Chirila Costel, Zheng Qingyao, Davenport Eric, Kaschinski Dagmar, Pfarr Egon, Hach Thomas, Palencia Roberto
RTI Health Solutions, 200 Park Offices Drive, Research Triangle Park, NC, 27709, USA.
Boehringer Ingelheim GmbH, Binger Str. 173, 55216, Ingelheim am Rhein, Germany.
Qual Life Res. 2016 May;25(5):1199-207. doi: 10.1007/s11136-015-1140-2. Epub 2015 Sep 30.
This exploratory analysis assessed and compared patients' treatment satisfaction with empagliflozin plus metformin versus glimepiride plus metformin, using data obtained from the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs) collected in a randomized, double-blind, double-dummy clinical trial.
Observed values for DTSQs scale score and each of its eight items were summarized by visit and treatment arm. Changes from baseline in these scores were analyzed using linear mixed models for repeated measures.
The baseline scale score and item scores were comparable between empagliflozin plus metformin (n = 765) and glimepiride plus metformin (n = 780). Compared with baseline, patients reported significant treatment satisfaction increases and significant decreases in perceived hyperglycemia with both treatments at all visits. Also, compared with baseline, a significant increase in perceived frequency of hypoglycemia was observed in the glimepiride treatment group at all visits. No statistically significant treatment difference was observed in DTSQs scale score and its items at week 104. The difference between the treatment groups was significant and in favor of empagliflozin from week 28 onward for perceived frequency of hyperglycemia (P ≤ 0.006) and perceived frequency of hypoglycemia (P ≤ 0.011).
Despite positive trends in favor of empagliflozin, there was no significant difference in DTSQs scale score between empagliflozin and glimepiride at 104 weeks. However, when compared with glimepiride, empagliflozin demonstrated significantly lower perceived frequency of hyperglycemia and hypoglycemia at all visits from week 28 onward. This finding is consistent with the clinical results reported for the EMPA-REG H2H-SU trial.
本探索性分析使用在一项随机、双盲、双模拟临床试验中收集的糖尿病治疗满意度问卷状态版（DTSQs）数据，评估并比较了恩格列净联合二甲双胍与格列美脲联合二甲双胍治疗患者的治疗满意度。
按访视和治疗组总结DTSQs量表评分及其八个项目各自的观察值。使用重复测量的线性混合模型分析这些评分相对于基线的变化。
恩格列净联合二甲双胍组（n = 765）和格列美脲联合二甲双胍组（n = 780）的基线量表评分和项目评分具有可比性。与基线相比，两种治疗在所有访视时患者均报告治疗满意度显著提高，且感知到的高血糖显著降低。此外，与基线相比，格列美脲治疗组在所有访视时均观察到感知到的低血糖发生频率显著增加。在第104周时，DTSQs量表评分及其项目未观察到统计学上的显著治疗差异。从第28周起，治疗组之间在感知到的高血糖发生频率（P≤0.006）和感知到的低血糖发生频率（P≤0.011）方面存在显著差异，且有利于恩格列净。
尽管有支持恩格列净的积极趋势，但在104周时恩格列净和格列美脲之间的DTSQs量表评分无显著差异。然而，与格列美脲相比，从第28周起，恩格列净在所有访视时均显示出显著更低的感知到的高血糖和低血糖发生频率。这一发现与EMPA-REG H2H-SU试验报告的临床结果一致。
