Background

The efficacy of dapagliflozin has been less extensively studied in the real-life context, limiting the comparability of observational real-world evidence with results from dapagliflozin clinical trials. This study aimed to evaluate HbA1c, blood pressure (BP), and weight outcomes in dapagliflozin-treated patients with type 2 diabetes (T2D) treated in a real-world setting.

Methods

A total of 1683 T2D patients (mean (SD) age: 54.6 years (9.1), 56.6% were females) initiating dapagliflozin were included in this multicenter retrospective observational cohort study. Data on patient demographics, comorbidities, duration of diabetes, and concomitant antidiabetic treatment were recorded. Change in glycated hemoglobin (HbA1c), body weight, body mass index (BMI), and BP levels with dapagliflozin treatment and dapagliflozin discontinuation rates were evaluated based on baseline, 3rd-month, and 6th-month data.

Results

At the end of 6-month dapagliflozin treatment (discontinued in 4.3% of patients), HbA1c levels were ≤7% in 30.1% of patients, BP was ≤140/90 mmHg in 95.9% of patients, and >5% weight loss was evident in 38.0% of patients. Less than 5-year diabetes duration was associated with significantly higher rate of achieving HbA1c ≤7% (p = 0.032), BP ≤140/90 mmHg (p = 0.001), and BP ≤130/80 mmHg (p < 0.001) targets at the 6th month (p = 0.032) as compared with longer diabetes duration.

Conclusion

In conclusion, this nationwide observational study in T2D patients treated with dapagliflozin in Turkey provided real-life evidence on significant and clinically meaningful reductions in HbA1c, body weight, and BP within 6-month therapy.

中文翻译：

---

达格列净在土耳其2型糖尿病患者的常规门诊治疗中的附加治疗：HbA1c，体重和血压结果的回顾性队列研究

背景

达格列净的疗效尚未在现实​​生活中得到广泛研究，从而限制了观察性现实证据与达格列净临床试验结果的可比性。这项研究旨在评估在现实环境中接受达格列净治疗的2型糖尿病（T2D）患者的HbA1c，血压（BP）和体重结局。

方法

这项多中心回顾性队列研究共纳入了1683名发起达格列净治疗的T2D患者（平均（SD）年龄：54.6岁（9.1），女性占56.6％）。记录有关患者人口统计学，合并症，糖尿病持续时间以及伴随的抗糖尿病治疗的数据。根据基线，第3个月和第6个月的数据评估了dapagliflozin治疗后糖化血红蛋白（HbA1c），体重，体重指数（BMI）和BP水平的变化以及dapagliflozin的停用率。

结果

在6个月达格列净治疗结束时（在4.3％的患者中终止），HbA1c水平在30.1％的患者中≤7％，BP在95.9％的患者中≤140/ 90 mmHg，并且体重减轻> 5％在38.0％的患者中很明显。少于5年的糖尿病持续时间与HbA1c≤7 ％（p = 0.032），BP≤140/90 mmHg（p = 0.001）和BP≤130/80 mmHg（p <0.001）的目标发生率显着相关与更长的糖尿病持续时间相比，在第6个月时（p = 0.032）。

结论

总之，这项在土耳其接受达格列净治疗的T2D患者的全国性观察性研究提供了现实生活中的证据，表明在6个月的治疗中HbA1c，体重和BP的显着降低和临床意义。