Portal de Periódicos da CAPES

Overall Efficacy and Safety of Sodium-Glucose Cotransporter 2 Inhibitor Luseogliflozin Versus Dipeptidyl-Peptidase 4 Inhibitors: Multicenter, Open-Label, Randomized-Controlled Trial (J-SELECT study)

2023; Adis, Springer Healthcare; Volume: 14; Issue: 9 Linguagem: Inglês

10.1007/s13300-023-01438-w

1869-6961

M. Sugawara, Masahiro Fukuda, Ichiro Sakuma, Yutaka Wakasa, Hideaki Funayama, Akira Kondo, Naoki Itabashi, Yasuyuki Maruyama, Takashi Kamiyama, Yasunori Utsunomiya, Akira Yamauchi, Hidenori Yoshii, Hirokazu Yamada, Koichi Mochizuki, Hiroaki Seino, Murata Kaori, Shigeo Yatagai, Hiroshi Koyama, Hareaki Yamamoto, Miho Shimizu, Toshio Kawada, Setsuya Sakagashira, S Ozeki, Tomoo Takeda, Tomohiro Katsuya, Mariko Oishi, K Doniwa, Nobuyuki Ueda, Makiko Sasamoto, Hatsumi Masaki, Takashi Kamiyama, Woon-Joo Lee, Hiroko Chimori, Hiroshi Takeda, Kazuo Ikeda, Hiroaki Nishioka, Kyoko Mitsuhashi, Toru Kinugawa, Motoko Miki, Toshiyuki Horiuchi, Kunihiro Doi, Y. Shinagawa, Isato Shimozono, Jinro Ishizuka, Shun-ichiro Sakurai, Shigeki Moritani, Norio Kase, Shigeru Watanabe, Shinsuke Nakata, Keiko Tsunoda, Tadashi Sawanishi, Yuji Ogawa, Tomokazu Matsuda, Tomohiro Tsuji, Shinichiro Shirabe, Satoshi Ashitomi, H. Ogata, Kaneyuki Matsuo, T Sugie, Ken Takenaka, Asami Tanaka, Yoshiro Suzuki, Masahiro Inoue, Hiroshi Hasegawa, Haruyoshi Nakao, Tetsuo Nishikawa, Mikio Uematsu, Daigaku Uchida, Masaaki Miyakawa, Masahiro Takihata, Hirotaka Ishii, Kenji Mizuno, Masahiko Inomata, K Minamisawa, Soichi Honda, Mitsuo Shirakawa, Katsuya Fuse, Takuji Yamao, Akihiko Nakazima, Masahiro Nagano, Masahiko Nakamura, Suzuko Iwami, Hisakazu Degawa, Naoko Katayanagi, Yoshiharu Okada, Hideaki Sawaki, H. Ogata, Motoshige Miyano, Yuki Matsuda,

Potassium and Related Disorders

Evidence of a direct comparison between dipeptidyl-peptidase 4 inhibitors (DPP-4is) and sodium-glucose cotransporter 2 inhibitors (SGLT2is) remains lacking, and no clear treatment strategy or rationale has been established using these drugs. This study aimed to compare the overall efficacy and safety of DPP-4is and the SGLT2i luseogliflozin in patients with type 2 diabetes mellitus (T2DM).Patients with T2DM who had not used antidiabetic agents or who had used antidiabetic agents other than SGLT2is and DPP-4is were enrolled in the study after written informed consent had been obtained. The enrolled patients were subsequently randomly assigned to either the luseogliflozin or DPP-4i group and followed up for 52 weeks. The primary (composite) endpoint was the proportion of patients who showed improvement in ≥ 3 endpoints among the following five endpoints from baseline to week 52: glycated hemoglobin (HbA1c), weight, estimated glomerular filtration rate (eGFR), systolic blood pressure, and pulse rate.A total of 623 patients were enrolled in the study and subsequently randomized to either the luseogliflozin or DPP-4i groups. The proportion of patients who showed improvement in ≥ 3 endpoints at week 52 was significantly higher in the luseogliflozin group (58.9%) than in the DPP-4i group (35.0%) (p < 0.001). When stratified by body mass index (BMI) (< 25 or ≥ 25 kg/m2) or age (< 65 or ≥ 65 years), regardless of BMI or age, the proportion of patients who achieved the composite endpoint was significantly higher in the luseogliflozin group than in the DPP-4i group. Hepatic function and high-density lipoprotein-cholesterol were also significantly improved in the luseogliflozin group compared with the DPP-4i group. The frequency of non-serious/serious adverse events did not differ between the groups.This study showed the overall efficacy of luseogliflozin compared with DPP-4is over the mid/long term, regardless of BMI or age. The results suggest the importance of assessing multiple aspects regarding the effects of diabetes management.jRCTs031180241.