Effect of ipragliflozin on carotid intima-media thickness in type 2 diabetes patients
Tanaka, Atsushi Saga University
Okada, Yosuke University of Occupational and Environmental Health
Teragawa, Hiroki JR Hiroshima Hospital
Eguchi, Kazuo Saitama Red Cross Hospital
Taguchi, Isao Dokkyo Medical University
Matsunaga, Kazuo Imari-Arita Kyoritsu Hospital
Kanzaki, Yumiko Osaka Medical and Pharmaceutical University
Yoshida, Hisako Osaka Metropolitan University
Ishizu, Tomoko University of Tsukuba
Ueda, Shinichiro University of the Ryukyus
Kitakaze, Masafumi Hanwa Daini Senboku Hospital
Murohara, Toyoaki Nagoya University
Node, Koichi Saga University
Carotid intima-media thickness
Type 2 diabetes
To examine the effects of a 24-month treatment with ipragliflozin on carotid intima-media thickness (IMT) in type 2 diabetes patients.
Methods and results
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.
European Heart Journal - Cardiovascular Pharmacotherapy
Oxford University Press|European Society of Cardiology
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