Kadowaki Takashi, Marubayashi Fuyuhiko, Yokota Shoko, Katoh Makoto, Iijima Hiroaki
The University of Tokyo, Graduate School of Medicine, Department of Metabolic Disease , Tokyo , Japan.
Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 10.1517/14656566.2015.1032249. Epub 2015 Apr 10.
To assess the safety and efficacy of long-term administration of teneligliptin alone and in combination with oral antidiabetic drugs in Japanese type 2 diabetes mellitus (T2DM) patients with insufficient glycemic control.
This post-hoc pooled analysis used data from two Phase III clinical studies involving 702 Japanese patients. We evaluated teneligliptin as monotherapy and combined with a sulfonylurea, glinide, biguanide, or α-glucosidase inhibitor. Safety measures included adverse events (AEs), adverse reactions and hypoglycemia. The main efficacy measure was the change in glycated hemoglobin (HbA1c) from baseline.
Incidences of AEs and adverse reactions were similar among the teneligliptin monotherapy group and all combination therapy groups except the combination with sulfonylurea. Hypoglycemia was more frequent in the sulfonylurea combination therapy group than in other groups. Teneligliptin administered once daily as monotherapy or combination therapy resulted in a decrease in HbA1c, which was maintained for 52 weeks. Bodyweight showed no change or a slight increase at the end of 52 weeks in all groups.
This pooled analysis provides evidence for the safety and efficacy of long-term use of teneligliptin as monotherapy or combination therapy in Japanese T2DM patients.
评估在血糖控制不佳的日本2型糖尿病（T2DM）患者中，长期单独使用替奈利汀以及与口服抗糖尿病药物联合使用的安全性和有效性。
这项事后汇总分析使用了两项III期临床研究的数据，涉及702名日本患者。我们评估了替奈利汀作为单一疗法以及与磺脲类、格列奈类、双胍类或α-葡萄糖苷酶抑制剂联合使用的情况。安全指标包括不良事件（AE）、不良反应和低血糖。主要疗效指标是糖化血红蛋白（HbA1c）相对于基线的变化。
替奈利汀单一疗法组与除磺脲类联合疗法组之外的所有联合疗法组的不良事件和不良反应发生率相似。磺脲类联合疗法组的低血糖发生率高于其他组。替奈利汀作为单一疗法或联合疗法每日给药一次可导致HbA1c降低，并持续52周。所有组在52周结束时体重未出现变化或略有增加。
这项汇总分析为替奈利汀作为单一疗法或联合疗法在日本T2DM患者中长期使用的安全性和有效性提供了证据。
