Serum glucose, cholesterol and blood pressure levels in Japanese type 1 and 2 diabetic patients: BioBank Japan

Yokomichi, Hiroshi; Nagai, Akiko; Hirata, Makoto; Kiyohara, Yutaka; Muto, Kaori; Ninomiya, Toshiharu; Matsuda, Koichi; Kamatani, Yoichiro; Tamakoshi, Akiko; Kubo, Michiaki; Nakamura, Yusuke; Yamagata, Zentaro

doi:10.1016/j.je.2016.12.013

Cited by 13 publications

(15 citation statements)

References 28 publications

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“…These results indicate that sex ratio may have some impact on HbA1c reductions, but the size of the possible impact appears minimal when trial backgrounds are adjusted. Previous studies report that mean HbA1c value at study enrollment was significantly higher in Japanese women with type 2 diabetes than in men, 13,19,20 and our findings without adjustment were consistent with these results. In the entire Japanese population (i.e.…”

Section: Discussionsupporting

confidence: 92%

Exploratory analysis of comparative clinical trials used for marketing approval in patients with type 2 diabetes in Japan

Kaneko

Ono

2019

SAGE Open Medicine

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Background/objectives:The results of phase 2 and 3 clinical trials, which justify decisions regarding marketing approval for new drugs, are used for comparison of drugs in the post-marketing phase. A number of meta-analyses of approved antidiabetics have been performed, but the heterogeneity of trials has not been fully examined. The aim of this study was to explore factors that may influence baseline HbA1c in trial samples and treatment outcomes (i.e. HbA1c reductions and effect sizes), with the goal of providing unbiased and fair retrospective comparisons between different antidiabetics.Method:We conducted three meta-regression analyses using 78 randomized or non-randomized comparative phase 2 or 3 trials of 24 approved antidiabetics in Japan, conducted from 1987 to 2012.Results:Baseline HbA1c of each arm was higher in phase 2 trials, trials with a greater number of subjects, trials with a lower proportion of male subjects, trials of combination therapy, or trials with longer subject disease duration. Entry criteria were different among drug classes and caused variations in baseline HbA1c. HbA1c reductions were larger in non-randomized trials, trials with a shorter treatment period, or trials with a lower proportion of male subjects. Effect sizes were larger in phase 2 trials, or trials of combination therapy. Larger effect sizes were observed in drugs with later market entry for alpha-glucosidase inhibitors and glinides.Conclusion:Baseline HbA1c, an important characteristic of subjects enrolled in trials of antidiabetics, differed significantly across trials. Differences in features of study subjects were caused by explicit stipulations in eligibility criteria of HbA1c and also by other conditions (e.g. trial design, regulatory guidance, treatment guideline) and/or interventions of investigators and pharmaceutical companies that were specific to drugs and trials. Healthcare professionals should carefully consider these heterogeneities in trials used for marketing approval review when making a retrospective comparison to select the best treatment option for patients.

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Section: Discussionsupporting

confidence: 92%

Exploratory analysis of comparative clinical trials used for marketing approval in patients with type 2 diabetes in Japan

Kaneko

Ono

2019

SAGE Open Medicine

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“…This study included patients with type 2 diabetes and diabetic nephropathy at registration. We excluded patients with other diabetes types and secondary diabetes 8 , 9 .…”

Section: Methodsmentioning

confidence: 99%

All‐cause and cardiovascular disease mortality in underweight patients with diabetic nephropathy: BioBank Japan cohort

Yokomichi

Mochizuki

Hirata

et al. 2021

J of Diabetes Invest

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We aimed to determine mortality risk in underweight patients with diabetic nephropathy for microalbuminuria or macroalbuminuria. We analyzed mortality and death-cause data from BioBank Japan, with baseline years [2003][2004][2005][2006][2007]. We analyzed mortality rates from all causes and ischemic heart disease, according to body mass index (<18.5, 18.5-21.9, 22-24.9 and ≥25 kg/m 2 ). The mean (standard deviation) of patient age, body mass index, and glycated hemoglobin at enrollment was 61.6 years (11.7 years), 25.0 kg/m 2 (4.4 kg/m 2 ) and 7.7% (1.5%), respectively. Hazard ratios of all-cause and ischemic heart disease mortality were highest (1.79 [P = 0.0001] and 2.95 [P = 0.027], respectively) in patients with body mass index <18.5 kg/m 2 , as compared with body mass index 22-24.9 kg/m 2 . All-cause mortality risk for body mass index <18.5 kg/m 2 was similar to that for current smokers (hazard ratio 1.70, P < 0.0001). Underweight could be a predictor of mortality risk in patients with diabetic nephropathy for microalbuminuria or macroalbuminuria.

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“…Ng et al reported that the metabolic syndrome was associated with an increased incidence of cognitive impairment and progression to dementia [ 5 ]. Furthermore, diabetes is increasingly recognized as an important risk factor of cognitive function [ 6 , 7 , 8 , 9 , 10 , 11 ]. However, the association of higher obesity in mid-age with the incidence of dementia is debatable.…”

Section: Introductionmentioning

confidence: 99%

Risk Factors for Dementia Incidence Based on Previous Results of the Specific Health Checkups in Japan

2020

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Dementia is a common disease in elderly people, with its prevalence expanding rapidly worldwide. Longitudinal and cohort studies on lifestyle and health conditions are needed to identify the risk of dementia. This study aimed to identify the risk factors for dementia incidence in Japan and to clarify the strategy for its primary care. In this study, an analysis was performed to investigate the association between the cognitive faculty level of the long-term care certification survey and the previous results of the specific health checkups in Japan. To investigate the risk factor for dementia incidence, a multivariable logistic regression analysis was performed, which showed a significant odds ratio for the incidence of dementia for two items, including abdominal circumference and insulin injections or oral hypoglycemic medications. The findings of our study suggested that a lower abdominal circumference had a higher risk for dementia incidence, and individuals who received insulin injections or oral hypoglycemic medications had a higher risk for dementia incidence based on the results of the health checkups conducted 10 years previously. Further, longer duration study with a larger sample is needed to identify the items from the specific health checkups that are associated with the risk of dementia.

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Serum glucose, cholesterol and blood pressure levels in Japanese type 1 and 2 diabetic patients: BioBank Japan

Cited by 13 publications

References 28 publications

Exploratory analysis of comparative clinical trials used for marketing approval in patients with type 2 diabetes in Japan

Exploratory analysis of comparative clinical trials used for marketing approval in patients with type 2 diabetes in Japan

All‐cause and cardiovascular disease mortality in underweight patients with diabetic nephropathy: BioBank Japan cohort

Risk Factors for Dementia Incidence Based on Previous Results of the Specific Health Checkups in Japan

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