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A randomized, open-label, clinical trial examined the effects of canagliflozin on albuminuria and eGFR decline using an individual pre-intervention eGFR slope

作者:Satoshi Miyamoto, Hiddo J.L. Heerspink, Dick de Zeeuw, Kota Sakamoto, Michihiro Yoshida, Masao Toyoda, Daisuke Suzuki, Takashi Hatanaka, Tohru Nakamura, Shinji Kamei, Satoshi Murao, Kazuyuki Hida, Shin’ichiro Ando, Hiroaki Akai, Yasushi Takahashi, Munehiro Kitada, Hisashi Sugano, Tomokazu Nunoue, Akihiko Nakamura, Motofumi Sasaki, Tatsuaki Nakatou, Kei Fujimoto, Daiji Kawanami, Takashi Wada, Nobuyuki Miyatake, Hiromi Kuramoto, Kenichi Shikata · 发表于:Kidney International · 年份:2024 · DOI:10.1016/j.kint.2024.08.019 · 被引用次数:10 · 研究领域:Diabetes Treatment and Management、Chronic Kidney Disease and Diabetes、Pancreatic function and diabetes

Demonstrating drug efficacy in slowing kidney disease progression requires large clinical trials when targeting participants with an early stage of chronic kidney disease (CKD). In this randomized, parallel-group, open-labeled trial (CANPIONE study), we assessed the effect of the sodium-glucose cotransporter 2 (SGLT2) inhibitor canagliflozin using the individual's change in estimated glomerular filtration rate (eGFR) slope before (pre-intervention slope) and during treatment (chronic slope). We randomly assigned (1:1) participants with type 2 diabetes, urinary albumin-to-creatinine ratio (UACR) of 50 to under 300 mg/g, and an eGFR of at least 45 ml/min/1.73m 2 to receive canagliflozin or guideline-recommended treatment except for SGLT2 inhibitors (control). The first and second primary outcomes were the geometric mean percentage change from baseline in UACR and the change in eGFR slope, respectively. Of 98 randomized participants, 96 received at least one study treatment. The least-squares mean change from baseline in log-transformed geometric mean UACR was significantly greater in the canagliflozin group than the control group (between group-difference, −30.8% (95% confidence interval −42.6 to −16.8). The between-group difference (canagliflozin group – control group) of change in eGFR slope (chronic – pre-intervention) was 4.4 (1.6 to 7.3) ml/min/1.73 m 2 per year, which was more pronounced in participants with faster eGFR decline. In summary, canagliflozin reduced albuminur...