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替奈利汀对2型糖尿病血液透析患者的安全性和有效性:一种新型二肽基肽酶-4抑制剂

Safety and efficacy of teneligliptin: a novel DPP-4 inhibitor for hemodialysis patients with type 2 diabetes.

作者信息

Otsuki Hideo, Kosaka Takeo, Nakamura Kenzo, Shimomura Fumihiko, Kuwahara Yoshitaka, Tsukamoto Takuji

机构信息

Department of Urology and Nephrology, Nagakubo Hospital, 6907-1, Yaho, Kunitachi, Tokyo, 186-0011, Japan,

出版信息

Int Urol Nephrol. 2014 Feb;46(2):427-32. doi: 10.1007/s11255-013-0552-6. Epub 2013 Sep 8.

Abstract

PURPOSE

Teneligliptin is a novel DPP-4 inhibitor in development for treating type 2 diabetes mellitus that does not require dose adjustment for diabetic patients with end-stage renal disease; however, it had not been known whether or not teneligliptin is safe or potent in dialysis patients. We conducted a prospective study to assess the utility of teneligliptin for diabetic patients undergoing hemodialysis.

METHODS

Blood glucose, glycated albumin, and HbA1c were measured every 4 weeks, at 4, 12, 20, and 28 weeks, and every 8 weeks, respectively, for patients treated with teneligliptin (n = 14; 7 patients newly started and 7 that switched from other medications) and patients of a control group who continued ongoing antidiabetic therapy (n = 29).

RESULTS

Blood glucose level showed a 36.7 mg/dl decrease from 4 weeks in the teneligliptin group (p < 0.05). The differences in glycated albumin (at 28 w) and HbA1c (at 24 w) between the teneligliptin group and the control group were -3.1 % (p < 0.05) and -0.57 % (p = 0.057), respectively. These parameters also decreased in patients who switched from voglibose 0.2 mg t.i.d. or vildagliptin 50 mg qd after teneligliptin administration. No case with hypoglycemia was identified. One patient had the dose of a laxative administered for constipation increased; however, no patient ceased teneligliptin due to side effects.

CONCLUSION

Teneligliptin 20 mg is well tolerated, safe, and significantly improves glycemic control in diabetic patients with end-stage renal disease. Teneligliptin 20 mg once daily was considered to be more potent than voglibose 0.2 mg t.i.d. or vildagliptin 50 mg qd.

摘要

目的

替格列汀是一种正在研发用于治疗2型糖尿病的新型二肽基肽酶-4(DPP-4)抑制剂,终末期肾病糖尿病患者无需调整剂量;然而,此前尚不清楚替格列汀在透析患者中是否安全有效。我们进行了一项前瞻性研究,以评估替格列汀对接受血液透析的糖尿病患者的效用。

方法

对接受替格列汀治疗的患者(n = 14;7例新开始用药患者和7例从其他药物转换而来的患者)和继续进行现有抗糖尿病治疗的对照组患者(n = 29),分别每4周(在第4、12、20和28周)以及每8周测量血糖、糖化白蛋白和糖化血红蛋白。

结果

替格列汀组血糖水平从第4周起下降了36.7mg/dl(p < 0.05)。替格列汀组与对照组之间糖化白蛋白(在第28周时)和糖化血红蛋白(在第24周时)的差异分别为-3.1%(p < 0.05)和-0.57%(p = 0.057)。在替格列汀给药后从伏格列波糖0.2mg每日三次或维格列汀50mg每日一次转换而来的患者中,这些参数也有所下降。未发现低血糖病例。有1例患者因便秘使用的泻药剂量增加;然而,没有患者因副作用而停用替格列汀。

结论

20mg替格列汀耐受性良好、安全,可显著改善终末期肾病糖尿病患者的血糖控制。每日一次20mg替格列汀被认为比伏格列波糖0.2mg每日三次或维格列汀50mg每日一次更有效。

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