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.

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.

• Authors: Takashi Kadowaki, Masakazu Haneda, Hiroshi Ito, Makoto Ueno, Miyuki Matsukawa, Tomoko Yamakura, Kazuyo Sasaki, Mayumi Kimura, Hiroaki Iijima
• Journal: Expert opinion on pharmacotherapy (Expert Opin Pharmacother) Vol. 19 Issue 2 Pg. 83-91 (Feb 2018) ISSN: 1744-7666 [Electronic] England
• PMID: 29268035 (Publication Type: Journal Article)

Chemical References

• 3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine
• Blood Glucose
• Glycated Hemoglobin A
• Hypoglycemic Agents
• Pyrazoles
• Thiazolidines

Topics

• Aged
• Blood Glucose
• Chemical and Drug Induced Liver Injury (etiology)
• Constipation (etiology)
• Diabetes Mellitus, Type 2 (drug therapy)
• Female
• Glycated Hemoglobin (analysis)
• Humans
• Hypoglycemia (etiology)
• Hypoglycemic Agents (adverse effects, therapeutic use)
• Japan
• Male
• Middle Aged
• Product Surveillance, Postmarketing
• Pyrazoles (adverse effects, therapeutic use)
• Surveys and Questionnaires
• Thiazolidines (adverse effects, therapeutic use)