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Background In Japan, six types of sodium–glucose cotransporter inhibitors (SGLT2Is) are currently in use. Here, we evaluated differences in renal composite outcomes between SGLT2Is with or without evidence of cardio vascular outcome trials (CVOTs). Methods We retrospectively surveyed 536 Japanese patients with type 2 diabetes mellitus with chronic kidney disease who received SGLT2Is for more than 1 year. Patients were classified as having received empagliflozin, canagliflozin, or dapagliflozin (n = 270, Evidence (+) group) or as having received ipragliflozin, tofogliflozin, or luseogliflozin (n = 266, Evidence (−) group). The propensity score matching method was performed. Result On matched cohort model including 205 cases in each group, there were no significant differences in the incidence of renal composite outcomes (n = 28 [14%] in the Evidence (+) group, n = 21 [10%] in the Evidence (−) group for the matched model; p = 0.29) between groups. Cox hazard analyses in the matched cohort model showed that the risk ratio for renal composite outcomes in the Evidence (−) group was 0.73 (95% confidence interval: 0.40–1.32), which was greater than the noninferiority margin of 1.22. Conclusion Three SGLT2Is with no CVOT’s evidence did not show noninferiority compared with other SGLT2Is with evidences.

OBJECTIVE: The aim was to compare short-term and long-term reproducibilities of in-office unattended blood pressure (BP), namely automated office blood pressure (AOBP), conventionally measured attended office BP, and self-measured home BP. METHODS: A multicentre, clinical study was conducted in Japan, and 287 Japanese outpatients on antihypertensive drug medication were followed-up for 1 year. RESULTS: The intensity of drug treatment was sustained consistently throughout the study period (defined daily doses, 1.62-1.68; P = 0.12). The mean SBP differences between baseline and 1 month later, as well as baseline and 1 year later, were less than 1.5 mmHg, whereas the standard deviations of the differences for home, AOBP, and attended office measurements for the 1-year interval were 7.7, 14.5, and 15.3 mmHg, respectively. The coefficients of variation were significantly smaller for home BP than for AOBP among all patients at both 1-month and 1-year intervals (P

Aims/Introduction Large‐scale clinical trials have reported that, in patients with type 2 diabetes mellitus, sodium–glucose cotransporter 2 (SGLT2) inhibitor treatment affords favorable renal outcomes; the underlying mechanisms, however, remain unclear. Thus, this study investigated how SGLT2 inhibitor‐induced changes in the mean arterial pressure (MAP; denoted as ΔMAP) are associated with renal outcomes in type 2 diabetes mellitus patients with chronic kidney disease (CKD). Materials and Methods We retrospectively assessed the data of 624 Japanese type 2 diabetes mellitus patients with CKD who had been using SGLT2 inhibitors for >1 year. For propensity score matching (1:1 nearest neighbor match, with caliper value = 0.053, no replacement), patients were categorized into two groups based on the ΔMAP (>−4 mmHg [n = 329] and ≤−4.0 mmHg [n = 295]). Composite albuminuria progression or a ≥15% annual reduction in the estimated glomerular filtration rate was regarded as the end‐point. Results Per group, 173 propensity‐matched patients were compared. Patients with ΔMAP ≤−4 mmHg had a significantly lower incidence of composite renal outcomes than those with ΔMAP ≥−4 mmHg (5.8% [n = 10] vs 15.6% [n = 27], P = 0.003). Although the between‐group differences in the estimated glomerular filtration rates were non‐significant, patients with a ΔMAP ≤−4 mmHg had significantly larger reductions in the logarithmic urine albumin‐to‐creatinine ratio (P = 0.005). Conclusions The degree of blood pressure reduction after SGLT2 inhibitor treatment influenced renal composite outcomes in Japanese type 2 diabetes mellitus patients with CKD, confirming the importance of blood pressure management in type 2 diabetes mellitus patients with CKD, even when they are under SGLT2 inhibitor treatment., From the results of the propensity score matching method, the incidence of renal composite outcome was significantly lower in patients with changes in the mean arterial pressure ≤−4 mmHg than in those with changes in the mean arterial pressure >−4 mmHg (n = 10 [5.8%] and n = 27 [15.6%], respectively, P = 0.003). The reduction in mean arterial pressure after sodium–glucose cotransporter 2 inhibitor treatment influenced the renal composite outcome in Japanese patients with type 2 diabetes mellitus and chronic kidney disease.

In 2019, the Japanese Society of Hypertension guidelines for the management of hypertension (JSH) were revised. We previously reported the awareness of JSH among general practitioners in 2014, and in the current study, the same questionnaire was administered to determine their awareness of JSH 2019, and their responses were compared. We also sought to identify effective strategies to raise awareness of hypertension. The questionnaires included the same 12 questions as in 2014 and were mailed to members of two professional organizations from October to November 2019. Responses from 256 general practitioners in 2019 and 209 in 2014 were compared using the propensity score matching method to align the responders’ backgrounds. Component analysis was performed to classify responders into appropriate clusters. The matched cohort of all 202 responders was analyzed. In both 2014 and 2019, >80% of responders instructed patients to perform home blood pressure monitoring (JSH 2014: 81.7% and JSH 2019: 84.6% in the matched cohort), and >70% instructed patients with hypertension to restrict their salt intake (JSH 2014: 79.7% and JSH 2019: 74.7% in the matched cohort). Regarding the clinical blood pressure measurement method, more responders answered “one time outside the consulting room” in the JSH 2019 group (p = 0.042). Fewer general practitioners responded that differential diagnosis for primary aldosteronism was performed in the JSH 2019 group (p = 0.032); however, the frequency of checking the aldosterone-renin ratio increased in the JSH 2019 group (p = 0.055). We confirmed the change in general practitioners’ awareness of hypertension management. The categorized clusters may be useful for the development of effective strategies for higher-quality hypertension management in clinical practice.

Aim: Sodium–glucose cotransporter 2 inhibitors (SGLT2is) provide renal protection in patients with type 2 diabetes mellitus (T2DM). The aim of this study was to elucidate the renal effects of long-...

Aims/Introduction Sodium–glucose cotransporter 2 inhibitors (SGLT2i) improve renal outcome in patients with type 2 diabetes mellitus, but the mechanism is not fully understood. The aim of this retrospective study was to assess the association of achieved blood pressure with renal outcomes in Japanese type 2 diabetes mellitus patients with chronic kidney disease. Materials and Methods We assessed 624 Japanese type 2 diabetes mellitus patients with chronic kidney disease taking SGLT2i for >1 year. The patients were classified as those with post‐treatment mean arterial pressure (MAP) of ≥92 mmHg (n = 344) and those with MAP of, Incidence of renal composite outcome and changes in logarithmic value of the albumin‐to‐creatinine ratio and estimated glomerular filtration rate.

Aims/Introduction Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long‐term treatments are available. Methods This was an investigator‐initiated multicenter prospective intervention study in which ipragliflozin (50 mg) was administered once daily, and glycemic control, estimated glomerular filtration rate (eGFR) and adverse events were evaluated until 104 weeks after starting research. Results There were 407 patients analyzed. In the eGFR ≥90 group and eGFR ≥60 to 300 group and the eGFR, In the estimated glomerular filtration rate (eGFR) ≥90 group and eGFR ≥60 to

Background: Sodium/glucose cotransporter-2 (SGLT2) inhibitors improve glycemic control and reduce body weight by increasing glycosuria. Although a compensatory increase of food intake has been repo...

SARS-CoV-2 infection elicits varying degrees of protective immunity conferred by neutralizing antibodies (nAbs). Here we report the persistence of nAb responses over 12 months after infection despite its decreasing trend noticed from 6 months. The study included sera from 358 individuals who had been infected with SARS-CoV-2 between January and May 2020. Samples were collected at 6 and 12 months after onset. The titers of IgG to the viral nucleocapsid protein (NP) and receptor-binding domain of the spike protein (RBD) were measured by CLEIA. The nAb titer was determined using lentivirus-based pseudovirus or authentic virus. Antibody titers of NP-IgG, RBD-IgG, and nAbs were higher in severe and moderate cases than in mild cases at 12 months after onset. While the nAb levels were likely to confer adequate protection against wild-type viral infection, the neutralization activity to recently circulating variants in some of the mild cases (∼30%) was undermined, implying the susceptibility of reinfection to the variants of concerns (VOCs). COVID-19 convalescent individuals have robust humoral immunity even at 12 months after infection albeit that the medical history and background of patients could affect the function and dynamics of antibody response to the VOCs.

Aim Long-term changes in body composition associated with SGLT2 inhibitors have not been characterized. Materials and methods In this multicenter, single-arm, open-label study, 107 subjects with type 2 diabetes were treated, as add-on therapy, with canagliflozin at 100 mg for 12 months. Body composition was measured with a body composition analyzer (T-SCAN PLUS) via the impedance method to prospectively analyze changes in body components, including percentage of body fat, body fat mass, total body water, muscle mass, and mineral mass. Estimated plasma volume (ePV) was calculated using the Kaplan formula. Results Body weight showed a significant decrease from 1 month to 12 months of treatment with canagliflozin, with a higher rate of decrease in body fat in body composition. A significant decrease in mineral mass was also observed, but its rate was low. Following treatment with canagliflozin, changes in total body water did not affect intracellular water, and a significant decrease in extracellular water, including plasma components, was observed early and sustained up to 12 months. Protein mass, a component of muscle mass, was not affected, with only a slight decrease in water volume observed. Conclusions Canagliflozin decreased extracellular fluid and plasma volume in addition to decreasing fat in the body due to calorie loss through urinary glucose excretion. This study suggested that SGLT2 inhibitors might reduce body weight by regulating fat mass or water distribution in the body and have cardiac and renal protective effects by resetting the homeostasis of fluid balance. This article is protected by copyright. All rights reserved.

Objective: There is scarce evidence regarding the long-term persistence of neutralizing antibodies among coronavirus disease 2019 (COVID-19) survivors. This study determined neutralizing antibody titers (NT50) and antibodies against spike protein (SP) or nucleocapsid protein (NP) antigens approximately 6 months after the diagnosis of COVID-19.Methods: COVID-19 survivors in Japan were recruited. Serum samples and data related to patients’ characteristics and COVID-19 history were collected. NT50 and titers of antibodies against NP and SP antigens were measured at 20–32 weeks after the first positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test results. Factors associated with NT50 were identified using the multivariable linear regression and the correlations among NT50 and titers of immunoglobulin G (IgG) and total immunoglobulins (Igs) against NP and SP were assessed by Spearman’s correlation.Results: Among 376 participants (median [range] days after testing positive for SARS-CoV-2, 180 (147–224); median [range] years of age, 50 (20–78); 188 [50%] male), most tested positive for NT50 (n = 367, 98%), SP-IgG (n = 344, 91%), SP-total Ig (n = 369, 98%), NP-IgG (n = 314, 84%), and NP-total Ig (n = 365, 97%). Regression analysis indicated that higher BMI, fever, and the requirement of mechanical ventilation or extracorporeal membrane oxygenation were significantly associated with higher NT50. Anti-SP antibodies correlated moderately with NT50 (Spearman’s correlation: 0.63 for SP IgG; 0.57 for SP-total Ig), while the correlation was weak for anti-NP antibodies (0.37 for NP IgG; 0.32 for NP-total Ig).Conclusions: Most COVID-19 survivors had sustained neutralizing antibodies and tested positive for SP-total Ig and NP-total Ig approximately 6 months after infection.

The decrease in blood pressure is thought to play an important role for the renoprotective effects of sodium-glucose cotransporter 2 inhibitors in patients with diabetes mellitus. However, their influence on blood pressure at home has not been well studied. The aim of this study is to clarify how long-term use of sodium-glucose cotransporter 2 inhibitors influence on blood pressure both at the office and at home, and the kidney function. We retrospectively analyzed 102 patients with type 2 diabetes mellitus and chronic kidney disease to whom sodium-glucose cotransporter 2 inhibitors were administered for more than 1 year, and whose blood pressure were monitored both at the office and at home. The blood pressure at the office and at home significantly decreased, and there was a significant positive correlation between both blood pressure values. Controlled, white-coat, and sustained hypertension were observed in 9.8%, 14.7%, and 55.9% of the patients at the beginning of the treatment, which changed to 16.7%, 15.7%, and 48.0% at the time of the survey, however, the ratio of masked hypertension was not changed (19.6%). The cutoff value of mean arterial pressure at home after treatment for the improvement of urine albumin to creatinine ratio was 92.0 mm Hg, with 54.1% of sensitivity and 60.0% of specificity. Sodium-glucose cotransporter 2 inhibitors can be useful for the strict management of blood pressures both at the office and at home. The decrease in blood pressure at home by this treatment might be related to the improvement of diabetic nephropathy.

Background: Sitagliptin, the first dipeptidyl peptidase-4 inhibitor, has demonstrated efficacy and safety as monotherapy and as add-on therapy to oral antidiabetic agents or insulin. However, there have been few reports about sitagliptin in elderly patients. The ASSIST-K observational study was performed in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin as add-on therapy to insulin. Changes of hemoglobin A1c (HbA1c), body weight, and the estimated glomerular filtration rate (eGFR), as well as adverse events, were investigated over 12 months in age-stratified groups. Methods: Among outpatients with T2DM treated at member institutions of Kanagawa Physicians Association, those starting sitagliptin as add-on therapy to insulin were followed for 12 months. HbA1c (National Glycohemoglobin Standardization Program), body weight, and eGFR were the efficacy endpoints, while adverse events were investigated to assess safety. Patients were stratified into three age groups (≤ 64 years, 65 - 74 years, and ≥ 75 years) for comparison of the endpoints. Results: Among 937 patients on insulin before starting sitagliptin, 821 patients were analyzed after excluding those without HbA1c data at baseline and 12 months. The two groups of elderly patients (65 - 74 years and ≥75 years) had more complications and their HbA1c was lower at initiation of sitagliptin therapy. The dose of sitagliptin, daily number of insulin injections, and number of concomitant oral antidiabetic agents were all lower in the elderly patients. HbA1c showed a significant decrease after initiation of sitagliptin in all age groups, and there were no significant intergroup differences in the change of HbA1c at 12 months. Body weight did not change significantly in any group. eGFR decreased significantly in all groups, with no significant intergroup differences at 12 months. Regarding adverse events, there were no significant intergroup differences in the incidence of severe hypoglycemia, gastrointestinal symptoms, or constipation. Conclusions: Despite baseline differences in demographic factors and medications, sitagliptin showed good efficacy and safety in all age groups of patients receiving it as add-on therapy to insulin during routine management of T2DM. Adding sitagliptin to insulin achieves similar efficacy and safety outcomes at 12 months in both elderly and non-elderly T2DM patients. J Clin Med Res. 2019;11(5):311-320 doi: https://doi.org/10.14740/jocmr3677

Decrease in blood pressure contributes to the reno-protective effects of sodium-glucose cotransporter 2 inhibitors; however, its relationship with home monitoring of blood pressure is unclear. We retrospectively analyzed 101 visiting members of the Kanagawa Physicians Association with type 2 diabetes mellitus and chronic kidney disease who were taking sodium-glucose cotransporter 2 inhibitors and who monitored blood pressure at home for a median treatment period of

The aim of this study was to assess the renal effects of the glucose-lowering SGLT2 inhibitors in Japanese type 2 diabetes mellitus patients with chronic kidney disease.The Kanagawa Physicians Association maintains a registry of patients who visit their 31 clinics. Clinical data of type 2 diabetes mellitus patients with chronic kidney disease, who were prescribed SGLT2 inhibitors in addition to other treatments, were collected and analysed.SGLT2i was associated with a fall in HbAThis study confirmed that the beneficial renal effects of SGLT2 inhibitor in Japanese type 2 diabetes mellitus patients with chronic kidney disease, similar to those reported in large-scale clinical trials conducted in Western countries.

We conducted a descriptive case study to examine the effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors on urinary angiotensinogen excretion, which represents the function of the intrarenal renin–angiotensin system, in patients with type 2 diabetes. An SGLT2 inhibitor (canagliflozin 100 mg/day, ipragliflozin 25 mg/day, dapagliflozin 5 mg/day, luseogliflozin 2.5 mg/day or tofogliflozin 20 mg/day) was administered for 1 month (n=9). ELISA kits were used to measure both urinary intact and total angiotensinogen levels. Treatment with SGLT2 inhibitors significantly decreased hemoglobin A1c, body weight, systolic blood pressure and diastolic blood pressure (8.5±1.3 to 7.5%±1.0%, 82.5±20.2 to 80.6±20.9 kg, 143±8 to 128±14 mm Hg, 78±10 to 67±9 mm Hg, p

To evaluate the Japanese Society of Hypertension Guidelines for the Management of Hypertension 2014 (JSH2014) among Japanese general practitioners (GPs), we used a questionnaire survey with 209 GPs from the Kanagawa Physicians Society. Overall, 93.6% of GPs felt that the contents of the JSH2014 were useful. Based on the results showing that 81.8% of GPs instructed the measurement of blood pressure (BP) in the early morning at home to most patients, GP's acceptance of home BP methods and their penetration among patients with hypertension were considerably high. Regarding the number of home BP measurements, percentages for "one time," "two times," "three times," and "as many times as the patient decides," were 20.2%, 44.9%, 12.2%, and 22.9%, respectively; as such, no consensus was reached. Overall, 80.6% of GPs instructed most patients on sodium restriction; however, the content and method of restriction varied. Furthermore, 14.7% collected spot urine to assess salt intake. Many GPs respected the JSH2014 and faithfully adopted the guidelines during medical care. However, GPs did not necessarily agree with all guidelines. GPs sometimes selected the appropriate method for the individual patients and careful observations of how the guidelines affect actual clinical practice may lead to better medical care.

Background: Ipragliflozin is a selective sodium glucose co-transporter 2 inhibitor. The ASSIGN-K study is investigating the efficacy and safety of ipragliflozin for type 2 diabetes mellitus (T2DM) in the real-world clinical setting. Methods: Japanese T2DM patients with inadequate glycemic control despite diet and exercise with/without pharmacotherapy were enrolled in an investigator-driven, multicenter, prospective, observational study examining the efficacy and safety of ipragliflozin treatment (50 mg/day for 52 weeks). We performed interim analysis after 24 weeks. Results: In 367 patients completing 24-week ipragliflozin therapy, hemoglobin A1c (HbA1c) decreased significantly from 8.07% at baseline to 7.26% in week 24 (P < 0.001). The change in HbA1c from treatment initiation to week 24 was -0.88% in patients < 65 years old versus -0.55% in those ≥ 65 years and -0.92% in men versus -0.70% in women (all P < 0.001). When baseline HbA1c was < 7%, 7% to < 8%, and ≥ 8%, the change was -0.18%, -0.45%, and -1.48%, respectively (P = 0.5352, P < 0.001, and P < 0.001, respectively). When baseline body mass index (BMI) was < 25, 25 to < 30, and ≥ 30, the change was -1.05%, -0.65%, and -0.87%, respectively (all P < 0.001). Multiple regression analysis showed that HbA1c decreased more in patients with a higher baseline HbA1c or shorter duration of diabetes. An HbA1c < 7% was achieved in 33.3% of the patients, and their baseline HbA1c was significantly lower than that of patients failing to achieve it (P < 0.001). Adverse events (AEs) occurred in 106/451 patients (23.5%), including 29.1% of patients aged 65 or older. Common AEs were vulvovaginal candidiasis (3.1%) and genital pruritus (1.8%). Serious AEs included urinary tract infection, unstable angina, and ketosis, which occurred in patients who did not suspend medication during acute illness. Conclusions: Ipragliflozin significantly improved HbA1c in T2DM patients with inadequate glycemic control. Improvement in HbA1c was significant irrespective of age, sex, baseline HbA1c, or BMI, but efficacy was greater with a higher baseline HbA1c and shorter duration of diabetes. For safe continuation of treatment, patients should be advised to suspend medication during acute illness. J Clin Med Res. 2017;9(9):793-801 doi: https://doi.org/10.14740/jocmr3116w

Background: In some large-scale clinical trials, the administration of sodium glucose co-transporter 2 inhibitors (SGLT2i) in patients with type 2 diabetes mellitus (T2DM) has revealed pronounced and consistently beneficial renal outcome. However, it is unclear whether long term SGLT2i administration led to similar results in Japanese T2DM patients. Objective: To elucidate the renal effects of long term SGLT2i administration in Japanese T2DM patients with chronic kidney disease (CKD). Method: Data from T2DM patients with CKD who were visiting members of Kanagawa Physicians Association and being administered SGLT2i for more than 1 year were used. Result: We analyzed 753 patients. Six SGLT2i types were used with median administration period of 33.0 months. The mean albumin-to-creatinine ratio (ACR) significantly decreased from 36.0 to 27.5 (mg/gCr, p Conclusion: This study confirmed that the improvement of ACR was also observed in the real world; however, eGFR gradually decreased after long term SGLT2i administration. The relationship between background factors should be further discussed in future. Disclosure K. Kobayashi: None. M. Toyoda: Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo Company, Limited, Eli Lilly and Company, Kyowa Hakko Kirin Co., Ltd., Medtronic Japan Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Novo Nordisk Inc., Sanofi, Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Company Limited. N. Hatori: None. H. Sakai: None. T. Furuki: None. K. Tamura: Advisory Panel; Self; AstraZeneca. Research Support; Self; AstraZeneca, Ono Pharmaceutical Co., Ltd. Speaker's Bureau; Self; AstraZeneca, Ono Pharmaceutical Co., Ltd. M. Miyakawa: None.

Self-measured blood pressure (BP) at home (HBP) has been commonly used in clinical practice. Although the unattended office BP (UBP), in which a patient is left alone before and during the measurement, has been investigated, the advantages of UBP over HBP or conventionally measured attended office BP obtained using automated devices (CBP) remain unclear. We performed a multicenter clinical study in Japan to compare the UBP, CBP, and HBP among 308 patients with hypertension at 3 clinics (women, 57.8%; mean age 71.8 years; under antihypertensive drug therapy, 96.4%). The patients measured HBP twice in the morning and twice in the evening for 5 days according to the Japanese Society of Hypertension guidelines. Using the Omron HEM-907 cuff-oscillometric device, the UBP and CBP were measured in line with the protocol in the Systolic blood PRessure INtervention Trial (SPRINT) and in accordance with the guidelines, respectively. Correlation coefficients were ≤0.16 for the comparison of UBP versus morning and evening HBP for the systolic measurement, whereas they were approximately 0.5 (P

Background: Ipragliflozin, a sodium-glucose transporter 2 inhibitor, was administered to patients with type 2 diabetes mellitus for 24 weeks to evaluate its effect on glycemic control and body composition. Methods: This was an investigator-initiated multicenter prospective intervention study in which ipragliflozin (50 mg) was administered once daily and glycemic control, blood pressure, body weight (BW), body composition (measured by a biological impedance method), the lipid profile, and adverse events were evaluated after 4, 12, and 24 weeks of treatment. Results: Efficacy and safety up to 24 weeks of ipragliflozin therapy were analyzed in 367 patients and 451 patients, respectively. Hemoglobin A1c decreased significantly from 8.07% at the start of ipragliflozin therapy to 7.26% in week 24 (P < 0.001). Fasting and postprandial blood glucose levels were significantly reduced by ipragliflozin. In week 24, there were significant decreases from baseline in BW (-2.6 kg), waist circumference (-2.9 cm), and body fat mass (-1.9 kg) (P < 0.001). The body water mass and mineral mass were decreased significantly by 0.5 and by 0.1 kg, respectively (P < 0.001), whereas the protein mass did not change significantly. Intracellular water mass did not change significantly, whereas extracellular water mass showed a significant decrease of 0.5 kg (P < 0.001). Muscle mass did not change in the upper and lower limbs, but that of the trunk decreased significantly (P < 0.001). There was a significant decrease in the fasting triglyceride level and a significant increase in fasting high-density lipoprotein cholesterol level, while low-density lipoprotein cholesterol was unchanged. Adverse events occurred in 23.5% of the patients, with a high frequency of genital infections, such as vulvovaginal candidiasis (3.1%) and genital pruritus (1.8%). Adverse drug reactions were noted in 13.7% of the patients. Conclusions: Administration of ipragliflozin for 24 weeks improved glycemic control and decreased BW. Reduction of body fat accounted for more than 70% of the total weight loss and reduction of extracellular water accounted for about 20%. J Clin Med Res. 2017;9(7):586-595 doi: https://doi.org/10.14740/jocmr3038w

Background: The influence of long-term sitagliptin therapy on office blood pressure (BP) and home BP has been unclear. Methods: In a retrospective cohort study of 454 patients with type 2 diabetes, the following variables were analyzed before and at 3, 6, 9, and 12 months after initiation of sitagliptin therapy: office systolic blood pressure (SBP), office diastolic blood pressure (DBP), office pulse rate, morning home SBP, morning home DBP, morning home pulse rate, evening home SBP, evening home DBP, evening home pulse rate, hemoglobin A1c (HbA1c), plasma glucose, lipid profile, and renal function parameters. Results: The office SBP showed a significant decrease after 6 and 12 months of sitagliptin therapy (P < 0.01 and P < 0.01, respectively), while office DBP was decreased significantly at all time points of evaluation (3, 6, 9, and 12 months: P < 0.05, P < 0.001, P < 0.001, and P < 0.05, respectively). Analysis of covariance revealed a significant decrease in office SBP after 6 and 12 months, as well as significant reduction of office DBP after 6 and 9 months. Morning home SBP and DBP were significantly reduced after 6 months, as was evening home DBP after 6 and 12 months, but there was no significant decrease in evening home SBP. HbA1c and plasma glucose levels were significantly reduced at all time points of evaluation. Examination of the lipid profile revealed that total cholesterol, low-density lipoprotein cholesterol, and triglycerides were also decreased at all time points of evaluation, while high-density lipoprotein cholesterol was significantly reduced after 3, 9, and 12 months. Significant reduction of the estimated glomerular filtration rate was observed after 6, 9, and 12 months, and the urinary albumin/creatinine ratio was significantly lower at 9 and 12 months. Serum creatinine was increased significantly at all time points of evaluation. Conclusions: BP was slightly but significantly reduced from 6 months after initiation of sitagliptin therapy, indicating that this antidiabetic drug has pleiotropic effects, including an antihypertensive effect. J Clin Med Res. 2017;9(3):188-192 doi: https://doi.org/10.14740/jocmr2820w

Aim. The renoprotective effect of sodium-glucose cotransporter 2 inhibitors is thought to be due, at least in part, to a decrease in blood pressure. The aim of this study was to determine the renal effects of these inhibitors in low blood pressure patients and the dependence of such effect on blood pressure management status. Methods. The subjects of this retrospective study were 740 patients with type 2 diabetes mellitus and chronic kidney disease who had been managed at the clinical facilities of the Kanagawa Physicians Association. Data on blood pressure management status and urinary albumin-creatinine ratio were analyzed before and after treatment. Results. Changes in the logarithmic value of urinary albumin-creatinine ratio in 327 patients with blood pressure<130/80 mmHg at the initiation of treatment and in 413 patients with BP above 130/80 mmHg were −0.13±1.05 and −0.24±0.97, respectively. However, there was no significant difference between the two groups by analysis of covariance models after adjustment of the logarithmic value of urinary albumin-creatinine ratio at initiation of treatment. Changes in the logarithmic value of urinary albumin-creatinine ratio in patients with mean blood pressure of n=537) and those with ≥102 mmHg (n=203) at the time of the survey were −0.25±1.02 and −0.03±0.97, respectively, and the difference was significant in analysis of covariance models even after adjustment for the logarithmic value of urinary albumin-creatinine ratio at initiation of treatment (p<0.001). Conclusion. Our results confirmed that blood pressure management status after treatment with SGLT2 inhibitors influences the extent of change in urinary albumin-creatinine ratio. Stricter blood pressure management is needed to allow the renoprotective effects of sodium-glucose cotransporter 2 inhibitors.

Background: Sitagliptin, a dipeptidyl peptidase-4 inhibitor, is an effective oral antidiabetic agent as both monotherapy and when combined with insulin. Data from three observational studies performed in patients with type 2 diabetes receiving sitagliptin therapy in the routine clinical setting were integrated to conduct factor analysis of the changes in hemoglobin A1c (HbA1c), body weight, and estimated glomerular filtration rate (eGFR) over 12 months. Methods: Among patients with type 2 diabetes attending medical institutions affiliated with Kanagawa Physicians Association, those using sitagliptin were followed for 1 year. In the ASSET-K and ASSIST-K studies, patients were managed by diabetologists, while they were managed by non-diabetologists in the ATTEST-K study. Patients were not administered insulin in ASSET-K, whereas insulin was administered in ASSIST-K. HbA1c (National Glycohemoglobin Standardization Program), blood glucose (fasting/postprandial), body weight, and renal function (serum creatinine and eGFR) were the efficacy endpoints. Factor analysis was performed by analysis of variance using the magnitude of the change in HbA1c, body weight, and eGFR after 12 months of sitagliptin therapy as response variables, and the study, sex, and age as explanatory variables. Results: Of 1,327 patients registered in ASSET-K (diabetologists/without insulin), 1,167 patients in ASSIST-K (diabetologists/with insulin), and 530 patients in ATTEST-K (non-diabetologists), statistical analysis was carried out on 1,074, 854, and 411 patients, respectively. There were significant inter-study differences in patient characteristics (complications, duration of diabetes, and baseline HbA1c), the sitagliptin dose, and the use of other antidiabetic agents. HbA1c decreased significantly in all three studies. According to factor analysis, the magnitude of the change in HbA1c over 12 months showed significant inter-study differences and was also significantly influenced by the age, duration of diabetes, and baseline HbA1c. Conclusions: Comparison of three observational studies identified differences in patient characteristics, treatment of diabetes (use/non-use of insulin), and the level of specialist care (diabetologist/non-diabetologist). Despite such differences, consistent reduction of HbA1c by sitagliptin was demonstrated in all three studies. The patients showing most improvement in HbA1c with sitagliptin therapy were older patients with a short duration of diabetes and high baseline HbA1c level. J Clin Med Res. 2016;8(6):461-471 doi: http://dx.doi.org/10.14740/jocmr2540w

Background: Ipragliflozin is a sodium-glucose co-transporter 2 inhibitor that can improve glycemic control and reduce body weight and blood pressure in patients with type 2 diabetes mellitus (T2DM). We evaluated the efficacy and safety of ipragliflozin in the real-world clinical setting, with a focus on the changes of body composition up to 3 months of treatment. Methods: This was a prospective multicenter interventional trial. We investigated changes of the blood pressure, body composition, blood glucose, hemoglobin A1c (HbA1c), ketone bodies, lipids, and insulin after treatment with ipragliflozin (50 - 100 mg/day) for 12 weeks in Japanese patients with T2DM who showed poor glycemic control despite receiving diet and exercise therapy with or without oral antidiabetic drugs for more than 12 weeks. Results: Two hundred and fifty-seven subjects were included in the efficacy analysis up to 12 weeks of treatment and 301 subjects were included in the safety analysis. From baseline to 12 weeks, HbA1c showed a change of -0.68% (95% confidence interval (CI): -0.83, -0.53) and fasting blood glucose showed a change of -23.9 mg/dL (95% CI: -30.5, -17.2), with both parameters displaying a significant reduction (P < 0.001). The difference of body weight from baseline was -1.82 kg (95% CI: -2.14, -1.50), and it also showed significant reduction (P < 0.001). Analysis of body composition revealed that body fat changed by -1.46 kg (95% CI: -1.79, -1.14, P < 0.001) and body water changed by -0.37 kg (95% CI: -0.60, -0.14, P < 0.01). Laboratory tests demonstrated improvement of liver function and the lipid profile. Adverse events (AEs) occurred in 22.6% of the subjects, with frequent events being vulvovaginal candidiasis in 2.7% and cystitis in 2.0%. Serious AEs occurred in three subjects. Conclusions: In patients with T2DM, ipragliflozin improved glycemic control after 1 month of treatment and caused weight loss by reducing body fat more than body water. J Clin Med Res. 2016;8(2):116-125 doi: http://dx.doi.org/10.14740/jocmr2417w Correction in J Clin Med Res. 2016;8(3):267-267, doi: http://dx.doi.org/10.14740/jocmr2417wc1

Background: It is unclear whether dipeptidyl peptidase-4 inhibitors decrease hemoglobin A 1c (HbA 1c ) in a glucose-dependent manner in patients on insulin therapy who have impaired insulin secretion. This study investigated factors influencing the efficacy of sitagliptin when used concomitantly with insulin to treat type 2 diabetes mellitus (T2DM) in the real-world setting. Methods: A retrospective study was conducted of 1,004 T2DM patients at 36 Japanese clinics associated with the Diabetes Task Force of the Kanagawa Physicians Association. Eligible patients had been on insulin for at least 6 months, with a baseline HbA 1c of 7.0% (53 mmol/mol) or higher. Baseline characteristics and laboratory data from 495 patients were subjected to multiple regression analysis to identify factors influencing the change of HbA 1c . Results: Most patients (n = 809) received sitagliptin at a dose of 50 mg. In the 1,004 patients, HbA 1c decreased by 0.74% (6 mmol/mol) and body weight increased by 0.1 kg after 6 months of combination therapy. Multiple regression analysis showed that a higher baseline HbA 1c , older age, and lower body mass index influenced the change of HbA 1c after 6 months. Hypoglycemic symptoms occurred in 7.4%, but none were severe. Conclusions: These results emphasize the importance of a higher HbA 1c at the commencement of sitagliptin therapy in patients on insulin. Glucose-dependent suppression of glucagon secretion by sitagliptin may be useful in patients with impaired insulin secretion. Sitagliptin can be used concomitantly with insulin irrespective of the insulin regimen, duration of insulin treatment, and concomitant medications. J Clin Med Res. 2015;7(8):607-612 doi: http://dx.doi.org/10.14740/jocmr2149w

Our goal was to evaluate liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, in monotherapy and combination therapy for Japanese type 2 diabetes patients. Patients with type 2 diabetes (111 men, 83 women; mean age 57.6 ± 12.6 years) were treated with liraglutide and divided into liraglutide monotherapy (n = 147 patients, group A) and liraglutide–sulfonylurea (SU) combination therapy (n = 47, group B) groups. Changes in clinical parameters after liraglutide administration were evaluated. In both groups, significant decreases in glycosylated hemoglobin (HbA1c) were seen after 12 (group A, 7.01 ± 1.38 vs. 7.72 ± 1.57 %, p

We performed a cross-sectional survey to investigate actual clinical practice concerning blood-pressure control among patients with hypertension in Kanagawa. The guidelines of the Japanese Society of Hypertension (JSH) for the management of patients with hypertension were revised in 2014. From October 1 to November 30, 2014, questionnaires on the care of patients with hypertension were sent via post to members of the Kanagawa Physicians Association in Kanagawa Prefecture, Japan. -Data on 1,105 patients (mean age: 68.4±12.3 years, 537 men and 568 women) were obtained. The overall mean systolic blood pressure (BP) of these patients was 128.7±12.1 mmHg for home monitoring and 132.9±12.6 mmHg for office monitoring; diastolic BP was 75.7±9.7 for home monitoring and 77.0±9.7 mmHg for office monitoring. According to the JSH 2014 guidelines, the target BP was achieved by 68.1% of all subjects; 89.2% of late-phase elderly patients (75 years or older); 69.1% of young, middle-aged, and early-phase elderly patients (younger than 75 years except in patients with diabetes mellitus [DM] or chronic kidney disease [CKD] with proteinuria); 9.3% of patients with DM except late-phase elderly patients; and 11.9% of CKD patients with proteinuria except DM. Cross-sectional analysis showed that the factors significantly associated with an increased likelihood of achieving the target BP were as follows: 1) good medication compliance even for a small number of antihypertensive agents at small amount of doses in patients 75 years and older; 2) good medication compliance in patients in younger than 75 years; 3) an older age, a larger proportion in the female-to-male ratio and a lower body mass index in patients with DM except late-phase elderly patients; and 4) usage of a large number of antihypertensive agents in CKD patients with proteinuria. Further follow-up surveys are necessary to investigate changes in clinical practice following the introduction of the revised guidelines.

Background: Ipragliflozin is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor that blocks glucose reabsorption in the proximal tubules. SGLT2 inhibitors are expected to be effective in patients with insulin resistance and obesity, but it is important to select treatment according to patient background factors that minimizes the risk of adverse events. There have been a limited number of investigations into the relationship between the clinical efficacy (reducing hemoglobin A1c (HbA1c) and body weight (BW)) or safety of SGLT2 inhibitors and patient characteristics. Methods: ASSIGN-K is an investigator-initiated, multicenter, prospective observational study examining the efficacy and safety of ipragliflozin (50 - 100 mg/day for 52 weeks) in Japanese patients with type 2 diabetes mellitus (T2DM) who had inadequate glycemic control with HbA1c ≥ 6.0% (National Glycohemoglobin Standardization Program) despite diet and exercise therapy or diet and exercise plus antidiabetic drug therapy. We conducted an interim analysis of the relationship between changes in HbA1c or BW and characteristics in patients who had been on treatment for more than 12 weeks. Results: In 257 patients completing 12 weeks of treatment, HbA1c decreased significantly from 8.23% to 7.55% (-0.68%, P < 0.01). The change in HbA1c after 12 weeks was -0.17%, -0.33%, and -1.16% when baseline HbA1c was < 7%, 7% to < 8%, and ≥ 8%, respectively (P < 0.05, P < 0.01, and P < 0.01, respectively), and -1.30%, -0.62%, and -0.62% when baseline body mass index (BMI) was < 25, 25 to < 30, and ≥ 30, respectively (all P < 0.01). Stratified analysis showed that age, gender, or BMI did not have a significant influence on the improvement in HbA1c. Multiple regression analysis showed that reduction in HbA1c was greater as baseline HbA1c increased and the duration of diabetes decreased. A higher baseline HbA1c was associated with less weight loss. Conclusions: Ipragliflozin significantly improved HbA1c in patients with T2DM. HbA1c improved more when baseline HbA1c was higher and the duration of diabetes was shorter, suggesting that current treatment policies for diabetes could be re-examined. J Clin Med Res. 2016;8(5):373-378 doi: http://dx.doi.org/10.14740/jocmr2492w

To (1) measure urinary albumin and estimated glomerular filtration rate (eGFR) in patients with type 2 diabetes mellitus (DM) in Kanagawa Prefecture, (2) assess the validity of the diabetic nephropathy (DN) stage classification system and current chronic kidney disease (CKD) stage classification system from the Kidney Disease Outcomes Quality Initiative—Kidney Disease: Improving Global Outcomes (K/DOQI-KDIGO), and (3) validate the new CKD stage classification system of KIDIGO 2009. The Kanagawa Physicians Association conducted a survey across 255 medical institutions over six months and measured urinary creatinine-corrected urinary albumin levels in 4,885 subjects, in addition to height, weight, blood pressure, sex, age, urinalysis, urinary albumin, blood glucose, hemoglobin A1c, and serum creatinine levels. In stages 1 and 2 of the DN classification system, many patients with urinary albumin

We performed a cross-sectional survey to investigate actual clinical practices regarding blood-pressure control in patients with hypertension. From October 16 to 31, 2008, postal questionnaires regarding the care of patients with hypertension were sent to members of the Kanagawa Physicians Association in Kanagawa, Japan. Data of 675 patients (mean age: 70.1 ± 10.6 years, 301 men and 374 women) were returned. The overall mean systolic blood pressure (BP) in these patients was 134.6 ± 10.6 mm Hg, and diastolic BP was 76.2 ± 8.3 mm Hg. According to the 2009 guidelines of the Japanese Society of Hypertension for the management of patients with hypertension, the target office BP was achieved by 53.9% of all subjects; 29.7% of patients with diabetes mellitus, chronic kidney disease, or a history of myocardial infarction; 72.0% of elderly patients; 23.6% of nonelderly patients (younger than 65 years); and 75.4% of patients with cerebrovascular disease. Cross-sectional analysis showed that factors significantly associated with an increased likelihood of achieving the target office BP were: 1) usage of a larger number of antihypertensive agents in nonelderly patienys and in patients with diabetes mellitus, chronic kidney disease, or a history of myocardial infarction and: 2) usage of a smaller number of antihypertensive agents in elderly patients and patients with cerebrovascular disease. Further follow-up surveys are necessary to provide a full assessment.

Aims/Introduction: The prevalence of diabetes mellitus is increasing rapidly in Japan, and diabetic neuropathy is a major factor decreasing diabetic patients’ quality of life, as well as a risk factor for sudden death. The present study aimed to determine the prevalence of diabetic neuropathy and raise awareness about it among patients and their physicians. Materials and Methods: Diabetic outpatients (N = 5077) at 249 medical institutions within Kanagawa Prefecture, Japan, were surveyed by questionnaire and underwent foot examinations. The questionnaire included 10 questions about sensory abnormalities of both feet, muscle cramps and autonomic symptoms. Foot examinations included testing for vibratory perception of the medial malleolus, Achilles tendon reflexes and touch sensation of the bottom of the great toe using tissue paper. Results: Of the 5077 patients surveyed, 70.4% reported symptoms. Overall, 75.4% of the patients underwent vibratory perception testing, of whom 44.9% had abnormal thresholds (≤10 s). On the tissue paper touch test, performed in 94.6% of patients, 11.9% had no touch sensation. Of the 2803 type 2 diabetic patients with known background factors who underwent foot examinations, 49.4% had diabetic neuropathy. There was a high prevalence of diabetic neuropathy (36.1%) in patients with

The optimal procedure for casual-clinic blood pressure (CBP) measurement is outlined in the 2004 Japanese guidelines. We investigated the status of physicians' practices and their awareness of CBP measurement immediately and 4 years after the publication of the guidelines using a questionnaire regarding CBP. This survey was conducted among physicians who attended educational seminars on hypertension in 2004-2005 and in 2007-2008; the questionnaire was distributed, completed and collected just before the start of the seminars. Of the 1966 respondents to the 2004-2005 survey and the 2995 respondents to the 2007-2008 survey, the proportion of physicians who answered that CBP was more important than self-measured BP at home (home BP) was less than 10% in both surveys. The proportion of physicians who used a mercury sphygmomanometer (68.1-75.5%) was higher than those who used an automatic and electronic sphygmomanometer (20.7-29.0%) in both surveys. However, the use of an automatic and electronic sphygmomanometer slightly increased from 20.7% in 2004-2005 to 29.0% in 2007-2008. Physicians who were younger or working in a hospital were less likely to measure CBP using the conditions of the guidelines. Approximately 50% of physicians correctly recognized the reference values of hypertension based on CBP measurement (systolic/diastolic, 140/90 mm Hg) in both surveys. The status of physicians' practice and awareness of CBP measurement varied by physicians' age, specialty and work place and those situations did not change over 4 years, underlying the importance of clarifying factors inherent in these situations.

The Japanese Society of Hypertension published guidelines for home blood pressure (HBP) measurement in 2003 and for the management of hypertension in 2004. The objective of this study was to investigate the status of physicians' practice and awareness of HBP measurement based on the Japanese guidelines and compare the status between immediately after and 4 years after publication of the guidelines. A questionnaire survey regarding HBP was conducted among physicians who attended educational seminars on hypertension in 2004-05 and in 2007-08. This questionnaire was distributed, completed, and collected just before the start of the seminars. Of the 1966 and 2995 respondents to the 2004-05 and 2007-08 surveys, respectively, 90.2 and 94.6% recommended HBP measurement to their patients. The majority of physicians recommended use of the upper-arm cuff device, and recommendation of the number of measurements, documentation and evaluation of the measured values varied widely among physicians, both in 2004-05 and in 2007-08. About 10% of physicians showed sufficient understanding of the optimal methods for HBP measurement based on Japanese guidelines both in 2004-05 and in 2007-08. Only 21.6 and 23.9% of physicians correctly recognized the reference values of hypertension based on HBP measurement (systolic/diastolic, 135/85 mm Hg) in 2004-05 and in 2007-08, respectively. Although most Japanese physicians recognized the importance of HBP measurement, many had inadequate knowledge of HBP measurement, both in 2004-05 and in 2007-08. More aggressive promotion of HBP measurement among physicians is warranted.

Japan has the highest number of magnetic resonance imaging units in the world, and citizens can freely choose medical care at any hospital or clinic. We aimed to investigate the triage of patients with suspected transient ischemic attack (TIA) or minor stroke in this unique Japanese healthcare system.In this cohort study, patients with suspected TIA or minor stroke (National Institutes of Health Stroke Scale score4) within 7 days after onset were prospectively enrolled and followed for 1 year. The high-risk group was defined as having at least one of the following 5 items at the initial visit: (1) atrial fibrillation, (2) carotid stenosis, (3) crescendo TIA, (4) definite focal brain symptoms, or (5) ABCD2 score of 4 or higher. After the initial assessment, the patients were diagnosed as having acute ischemic cerebrovascular syndrome (AICS) or stroke mimic. AICS was classified into 3 categories including definite, probable, and possible AICS, based on evidence of neurological deficits and brain infarction on the imaging study.A total of 353 patients were enrolled and 89.8% of the patients were examined by diffusion-weighted imaging at the initial visit. Kaplan-Meier analyses demonstrated a statistically significant difference in subsequent stroke risk when the patients were triaged by the ABCD2 score (P = .031), 5-item high-risk categorization (P = .032), or AICS classification (P = .001).This study demonstrates that hospitals and clinics with imaging facilities play a major role in triage and that the ABCD2 score, 5-item high-risk categorization, and AICS classification are useful as triage tools for patients with suspected TIA or minor stroke.

Home blood pressure (BP) measurements are indispensable for the improvement of hypertension management in medical practice as well as for the recognition of hypertension in the population. The Working Group for Establishment of Guidelines for Measurement Procedures of Self-Monitoring of Blood Pressure at Home of the Japanese Society of Hypertension has established standards for all techniques and procedures of home BP measurements. The recommendations are as follows. Recommendation: 1) Arm-cuff devices based on the cuff-oscillometric method that have been validated officially, and the accuracy of which has been confirmed in each individual, should be used for home BP measurement. 2) The BP should be measured at the upper arm. Finger-cuff devices and wrist-cuff devices should not be used for home BP measurements. 3) Devices for home BP measurement should be adapted to the American Association for Medical Instrumentation (AAMI) standards and the British Hypertension Society (BHS) guidelines. In addition, the difference between the BP measured by the auscultatory method and that measured using the device should be within 5 mmHg in each individual. The home measurement device should be validated before use, and at regular intervals during use. 4) Home BP should be monitored under the following conditions. The morning measurement should be made within 1 h after waking, after micturition, sitting after 1 to 2 min of rest, before drug ingestion, and before breakfast. The evening measurement should be made just before going to bed, sitting after 1 to 2 min of rest. 5) Home BP should be measured at least once in the morning and once in the evening. 6) All home BP measurements should be documented without selection, together with the date, time, and pulse rate. Use of devices with a printer or an integrated circuit memory is useful to avoid selection bias. 7) The home BP in the morning and that in the evening should be averaged separately for a certain period. The first measurement on each occasion should be used for totaling. 8) Home BP values averaged for a certain period indicate hypertension when 135/80 mmHg and over and definite hypertension when 135/85 mmHg and over. Normotension is defined as less than 125/80 mmHg and definite normotension as less than 125/75 mmHg. Home BP measurements based on these guidelines can be considered an appropriate tool for clinical decision-making, and it is hoped that these guidelines will serve to reduce confusion and confirm the place of home BP measurement in clinical practice. (Hypertens Res 2003; 26: 771‐782)

We performed cross-sectional surveys to investigate changes in clinical practices regarding blood-pressure control in patients with hypertension from 2008 through 2011. Questionnaires regarding the care of patients with hypertension were mailed to members of the Kanagawa Physicians Association in Kanagawa Prefecture, Japan. Data were obtained on 675 patients in 2008, 332 in 2009, and 1,076 in 2011. The mean systolic blood pressure (BP) was significantly lower in 2011 than in 2008 (132.2±11.9 mm Hg versus 134.6±10.6 mm Hg). The office-measured target BP, according to the 2009 guidelines of the Japanese Society of Hypertension for the management of patients with hypertension, was achieved in 53.9% of patients in 2008, 55.1% in 2009, and 57.1% in 2011. In nonelderly patients (younger than 65 years), the achievement rate was significantly greater in 2011 (41.2%) than in 2008 (23.6%). This analysis showed that the factor most significantly associated with a decrease in office-measured BP was treatment with a larger number and higher doses of antihypertensive agents. To investigate changes in clinical practices according to the guidelines, further follow-up surveys are necessary.

高血圧を合併した慢性血液透析 (HD) 患者の血圧の日内変動を携帯型自動血圧計 (ABPM) を用いて測定した. 得られたデータを最大エントロピー法 (maximum entropy method: MEM) の理論に基づいた時系列解析データシステムMEM least square method (MEM-LSM) で解析しHD患者の高血圧の特徴と降圧療法を検討した.その結果, 1) 検討した20例の高血圧を合併したHD患者中, non-dipper型は15例 (75%), dipper型は5例 (25%) であった. 2) non-dipper型の夜間収縮期血圧 (SBP) は, dipper型に比べて有意に高値を示した (180±19mmHg for the non-dippers vs 146±17mmHg for the dippers, p

An electronic system for salt intake assessment using a 24-h dietary recall method has been developed in Japan. We evaluated the validity of this salt intake system for assessing salt intake.We prospectively obtained data on estimated salt intake using 24-hour urinary sodium excretion (24-hUNaCl) and salt intake by the salt intake assessment system from 203 consecutive outpatients with essential hypertension (age: 67.8 ± 10.7 years; 53.7% men).Mean values were 9.7 ± 2.9 g/day for 24-hUNaCl and 9.1 ± 2.9 g/day for the salt intake assessment system before corrections. The salt intake estimated by the present system was significantly correlated with 24-hUNaCl (r = 0.66, p0.0001). After corrections for habitual use of discretionary seasonings, habitual intake of salty foods, and physical activity, correlation coefficients between salt intake and 24-hUNaCl increased from 0.60 to 0.66 in men65 years, from 0.80 to 0.81 in men ≥ 65 years, from 0.64 to 0.75 in women65 years, and from 0.52 to 0.59 in women ≥ 65 years. After further correction for regional differences in average salt intake, the correlation coefficient reached 0.72 in all patients.After correction for dietary habits, lifestyle factors, and differences in average salt intake by region, this system may be a useful tool in Japan to encourage salt restriction in the clinical treatment of hypertension and improve public health in terms of salt restriction overall.

Background : To evaluate the efficacy of switching from insulin to the GLP-1 receptor agonist liraglutide in type 2 diabetes mellitus patients. Methods : The subjects were 231 outpatients with type 2 diabetes mellitus being treated with liraglutide for the first time. For 161 patients, liraglutide was continued for 24 weeks (continuation group), and for 70 patients, liraglutide was discontinued before 24 weeks (discontinuation group). Fasting and postprandial blood glucose levels, HbA1c, body weight, and insulin dose were evaluated before the switch to liraglutide (baseline) and at 12 and 24 weeks of administration. Trends in HbA1c and weight were compared at 12 and 24 weeks of administration. Multiple regression analyses were conducted to identify clinical factors predicting a successful switch to liraglutide. Results : Multiple regression analysis with Δ HbA1c as the dependent variable in the continuation group indicated that HbA1c at 12 weeks of administration decreased with higher baseline HbA1c and increased with higher baseline daily insulin doses. Multiple regression analysis with Δ weight as the dependent variable indicated that Δ weight at 24 weeks of liraglutide administration was higher with higher baseline daily insulin doses and longer duration of diabetes. Based on the area under the receiver operating characteristic curve, cut-off values of 19 units for daily insulin dose and nine years for duration of diabetes were identified. Conclusions : Switching from insulin to liraglutide therapy is possible for carefully selected patients. Daily insulin dosage and duration of insulin therapy appear to be clinically useful indicators for the efficacy of liraglutide therapy. J Clin Med Res. 2014;6(2):138-144 doi: http://dx.doi.org/10.14740/jocmr1719w

There are limited clinical trials examining the efficacy of antihypertensive drug combinations aimed at preventing cardiovascular events. Therefore, we designed a randomized controlled trial using amlodipine as the base drug of a multi-drug regimen, the Optimal Combination of Effective ANtihypertensives (OCEAN) Study, to determine the drug combination that is most efficacious in the prevention of cardiovascular events, such as stroke. The OCEAN Study is a collaborative study between Japan and China, enrolling 20 000 patients and following them for 3 to 4 years. A pilot study was conducted before the full-scale study to confirm the feasibility of the protocol and that the study groups and infrastructures could function properly. A total of 279 Japanese patients were enrolled from 57 participating medical institutions between June and December 2004. Two hundred and sixty-six patients (mean age: 65.9 years) were treated with amlodipine alone. One hundred and fifty-four of these patients (57.9%) did not reach the treatment targets (