AstraZeneca LP, Wilmington, DE, USA.
Diabetes Obes Metab. 2014 Jul;16(7):645-50. doi: 10.1111/dom.12263. Epub 2014 Feb 9.
This study evaluated change in health-related quality of life (HRQOL) associated with ongoing weight change among patients with type 2 diabetes mellitus (T2DM) treated with dapagliflozin, a highly selective sodium-glucose cotransporter 2 (SGLT2) inhibitor that lowers blood glucose by increasing urinary glucose excretion and is associated with body weight reductions.
Patients with T2DM who had inadequate glycaemic control on metformin (MET) alone were enrolled in a 24-week, double-blind, randomized, placebo-controlled study with a 78-week extension to evaluate the effect of dapagliflozin + MET on body weight. Patients also completed the Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes Weight Questionnaire-9 (SHIELD-WQ-9), a weight change-related HRQOL survey. Difference in proportions of patients treated with dapagliflozin 10 mg + MET (n = 89) or placebo + MET (n = 91) who reported improvement in HRQOL was analysed with Fisher's exact test.
Dapagliflozin patients had significantly greater weight loss than placebo patients over 102 weeks (p < 0.05). This corresponded to a numerically greater proportion of dapagliflozin-treated patients reporting ongoing weight loss and associated improvements in most HRQOL domains at three different evaluation points (weeks 24, 50 and 102) than placebo-treated patients. In a post-hoc analysis among patients who reported ongoing weight loss regardless of treatment arm, a significantly greater proportion of patients reporting weight loss versus weight gain reported improvements in physical health, self-esteem and overall HRQOL at weeks 24, 50 and 102.
Dapagliflozin-induced weight loss was associated with improvement in overall HRQOL. Overall, ongoing weight loss was associated with improvements in several HRQOL domains compared with weight gain.
本研究评估了在接受达格列净治疗的 2 型糖尿病（T2DM）患者中，与持续体重变化相关的健康相关生活质量（HRQOL）变化。达格列净是一种高度选择性的钠-葡萄糖协同转运蛋白 2（SGLT2）抑制剂，通过增加尿糖排泄降低血糖，与体重减轻有关。
单独使用二甲双胍（MET）血糖控制不佳的 T2DM 患者参加了一项为期 24 周、双盲、随机、安慰剂对照的研究，其中有 78 周的扩展期，以评估达格列净+MET 对体重的影响。患者还完成了有助于改善早期评估和管理糖尿病风险因素的研究，以评估体重问卷-9（SHIELD-WQ-9），这是一项与体重变化相关的 HRQOL 调查。采用 Fisher 确切检验分析接受达格列净 10mg+MET（n=89）或安慰剂+MET（n=91）治疗的患者中报告 HRQOL 改善的患者比例差异。
在 102 周时，达格列净治疗组患者体重减轻明显多于安慰剂治疗组（p<0.05）。这对应于达格列净治疗组患者报告持续体重减轻和大多数 HRQOL 领域改善的比例，在三个不同的评估点（第 24、50 和 102 周），比安慰剂治疗组患者更高。在报告持续体重减轻的患者中进行的事后分析中，无论治疗组如何，报告体重减轻而非体重增加的患者在第 24、50 和 102 周时报告体重减轻与体重增加相比，在生理健康、自尊和总体 HRQOL 方面的改善比例显著更高。
达格列净诱导的体重减轻与总体 HRQOL 改善相关。总体而言，与体重增加相比，持续体重减轻与多个 HRQOL 领域的改善相关。
