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Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes stratified by body mass index: A subgroup analysis of five randomized clinical trials.

ABSTRACT: AIMS/INTRODUCTION:The influence of overweight/obesity on the clinical efficacy and safety of sodium-glucose co-transporter 2 inhibitors is unclear. We carried out a pooled analysis to examine the impact of body mass index on the efficacy and safety of ipragliflozin. MATERIALS AND METHODS:Patient-level data were pooled for five Japanese double-blind trials (NCT00621868, NCT01057628, NCT01135433, NCT01225081 and NCT01242215) in which patients were randomized to ipragliflozin or a placebo as monotherapy, or in combination with metformin, pioglitazone or a sulfonylurea. Outcomes included the changes in hemoglobin A1c, fasting plasma glucose, bodyweight and treatment-emergent adverse events. Patients were divided into four body mass index categories. RESULTS:Hemoglobin A1c, fasting plasma glucose and bodyweight decreased significantly in the ipragliflozin group compared with the placebo group in all body mass index categories, and in the total cohort (all P < 0.001). Hemoglobin A1c did not improve in 11.2 and 69.2% of patients in the ipragliflozin and placebo groups, respectively. The change in hemoglobin A1c was weakly correlated with the change in bodyweight in all patients (r = 0.136, P = 0.002). Regarding laboratory variables, the placebo-subtracted difference tended to be greater in patients with higher body mass index for aspartate aminotransferase, alanine aminotransferase, ?-glutamyl transpeptidase and uric acid. The incidences of treatment-emergent adverse events were similar between the ipragliflozin and placebo groups in all patients combined and in the four body mass index categories. CONCLUSIONS:These results show that the efficacy and safety of ipragliflozin are not influenced by obesity/overweight in Japanese patients.

SUBMITTER: Kashiwagi A

PROVIDER: S-EPMC4931205 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature

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Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes stratified by body mass index: A subgroup analysis of five randomized clinical trials.

Kashiwagi Atsunori A Yoshida Satoshi S Nakamura Ichiro I Kazuta Kenichi K Ueyama Eiji E Takahashi Hideyuki H Satomi Hayato H Kosakai Yoshinori Y Kawamuki Kosei K

Journal of diabetes investigation 20160301 4

<h4>Aims/introduction</h4>The influence of overweight/obesity on the clinical efficacy and safety of sodium-glucose co-transporter 2 inhibitors is unclear. We carried out a pooled analysis to examine the impact of body mass index on the efficacy and safety of ipragliflozin.<h4>Materials and methods</h4>Patient-level data were pooled for five Japanese double-blind trials (NCT00621868, NCT01057628, NCT01135433, NCT01225081 and NCT01242215) in which patients were randomized to ipragliflozin or a pl ...[more]

PMID: 27181576

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Project description:BackgroundIn patients without coronary artery disease (CAD), few studies have evaluated the association between mean pericoronary adipose tissue attenuation (PCATMA) and patient-based demographic factors, for example, age or sex. Therefore, the purpose of this study is to investigate the association between PCATMA and various demographic factors in patients without CAD.MethodsIn this case-control study, the 806 patients who underwent coronary computed tomography angiography and were not diagnosed with CAD between July 2020 and July 2022 were retrospectively enrolled. Their PCATMA values of the proximal right coronary artery were measured automatically. Patients without CAD were stratified according to sex, body mass index (BMI), and age, and the relationship between PCATMA and different clinical characteristics was explored using Fisher's exact test or Chi-squared test and independent t-tests or Wilcoxon Mann-Whitney U tests.ResultsCompared to non-smoking women [-88.00 (-95.00, -81.00) HU], women who smoked [-84.00 (-94.00, -78.00) HU, P=0.037] had higher PCATMA values and a positive correlation with PCATMA (rs=0.101, P=0.036). Compared to non-hypertensive patients with BMI ≥24.91 kg/m2 [-87.00 (-95.00, -81.00) HU], hypertensive patients with BMI ≥24.91 kg/m2 [-84.00 (-92.00, -78.00) HU, P=0.004] had higher PCATMA values, and a positive correlation with PCATMA (rs=0.144, P=0.004). In a subgroup of patients without CAD stratified by sex, BMI, and age, PCATMA values were all higher in patients with dyslipidemia (women, men, BMI ≥24.91 kg/m2, BMI <24.91 kg/m2, age ≥55 years, and age <55 years: -82.00, -82.00, -81.50, -82.00, -81.00 and -83.50 HU, respectively) than in those without dyslipidemia (-89.00, -89.00, -89.00, -90.00, -90.00 and -88.00 HU, respectively; all P<0.001) and showed a positive relationship (rs=0.328, 0.339, 0.342, 0.326, 0.367, and 0.298, respectively; all P<0.001).ConclusionsHigher PCATMA attenuation values were observed in patients with dyslipidemia, smoking women, and hypertensive patients with BMI ≥24.91 kg/m2, suggesting that PCATMA values can be used to detect patients at high risk for future events with CAD even if they do not currently have atherosclerosis.

Dataset Information

Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes stratified by body mass index: A subgroup analysis of five randomized clinical trials.

Publications

Efficacy and safety of ipragliflozin in Japanese patients with type 2 diabetes stratified by body mass index: A subgroup analysis of five randomized clinical trials.

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