There is a paucity of global data on cardiovascular disease (CVD) prevalence in people with type 2 diabetes (T2D). The primary objective of the CAPTURE study was to estimate the prevalence of ...established CVD and its management in adults with T2D across 13 countries from five continents. Additional objectives were to further characterize the study sample regarding demographics, clinical parameters and medication usage, with particular reference to blood glucose-lowering agents (GLAs: glucagon-like peptide-1 receptor agonists and sodium-glucose co-transporter-2 inhibitors) with demonstrated cardiovascular benefit in randomized intervention trials.
Data were collected from adults with T2D managed in primary or specialist care in Australia, China, Japan, Czech Republic, France, Hungary, Italy, Argentina, Brazil, Mexico, Israel, Kingdom of Saudi Arabia, and Turkey in 2019, using standardized methodology. CVD prevalence, weighted by diabetes prevalence in each country, was estimated for the overall CAPTURE sample and participating countries. Country-specific odds ratios for CVD prevalence were further adjusted for relevant demographic and clinical parameters.
The overall CAPTURE sample included 9823 adults with T2D (n = 4502 from primary care; n = 5321 from specialist care). The overall CAPTURE sample had median (interquartile range) diabetes duration 10.7 years (5.6-17.9 years) and glycated hemoglobin 7.3% (6.6-8.4%) 56 mmol/mol (49-68 mmol/mol). Overall weighted CVD and atherosclerotic CVD prevalence estimates were 34.8% (95% confidence interval CI 32.7-36.8) and 31.8% (95% CI 29.7-33.8%), respectively. Age, gender, and clinical parameters accounted for some of the between-country variation in CVD prevalence. GLAs with demonstrated cardiovascular benefit were used by 21.9% of participants, which was similar in participants with and without CVD: 21.5% and 22.2%, respectively.
In 2019, approximately one in three adults with T2D in CAPTURE had diagnosed CVD. The low use of GLAs with demonstrated cardiovascular benefit even in participants with established CVD suggested that most were not managed according to contemporary diabetes and cardiology guidelines. Study registration NCT03786406 (registered on December 20, 2018), NCT03811288 (registered on January 18, 2019).
Introduction
CAPTURE was a cross-sectional, non-interventional study (NCT03786406, NCT03811288) investigating the prevalence and characteristics of cardiovascular disease (CVD) in adults with type 2 ...diabetes (T2D) across 13 countries worldwide. Here we present the findings for Japan.
Materials and methods
Data were collected from adults aged ≥ 20 years (aged ≥ 18 years in countries outside Japan) with T2D who were managed in clinics or hospitals in 2019. Standardized methodology was used for all countries. The prevalence of CVD and its subtypes was estimated, weighted by care setting (clinics versus hospitals).
Results
Among participants from Japan (total: 800; clinics: 440; hospitals: 360), mean (standard deviation) age was 65.6 (11.2) years and glycated hemoglobin 7.2% (0.9). Sixty-seven percent of participants were male, 57.8% had diabetes duration > 10 years, 49.8% had body mass index ≥ 25 kg/m
2
and 63.1% had hypertension. The weighted prevalences (95% confidence interval CI) of CVD and atherosclerotic CVD were 37.3% (34.2;40.3) and 33.5% (30.6;36.4), respectively. The prevalence (95% CI) of the most common subtypes of CVD was: carotid artery disease 20.5% (18.2;22.8), coronary heart disease 11.9% (9.7;14.1) and cerebrovascular disease 10.4% (8.3;12.5).
Conclusions
These contemporary data from the CAPTURE study on CVD prevalence in adults with T2D in Japan show that approximately one in three adults with T2D had established CVD, which is comparable to the prevalence in the global study cohort.
ABSTRACT
We assessed the prescription patterns of oral antidiabetic drugs in Japanese patients with type 2 diabetes between 2002 and 2020 using data from the Computerized Diabetes Care database. ...Among 172,960 patients treated with oral antidiabetic drugs, both the sulfonylurea prescription rate and dose decreased from 2002 to 2020. Prescriptions of biguanides, dipeptidyl peptidase‐4 inhibitors and sodium–glucose cotransporter 2 inhibitors increased; their dose and dose frequency remained relatively stable. Trends in oral antidiabetic drug prescriptions changed over time, reflecting guideline recommendations and existing evidence.
This study using a large diabetes database in Japan assessed prescription patterns of oral antidiabetic drugs in patients with type 2 diabetes and reported a steady decrease in sulfonylurea prescriptions and dose from 2002 to 2020. Conversely, prescriptions for biguanides, dipeptidyl peptidase‐4 inhibitors, and sodium‐glucose cotransporter 2 inhibitors increased, with their doses and dose frequencies remaining relatively stable over time.
Imeglimin is a novel type 2 diabetes (T2D) drug that is expected to improve mitochondrial function. In its phase 3 clinical trials in Japanese patients with T2D, the hemoglobin A1c (HbA1c) decrease ...following imeglimin administration was slow, reaching a plateau after 20-24 weeks of treatment. In general, the erythrocyte lifespan may be a factor when HbA1c shows an abnormal value. Therefore, this study will comparatively evaluate HbA1c and other markers of glycemic control in patients with T2D after imeglimin administration and also examine the effects of imeglimin on erythrocytes.
This single-arm, open-label, prospective, exploratory study is designed to evaluate the divergence between HbA1c and glycoalbumin (GA) or 1,5-anhydroglucitol (1,5-AG) and the glycemic reduction rate in 30 patients with T2D with inadequate glycemic control when imeglimin 2,000 mg is administered for 6 months. In addition, we will examine the effect on erythrocytes, the presumed cause of this divergence. We will measure sustained glycemic variability using flash glucose monitoring and examine the relationship between changes in these indices and HbA1c. Moreover, because prolonged erythrocyte lifespan is a possible cause of falsely high HbA1c levels, erythrocyte lifespan, erythrocyte deformability, and hemoglobin concentration will be evaluated as effects of imeglimin on erythrocytes. Furthermore, if imeglimin has an ameliorative effect on erythrocyte deformability, it may improve peripheral arterial disease; thus, we will also evaluate the toe-brachial pressure index, a measure of this effect.
In this study, if imeglimin administration results in diverging rates of hypoglycemic effect between HbA1c and GA or 1,5-AG and prolongs erythrocyte lifespan, GA and 1,5-AG, rather than HbA1c, will be considered appropriate measures of the hypoglycemic effect in the early stages of imeglimin administration. If imeglimin improves erythrocyte deformability, it may also be a new treatment strategy for peripheral arterial disease, a chronic complication of T2D.
The study protocol was scientifically and ethically reviewed and approved by the Certified Clinical Research Review Board of Toho University (approval number: THU22002). The study protocol was registered in the Japan Registry of Clinical Trials (jRCT) in December 2022 (jRCTs031220489).
Introduction
The CAPTURE study estimated the global prevalence of established cardiovascular disease (CVD) and characterized the usage of glucose-lowering agents (GLAs) in adults with type 2 diabetes ...(T2D) across 13 countries. The purpose of this secondary analysis of data from the Japanese sites within CAPTURE (NCT03786406, NCT03811288) was to provide data about medication usage stratified by CVD status among Japanese participants with T2D.
Materials and methods
Data on GLA usage (including those with proven cardiovascular CV benefits) in Japanese participants with T2D managed in clinics or hospitals were collected and stratified by CVD subgroups.
Results
There were 800 Japanese participants in the CAPTURE study (
n
= 502 no CVD group,
n
= 298 CVD group,
n
= 268 atherosclerotic CVD subgroup). Oral antidiabetic agents and insulin were used by 88.5% and 23.4%, respectively, of participants overall. Among participants with established CVD, dipeptidyl peptidase-4 inhibitors (65.1%) were most frequently used, followed by biguanides (50.7%) and insulins (26.2%). The pattern was similar among participants with atherosclerotic CVD. A lower proportion of participants in the CVD group used glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and sodium-glucose cotransporter-2 inhibitors (SGLT-2is) with proven CV benefits versus the no CVD group (GLP-1 RAs: 7.0% vs. 8.6%; SGLT-2is: 13.4% vs. 19.1%).
Conclusion
This analysis of the CAPTURE study provided a comprehensive overview of prescription patterns for the treatment of T2D in Japan. Use of GLAs with proven CV benefit was low, even in participants with established CVD, which was comparable to the findings from the global cohort.
In this study, we examined the effects of dapagliflozin on changes in hematopoiesis, iron metabolism, and body composition indices in elderly type 2 diabetic patients with renal impairment and ...investigated the potential of dapagliflozin to treat renal anemia.
The participants were elderly type 2 diabetics with renal impairment, and the indices of diabetes management, hematopoiesis, iron metabolism, and body composition were compared before and after dapagliflozin treatment.
Fourteen subjects were given dapagliflozin 5 mg once daily for 12 weeks, three of whom had eligibility criteria deviations, such as serum ferritin <50 ng/mL. For this purpose, 14 subjects were analyzed as full analysis set (FAS) and 11 as per-protocol set (PPS). FAS analysis revealed that dapagliflozin had no effect on hemoglobin A1c after 12 weeks but significantly decreased body mass index, significantly increased hemoglobin, hematocrit, and red blood cell count, significantly decreased log ferritin level only of iron metabolism index, and no important change in body water content. PPS analysis, on the other hand, revealed that dapagliflozin 12-week treatment showed a significant decrease in log hepcidin, serum iron, and transferrin saturation.
These findings suggest that a 12-week course of dapagliflozin causes an increase in hemoglobin levels due to its hematopoietic effects in elderly type 2 diabetics with renal impairment, but that these effects may be independent of body water loss and iron metabolism improvement.
Since a serum level of alanine aminotransferase (ALT) exceeding that of aspartate aminotransferase (AST) suggests hyperalimentary fatty liver, we examined its prevalence among and the clinical ...characteristics of afflicted type 2 diabetic patients as well as the effect of antidiabetic agents on AST/ALT with the CoDiC-MS database prepared by the Japan Diabetes Clinical Data Management study group (JDDM). AST<ALT patients accounted for 37.5 % of 12,710 participants. These patients tended to be more frequently male, younger, and have higher values of body mass index, HbA1c, serum triglyceride, serum C peptide immunoreactivity, and HOMA-IR and lower values of FIB-4 index and rates of diabetic complications than AST≥ALT patients. Pioglitazone and sodium-glucose cotransporter 2 inhibitors remarkably reduced the ALT level, and 24.9 % of AST<ALT patients became AST≥ALT 1 year after starting these prescriptions. A multiple comparison test indicated that these patients tended to be more frequently female, older, and have a longer duration of diabetes mellitus, lower AST and HSI values and higher body mass index, γ-glutamyl transpeptidase, and FIB-4 index values than others.
Among 21,217 type 2 diabetic patients under 75 years old and receiving pharmacological treatment from diabetes specialists for more than 3 years, there were 3.9 % whose HbA1c value at each consulting ...session exceeded 8.0 %, with a mean value exceeding 8.5 % in the past year (poor glycemic group). In addition, in 14.0 % of patients, every HbA1c measurement was <7.0 %, and the mean HbA1c was <6.5 % in the same period (good glycemic group). On comparing these two groups, the poor glycemic group included higher proportions of women, a family history of diabetes, complicated drug therapy, and two times more in microangiopathy and coronary heart disease. After 1 year, 39 % of patients in the poor glycemic group had improved their glycemic control (improved group). Compared with the nonimproved group, the improved group patients were three years older on average and changed the prescription to drugs with different mechanism of action or decreased dosages of the prescribed drugs. The main reasons for this improvement according to the attending physicians were the amelioration of medical compliance and patients' willingness to achieve good diabetic control. A prospective study is needed in order to elucidate the method for escaping long-term poor glycemic control.
We retrospectively analyzed the CoDiC data from 39 institutes in the JDDM in order to clarify the progression of kidney dysfunction over 5 years and factors related to this progression among type 2 ...diabetes patients progressing to stage 4 diabetic nephropathy. The present study clarified that 1) about 1.7 times more patients recovered from the stage 4 to the stage 3 than those who remained in stage 4, 2) the estimated glomerular filtration rate (eGFR) in 37.4 % of patients who remained in stage 4 progressively declined with a mean rate of −3.6 mL/min/year over 5 years, while that in the rest of patients was maintained at roughly the starting value (initially 25.8; 5 years later 24.4 mL/min/1.73 m2). On comparing the patient profiles between the decliners and the non-decliners, a younger age, a low eGFR just before the study, a high systolic blood pressure and a high non-HDL cholesterol level were significantly associated with a severe decline (P<0.01). However, a propensity score matching analysis further clarified that the influence of these four risk factors on a severe decline was slight. These findings suggested that direct causes provoked the stage 4 by acute kidney injury were important for the kidney function prognosis, in addition to the genetic and pathological background characteristics of each patient.
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