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Expert Opin Pharmacother. 2018 Feb;19(2):83-91. doi: 10.1080/14656566.2017.1420165. Epub 2018 Jan 19.

Safety and efficacy of long-term treatment with teneligliptin: Interim analysis of a post-marketing surveillance of more than 10,000 Japanese patients with type 2 diabetes mellitus.

Author information

1
a Department of Diabetes and Metabolic Diseases, Graduate School of Medicine , The University of Tokyo , Tokyo , Japan.
2
b Department of Medicine , Asahikawa Medical University , Hokkaido , Japan.
3
c Medical Corporation Kyousoukai , Osaka , Japan.
4
d Department of Cardiovascular Medicine , Okayama University , Okayama , Japan.
5
e Ikuyaku. Integrated Value Development Division , Mitsubishi Tanabe Pharma Corporation , Osaka , Japan.
6
f Ikuyaku. Integrated Value Development Division , Mitsubishi Tanabe Pharma Corporation , Tokyo , Japan.

Abstract

BACKGROUND:

This post-marketing surveillance examined the safety and efficacy of long-term teneligliptin therapy in Japanese patients.

RESEARCH DESIGN AND METHODS:

We report interim results (cut-off date: 28 June 2017) of a 3-year PMS undertaken in subjects with type 2 diabetes mellitus (T2DM). Survey items included demographics, treatments, adverse drug reactions (ADRs), and laboratory variables. A subgroup analysis was also performed across three age groups (<65 years; 65 to <75 years; ≥75 years). Main outcome measures were incidence of ADRs, laboratory variables, and change in glycated hemoglobin (HbA1c) from baseline over time.

RESULTS:

Of 11,677 patients registered, data from 10,532 patients (6,338 males/4,194 females) were analyzed for the safety analysis set; the median administration period was 731 days. Overall, ADRs and serious ADRs were reported in 364 (3.46%) and 91 patients (0.86%), respectively. The most common ADRs were all hypoglycemia (0.32%), constipation (0.27%), and hepatic function abnormal (0.24%). No change in mean body weight occurred, and a reduction in mean HbA1c was observed until 2 years. The safety and efficacy profiles did not differ markedly among the three age groups.

CONCLUSIONS:

These interim results show that teneligliptin was well tolerated and improved hyperglycemia in Japanese patients with T2DM in clinical practice.

KEYWORDS:

DPP-4 inhibitors; Japanese; elderly; post-marketing surveillance; teneligliptin; type 2 diabetes mellitus

PMID:
29268035
DOI:
10.1080/14656566.2017.1420165
[Indexed for MEDLINE]

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