Fadini Gian Paolo, Zatti Giancarlo, Baldi Ileana, Bottigliengo Daniele, Consoli Agostino, Giaccari Andrea, Sesti Giorgio, Avogaro Angelo
Department of Medicine, University of Padova, Padova, Italy.
Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Padova, Italy.
Diabetes Obes Metab. 2018 Jul;20(7):1781-1786. doi: 10.1111/dom.13280. Epub 2018 Mar 30.
In randomized controlled trials (RCTs), sodium-glucose co-transporter-2 (SGLT2) inhibitors have been shown to confer glycaemic and extra-glycaemic benefits. The DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes) study was a multicentre retrospective study designed to evaluate the baseline characteristics of patients receiving dapagliflozin vs those receiving selected comparators (dipeptidyl peptidase-4 inhibitors, gliclazide, or glucagon-like peptide-1 receptor agonists), and drug effectiveness in routine clinical practice. From a population of 281 217, the analysis included 17 285 patients initiating dapagliflozin or comparator glucose-lowering medications (GLMs), 6751 of whom had a follow-up examination. At baseline, participants starting dapagliflozin were younger, had a longer disease duration, higher glycated haemoglobin (HbA1c) concentration, and a more complex history of previous GLM use, but the clinical profile of patients receiving dapagliflozin changed during the study period. Dapagliflozin reduced HbA1c by 0.7%, body weight by 2.7 kg, and systolic blood pressure by 3.0 mm Hg. Effects of comparator GLMs were also within the expected range, based on RCTs. This real-world study shows an initial channelling of dapagliflozin to difficult-to-treat patients. Nonetheless, dapagliflozin provided significant benefits with regard to glucose control, body weight and blood pressure that were in line with findings from RCTs.
在随机对照试验（RCT）中，钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂已显示出具有降糖和糖外益处。DARWIN-T2D（达格列净在2型糖尿病中的真实世界证据）研究是一项多中心回顾性研究，旨在评估接受达格列净治疗的患者与接受选定对照药物（二肽基肽酶-4抑制剂、格列齐特或胰高血糖素样肽-1受体激动剂）的患者的基线特征，以及在常规临床实践中的药物疗效。在281217名患者中，分析纳入了17285名开始使用达格列净或对照降糖药物（GLM）的患者，其中6751人接受了随访检查。在基线时，开始使用达格列净的参与者更年轻，病程更长，糖化血红蛋白（HbA1c）浓度更高，既往GLM使用史更复杂，但在研究期间，接受达格列净治疗的患者的临床特征发生了变化。达格列净使HbA1c降低了0.7%，体重降低了2.7千克，收缩压降低了3.0毫米汞柱。基于随机对照试验，对照GLM的效果也在预期范围内。这项真实世界研究表明，达格列净最初被用于治疗难治性患者。尽管如此，达格列净在血糖控制、体重和血压方面提供了显著益处，这与随机对照试验的结果一致。
