-related quality of life total scores and in several domain scores. Health utility scores improved significantly for exenatide once weekly and sitagliptin groups (P < 0.05) with no significant difference between the exenatide once weekly group and either comparison group. All groups experienced significant improvements on the psychological well-being global scale and all six domain scores, with no significant difference between the exenatide once weekly group and either comparator. All groups experienced significant improvements in total diabetes treatment satisfaction scores. The exenatide once weekly group experienced greater improvement than the sitagliptin group in treatment satisfaction total scores.
In combination with clinical outcomes from this study, these results indicate it is possible for patients treated with metformin to initiate exenatide therapy with potential benefits in both clinical and patient-reported outcomes.
评估每周一次给予艾塞那肽与每周一次给予西格列汀或吡格列酮治疗 2 型糖尿病患者的患者报告结局变化。
在这项 26 周随机、多中心、双盲研究中,491 例患者接受每周一次 2mg 艾塞那肽或最大日剂量西格列汀(100mg)或吡格列酮(45mg)治疗,同时使用二甲双胍。在基线和 26 周时评估与体重相关的生活质量、健康效用、心理幸福感和糖尿病治疗满意度。采用协方差分析估计从基线到 26 周的平均组间变化。
仅在艾塞那肽每周一次和西格列汀组中,与体重相关的生活质量总分显著改善;与吡格列酮组相比,艾塞那肽每周一次组在与体重相关的生活质量总分和几个领域评分方面的改善更为显著。艾塞那肽每周一次和西格列汀组的健康效用评分显著提高(P<0.05),但艾塞那肽每周一次组与任何比较组之间无显著差异。所有组在心理幸福感总体评分和所有 6 个领域评分方面均有显著改善,且艾塞那肽每周一次组与任何比较组之间无显著差异。所有组的糖尿病总体治疗满意度评分均有显著提高。与西格列汀组相比,艾塞那肽每周一次组在治疗满意度总分方面的改善更大。
结合本研究的临床结果,这些结果表明,对于接受二甲双胍治疗的患者,起始艾塞那肽治疗可能具有临床和患者报告结局的潜在获益。