Nakajima Hanako, Okada Hiroshi, Kogure Akinori, Osaka Takafumi, Tsutsumi Takeshi, Onishi Masayoshi, Mitsuhashi Kazuteru, Kitagawa Noriyuki, Mogami Shinichi, Kitamura Akane, Ishii Michiyo, Nakamura Naoto, Kishi Akio, Eiko Sato, Hamaguchi Masahide, Fukui Michiaki
Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Department of Diabetes and Endocrinology, Matsushita Memorial Hospital, Moriguchi, Japan.
J Diabetes Investig. 2024 Dec;15(12):1809-1817. doi: 10.1111/jdi.14314. Epub 2024 Sep 18.
Nocturia impairs the quality of life in patients with type 2 diabetes mellitus. Although sodium glucose co-transporter 2 inhibitors (SGLT2i) such as tofogliflozin increase urine volume, their impact on nocturia, in conjunction with dietary salt restriction, is less clear.
This multicenter, open-label, randomized, parallel-group trial included 80 subjects with type 2 diabetes and nocturia. The patients were divided into two groups: one receiving tofogliflozin, the shortest half-life, without salt restriction, and the other receiving both tofogliflozin and dietary salt restriction. The primary endpoint was nocturia frequency at 12 weeks. The secondary outcomes included changes in daytime urination frequency, urine volume, and home blood pressure.
At 12 weeks, there were no significant differences in nocturia changes between both groups. Nocturia frequency did not change in the tofogliflozin without salt restriction group from 1.5 ± 0.8 to 1.3 ± 1.1 times per night (P = 0.297), and significantly decreased from 1.6 ± 1.0 to 1.3 ± 0.7 times per night in the tofogliflozin and dietary salt restriction group (P = 0.049). There was a trend toward increased urine volume and frequency during the daytime in the group with salt restriction, indicating a time-shift effect of the short half-life tofogliflozin and salt restriction on urinary time.
The frequency of nocturia after tofogliflozin did not increase. Tofogliflozin reduced nocturia when combined with salt restriction. Furthermore, daytime urine volume and frequency showed an increasing trend, suggesting a shift in urine production to daytime hours due to the short half-life of tofogliflozin. Dietary modifications can enhance the therapeutic benefits of tofogliflozin in managing nocturia in people with type 2 diabetes.
夜尿症会损害2型糖尿病患者的生活质量。尽管诸如托格列净之类的钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）会增加尿量，但它们与饮食限盐联合使用时对夜尿症的影响尚不清楚。
这项多中心、开放标签、随机、平行组试验纳入了80名患有2型糖尿病和夜尿症的受试者。患者被分为两组：一组接受半衰期最短的托格列净且不限盐，另一组接受托格列净并进行饮食限盐。主要终点是12周时的夜尿频率。次要结局包括白天排尿频率、尿量和家庭血压的变化。
在12周时，两组之间夜尿变化无显著差异。不限盐的托格列净组夜尿频率未从每晚1.5±0.8次变化至1.3±1.1次（P = 0.297），而托格列净和饮食限盐组的夜尿频率从每晚1.6±1.0次显著降至1.3±0.7次（P = 0.049）。限盐组白天尿量和排尿频率有增加趋势，表明半衰期短的托格列净和限盐对排尿时间有时间转移效应。
托格列净治疗后的夜尿频率未增加。托格列净与限盐联合使用可减少夜尿。此外，白天尿量和排尿频率呈增加趋势，提示由于托格列净半衰期短，尿量产生转移至白天。饮食调整可增强托格列净对2型糖尿病患者夜尿症的治疗效果。
