title: Efficacy and Safety of Alogliptin in Patients With Type 2 Diabetes: Analysis of the ATTAK-J Study.
abstract: BACKGROUND
  Dipeptidyl peptidase-4 (DPP-4) inhibitors have been shown to reduce hemoglobin A1c (HbA1c) in patients with type 2 diabetes, but the reduction varies between patients and adequate glycemic control may not be achieved. We evaluated the efficacy and safety of the DPP-4 inhibitor alogliptin in the real clinical setting, and analyzed factors associated with the improvement of HbA1c by alogliptin treatment.
  
  
  METHODS
  A retrospective observational study was performed in patients with type 2 diabetes attending hospitals or clinics belonging to the Kanagawa Physicians Association who received treatment with alogliptin for 1 year or longer. Patients using insulin were excluded from the study. The efficacy endpoints were HbA1c (National Glycohemoglobin Standardization Program value), blood glucose (fasting/postprandial), body weight, blood pressure (systolic/diastolic), liver function (glutamate oxaloacetate transaminase, glutamate pyruvate transaminase, and γ-glutamyl transpeptidase), kidney function (serum creatinine and estimated glomerular filtration rate), serum lipids (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides), and serum amylase. Adverse events were compiled to assess safety.
  
  
  RESULTS
  Of 330 patients whose case records were collected, 27 patients were excluded for protocol violations, leaving 303 patients to form the full analysis set. Compared with baseline, HbA1c showed a decrease by 0.54±1.22% (mean ± standard deviation) after 12 months of alogliptin treatment. Factor analysis demonstrated that the change of HbA1c after 12 months was significantly influenced by the baseline HbA1c level, duration of diabetes, concomitant use of sulfonylureas, and compliance with diet therapy. In addition, there was a significant reduction of total cholesterol, low-density lipoprotein cholesterol, and the estimated glomerular filtration rate after 12 months of alogliptin treatment, as well as a significant increase in serum creatinine. No significant changes of body weight, blood pressure, or liver function were observed. Symptoms of hypoglycemia occurred in two patients (0.6%).
  
  
  CONCLUSIONS
  Alogliptin displayed a significant hypoglycemic effect and excellent safety in routine clinical use. Factors influencing the change of HbA1c with alogliptin therapy may include the HbA1c at the start of treatment, the duration of diabetes, use of sulfonylureas, and compliance with diet therapy.
authors.affiliation: Diabetes Committee Study Group, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Takeda
authors.affiliation: Diabetes Committee Study Group, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Sasai
authors.affiliation: Diabetes Committee Study Group, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Shogo
authors.initials: S
authors.lastname: Ito
authors.affiliation: Diabetes Committee Study Group, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Obana
authors.affiliation: Diabetes Committee Study Group, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Takuma
authors.affiliation: Diabetes Committee Study Group, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Takai
authors.affiliation: Diabetes Committee Study Group, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Kaneshige
authors.affiliation: Diabetes Committee Study Group, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Hideo
authors.initials: H
authors.lastname: Machimura
authors.affiliation: Diabetes Committee Study Group, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Kanamori
authors.affiliation: Nakajima Clinic, Kanagawa, Japan.
authors.forename: Kazumi
authors.initials: K
authors.lastname: Nakajima
authors.affiliation: Diabetes Committee Study Group, Kanagawa Physicians Association, Kanagawa, Japan.
authors.forename: Ikuro
authors.initials: I
authors.lastname: Matsuba
keywords: Alogliptin; Dipeptidyl peptidase-4 inhibitor; Hemoglobin A1c; Type 2 diabetes