Long-term safety, tolerability, and efficacy of the dipeptidyl peptidase-4 inhibitor sitagliptin in Japanese patients with type 2 diabetes

被引：6

作者：

Odawara M. ^{[1
]}

Kadowaki T. ^{[2
]}

Tajima N. ^{[3
]}

Nishii M. ^{[4
]}

Taniguchi T. ^{[5
]}

Ferreira J.C.A. ^{[6
]}

机构：

[1] Department of Diabetes, Endocrinology and Metabolism, Tokyo Medical University, Tokyo

[2] Department of Diabetes and Metabolic Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo

[3] Jikei University School of Medicine, Tokyo

[4] Global Clinical Development, Ono Pharmaceutical Co., Ltd., Osaka 541-8564, 8-2 Kyutaromachi, 1-Chome, Chuo-ku

[5] MSD K. K., Tokyo

[6] Merck Sharp and Dohme Corp., a subsidiary of Merck and Co., Inc., Whitehouse Station, NJ

来源：

Diabetology International | 2011年 / 2卷 / 2期

关键词：

DPP-4; Incretins; Sitagliptin; Type; 2; diabetes;

D O I：

10.1007/s13340-011-0029-8

中图分类号：

学科分类号：

摘要：

The long-term safety, tolerability, and efficacy of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, were evaluated in a multicenter, open-label, single-arm, 52-week study in Japanese patients with type 2 diabetes mellitus who had inadequate glycemic control (HbA1c 6. 9-10. 4%) on diet and exercise therapy. A total of 177 patients entered the study and 139 (78. 5%) completed the 52-week treatment period. Through 52 weeks of treatment, sitagliptin (50 or 100 mg once daily) was well tolerated. The most commonly reported adverse experiences were nasopharyngitis (35. 0%), constipation (8. 5%), back pain (5. 1%) and upper respiratory tract inflammation (5. 1%). The incidences of hypoglycemia and pre-specified pooled gastrointestinal adverse experiences were low (each 1. 7%). No significant changes in body weight were observed with sitagliptin treatment over the 52-week treatment period. In general, there was no change in the type, severity or incidence of adverse experiences with long-term treatment (52 weeks) compared with shorter-term treatment (28 weeks). The safety and tolerability profile of sitagliptin in this study was consistent with that previously reported for Japanese and non-Japanese patients. After 52 weeks of sitagliptin treatment, HbA1c was significantly (p < 0. 001) reduced from baseline (-0. 7% ± 0. 6). Consistent with this observation, mean changes from baseline in 2 h post-meal glucose and fasting plasma glucose were also significantly reduced from baseline at week 52 (both p < 0. 001). In summary, in this study of Japanese patients with type 2 diabetes who had inadequate glycemic control on diet and exercise, sitagliptin was well tolerated and provided an effective improvement in glycemic parameters over 52 weeks. © 2011 The Japan Diabetes Society.

引用

页码：94 / 105

页数：11

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