Department of Cardiovascular Medicine, Saga University, 5-1-1 Nabeshima, Saga, Saga, 849-8501, Japan.
Department of Cardiovascular Medicine, Tokushima University Hospital , 2-50-1 Kuramoto-machi, Tokushima, Tokushima, 770-8503, Japan.
Eur Heart J Cardiovasc Pharmacother. 2023 Feb 2;9(2):165-172. doi: 10.1093/ehjcvp/pvac059.
To examine the effects of a 24-month treatment with ipragliflozin on carotid intima-media thickness (IMT) in type 2 diabetes patients.
In this multicenter, prospective, randomized, open-label, and blinded-endpoint investigator-initiated clinical trial, adults with type 2 diabetes and haemoglobin A1C (HbA1c) of 6.0-10.0% (42-86 mmol/mol) were randomized equally to ipragliflozin (50 mg daily) and non-sodium-glucose cotransporter-2 (SGLT2) inhibitor use of standard-care (control group) for type 2 diabetes and were followed-up to 24 months. The primary endpoint was the change in mean common carotid artery IMT (CCA-IMT) from baseline to 24 months. A total of 482 patients were equally allocated to the ipragliflozin (N = 241) and control (N = 241) groups, and 464 patients (median age 68 years, female 31.7%, median type 2 diabetes duration 8 years, median HbA1c 7.3%) were included in the analyses. For the primary endpoint, the changes in the mean CCA-IMT from baseline to 24 months were 0.0013 [95% confidence interval (CI), -0.0155-0.0182] mm and 0.0015 (95% CI, -0.0155-0.0184) mm in the ipragliflozin and control groups, respectively, with an estimated group difference (ipragliflozin-control) of -0.0001 mm (95% CI, -0.0191-0.0189; P = 0.989). A group difference in HbA1c change at 24 months was also non-significant between the treatment groups [-0.1% (95% CI, -0.2-0.1); P = 0.359].
Twenty-four months of ipragliflozin treatment did not affect carotid IMT status in patients with type 2 diabetes recruited in the PROTECT study, relative to the non-SGLT2 inhibitor-use standard care for type 2 diabetes.
观察伊格列净治疗 24 个月对 2 型糖尿病患者颈动脉内膜中层厚度（IMT）的影响。
在这项多中心、前瞻性、随机、开放标签、盲终点研究者发起的临床试验中，将糖化血红蛋白（HbA1c）为 6.0-10.0%（42-86mmol/mol）的成年 2 型糖尿病患者随机等分为伊格列净（每天 50mg）和非钠-葡萄糖共转运蛋白 2（SGLT2）抑制剂标准治疗（对照组）的 2 型糖尿病组，并随访 24 个月。主要终点为从基线到 24 个月时平均颈总动脉 IMT（CCA-IMT）的变化。共有 482 例患者被平均分配到伊格列净（N=241）和对照组（N=241）组，464 例患者（中位年龄 68 岁，女性 31.7%，中位 2 型糖尿病病程 8 年，中位 HbA1c 7.3%）纳入分析。对于主要终点，从基线到 24 个月时 CCA-IMT 的平均变化，伊格列净组为 0.0013 [95%置信区间（CI），-0.0155-0.0182]mm，对照组为 0.0015（95%CI，-0.0155-0.0184）mm，两组之间的估计组间差异（伊格列净-对照组）为-0.0001mm（95%CI，-0.0191-0.0189；P=0.989）。治疗组 24 个月时 HbA1c 变化的组间差异也无统计学意义[-0.1%（95%CI，-0.2-0.1）；P=0.359]。
在 PROTECT 研究中，与非 SGLT2 抑制剂标准治疗 2 型糖尿病相比，24 个月的伊格列净治疗并未影响 2 型糖尿病患者的颈动脉 IMT 状态。
