日本語フィールド
著者：○Tanaka A, Sata M, Okada Y, Teragawa H, Eguchi K, Shimabukuro M, Taguchi I, Matsu-naga K, Kanzaki Y, Yoshida H, Ishizu T, Ueda S, Kitakaze M, Murohara T, Node K; PRO-TECT study investigators(Takamori A et al)題名：Effect of ipragliflozin on carotid intima-media thickness in patients with type 2 diabetes: A multicenter, randomized, controlled trial発表情報：Eur Heart J Cardiovasc Pharmacother 巻: 9 号: 2 ページ: 165-172キーワード：Atherosclerosis; Carotid intima-media thickness; Ipragliflozin; Type 2 diabetes概要：Aim: To examine the effects of 24-month treatment with ipragliflozin on carotid intima-media thickness (IMT) in type 2 diabetes patients.
Methods: In this multicenter, prospective, randomized, open-label, blinded-endpoint investigator-initiated clinical trial, adults with type 2 diabetes and hemoglobin 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 for 24 months. The primary endpoint was the change in mean common carotid artery IMT (CCA-IMT) from baseline to 24 months.
Results: 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% 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).
Conclusions: 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.抄録：英語フィールド
Author：○Tanaka A, Sata M, Okada Y, Teragawa H, Eguchi K, Shimabukuro M, Taguchi I, Matsu-naga K, Kanzaki Y, Yoshida H, Ishizu T, Ueda S, Kitakaze M, Murohara T, Node K; PRO-TECT study investigators(Takamori A et al)Title：Effect of ipragliflozin on carotid intima-media thickness in patients with type 2 diabetes: A multicenter, randomized, controlled trialAnnouncement information:Eur Heart J Cardiovasc Pharmacother Vol: 9 Issue: 2 Page: 165-172Keyword：Atherosclerosis; Carotid intima-media thickness; Ipragliflozin; Type 2 diabetesAn abstract：Aim: To examine the effects of 24-month treatment with ipragliflozin on carotid intima-media thickness (IMT) in type 2 diabetes patients.
Methods: In this multicenter, prospective, randomized, open-label, blinded-endpoint investigator-initiated clinical trial, adults with type 2 diabetes and hemoglobin 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 for 24 months. The primary endpoint was the change in mean common carotid artery IMT (CCA-IMT) from baseline to 24 months.
Results: 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% 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).
Conclusions: 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.