Long-Term Safety and Efficacy of Teneligliptin in Elderly Patients with Type 2 Diabetes: Subgroup Analysis of a 3-Year Post-Marketing Surveillance ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2020-04-22

AUTHORS

Takashi Kadowaki, Masakazu Haneda, Hiroshi Ito, Kazuyo Sasaki, Yuka Yamada

ABSTRACT

IntroductionTeneligliptin, a dipeptidyl peptidase 4 inhibitor, was approved for the treatment of type 2 diabetes mellitus (T2DM) in Japan in 2012. However, clinical trials of teneligliptin involved limited numbers of elderly patients. Therefore, we investigated the safety and efficacy of teneligliptin in elderly patients with T2DM.MethodsThis 3-year follow-up RUBY surveillance registered patients with T2DM who started treatment with teneligliptin between May 2013 and February 2015 in Japan. Collected data included demographics, treatments, adverse drug reactions (ADRs), and laboratory variables. Data were analysed for patients in three age subgroups (< 65, ≥ 65 to < 75, or ≥ 75 years old). Safety was assessed as the incidence of ADRs and efficacy was assessed in terms of glycaemic control, for up to 3 years.ResultsThe ADRs and serious ADRs occurred in 3.35% and 0.65% of 4596 patients aged < 65 years, in 4.42% and 1.22% of 3371 patients aged ≥ 65 to < 75 years, and in 3.99% and 1.69% of 2729 patients aged ≥ 75 years. The most common ADRs in patients aged ≥ 65 to < 75 years and ≥ 75 years were gastrointestinal disorders, but the incidence of these ADRs did not show an age-dependent increase. Hypoglycaemia occurred in 0.24%, 0.56%, and 0.29% of patients in each age subgroup, respectively. The least-squares mean changes in glycosylated haemoglobin (HbA1c) adjusted for baseline were − 0.66 ± 0.02% (n = 2177), − 0.72 ± 0.02% (n = 1689), and − 0.77 ± 0.03% (n = 1161) at 3 years.ConclusionThere was no clear difference in the number of ADRs among the three age subgroups, although the incidence of serious ADRs was higher in elderly patients than in patients aged < 65 years. We found no additional safety or efficacy concerns among elderly patients beyond those already described in the package insert. The present results support the use of teneligliptin in elderly patients with T2DM in real-world clinical practice.Trial RegistrationJapic Clinical Trials Information identifier, Japic CTI-153047. More... »

PAGES

2477-2492

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12325-020-01306-0

DOI

http://dx.doi.org/10.1007/s12325-020-01306-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1126886546

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/32323194


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