Utsunomiya Kazunori, Shimmoto Naoki, Senda Masayuki, Kurihara Yuji, Gunji Ryoji, Fujii Shoko, Kakiuchi Seigo, Fujiwara Hisataka, Kameda Hiroyuki, Tamura Masahiro, Kaku Kohei
Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
Post Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
J Diabetes Investig. 2017 Nov;8(6):766-775. doi: 10.1111/jdi.12626. Epub 2017 Mar 6.
AIMS/INTRODUCTION: Although sodium-glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing study of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus.
This was a prospective, observational and multicenter post-marketing study carried out in the context of routine clinical practice. The study included all type 2 diabetes patients aged ≥65 years who started treatment with tofogliflozin during the first 3 months after its launch on 23 May 2014.
Of 1,535 patients registered, 1,507 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis. A total of 270 of 1,507 patients (17.92%) had at least one adverse drug reaction to tofogliflozin. The incidences of adverse drug reactions of special interest, namely, polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, hypoglycemia and skin disorders were 2.92, 3.85, 2.06, 1.33, 1.06 and 2.39%, respectively. Among those patients evaluable for clinical effectiveness, the mean change in glycated hemoglobin and bodyweight from baseline to last visit was -0.46% (P < 0.0001) and -2.71 kg (P < 0.0001), respectively.
The present study showed that the incidence of adverse drug reactions to tofogliflozin in this study of elderly patients aged ≥65 years differed little from the incidence in the preapproval clinical trials. It was shown that tofogliflozin significantly decreased glycated hemoglobin levels.
目的/引言：尽管钠-葡萄糖协同转运蛋白2抑制剂是2型糖尿病的一种有前景的治疗方法，但它们与特定药物不良反应的担忧有关。我们对这类新型药物托格列净在日本老年2型糖尿病患者中进行了为期1年的上市后研究。
这是一项在常规临床实践背景下进行的前瞻性、观察性多中心上市后研究。该研究纳入了所有在2014年5月23日上市后的前3个月内开始使用托格列净治疗的≥65岁的2型糖尿病患者。
在登记的1535例患者中，收集了电子病例报告表且至少有一次随访的1507例患者纳入安全性分析。1507例患者中共有270例（17.92%）对托格列净至少有一次药物不良反应。特别关注的药物不良反应发生率，即多尿/尿频、容量耗竭相关事件、尿路感染、生殖器感染、低血糖和皮肤疾病分别为2.92%、3.85%、2.06%、1.33%、1.06%和2.39%。在可评估临床疗效的患者中，糖化血红蛋白和体重从基线到最后一次随访的平均变化分别为-0.46%（P<0.0001）和-2.71kg（P<0.0001）。
本研究表明，在这项≥65岁老年患者的研究中，托格列净的药物不良反应发生率与批准前临床试验中的发生率差异不大。结果显示托格列净显著降低了糖化血红蛋白水平。
