Efficacy and Safety of alogliptin administered to 219 type 2 diabetic patients for 12 months

Takeshi Nishimura, Masami Tanaka, Risa Sekioka, Toshihide Kawai, Shu Meguro, Junichiro Irie, Yoshifumi Saisho, Hiroshi Itoh

Research output: Contribution to journalArticle

Abstract

Objectives: This retrospective study was undertaken to clarify the efficacy and safety of alogliptin. The characteristics of the patients in whom alogliptin exerts its HbA1c-lowering effect fully were also explored. Methods: Alogliptin was administered as initial, additive, or exchange medication to 219 type 2 diabetic patients. The primary efficacy endpoint was the change in HbA1c at 12 months after the start of alogliptin treatment. Results: Administration of alogliptin significantly decreased HbA1c (7.79±0.96% at baseline→7.24±0.85 at 3 months→7.18±0.89% at 6 months→7.20±0.98% at 9 months→7.23±0.94% at 12 months at all time points : P<0.0001 vs. baseline). There was no significant difference in ΔHbA1c (=HbA1c at 12 months-HbA1c at baseline) between patients who took other oral hypoglycemic agents (OHA) concomitantly and those who took alogliptin as the only OHA. There was no significant difference in ΔHbA1c with respect to the kind of oral hypoglycemic agents used concomitantly, either. Multiple logistic regression analysis indicated that factors that contributed to ΔHbA1c were baseline HbA1c and initial/additive rather than exchange administration of alogliptin. ΔHbA1c was significantly, negatively correlated with baseline HbA1c value. There were no changes in clinical parameters thought to be adverse events. Conclusions: Administration of alogliptin provided a significant and clinically relevant reduction in HbA1c. High baseline HbA1c value may predict a large effect of alogliptin.

Original languageEnglish
Pages (from-to)495-501
Number of pages7
JournalJapanese Pharmacology and Therapeutics
Volume42
Issue number7
Publication statusPublished - 2014

Fingerprint

Safety
Hypoglycemic Agents
alogliptin
Retrospective Studies
Logistic Models
Regression Analysis

Keywords

  • Alogliptin
  • Dipeptidyl peptidase-4 inhibitor
  • Safety
  • Type 2 diabetes

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology

Cite this

Efficacy and Safety of alogliptin administered to 219 type 2 diabetic patients for 12 months. / Nishimura, Takeshi; Tanaka, Masami; Sekioka, Risa; Kawai, Toshihide; Meguro, Shu; Irie, Junichiro; Saisho, Yoshifumi; Itoh, Hiroshi.

In: Japanese Pharmacology and Therapeutics, Vol. 42, No. 7, 2014, p. 495-501.

Research output: Contribution to journalArticle

@article{32394efaf01247c6a7ca636d11714fe9,
title = "Efficacy and Safety of alogliptin administered to 219 type 2 diabetic patients for 12 months",
abstract = "Objectives: This retrospective study was undertaken to clarify the efficacy and safety of alogliptin. The characteristics of the patients in whom alogliptin exerts its HbA1c-lowering effect fully were also explored. Methods: Alogliptin was administered as initial, additive, or exchange medication to 219 type 2 diabetic patients. The primary efficacy endpoint was the change in HbA1c at 12 months after the start of alogliptin treatment. Results: Administration of alogliptin significantly decreased HbA1c (7.79±0.96{\%} at baseline→7.24±0.85 at 3 months→7.18±0.89{\%} at 6 months→7.20±0.98{\%} at 9 months→7.23±0.94{\%} at 12 months at all time points : P<0.0001 vs. baseline). There was no significant difference in ΔHbA1c (=HbA1c at 12 months-HbA1c at baseline) between patients who took other oral hypoglycemic agents (OHA) concomitantly and those who took alogliptin as the only OHA. There was no significant difference in ΔHbA1c with respect to the kind of oral hypoglycemic agents used concomitantly, either. Multiple logistic regression analysis indicated that factors that contributed to ΔHbA1c were baseline HbA1c and initial/additive rather than exchange administration of alogliptin. ΔHbA1c was significantly, negatively correlated with baseline HbA1c value. There were no changes in clinical parameters thought to be adverse events. Conclusions: Administration of alogliptin provided a significant and clinically relevant reduction in HbA1c. High baseline HbA1c value may predict a large effect of alogliptin.",
keywords = "Alogliptin, Dipeptidyl peptidase-4 inhibitor, Safety, Type 2 diabetes",
author = "Takeshi Nishimura and Masami Tanaka and Risa Sekioka and Toshihide Kawai and Shu Meguro and Junichiro Irie and Yoshifumi Saisho and Hiroshi Itoh",
year = "2014",
language = "English",
volume = "42",
pages = "495--501",
journal = "Japanese Pharmacology and Therapeutics",
issn = "0386-3603",
publisher = "Life Science Publishing Co. Ltd",
number = "7",

}

TY - JOUR

T1 - Efficacy and Safety of alogliptin administered to 219 type 2 diabetic patients for 12 months

AU - Nishimura, Takeshi

AU - Tanaka, Masami

AU - Sekioka, Risa

AU - Kawai, Toshihide

AU - Meguro, Shu

AU - Irie, Junichiro

AU - Saisho, Yoshifumi

AU - Itoh, Hiroshi

PY - 2014

Y1 - 2014

N2 - Objectives: This retrospective study was undertaken to clarify the efficacy and safety of alogliptin. The characteristics of the patients in whom alogliptin exerts its HbA1c-lowering effect fully were also explored. Methods: Alogliptin was administered as initial, additive, or exchange medication to 219 type 2 diabetic patients. The primary efficacy endpoint was the change in HbA1c at 12 months after the start of alogliptin treatment. Results: Administration of alogliptin significantly decreased HbA1c (7.79±0.96% at baseline→7.24±0.85 at 3 months→7.18±0.89% at 6 months→7.20±0.98% at 9 months→7.23±0.94% at 12 months at all time points : P<0.0001 vs. baseline). There was no significant difference in ΔHbA1c (=HbA1c at 12 months-HbA1c at baseline) between patients who took other oral hypoglycemic agents (OHA) concomitantly and those who took alogliptin as the only OHA. There was no significant difference in ΔHbA1c with respect to the kind of oral hypoglycemic agents used concomitantly, either. Multiple logistic regression analysis indicated that factors that contributed to ΔHbA1c were baseline HbA1c and initial/additive rather than exchange administration of alogliptin. ΔHbA1c was significantly, negatively correlated with baseline HbA1c value. There were no changes in clinical parameters thought to be adverse events. Conclusions: Administration of alogliptin provided a significant and clinically relevant reduction in HbA1c. High baseline HbA1c value may predict a large effect of alogliptin.

AB - Objectives: This retrospective study was undertaken to clarify the efficacy and safety of alogliptin. The characteristics of the patients in whom alogliptin exerts its HbA1c-lowering effect fully were also explored. Methods: Alogliptin was administered as initial, additive, or exchange medication to 219 type 2 diabetic patients. The primary efficacy endpoint was the change in HbA1c at 12 months after the start of alogliptin treatment. Results: Administration of alogliptin significantly decreased HbA1c (7.79±0.96% at baseline→7.24±0.85 at 3 months→7.18±0.89% at 6 months→7.20±0.98% at 9 months→7.23±0.94% at 12 months at all time points : P<0.0001 vs. baseline). There was no significant difference in ΔHbA1c (=HbA1c at 12 months-HbA1c at baseline) between patients who took other oral hypoglycemic agents (OHA) concomitantly and those who took alogliptin as the only OHA. There was no significant difference in ΔHbA1c with respect to the kind of oral hypoglycemic agents used concomitantly, either. Multiple logistic regression analysis indicated that factors that contributed to ΔHbA1c were baseline HbA1c and initial/additive rather than exchange administration of alogliptin. ΔHbA1c was significantly, negatively correlated with baseline HbA1c value. There were no changes in clinical parameters thought to be adverse events. Conclusions: Administration of alogliptin provided a significant and clinically relevant reduction in HbA1c. High baseline HbA1c value may predict a large effect of alogliptin.

KW - Alogliptin

KW - Dipeptidyl peptidase-4 inhibitor

KW - Safety

KW - Type 2 diabetes

UR - http://www.scopus.com/inward/record.url?scp=84906275348&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84906275348&partnerID=8YFLogxK

M3 - Article

VL - 42

SP - 495

EP - 501

JO - Japanese Pharmacology and Therapeutics

JF - Japanese Pharmacology and Therapeutics

SN - 0386-3603

IS - 7

ER -