Safety and efficacy of teneligliptin, a dipeptidyl peptidase-4 inhibitor, in monotherapy and in combination therapy with antihyperglycemic agents in patients with type 2 diabetes mellitus - An interim analysis of post-marketing surveillance, RUBY-

Takashi Kadowaki, Masakazu Haneda, Hiroshi Itoh, Kazuyo Sasaki, Manabu Ishii, Makoto Ueno, Sonoe Baba, Miyuki Matsukawa, Yumi Watanabe

Research output: Contribution to journalArticle

Abstract

Objective: Safety and efficacy of the dipeptidyl peptidase-4 inhibitor teneligliptin were examined in clinical practice by post-marketing surveillance (RUBY) in patients with type 2 diabetes mellitus (T2DM) in monotherapy and combination therapies. Method: Interim analysis was conducted based on case report forms collected by June 28, 2017 in RUBY surveillance in Japanese patients with T2DM who started administration of teneligliptin. We analyzed safety by the number of concomitant antihyperglycemic agents for combination therapy, and the safety and efficacy of teneligliptin in add-on therapy with prior antihyperglycemic agents. Results: The number of subjects in safety analysis set was 10,532. Compared to the teneligliptin monotherapy group, as the number of concomitant drugs increased, the incidence of adverse drug reactions (ADRs), including hypoglycemia, was higher. The incidence of ADRs was 2.24% in monotherapy and 4.13% in add-on therapy with biguanides (BG), 1.57% with sulfonylureas (SU), 4.44% with crglucosidase inhibitors (α-Gl), 2.06% with thiazolidines (TZD), 2.47% with insulin, 2.29% with BG + SU, 1.27% with SU+α-GI, and 1.1996 with SU+TZD. The profile of ADRs was not deviated in any combination. HbAlc levels decreased significantly until 2 years after administration (-0.90% ±1.23% after 2 years) in monotherapy and also similarly decreased in all combination groups. Conclusion: It is considered that careful management to avoid ADRs, including hypoglycemia, are required when teneligliptin is used in combination with multiple antihyperglycemic agents. On the other hand, teneligliptin was generally well-tolerated and improved glycemic control in monotherapy and add-on therapies to 1 or 2 frequently use antihyperglycemic agents.

Original languageEnglish
Pages (from-to)481-498
Number of pages18
JournalJapanese Pharmacology and Therapeutics
Volume46
Issue number4
Publication statusPublished - Jan 1 2018

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Dipeptidyl-Peptidase IV Inhibitors
Marketing
Hypoglycemic Agents
Type 2 Diabetes Mellitus
Drug-Related Side Effects and Adverse Reactions
Safety
Thiazolidines
Biguanides
Hypoglycemia
Therapeutics
Incidence
3-(4-(4-(3-methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl)pyrrolidin-2-ylcarbonyl)thiazolidine
Insulin
Pharmaceutical Preparations

Keywords

  • Combination therapy
  • Dipeptidyl peptidase-4 inhibitor
  • Post-marketing surveillance
  • Teneligliptin
  • Type 2 diabetes mellitus

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Safety and efficacy of teneligliptin, a dipeptidyl peptidase-4 inhibitor, in monotherapy and in combination therapy with antihyperglycemic agents in patients with type 2 diabetes mellitus - An interim analysis of post-marketing surveillance, RUBY-. / Kadowaki, Takashi; Haneda, Masakazu; Itoh, Hiroshi; Sasaki, Kazuyo; Ishii, Manabu; Ueno, Makoto; Baba, Sonoe; Matsukawa, Miyuki; Watanabe, Yumi.

In: Japanese Pharmacology and Therapeutics, Vol. 46, No. 4, 01.01.2018, p. 481-498.

Research output: Contribution to journalArticle

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abstract = "Objective: Safety and efficacy of the dipeptidyl peptidase-4 inhibitor teneligliptin were examined in clinical practice by post-marketing surveillance (RUBY) in patients with type 2 diabetes mellitus (T2DM) in monotherapy and combination therapies. Method: Interim analysis was conducted based on case report forms collected by June 28, 2017 in RUBY surveillance in Japanese patients with T2DM who started administration of teneligliptin. We analyzed safety by the number of concomitant antihyperglycemic agents for combination therapy, and the safety and efficacy of teneligliptin in add-on therapy with prior antihyperglycemic agents. Results: The number of subjects in safety analysis set was 10,532. Compared to the teneligliptin monotherapy group, as the number of concomitant drugs increased, the incidence of adverse drug reactions (ADRs), including hypoglycemia, was higher. The incidence of ADRs was 2.24{\%} in monotherapy and 4.13{\%} in add-on therapy with biguanides (BG), 1.57{\%} with sulfonylureas (SU), 4.44{\%} with crglucosidase inhibitors (α-Gl), 2.06{\%} with thiazolidines (TZD), 2.47{\%} with insulin, 2.29{\%} with BG + SU, 1.27{\%} with SU+α-GI, and 1.1996 with SU+TZD. The profile of ADRs was not deviated in any combination. HbAlc levels decreased significantly until 2 years after administration (-0.90{\%} ±1.23{\%} after 2 years) in monotherapy and also similarly decreased in all combination groups. Conclusion: It is considered that careful management to avoid ADRs, including hypoglycemia, are required when teneligliptin is used in combination with multiple antihyperglycemic agents. On the other hand, teneligliptin was generally well-tolerated and improved glycemic control in monotherapy and add-on therapies to 1 or 2 frequently use antihyperglycemic agents.",
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AU - Kadowaki, Takashi

AU - Haneda, Masakazu

AU - Itoh, Hiroshi

AU - Sasaki, Kazuyo

AU - Ishii, Manabu

AU - Ueno, Makoto

AU - Baba, Sonoe

AU - Matsukawa, Miyuki

AU - Watanabe, Yumi

PY - 2018/1/1

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N2 - Objective: Safety and efficacy of the dipeptidyl peptidase-4 inhibitor teneligliptin were examined in clinical practice by post-marketing surveillance (RUBY) in patients with type 2 diabetes mellitus (T2DM) in monotherapy and combination therapies. Method: Interim analysis was conducted based on case report forms collected by June 28, 2017 in RUBY surveillance in Japanese patients with T2DM who started administration of teneligliptin. We analyzed safety by the number of concomitant antihyperglycemic agents for combination therapy, and the safety and efficacy of teneligliptin in add-on therapy with prior antihyperglycemic agents. Results: The number of subjects in safety analysis set was 10,532. Compared to the teneligliptin monotherapy group, as the number of concomitant drugs increased, the incidence of adverse drug reactions (ADRs), including hypoglycemia, was higher. The incidence of ADRs was 2.24% in monotherapy and 4.13% in add-on therapy with biguanides (BG), 1.57% with sulfonylureas (SU), 4.44% with crglucosidase inhibitors (α-Gl), 2.06% with thiazolidines (TZD), 2.47% with insulin, 2.29% with BG + SU, 1.27% with SU+α-GI, and 1.1996 with SU+TZD. The profile of ADRs was not deviated in any combination. HbAlc levels decreased significantly until 2 years after administration (-0.90% ±1.23% after 2 years) in monotherapy and also similarly decreased in all combination groups. Conclusion: It is considered that careful management to avoid ADRs, including hypoglycemia, are required when teneligliptin is used in combination with multiple antihyperglycemic agents. On the other hand, teneligliptin was generally well-tolerated and improved glycemic control in monotherapy and add-on therapies to 1 or 2 frequently use antihyperglycemic agents.

AB - Objective: Safety and efficacy of the dipeptidyl peptidase-4 inhibitor teneligliptin were examined in clinical practice by post-marketing surveillance (RUBY) in patients with type 2 diabetes mellitus (T2DM) in monotherapy and combination therapies. Method: Interim analysis was conducted based on case report forms collected by June 28, 2017 in RUBY surveillance in Japanese patients with T2DM who started administration of teneligliptin. We analyzed safety by the number of concomitant antihyperglycemic agents for combination therapy, and the safety and efficacy of teneligliptin in add-on therapy with prior antihyperglycemic agents. Results: The number of subjects in safety analysis set was 10,532. Compared to the teneligliptin monotherapy group, as the number of concomitant drugs increased, the incidence of adverse drug reactions (ADRs), including hypoglycemia, was higher. The incidence of ADRs was 2.24% in monotherapy and 4.13% in add-on therapy with biguanides (BG), 1.57% with sulfonylureas (SU), 4.44% with crglucosidase inhibitors (α-Gl), 2.06% with thiazolidines (TZD), 2.47% with insulin, 2.29% with BG + SU, 1.27% with SU+α-GI, and 1.1996 with SU+TZD. The profile of ADRs was not deviated in any combination. HbAlc levels decreased significantly until 2 years after administration (-0.90% ±1.23% after 2 years) in monotherapy and also similarly decreased in all combination groups. Conclusion: It is considered that careful management to avoid ADRs, including hypoglycemia, are required when teneligliptin is used in combination with multiple antihyperglycemic agents. On the other hand, teneligliptin was generally well-tolerated and improved glycemic control in monotherapy and add-on therapies to 1 or 2 frequently use antihyperglycemic agents.

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KW - Dipeptidyl peptidase-4 inhibitor

KW - Post-marketing surveillance

KW - Teneligliptin

KW - Type 2 diabetes mellitus

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