Haneda Masakazu, Kadowaki Takashi, Ito Hiroshi, Sasaki Kazuyo, Hiraide Sonoe, Ishii Manabu, Matsukawa Miyuki, Ueno Makoto
Department of Medicine, Asahikawa Medical University, Hokkaido, Japan.
Medical Corporation Kyousoukai, Osaka, Japan.
Diabetes Ther. 2018 Jun;9(3):1083-1097. doi: 10.1007/s13300-018-0416-2. Epub 2018 Apr 10.
Teneligliptin is a novel oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes mellitus (T2DM). Safety and efficacy of teneligliptin have been demonstrated in clinical studies; however, data supporting its use in patients with moderate or severe renal impairment are limited. This interim analysis of a post-marketing surveillance of teneligliptin, exploRing the long-term efficacy and safety included cardiovascUlar events in patients with type 2 diaBetes treated bY teneligliptin in the real-world (RUBY), aims to verify the long-term safety and efficacy of teneligliptin in Japanese patients with T2DM and impaired renal function.
For this analysis, we used the data from case report forms of the RUBY surveillance between May 2013 and June 2017. The patients were classified into G1-G5 stages of chronic kidney disease according to estimated glomerular filtration rate (eGFR) at initiation of teneligliptin treatment. Safety and efficacy were evaluated in these subgroups. Patients on dialysis were also assessed. Safety was assessed from adverse drug reactions (ADRs). Glycemic control was evaluated up to 2 years after teneligliptin initiation.
A total of 11,677 patients were enrolled in the surveillance and 11,425 patient case-report forms were collected for the interim analysis. The incidence of ADRs in each subgroup was 2.98-6.98% of patients, with no differences in the ADR profile (including hypoglycemia and renal function ADRs) between subgroups. At 1 and 2 years after starting teneligliptin, the least-squares mean change in HbA1c adjusted to the baseline was - 0.68 to - 0.85% and - 0.71 to - 0.85% across the eGFR groups, respectively. Treatment with teneligliptin in patients on dialysis reduced or tended to reduce glycated albumin levels [- 2.29%, (p < 0.001) after 1 year; - 1.64%, (p = 0.064) after 2 years].
During long-term treatment, teneligliptin was generally well tolerated in patients with any stage of renal impairment from normal to end-stage renal disease, including those on dialysis, and improved glycemic control.
Japic CTI-153047.
Mitsubishi Tanabe Pharma Corporation and Daiichi Sankyo Co, Ltd.
替格列汀是一种新型口服二肽基肽酶-4抑制剂，用于治疗2型糖尿病（T2DM）。替格列汀的安全性和有效性已在临床研究中得到证实；然而，支持其用于中度或重度肾功能损害患者的数据有限。这项对替格列汀上市后监测的中期分析，探索长期疗效和安全性，包括在现实世界中接受替格列汀治疗的2型糖尿病患者的心血管事件（RUBY），旨在验证替格列汀在日本T2DM和肾功能受损患者中的长期安全性和有效性。
对于本次分析，我们使用了2013年5月至2017年6月RUBY监测病例报告表中的数据。根据替格列汀治疗开始时的估计肾小球滤过率（eGFR），将患者分为慢性肾脏病G1-G5期。在这些亚组中评估安全性和有效性。还对接受透析的患者进行了评估。从药物不良反应（ADR）评估安全性。在替格列汀开始治疗后长达2年的时间里评估血糖控制情况。
共有11677名患者纳入监测，收集了11425份患者病例报告表用于中期分析。各亚组中ADR的发生率为患者的2.98%-6.98%，亚组间ADR谱（包括低血糖和肾功能ADR）无差异。在开始替格列汀治疗1年和2年后，各eGFR组中调整至基线的HbA1c最小二乘均值变化分别为-0.68%至-0.85%和-0.71%至-0.85%。接受透析的患者使用替格列汀治疗可降低或倾向于降低糖化白蛋白水平[1年后为-2.29%，（p<0.001）；2年后为-1.64%，（p=0.064）]。
在长期治疗期间，替格列汀在从正常到终末期肾病的任何肾功能损害阶段的患者中，包括接受透析的患者，总体耐受性良好，并改善了血糖控制。
Japic CTI-153047。
三菱田边制药株式会社和第一三共株式会社。
