Hirose Sachie, Nakajima Shinsuke, Iwahashi Yasuyuki, Seo Akane, Takahashi Tetsuya, Tamori Yoshikazu
Division of Diabetes and Endocrinology, Department of Internal Medicine, Chibune General Hospital, Japan.
Intern Med. 2016;55(22):3239-3245. doi: 10.2169/internalmedicine.55.6367. Epub 2016 Nov 15.
Objective The adverse effects of selective sodium-glucose co-transporter 2 (SGLT2) inhibitors generally appear within about two or three months after treatment initiation in Japan. Therefore, we investigated the impact of tofogliflozin, a class of SGLT2 inhibitors, on glycemic control and body composition during this period in Japanese patients with type 2 diabetes mellitus. Methods This single-arm open-label study enrolled 20 patients. Patients received tofogliflozin 20 mg once daily for 8 weeks. At week 8, changes from baseline in body weight, serum metabolic markers, and body composition were evaluated. Results A total of 17 patients completed the 8-week administration of tofogliflodin. No serious adverse events were noted. Hemoglobin A1c (HbA1c) decreased significantly, from 7.8% to 7.3% with 8-week administration of tofogliflozin. Both the body weight and body mass index (BMI) also decreased. In addition, a decreased renal function of the boundary zone and hemoconcentration were detected. As for body composition, the free fat mass, total body water, extracellular water and intracellular water were all decreased significantly. Interestingly, the amount of fat mass did not change. The degree of improvement in HbA1c was correlated with the baseline fat mass and BMI. Conclusion An eight-week administration of tofogliflozin improved glycemic control and reduced the body weight and free fat mass in type 2 diabetic patients without affecting the fat mass. In this period, the hematocrit level and renal function should be monitored to guard against hemoconcentration and renal impairment, respectively.
目的 在日本，选择性钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂的不良反应通常在开始治疗后的两三个月内出现。因此，我们研究了SGLT2抑制剂类药物托格列净对日本2型糖尿病患者在此期间血糖控制和身体成分的影响。方法 这项单臂开放标签研究纳入了20名患者。患者每天服用一次20 mg托格列净，持续8周。在第8周时，评估体重、血清代谢标志物和身体成分相对于基线的变化。结果 共有17名患者完成了8周的托格列净给药。未观察到严重不良事件。服用托格列净8周后，糖化血红蛋白（HbA1c）显著降低，从7.8%降至7.3%。体重和体重指数（BMI）也均下降。此外，检测到边界区肾功能下降和血液浓缩。至于身体成分，游离脂肪量、总体水、细胞外水和细胞内水均显著减少。有趣的是，脂肪量没有变化。HbA1c的改善程度与基线脂肪量和BMI相关。结论 服用托格列净8周可改善2型糖尿病患者的血糖控制，减轻体重和游离脂肪量，而不影响脂肪量。在此期间，应监测血细胞比容水平和肾功能，分别预防血液浓缩和肾功能损害。
