Shiba Teruo, Ishii So, Okamura Tomoo, Mitsuyoshi Rika, Pfarr Egon, Koiwai Kazuki
Division of Diabetes and Metabolism, Toho University Ohashi Medical Center, 2-17-6 Ohashi, Meguro-ku, Tokyo 153-8515, Japan.
Eli Lilly Japan K.K., 4-15-1, Akasaka, Minato-ku, Tokyo 107-0052, Japan.
Diabetes Res Clin Pract. 2017 Sep;131:169-178. doi: 10.1016/j.diabres.2017.07.004. Epub 2017 Jul 8.
To investigate the efficacy and safety of empagliflozin in subgroups based on body mass index (BMI) and age, using a pooled data set from Japanese patients with type 2 diabetes mellitus (T2DM).
Pooled data from 1403 patients treated with empagliflozin at 10mg/day or 25mg/day in three clinical studies (≥52week treatment) were stratified by baseline BMI (<22, 22 to <25 and ≥25kg/m) and baseline age (<50, 50 to <65 and ≥65years).
Empagliflozin at 10mg/day and 25mg/day reduced mean glycated hemoglobin (HbA1c) (-0.77 to -0.87% and -0.76 to -0.97%, respectively), mean fasting plasma glucose (FPG) (-20.79 to -27.06mg/dL and -26.08 to -29.60mg/dL) and mean body weight (-3.4 to -4.7% and -3.7 to -4.7%) in all subgroups of baseline BMI and age, regardless of age and degree of obesity. Adverse events were observed in approximately 70-80% patients in BMI and age subgroups of both empagliflozin groups. No hypoglycemia requiring assistance was observed. Neither UTI nor genital infection rates differed markedly among the BMI and age subgroups. Volume depletion was increased in patients ≥65years of age as compared to younger patients.
Empagliflozin was well tolerated and improved HbA1c, FPG and body weight in all BMI and age subgroups of Japanese patients with T2DM, regardless of age and degree of obesity. Empagliflozin is considered to be effective and well tolerated for treating a wide range of Japanese patients with T2DM.
Study 1 (NCT01193218), Study 2 (NCT01289990) and Study 3 (NCT01368081).
利用来自日本2型糖尿病（T2DM）患者的汇总数据集，研究恩格列净在基于体重指数（BMI）和年龄的亚组中的疗效和安全性。
在三项临床研究（治疗≥52周）中，将1403例接受10mg/天或25mg/天恩格列净治疗的患者的汇总数据，按基线BMI（<22、22至<25以及≥25kg/m²）和基线年龄（<50、50至<65以及≥65岁）进行分层。
10mg/天和25mg/天的恩格列净在所有基线BMI和年龄亚组中均降低了平均糖化血红蛋白（HbA1c）（分别为-0.77至-0.87%和-0.76至-0.97%）、平均空腹血糖（FPG）（-20.79至-27.06mg/dL和-26.08至-29.60mg/dL）以及平均体重（-3.4至-4.7%和-3.7至-4.7%），无论年龄和肥胖程度如何。在恩格列净两个组的BMI和年龄亚组中，约70-80%的患者观察到不良事件。未观察到需要协助的低血糖情况。在BMI和年龄亚组中，尿路感染和生殖器感染率均无明显差异。与年轻患者相比，≥65岁患者的血容量减少有所增加。
恩格列净耐受性良好，在日本T2DM患者的所有BMI和年龄亚组中均改善了HbA1c、FPG和体重，无论年龄和肥胖程度如何。恩格列净被认为对广泛的日本T2DM患者有效且耐受性良好。
研究1（NCT01193218）、研究2（NCT01289990）和研究3（NCT01368081）。
