Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
Medical Affairs, Sanofi K.K., Tokyo, Japan.
J Diabetes Investig. 2020 Jan;11(1):132-141. doi: 10.1111/jdi.13097. Epub 2019 Jul 8.
AIMS/INTRODUCTION: Due to the paucity of tofogliflozin data, we assessed the safety and effectiveness of tofogliflozin among Japanese patients with type 2 diabetes mellitus in the clinical setting, stratifying the patients by age, sex, estimated glomerular filtration (eGFR) rate and body mass index. We report the results of a 12-month interim analysis.
This was a 3-year prospective, observational and multicenter post-marketing study (Japanese Study of tofogliflozin with type 2 diabetes mellitus Patients/Long Term).
Out of 6,897 patients enrolled, the safety and effectiveness analysis populations consisted of 6,712 and 6,449 patients, respectively. During 12 months, adverse drug reactions and their incidence were 9.12 and 0.88%, respectively. The incidence of hypoglycemia was 0.67%. Polyuria/pollakiuria occurred more frequently in patients aged ≥65 years than in patients aged <65 years. Women experienced higher rates of urinary tract and genital infection than men. The lowest eGFR subgroup experienced maximum volume depletion-related events. Cardiovascular and cerebrovascular disorders occurred in 0.55% of the patients. Glycated hemoglobin (HbA1c) and bodyweight significantly decreased by -0.76% and -2.73 kg, respectively, from baseline to the last observation carried forward (P < 0.0001). Except for the lowest eGFR subgroup, other eGFR subgroups showed significantly decreased HbA1c values. All eGFR subgroups showed significantly decreased bodyweight, and all body mass index subgroups showed significantly decreased HbA1c and bodyweight.
Our interim 12-month data suggest that tofogliflozin could be used safely and effectively in Japanese patients with type 2 diabetes mellitus, as tofogliflozin was well tolerated with low hypoglycemia risk, and significantly improved HbA1c and bodyweight.
目的/引言：由于托格列净的数据有限，我们评估了托格列净在日本 2 型糖尿病患者中的安全性和有效性，根据年龄、性别、估算肾小球滤过率（eGFR）和体重指数对患者进行分层。我们报告了 12 个月中期分析的结果。
这是一项为期 3 年的前瞻性、观察性和多中心上市后研究（日本托格列净治疗 2 型糖尿病患者/长期研究）。
在纳入的 6897 名患者中，安全性和有效性分析人群分别为 6712 名和 6449 名患者。在 12 个月期间，不良药物反应及其发生率分别为 9.12%和 0.88%。低血糖的发生率为 0.67%。多尿/尿频在≥65 岁的患者中比<65 岁的患者更常见。女性尿路感染和生殖器感染的发生率高于男性。eGFR 最低亚组发生与最大容量耗竭相关的事件的比例最高。0.55%的患者发生心血管和脑血管疾病。糖化血红蛋白（HbA1c）和体重分别从基线下降至最后一次向前观察（LOCF）（P<0.0001）-0.76%和-2.73kg。除了 eGFR 最低亚组外，其他 eGFR 亚组的 HbA1c 值也显著下降。所有 eGFR 亚组的体重均显著下降，所有体重指数亚组的 HbA1c 和体重均显著下降。
我们的 12 个月中期数据表明，托格列净可在日本 2 型糖尿病患者中安全有效地使用，因为托格列净低血糖风险低，耐受性良好，显著改善 HbA1c 和体重。
