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

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

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.

MeSH terms

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

Substances

  • 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