1. Effect of ipragliflozin on carotid intima-media thickness in type 2 diabetes patients
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Atsushi, Tanaka, Masataka, Sata, Yosuke, Okada, Hiroki, Teragawa, Kazuo, Eguchi, Michio, Shimabukuro, Isao, Taguchi, Kazuo, Matsunaga, Yumiko, Kanzaki, Hisako, Yoshida, Tomoko, Ishizu, Shinichiro, Ueda, Masafumi, Kitakaze, Toyoaki, Murohara, Koichi, Node, Yoshihiko, Nishio, Mitsuru, Ohishi, Kazuomi, Kario, Wataru, Shimizu, Hideaki, Jinnouchi, Hirofumi, Tomiyama, Koji, Maemura, Makoto, Suzuki, Shinichi, Ando, Haruo, Kamiya, Tomohiro, Sakamoto, Mamoru, Nanasato, Munehide, Matsuhisa, Junya, Ako, Yoshimasa, Aso, Masaharu, Ishihara, Kazuo, Kitagawa, Akira, Yamashina, Yumi, Ikehara, Ayako, Takamori, Miki, Mori, Kaori, Yamaguchi, Machiko, Asaka, Tetsuya, Kaneko, Masashi, Sakuma, Shigeru, Toyoda, Takahisa, Nasuno, Michiya, Kageyama, Jojima, Teruo, Iijima, Toshie, Haruka, Kishi, Hirotsugu, Yamada, Kenya, Kusunose, Daiju, Fukuda, Shusuke, Yagi, Koji, Yamaguchi, Takayuki, Ise, Yutaka, Kawabata, Akio, Kuroda, Yuichi, Akasaki, Mihoko, Kurano, Satoshi, Hoshide, Takahiro, Komori, Tomoyuki, Kabutoya, Yukiyo, Ogata, Yuji, Koide, Hiroaki, Kawano, Satoshi, Ikeda, Satoki, Fukae, Seiji, Koga, Yukihito, Higashi, Shinji, Kishimoto, Masato, Kajikawa, Tatsuya, Maruhashi, Yoshiaki, Kubota, Yoshisato, Shibata, Nehiro, Kuriyama, Ikuko, Nakamura, Kanemitsu, Hironori, Bonpei, Takase, Yuichi, Orita, Chikage, Oshita, Yuko, Uchimura, Ruka, Yoshida, Yukihiko, Yoshida, Hirohiko, Suzuki, Yasuhiro, Ogura, Mayuho, Maeda, Masaki, Takenaka, Takumi, Hayashi, Mirai, Hirose, Itaru, Hisauchi, Toshiaki, Kadokami, Ryo, Nakamura, Junji, Kanda, Masaaki, Hoshiga, Koichi, Sohmiya, Arihiro, Koyosue, Hiroki, Uehara, Naoto, Miyagi, Toshiya, Chinen, Kentaro, Nakamura, Chikashi, Nago, Suguru, Chiba, Sho, Hatano, Yoshikatsu, Gima, Masami, Abe, Masayoshi, Ajioka, Hiroshi, Asano, Yoshihiro, Nakashima, Hiroyuki, Osanai, Takahiro, Kanbara, Yusuke, Sakamoto, Mitsutoshi, Oguri, Shiou, Ohguchi, Kunihiko, Takahara, Kazuhiro, Izumi, Kenichiro, Yasuda, Akihiro, Kudo, Noritaka, Machii, Ryota, Morimoto, Yasuko, Bando, Takahiro, Okumura, Toru, Kondo, Shin-Ichiro, Miura, Yuhei, Shiga, Joji, Mirii, Makoto, Sugihara, Tadaaki, Arimura, Junko, Nakano, Kazuhisa, Kodama, Nobuyuki, Ohte, Tomonori, Sugiura, Kazuaki, Wakami, Yasuhiko, Takemoto, Minoru, Yoshiyama, Taichi, Shuto, Kazuo, Fukumoto, Kenichi, Tanaka, Satomi, Sonoda, Akemi, Tokutsu, Takashi, Otsuka, Fumi, Uemura, Kenji, Koikawa, Megumi, Miyazaki, Maiko, Umikawa, Manabu, Narisawa, Machi, Furuta, Hiroshi, Minami, Masaru, Doi, Kazuhiro, Sugimoto, Susumu, Suzuki, Akira, Kurozumi, and Kosuke, Nishio
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Ipragliflozin ,Type 2 diabetes ,Pharmacology (medical) ,Carotid intima-media thickness ,Atherosclerosis ,Cardiology and Cardiovascular Medicine - 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.
- Published
- 2022
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