DAPagliflozin for the attenuation of albuminuria in Patients with hEaRt failure and type 2 diabetes (DAPPER study): a multicentre, randomised, open-label, parallel-group, standard treatment-controlled trial

作者：Fumiki Yoshihara, Miki Imazu, Ichiro Sakuma, Yukio Hiroi, Hisao Hara, Osamu Okazaki, Chizuru Ishiguro, Chisato Izumi, Teruo Noguchi, Toshihiko Shiraiwa, Norio Nishioka, Kenshi Fujii, Katsuomi Iwakura, Osamu Tomonaga, Koichi Kobayashi, Masahiro Takihata, Kazuhiko Yumoto, Hiroyuki Takase, Toshiharu Himi, Ikki Shimizu, Tsutomu Murakami, Kenji Wagatsuma, Katsuhiko Sato, Takeyuki Hiramatsu, Satoshi Akabame, Shiro Hata, Masanori Asakura, Takanori Kawabata, Katsuhiro Omae, Shin Ito, Masafumi Kitakaze, Fumiki Yoshihara, Miki Imazu, Takanori Kawabata, Katsuhiro Omae, Chisato Izumi, Hideaki Kanzaki, Makoto Amaki, Atsushi Okada, Masashi Amano, Kenji Moriuchi, Shin Ito, Kiminori Hosoda, Hisashi Makino, Yoko Omura‐Ohata, Tamiko Tamanaha, Ryo Koezuka, Michio Noguchi, Tetsuya Arisato, Teruo Noguchi, Yoshio Tahara, Yu Kataoka, Yasuhide Asaumi, Masashi Fujino, Fumiyuki Otsuka, Shuichi Yoneda, Satoshi Honda, Hiroyuki Miura, Ichiro Sakuma, Yukio Hiroi, Hisao Hara, Masaya Yamamoto, Toru Okazaki, Takashi Nakagawa, Shuji Kubota, Shunsuke Torii, Jumpei Yamamoto, Wataru Miyake, R Nagai, Mai Ishiwata, Osamu Okazaki, Chizuru Ishiguro, Toshihiko Shiraiwa, Norio Nishioka, Yoshifumi Maeno, Kaoru Yamamoto, Yoko Yoshida, Y Shiraiwa, Kenshi Fujii, Katsuomi Iwakura, Atsunori Okamura, Yuko Hirao, Koji Tanaka, Mutsumi Iwamoto, Nobuaki Tanaka, Masato Okada, Akinori Sumiyoshi, Kota Tanaka, Satoshi Watanabe, Shinichi Harada, Toshikazu Kashiyama, Osamu Tomonaga, Koichi Kobayashi, Ryoji Ishiki, Dai Yamamoto, Tadahiro Ito, Masahiro Takihata, Kazuhiko Yumoto, Tomoyuki Fukuzawa, Hiroyuki Takase, Kazusa Hayashi, Toshiharu Himi, Yusuke Hyodo, Ryoichi Ishibashi, Ikki Shimizu, Tsutomu Murakami, Yuji Ikari, Yohei Ohno, Susumu Sakama, Norihito Nakamura, Junichi Miyamoto, Sho Torii, Takeshi Ijichi, Kyong Hee Lee, Kenji Wagatsuma, Hideo Nii, Yasuto Uchida, Katsuhiko Sato, Takeyuki Hiramatsu, Yasunobu Takada, Satoshi Akabame, Masahiro Koide, Hiroki Kitajima, Yukinori Kato, Koji Sogabe, Kento Fukui, Masaya Kogure, Akio Kishi, Shiro Hata, Hiroki Shinboku, Takahiro Muroya, Koichiro Sonoda, Masanori Asakura, Masafumi Kitakaze · 发表于：EClinicalMedicine · 年份：2023 · DOI：10.1016/j.eclinm.2023.102334 · 被引用次数：9 · 研究领域：Diabetes Treatment and Management、Chronic Kidney Disease and Diabetes、Parathyroid Disorders and Treatments

Background: Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the urinary albumin-to-creatinine ratio (UACR) in patients with elevated levels of albuminuria in the presence or absence of heart failure (HF) or type 2 diabetes mellitus (T2D). However, these effects have not yet been reported in the presence of both HF and T2D. This lack of evidence prompted us to conduct a clinical trial on the effects of dapagliflozin on UACR in patients with HF and T2D. Methods: DAPPER is a multicentre, randomised, open-labeled, parallel-group, standard treatment-controlled trial that enrolled patients at 18 medical facilities in Japan. Eligible participants with both HF and T2D and aged between 20 and 85 years were randomly assigned to a dapagliflozin or control (anti-diabetic drugs other than SGLT 2 inhibitors) group with a 1:1 allocation. The primary outcome was changes in UACR from baseline after a two-year observation, and secondary endpoints were cardiovascular (CV) events and parameters related to HF. This trial was registered with the UMIN-CTR registry, UMIN000025102 and the Japan Registry of Clinical Trials, jRCTs051180135. Findings: , and median UACR was 25.0 (8.8-74.6) mg/g Cr in the dapagliflozin group and 25.6 (8.2-95.0) mg/g Cr in the control group. Of the 146 patients in the dapagliflozin group, 122 completed the study, and 107 (87.7%) were taking 5 mg of dapagliflozin daily at the end of the observation period. The primary outcome did not significantly differ between th...