학술논문
Lack of impact of ipragliflozin on endothelial function in patients with type 2 diabetes: sub-analysis of the PROTECT study
Document Type
Clinical report
Author
Kishimoto, Shinji; Higashi, Yukihito; Imai, Takumi; Eguchi, Kazuo; Fukumoto, Kazuo; Tomiyama, Hirofumi; Maemura, Koji; Tanaka, Atsushi; Node, Koichi; Murohara, Toyoaki; Kitakaze, Masafumi; Nishio, Yoshihiko; Inoue, Teruo; Ohishi, Mitsuru; Kario, Kazuomi; Sata, Masataka; Shimabukuro, Michio; Shimizu, Wataru; Jinnouchi, Hideaki; Taguchi, Isao; Suzuki, Makoto; Ando, Shinichi; 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; Yoshida, Hisako; 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; 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; Kodama, Kazuhisa; Ohte, Nobuyuki; Sugiura, Tomonori; Wakami, Kazuaki; Takemoto, Yasuhiko; Yoshiyama, Minoru; Shuto, Taichi; 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
Source
Cardiovascular Diabetology. May 20, 2023, Vol. 22 Issue 1
Subject
Language
English
Abstract
Author(s): Shinji Kishimoto[sup.1], Yukihito Higashi[sup.1,2], Takumi Imai[sup.3], Kazuo Eguchi[sup.4], Kazuo Fukumoto[sup.5], Hirofumi Tomiyama[sup.6], Koji Maemura[sup.7], Atsushi Tanaka[sup.8], Koichi Node[sup.8], Toyoaki Murohara, Masafumi Kitakaze, Yoshihiko Nishio, Teruo Inoue, Mitsuru Ohishi, Kazuomi [...]
Background We assessed the impact of 24 months of treatment with ipragliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, on endothelial function in patients with type 2 diabetes as a sub-analysis of the PROTECT study. Methods In the PROTECT study, patients were randomized to receive either standard antihyperglycemic treatment (control group, n = 241 ) or add-on ipragliflozin treatment (ipragliflozin group, n = 241) in a 1:1 ratio. Among the 482 patients in the PROTECT study, flow-mediated vasodilation (FMD) was assessed in 32 patients in the control group and 26 patients in the ipragliflozin group before and after 24 months of treatment. Results HbA1c levels significantly decreased after 24 months of treatment compared to the baseline value in the ipragliflozin group, but not in the control group. However, there was no significant difference between the changes in HbA1c levels in the two groups (7.4 [+ or -] 0.8% vs. 7.0 [+ or -] 0.9% in the ipragliflozin group and 7.4 [+ or -] 0.7% vs. 7.3 [+ or -] 0.7% in the control group; P = 0.08). There was no significant difference between FMD values at baseline and after 24 months in both groups (5.2 [+ or -] 2.6% vs. 5.2 [+ or -] 2.6%, P = 0.98 in the ipragliflozin group; 5.4 [+ or -] 2.9% vs. 5.0 [+ or -] 3.2%, P = 0.34 in the control group). There was no significant difference in the estimated percentage change in FMD between the two groups (P = 0.77). Conclusions Over a 24-month period, the addition of ipragliflozin to standard therapy in patients with type 2 diabetes did not change endothelial function assessed by FMD in the brachial artery. Trial registration Registration Number for Clinical Trial: jRCT1071220089 (https://jrct.niph.go.jp/en-latest-detail/jRCT1071220089). Keywords: Ipragliflozin, Sodium-glucose cotransporter-2 inhibitors, Endothelial function, Type 2 diabetes
Background We assessed the impact of 24 months of treatment with ipragliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, on endothelial function in patients with type 2 diabetes as a sub-analysis of the PROTECT study. Methods In the PROTECT study, patients were randomized to receive either standard antihyperglycemic treatment (control group, n = 241 ) or add-on ipragliflozin treatment (ipragliflozin group, n = 241) in a 1:1 ratio. Among the 482 patients in the PROTECT study, flow-mediated vasodilation (FMD) was assessed in 32 patients in the control group and 26 patients in the ipragliflozin group before and after 24 months of treatment. Results HbA1c levels significantly decreased after 24 months of treatment compared to the baseline value in the ipragliflozin group, but not in the control group. However, there was no significant difference between the changes in HbA1c levels in the two groups (7.4 [+ or -] 0.8% vs. 7.0 [+ or -] 0.9% in the ipragliflozin group and 7.4 [+ or -] 0.7% vs. 7.3 [+ or -] 0.7% in the control group; P = 0.08). There was no significant difference between FMD values at baseline and after 24 months in both groups (5.2 [+ or -] 2.6% vs. 5.2 [+ or -] 2.6%, P = 0.98 in the ipragliflozin group; 5.4 [+ or -] 2.9% vs. 5.0 [+ or -] 3.2%, P = 0.34 in the control group). There was no significant difference in the estimated percentage change in FMD between the two groups (P = 0.77). Conclusions Over a 24-month period, the addition of ipragliflozin to standard therapy in patients with type 2 diabetes did not change endothelial function assessed by FMD in the brachial artery. Trial registration Registration Number for Clinical Trial: jRCT1071220089 (https://jrct.niph.go.jp/en-latest-detail/jRCT1071220089). Keywords: Ipragliflozin, Sodium-glucose cotransporter-2 inhibitors, Endothelial function, Type 2 diabetes