Effect of ipragliflozin on carotid intima-media thickness in patients with type 2 diabetes: a multicenter, randomized, controlled trial
Author:
Tanaka Atsushi1ORCID, Sata Masataka2, Okada Yosuke3, Teragawa Hiroki4ORCID, Eguchi Kazuo5, Shimabukuro Michio6ORCID, Taguchi Isao7, Matsunaga Kazuo8, Kanzaki Yumiko9, Yoshida Hisako10, Ishizu Tomoko11, Ueda Shinichiro12, Kitakaze Masafumi13, Murohara Toyoaki14, Node Koichi1ORCID, Node Koichi, Murohara Toyoaki, Kitakaze Masafumi, Nishio Yoshihiko, Inoue Teruo, Ohishi Mitsuru, Kario Kazuomi, Sata Masataka, Shimabukuro Michio, Shimizu Wataru, Jinnouchi Hideaki, Taguchi Isao, Tomiyama Hirofumi, Maemura Koji, Suzuki Makoto, Ando Shinichi, Eguchi Kazuo, Kamiya Haruo, Sakamoto Tomohiro, Teragawa Hiroki, Nanasato Mamoru, Matsuhisa Munehide, Ako Junya, Aso Yoshimasa, Ishihara Masaharu, Kitagawa Kazuo, Yamashina Akira, Ishizu Tomoko, Ikehara Yumi, Ueda Shinichiro, Takamori Ayako, Tanaka Atsushi, Mori Miki, Yamaguchi Kaori, Asaka Machiko, Kaneko Tetsuya, Sakuma Masashi, Toyoda Shigeru, Nasuno Takahisa, Kageyama Michiya, Teruo Jojima, Toshie Iijima, Kishi Haruka, Yamada Hirotsugu, Kusunose Kenya, Fukuda Daiju, Yagi Shusuke, Yamaguchi Koji, Ise Takayuki, Kawabata Yutaka, Kuroda Akio, Akasaki Yuichi, Kurano Mihoko, Hoshide Satoshi, Komori Takahiro, Kabutoya Tomoyuki, Ogata Yukiyo, Koide Yuji, Kawano Hiroaki, Ikeda Satoshi, Fukae Satoki, Koga Seiji, Higashi Yukihito, Kishimoto Shinji, Kajikawa Masato, Maruhashi Tatsuya, Kubota Yoshiaki, Shibata Yoshisato, Kuriyama Nehiro, Nakamura Ikuko, Hironori Kanemitsu, Takase Bonpei, Orita Yuichi, Oshita Chikage, Uchimura Yuko, Yoshida Ruka, Yoshida Yukihiko, Suzuki Hirohiko, Ogura Yasuhiro, Maeda Mayuho, Takenaka Masaki, Hayashi Takumi, Hirose Mirai, Hisauchi Itaru, Kadokami Toshiaki, Nakamura Ryo, Kanda Junji, Matsunaga Kazuo, Hoshiga Masaaki, Sohmiya Koichi, Kanzaki Yumiko, Koyosue Arihiro, Uehara Hiroki, Miyagi Naoto, Chinen Toshiya, Nakamura Kentaro, Nago Chikashi, Chiba Suguru, Hatano Sho, Gima Yoshikatsu, Abe Masami, Ajioka Masayoshi, Asano Hiroshi, Nakashima Yoshihiro, Osanai Hiroyuki, Kanbara Takahiro, Sakamoto Yusuke, Oguri Mitsutoshi, Ohguchi Shiou, Takahara Kunihiko, Izumi Kazuhiro, Yasuda Kenichiro, Kudo Akihiro, Machii Noritaka, Morimoto Ryota, Bando Yasuko, Okumura Takahiro, Kondo Toru, Miura Shin-ichiro, Shiga Yuhei, Mirii Joji, Sugihara Makoto, Arimura Tadaaki, Nakano Junko, Sakamoto Tomohiro, Kodama Kazuhisa, Ohte Nobuyuki, Sugiura Tomonori, Wakami Kazuaki, Takemoto Yasuhiko, Yoshiyama Minoru, Shuto Taichi, Fukumoto Kazuo, Okada Yosuke, Tanaka Kenichi, Sonoda Satomi, Tokutsu Akemi, Otsuka Takashi, Uemura Fumi, Koikawa Kenji, Miyazaki Megumi, Umikawa Maiko, Narisawa Manabu, Furuta Machi, Minami Hiroshi, Doi Masaru, Sugimoto Kazuhiro, Suzuki Susumu, Kurozumi Akira, Nishio Kosuke,
Affiliation:
1. Department of Cardiovascular Medicine, Saga University , 5-1-1 Nabeshima, Saga, Saga, 849-8501 , Japan 2. Department of Cardiovascular Medicine, Tokushima University Hospital , 2-50-1 Kuramoto-machi, Tokushima, Tokushima, 770-8503 , Japan 3. First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health , 1-1 Iseigaoka, Yahatanishi-ku Kitakyushu, 807-8556 , Japan 4. Department of Cardiovascular Medicine, JR Hiroshima Hospital , 3-1-36 Futabanosato, Higashi-ku, Hiroshima, 732-0057 , Japan 5. Department of General Internal Medicine, Saitama Red Cross Hospital , 1-5 Shintoshin, Chuo-ku, Saitama, 330-0081 , Japan 6. Department of Diabetes, Endocrinology, and Metabolism, Fukushima Medical University , 1 Hikarigaoka, Fukushima, Fukushima, 960-1295 , Japan 7. Department of Cardiology, Dokkyo Medical University Saitama Medical Center , 2-1-50 Minamikoshigaya, Koshigaya, 343-8555 , Japan 8. Department of Internal Medicine, Imari-Arita Kyoritsu Hospital , 860 Ninoseko, Matsuura, Saga, 849-4141 , Japan 9. Department of Cardiology, Osaka Medical and Pharmaceutical University , 2-7 Daigakumachi, Takatsuki, Osaka, 569-8686 , Japan 10. Department of Medical Statistics, Osaka Metropolitan University , 1-4-3 Asahimachi, Abeno-ku, Osaka, Osaka, 545-8585 , Japan 11. Department of Cardiology, Faculty of Medicine, University of Tsukuba , 2-1-1 Amakubo, Tsukuba, 305-8576 , Japan 12. Department of Clinical Pharmacology and Therapeutics, University of the Ryukyus , 207 Uehara, Nishihara, 903-0215, Okinawa , Japan 13. Hanwa Daini Senboku Hospital , 3176 Fukaikitamachi, Naka-ku, Sakai, 599-8271 , Japan 14. Department of Cardiology, Nagoya University Graduate School of Medicine , 65 Tsurumaicho, Showa-ku Nagoya, 466-0065 , Japan
Abstract
Abstract
Aims
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].
Conclusion
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.
Funder
Astellas Pharma US
Publisher
Oxford University Press (OUP)
Subject
Pharmacology (medical),Cardiology and Cardiovascular Medicine
Cited by
18 articles.
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