Home blood pressure measurement consistency and cognitive impairment.

Cognitive function tends to decline with age, and individuals with mild cognitive impairment (MCI) often have difficulty completing established self-management tasks. The aim of this study was to investigate the association between the number of days within a 5-and-a-half-day period that patients took their home blood pressure (BP) as instructed and MCI assessed by the Japanese version of the Montreal Cognitive Assessment (MoCA-J) in an elderly clinical population. We analyzed 303 ambulatory patients (mean age 77.3 ± 8.2 years) in whom MoCA-J had been assessed, who were instructed to take home BP for 1 evening and twice a day for the next five days, and who had at least one morning home BP measurement. After accounting for patient characteristics including age, sex, body mass index, drinking, smoking, prevalent cardiovascular disease, morning systolic BP and diastolic BP, and the use of antihypertensive drugs, the number of days home BP was measured was independently associated with both total MoCA-J score (estimate, 0.82; 95% confidence interval [CI], 0.43-1.21; P < 0.001) and the lowest quartile of MoCA-J score (13 or below) (odds ratio [OR], 0.72; 95%CI, 0.59-0.87; P = 0.001). Home BP measurement noncompliance (<5 days' measurement) was also independently associated with the total MoCA-J score (estimate, -2.56; 95%CI, -4.09 to -1.03; P = 0.001) and the lowest quartile of MoCA-J score (OR, 3.32; 95%CI, 1.59-6.96; P = 0.001). In conclusion, poor compliance with home BP monitoring was associated with cognitive impairment in elderly cases who had been specifically instructed to perform home BP monitoring during a designated period.

Agreement Between Guideline Thresholds Using an "All-in-One" Device to Measure Office, Home, and Ambulatory Blood Pressures.

BACKGROUND: Blood pressure (BP) thresholds for diagnosing and managing hypertension vary for office, home, and ambulatory readings, and between guideline documents. This analysis determined corresponding office, home, and ambulatory BP thresholds using baseline data from the HI-JAMP (Home-Activity Information and Communication Technology-Based Japan Ambulatory Blood Pressure Monitoring Prospective) study, which used a validated "all-in-one" BP monitoring device. METHODS AND RESULTS: Data from 2322 treated patients with hypertension who underwent office BP measurement, then 24-hour ambulatory BP monitoring, then home BP monitoring for 5 days were analyzed. Corresponding BP thresholds for office, home, and ambulatory measurements were determined using Deming regression. Values equivalent to office systolic BP (SBP) of 120 and 140 mm Hg were as follows: 115.9 and 127.7 mm Hg for 24-hour ambulatory SBP; 120.8 and 134.0 mm Hg for daytime ambulatory SBP; 104.9 and 117.9 mm Hg for nighttime ambulatory SBP; and 122.0 and 134.2 mm Hg for morning-evening average home SBP. Deming regression showed that morning-evening average home SBP and daytime ambulatory SBP were almost the same (home SBP=0.99×daytime ambulatory SBP+0.27 mm Hg; r=0.627). Morning-evening average home SBP values of 120 and 135 mm Hg were equivalent to daytime ambulatory SBP values of 119.1 and 133.9 mm Hg, respectively. A home SBP threshold of 130 mm Hg corresponded to 24-hour and nighttime ambulatory SBP values of 123.5 and 113.6 mm Hg, whereas a home SBP threshold of 135 mm Hg corresponded to 24-hour and nighttime ambulatory SBP values of 128.0 and 119.2 mm Hg. CONCLUSIONS: Ambulatory and home BP thresholds in this analysis were similar to those proposed by existing guidelines. The similarity between the home BP and daytime ambulatory BP thresholds was a clinically relevant finding.

Effectiveness and safety of lubiprostone after switching from stimulant laxatives in elderly patients with chronic constipation.

Background and Aim: Stimulant laxatives may cause electrolyte abnormalities, dehydration, and abdominal pain; their long-term use can lead to tolerance and subsequent refractory constipation. We investigated the effectiveness, safety, and quality of life after switching from stimulant laxatives to lubiprostone in elderly patients with chronic constipation (CC). Methods: This multicenter, interventional, open-label, single-arm, before-and-after comparison study enrolled 99 Japanese patients aged 65-90 years with CC who took stimulant laxatives for ≥2 weeks prior to switching to lubiprostone monotherapy. Results: The mean ± SD spontaneous defecations at Week 1 of 7.8 ± 6.2 times/week was not significantly different from that at baseline (8.3 ± 4.7). Spontaneous defecations were significantly reduced at Weeks 2 (-1.5 ± 4.0, P < 0.001) and 4 (-1.5 ± 3.7, P < 0.001). The Bristol Stool Form Scale score did not change from baseline (4.7 ± 0.9) at Weeks 1 (4.5 ± 1.3) or 4 (4.3 ± 1.3), but it did at Week 2 (4.3 ± 1.5, P < 0.05). The Patient Assessment of Constipation Quality of Life questionnaire score increased (0.36 ± 0.07, P < 0.001) after 28 days. Nausea was the only symptom that worsened from baseline and was the most frequently reported adverse drug reaction (15.2%). Conclusion: Switching to lubiprostone monotherapy for CC was not associated with significant concerns in short-term spontaneous defecation frequency and safety, but it might affect the efficacy and patient quality of life over 2 weeks. Careful treatment strategies facilitating gradual switching to lubiprostone monotherapy may be needed in patients using stimulant laxatives.

Different Home Blood Pressure Thresholds to Predict Perfect 24-Hour Ambulatory Blood Pressure Control in Treated Hypertension Based on an "All-in-One" Device.

BACKGROUND: Home blood pressure (BP) is an important component of digital strategies for hypertension management. However, no studies have used the same device to investigate 24-hour BP control status in relation to different home BP control thresholds. METHODS: Participants in the general practitioner-based, multicenter HI-JAMP study (Home-Activity Information and Communication Technology-Based Japan Ambulatory Blood Pressure Monitoring Prospective) underwent office BP measurement, then 24-hour ambulatory BP monitoring, then home BP monitoring for 5 days. A validated all-in-one BP monitoring device was used to measure office, home, and ambulatory BP. Baseline data were used to investigate ambulatory BP control status in individuals with well-controlled home BP based on the different guideline thresholds (125/75 mm Hg, 130/80 mm Hg, and 135/85 mm Hg). RESULTS: Data from 2269 patients were analyzed. For individuals with well-controlled home BP <135/85 mm Hg (59.5% of the total population), the prevalence of uncontrolled 24-hour (≥130/80 mm Hg), daytime (≥135/85 mm Hg), and nighttime ambulatory BP (≥120/70 mm Hg) was 19.9%, 18.5%, and 33.6%, respectively. Corresponding prevalence rates in the 42.7% of participants with well-controlled home BP <130/80 mm Hg were 13.4%, 12.9%, and 26.0%, and when well-controlled home BP was strictly defined as <125/75 mm Hg (23.9% of the population), prevalence of rates of uncontrolled 24-hour, daytime, and nighttime ambulatory BP were 7.0%, 9.0%, and 15.3%, respectively. CONCLUSIONS: Home BP control status defined using different thresholds could predict 24-hour ambulatory BP control status in treated hypertension. One-third of individuals still had uncontrolled nocturnal hypertension when home BP was controlled to <135/85 mm Hg, but ambulatory BP was quite well controlled when home BP was <125/75 mm Hg.

Nighttime home blood pressure lowering effect of esaxerenone in patients with uncontrolled nocturnal hypertension: the EARLY-NH study.

There is limited evidence on the blood pressure (BP)-lowering effect of esaxerenone on home BP, including nighttime BP. Using two newly developed nocturnal home BP monitoring devices (brachial and wrist), this multicenter, open-label, prospective study investigated the nighttime home BP-lowering effect of esaxerenone in patients with uncontrolled nocturnal hypertension being treated with an angiotensin receptor blocker (ARB) or calcium-channel blocker (CCB). In total, 101 patients were enrolled. During the 12-week study period, change in nighttime home systolic/diastolic BP from baseline to end of treatment measured by the brachial device was -12.9/-5.4 mmHg in the total population and -16.2/-6.6 and -10.0/-4.4 mmHg in the ARB and CCB subcohorts, respectively (all p < 0.001). For the wrist device, the change was -11.7/-5.4 mmHg in the total population and -14.6/-6.2 and -8.3/-4.5 mmHg in each subcohort, respectively (all p < 0.001). Similar significant reductions were shown for morning and bedtime home BP and office BP. Urinary albumin-to-creatinine ratio, N-terminal pro-brain natriuretic peptide, and cardio-ankle vascular index improved in the total population and each subcohort. Incidences of treatment-emergent adverse events (TEAEs) and drug-related TEAEs were 38.6% and 16.8%, respectively; most were mild or moderate. The most frequent drug-related TEAEs were associated with serum potassium elevation (hyperkalemia, 9.9%; blood potassium increased, 3.0%); however, no new safety concerns were raised. Esaxerenone was effective in lowering nighttime home BP as well as morning and bedtime home BP and office BP, safe, and showed organ-protective effects in patients with uncontrolled nocturnal hypertension. Caution is warranted regarding elevated serum potassium levels. This study investigated the effect of esaxerenone on nighttime home BP and organ damage (UACR and NT-proBNP) in patients with uncontrolled nocturnal hypertension despite treatment with an ARB or CCB. Our results show that safe 24-h BP control and organ protection are possible with esaxerenone.

Evacuation at Home Delayed the First Medical Intervention in Minamisanriku Town after the 2011 Great East Japan Earthquake.

INTRODUCTION: In Japan, evacuation at home is expected to increase in the future as a post-disaster evacuation type due to the pandemic, aging, and diverse disabilities of the population. However, more disaster-related indirect deaths occurred in homes than in evacuation centers after the 2011 Great East Japan Earthquake (GEJE). The health risks faced by evacuees at home have not been adequately discussed. STUDY OBJECTIVE: This study aimed to clarify the gap in disaster health management for evacuees at home compared to the evacuees at the evacuation centers in Minamisanriku Town, which lost all health care facilities after the 2011 GEJE. METHODS: This was a retrospective cross-sectional and quasi-experimental study based on the anonymized disaster medical records (DMRs) of patients from March 11 through April 10, 2011, that compared the evacuation-at-home and evacuation-center groups focusing on the day of the first medical intervention after the onset. Multivariable Cox regression analysis and propensity score (PS)-matching analysis were performed to identify the risk factors and causal relationship between the evacuation type and the delay of medical intervention. RESULTS: Of the 2,838 eligible patients, 460 and 2,378 were in the evacuation-at-home and evacuation-center groups, respectively. In the month after the onset, the evacuation-at-home group had significantly lower rates of respiratory and mental health diseases than the evacuation-center group. However, the mean time to the first medical intervention was significantly delayed in the evacuation-at-home group (19.3 [SD = 6.1] days) compared to that in the evacuation-center group (14.1 [SD = 6.3] days); P <.001). In the multivariable Cox regression analysis, the hazard ratio (HR) of delayed medical intervention for evacuation-at-home was 2.31 with a 95% confident interval of 2.07-2.59. The PS-matching analysis of the adjusted 459 patients in each group confirmed that evacuation at home was significantly associated with delays in the first medical intervention (P <.001). CONCLUSION: This study suggested, for the first time, the causal relationship between evacuation at home and delay in the first medical intervention by PS-matching analysis. Although evacuation at home had several advantages in reducing the frequencies of some diseases, the delay in medical intervention could exacerbate the symptoms and be a cause of indirect death. As more evacuees are likely to remain in their homes in the future, this study recommends earlier surveillance and health care provision to the home evacuees.

Concept, study design, and baseline blood pressure control status of the nationwide prospective HI-JAMP study using multisensor ABPM.

The Home-Activity Information and Communication Technology (ICT)-based Japan Ambulatory Blood Pressure Monitoring Prospective (HI-JAMP) study is a nationwide general practitioner-based cohort of medicated hypertensive patients that began in 2017. The primary objective of this study is to clarify which blood pressure (BP) measure is the best predictor of cardiovascular disease: office, home, or ambulatory BP. To this end, we used a newly developed ICT-based multisensor ambulatory BP monitoring (IMS-ABPM) device (TM-2441; A&D Company), which can also be used for home BP monitoring and is equipped with a high-sensitivity actigraph, a thermometer, and a barometer. This is the first study to evaluate three hemodynamic properties under resting home and active ambulatory conditions using the same device: (1) BP variability; (2) trigger-specific BP sensitivity to physical activity, temperature, and atmospheric pressure; and (3) central hemodynamics. A total of 2754 patients were enrolled, and 2731 patients with the required number of ambulatory BP readings (at least 6 daytime and 3 nighttime readings) were included in the final analysis. The overall patient group showed worse control of morning and nighttime BPs compared to office and daytime BPs, and the control rate was also poor among patients with a higher number of antihypertensive drugs. In conclusion, the baseline data of the HI-JAMP study demonstrated that morning home and nighttime BP remain difficult to control even among patients taking two or more hypertensive agents. By simultaneously considering office, home, and ambulatory BPs, the HI-JAMP study will contribute to the development of hypertension management strategies and new BP indices.

Nighttime hemodynamic phenotype. A novel risk factor for cardiovascular disease, especially heart failure: the practitioner-based nationwide JAMP study.

BACKGROUND: Non-dipper and riser patterns of nocturnal blood pressure (BP) are risk factors for cardiovascular disease (CVD), including heart failure (HF). However, the risk associated with a disrupted nocturnal pattern of heart rate is not well known. OBJECTIVES: To investigate whether the nighttime heart rate is a risk factor for HF, alongside nighttime BP phenotype. METHODS: The practitioner-based, nationwide, prospective Japan Ambulatory Blood Pressure Monitoring Prospective (JAMP) study included patients with ≥ 1 CVD risk factor but without symptomatic CVD at baseline. All patients underwent 24-h ambulatory BP monitoring at baseline and were followed annually. Nocturnal heart rate dipping (%) was calculated as 100•[1 - nighttime/daytime heart rate]. RESULTS: During a mean 4.5 years' follow-up in 6,359 patients (mean age 68.6 years), there were 306 CVD events (119 stroke, 99 coronary artery disease, and 88 HF). A 10-beats/min increase in nighttime heart rate was significantly associated with a 36-47% increase in the risk of total CVD, stroke and HF events independently of office SBP and nighttime SBP (all p < 0.005). The CVD and HF risk associated with nocturnal heart rate dipping status was independent of office and 24-h systolic BP and nocturnal BP dipping status (p < 0.001). Performance of the final model for predicting HF including BP parameters was significantly improved by the addition of nocturnal heart rate dipping patterns (p = 0.038; C-statistic 0.852). CONCLUSION: Nighttime non-dipper and riser patterns of heart rate were associated with CVD especially HF, independently and additively of nocturnal BP dipping status, indicating the importance of antihypertensive strategies targeting nighttime hemodynamics. CLINICAL TRIAL REGISTRATION: URL: https://www.umin.ac.jp/ctr/ ; Unique identifier: UMIN000020377.

Inconsistent Control Status of Office, Home, and Ambulatory Blood Pressure All Taken Using the Same Device: The HI-JAMP Study Baseline Data.

BACKGROUND: Inconsistencies between the office and out-of-office blood pressure (BP) values (described as white-coat hypertension or masked hypertension) may be attributable in part to differences in the BP monitoring devices used. METHODS: We studied consistency in the classification of BP control (well-controlled BP vs. uncontrolled BP) among office, home, and ambulatory BPs by using a validated "all-in-one" BP monitoring device. In the nationwide, general practitioner-based multicenter HI-JAMP study, 2,322 hypertensive patients treated with antihypertensive drugs underwent office BP measurements and 24-hour ambulatory BP monitoring (ABPM), consecutively followed by 5-day home BP monitoring (HBPM), for a total of seven BP measurement days. RESULTS: Using the thresholds of the JSH2019 and ESC2018 guidelines, the patients with consistent classification of well-controlled status in the office (<140 mmHg) and home systolic BP (SBP) (<135 mmHg) (n = 970) also tended to have well-controlled 24-hour SBP (<130 mmHg) (n = 808, 83.3%). The patients with the consistent classification of uncontrolled status in office and home SBP (n = 579) also tended to have uncontrolled 24-hour SBP (n = 444, 80.9%). Among the patients with inconsistent classifications of office and home BP control (n = 803), 46.1% had inconsistent ABPM-vs.-HBPM out-of-office BP control status. When the 2017 ACC/AHA thresholds were applied as an alternative, the results were essentially the same. CONCLUSIONS: The combined assessment of the office and home BP is useful in clinical practice. Especially for patients whose office BP classification and home BP classification conflict, the complementary clinical use of both HBPM and ABPM might be recommended.

Novel breeding method, matα2-PBT, to construct isogenic series of polyploid strains of Saccharomyces cerevisiae.

How ploidy is determined in organisms is an important issue in bioscience. Polyploidy is believed to be relevant to useful traits of domesticated plants and microorganisms. As such, polyploidy is central to many applications in biotechnology. However, studies of polyploidy are poorly advanced because no methodologies to construct desired polyploid have been developed for any organism. Herein we describe the development of a novel breeding technology, matα2-PBT, to generate polyploid strains of Saccharomyces cerevisiae. S. cerevisiae has two mating types, a and α, determined by MATa and MATα gene each of which consists of a1 and a2 and α1 and α2 cistrons. This novel technology exploits an interesting feature of a specific mutation, matα2-102, in the MATα2 gene. Unlike the MATα wild-type strain, which gives a non-mating phenotype when mated with MATa cells, the matα2-102 strain confers an α mating-type to a-type strains when mated with a-type strains. We constructed plasmid with the cloned matα2-102 mutant gene. An a-type cells harboring this plasmid displayed an α mating-type and mated with a-type cells. Because the resultant hybrid displays an α mating-type, it can mate again with a-type cells. By repeating this procedure, we have constructed an isogenic series of haploid to tetraploid of S. cerevisiae. Although whether even higher polyploid than tetraploid can be constructed by using this technology remains to be determined in the future, we believe that it became possible for the first time with matα2-PBT method to investigate whether higher polyploid than tetraploid can be constructed.

Comparative effects of topiroxostat and febuxostat on arterial properties in hypertensive patients with hyperuricemia.

Elevated serum uric acid is a cardiovascular risk factor in patients with hypertension, even when blood pressure (BP) is well controlled. Xanthine oxidoreductase inhibitors (XORi) reduce serum uric acid levels and have several other potential effects. This multicenter, randomized, open-label study compared the effects of two XORi, topiroxostat and febuxostat, on arterial stiffness, uric acid levels, and BP in hypertensive patients with hyperuricemia. Patients received topiroxostat 40-160 mg/day or febuxostat 10-60 mg/day, titrated to maintain serum uric acid <6 mg/dl, for 24 weeks. The primary endpoint was change in the cardio-ankle vascular index (CAVI) from baseline to 24 weeks. There were no significant changes in CAVI from baseline to 24 weeks (from 9.13 to 9.16 [feboxustat] and 8.98 to 9.01 [topiroxostat]). Compared with baseline, there were significant reductions in serum uric acid (-2.9 and -2.5 mg/dl; both p < 0.001) and morning home systolic BP (-3.6 and -5.1 mm Hg; both p < 0.01) after 24 weeks' treatment with febuxostat and topiroxostat. BP decreased to the greatest extent in the subgroup of patients with uncontrolled blood pressure at baseline. Topiroxostat, but not febuxostat, significantly decreased plasma xanthine oxidoreductase activity versus baseline. The urinary albumin-creatinine ratio (UACR) decreased significantly from baseline to 24 weeks with topiroxostat (-20.8%; p = 0.021), but not febuxostat (-8.8%; p = 0.362). In conclusion, neither topiroxostat nor febuxostat had any significant effects on arterial stiffness over 24 weeks' treatment.

Nighttime Blood Pressure Phenotype and Cardiovascular Prognosis: Practitioner-Based Nationwide JAMP Study.

BACKGROUND: Ambulatory and home blood pressure (BP) monitoring parameters are better predictors of cardiovascular events than are office BP monitoring parameters, but there is a lack of robust data and little information on heart failure (HF) risk. The JAMP study (Japan Ambulatory Blood Pressure Monitoring Prospective) used the same ambulatory BP monitoring device, measurement schedule, and diary-based approach to data processing across all study centers and determined the association between both nocturnal hypertension and nighttime BP dipping patterns and the occurrence of cardiovascular events, including HF, in patients with hypertension. METHODS: This practitioner-based, nationwide, multicenter, prospective, observational study included patients with at least 1 cardiovascular risk factor, mostly hypertension, and free of symptomatic cardiovascular disease at baseline. All patients underwent 24-hour ambulatory BP monitoring at baseline. Patients were followed annually to determine the occurrence of primary end point cardiovascular events (atherosclerotic cardiovascular disease and HF). RESULTS: A total of 6,359 patients (68.6±11.7 years of age, 48% men) were included in the final analysis. During a mean±SD follow-up of 4.5±2.4 years, there were 306 cardiovascular events (119 stroke, 99 coronary artery disease, 88 HF). Nighttime systolic BP was significantly associated with the risk of atherosclerotic cardiovascular disease and HF (hazard ratio adjusted for demographic and clinical risk factors per 20-mm Hg increase: 1.18 [95% CI, 1.02-1.37], P=0.029; and 1.25 [95% CI, 1.00-1.55], P=0.048, respectively). Disrupted circadian BP rhythm (riser pattern, nighttime BP higher than daytime BP) was significantly associated with higher overall cardiovascular disease risk (1.48 [95% CI, 1.05-2.08]; P=0.024), and especially HF (2.45 [95% CI, 1.34-4.48]; P=0.004) compared with normal circadian rhythm. CONCLUSIONS: Nighttime BP levels and a riser pattern were independently associated with the total cardiovascular event rate, in particular for HF. These findings suggest the importance of antihypertensive strategies targeting nighttime systolic BP. Registration: URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000020377.

Sleep Disturbance of Evacuees in Minamisanriku Town after Great East Japan Earthquake: Risk Factors and Treatment.

In 2011, Minamisanriku Town lost all of its medical facilities during the Great East Japan Earthquake. Using 10,459 anonymized disaster medical records of affected people in Minamisanriku Town, we assessed the prevalence and risk factors of sleep disturbance, which is known to exacerbate non-communicable diseases (NCDs) and anxiety disorder. Because sleep disturbance is a part of mental health issues, we divided the patients into two groups: patients (n = 492) with mental health issues other than sleep disturbance and the remaining (n = 9,967) with other comorbidities. Out of 492 patients with mental health issues, 295 patients (60.0%, 114 male, 158 female and 23 unknown) had sleep disturbance who might have required specific treatments. Out of the remaining 9,967 patients, 1,203 patients (12.1%, 361 male and 769 female and 73 unknown) had sleep disturbance. Univariate and multivariate analyses of the 9,967 patients revealed that the odds ratio (OR) of sleep disturbance was higher for female (OR 1.95), elderly persons over 60 (OR 16.15) and residing in evacuation centers (OR 1.36). Patients with two or more NCD had higher risk (OR 1.42). Importantly, sleep disturbance affects younger patients without NCD residing in evacuation center. Emergency medical teams most frequently prescribed benzodiazepines both for sleep induction and anxiolysis. In addition to high risk groups (female, older, with other mental health issues, residing in evacuation center), it is important to survey sleep disturbance in younger and healthier populations especially in evacuation centers and to provide psychosocial and medical support for them.

Age-related difference of the association of cardiovascular risk factors with the cardio-ankle vascular index in the Cardiovascular Prognostic Coupling Study in Japan (the Coupling Registry).

The value of the cardio-ankle vascular index (CAVI) increases with age. All large-scale studies of the CAVI have investigated patients <80 years old. Thus, the clinical characteristics of high CAVI in patients aged 80 or more remain unclear. Therefore, we investigated (1) the CAVI in very elderly patients and (2) the determinants of a high CAVI in high-risk patients, including very elderly patients. The Cardiovascular Prognostic Coupling Study in Japan (Coupling Registry) is a prospective observational study of Japanese outpatients with any cardiovascular risk factors. We enrolled 5109 patients from 30 institutions (average age 68.7 ± 11.4 years, 52.4% males). We investigated the determinants of the CAVI by separating the patients into three groups: 970 middle-aged (<60 years), 3252 elderly (60-79 years), and 887 very elderly (≥80 years) patients. The CAVI values of the males were significantly higher those of the females in all age groups (<60 years: 7.81 ± 1.11 vs. 7.38 ± 0.99, P < .001; 60-79 years: 9.20 ± 1.29 vs. 8.66 ± 1.07, P < .001; ≥80 years: 10.26 ± 1.39 vs. 9.51 ± 1.12, P < .001). In all age groups, the CAVI of the patients with diabetes/glucose tolerance disorder was higher than that of the patients without diabetes/glucose tolerance disorder (<60 years: 7.82 ± 1.22 vs 7.58 ± 1.03, P = .002; 60-79 years: 9.23 ± 1.20 vs 8.78 ± 1.19, P < .001; ≥80 years: 10.04 ± 1.24 vs 9.75 ± 1.32, P = .002). The determinants of the CAVI in these very elderly patients were age, male sex, low BMI, and mean blood pressure. Diabetes/glucose tolerance disorder and glucose were independently associated with the CAVI in the patients aged <60 years and 60-79 years, but not in those aged ≥80 years after adjusting for other covariates.

Rationale, design, and baseline characteristics of the Cardiovascular Prognostic COUPLING Study in Japan (the COUPLING Registry).

Vascular biomarkers, including the cardio-ankle vascular index (CAVI), are increasingly being recognized as important indicators of cardiovascular risk. CAVI has been shown to have good discriminative ability for detecting new-onset hypertension, but results of studies investigating cardiovascular risk prediction are inconsistent. Furthermore, there is a lack of data on the prognostic value of changes in CAVI over time. The Cardiovascular Prognostic Coupling study was designed to determine the impact of baseline CAVI and changes in CAVI on cardiovascular events in a Japanese cohort. The design of the ongoing, multicenter, prospective, observational registry and baseline characteristics of the enrolled population are reported. Eligible consecutive patients were aged ≥30 years, had ≥1 cardiovascular risk factor, and were being treated according to relevant Japanese guidelines. The primary outcome is time to onset of a major cardiovascular event (a composite of cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, stroke of unknown etiology, myocardial infarction, cardiovascular intervention for angina pectoris, and sudden death). Screening and enrollment occurred over a period of 3 years, followed by ≥7 years of follow-up, with CAVI determined annually. A total of 5279 patients were registered, of whom 5109 had baseline data available and will be included in future analyses. Mean CAVI at baseline was 8.8 ± 1.4. The proportion of patients with CAVI of <8, 8-10 or >10 was 25.3%, 57.0%, and 17.7%, respectively. Data from this registry should provide information on the significance of baseline CAVI and change in CAVI as indicators of cardiovascular prognosis in a representative patient population.

Salt Intake and Risk of Disaster Hypertension Among Evacuees in a Shelter After the Great East Japan Earthquake.

This study investigated the association between salt intake and risk of disaster hypertension. We analyzed the data of surveys evaluating the health condition of evacuees in shelters after the Great East Japan Earthquake on April 30 and May 5, 2011. Among 272 subjects who completed the basic health condition questionnaire and underwent a medical examination, 158 (58%) had disaster hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg). Average estimated sodium intake assessed by spot urine was significantly associated with disaster hypertension (odds ratio per 1 g/d, 1.16; 95% CI, 1.05-1.30). When we defined the high risk factors for salt-sensitive hypertension as older age (≥65 years), obesity (body mass index, ≥25 kg/m2), chronic kidney disease, and diabetes mellitus, estimated sodium intake was found to be a risk factor for disaster hypertension in the total group (odds ratio per 1 g/d, 1.27; 95% CI, 1.12-1.43) and even in the group without prevalent hypertension before disaster (n=146; odds ratio per 1 g/d, 1.46; 95% CI, 1.19-1.79). There was an interaction between estimated sodium intake and disaster hypertension according to the presence or absence of high risk of salt-sensitive hypertension in the group without prevalent hypertension (P=0.03). Disaster hypertension conferred a risk of microalbuminuria (odds ratio, 3.00; 95% CI, 1.71-5.26; P<0.001). We conclude that increased estimated sodium intake was associated with disaster hypertension in evacuees after disaster. This association was noted in the population with high risk of salt-sensitive hypertension and without prevalent hypertension before natural disaster. Additionally, disaster hypertension was associated with subclinical organ damage.

Medical Needs in Minamisanriku Town after the Great East Japan Earthquake.

The medical records of service in disaster provided at a place other than a medical facility are defined as disaster medical records (DMRs). In this epidemiological study, to clarify medical need characteristics and trends after disaster, we analyzed the all anonymized DMRs of Minamisanriku Town that lost medical facilities in 2011 Great East Japan Earthquake and its consequent tsunami. After screening of duplicated or irrelevant documents, there were 10,464 DMRs with 18,532 diagnoses from March 11 through May 13. From 34 diagnostic groups according to International Classification of Diseases (ICD)-10, we integrated diagnostic groups into five modules that might require treatment concepts of different types: non-communicable disease (NCD), infectious disease, mental health issue, trauma, and maternal and child health (MCH). Age and sex distributions of the patients were similar to those of population before the disaster. The largest diagnostic module was NCD (68%), followed by infectious disease (21%), mental health issues (6%), trauma (4%), and MCH (0.2%). The age-specific rate of NCD exhibited a similar or suppressed level from that of nationwide survey, with higher rate of pollinosis among young population. Infectious disease increased in most age groups but there was no apparent outbreak because of early interventions. Sleep deprivation was twice as frequent in middle-aged women, compared with men. Trauma and MCH were less frequent, but each exhibited a unique time trend. Trauma onset was continuously recorded, while MCH visits were concentrated on a specific day. The medical need after disaster dynamically changes, and appropriate anticipatory countermeasures are necessary.

Winter morning surge in blood pressure after the Great East Japan Earthquake.

This study investigated the association between winter morning surge in systolic blood pressure (SBP) as measured by ambulatory BP monitoring and the housing conditions of subjects in an area damaged by the Great East Japan Earthquake. In 2013, 2 years after disaster, hypertensives who lived in homes that they had purchased before the disaster (n = 299, 74.6 ± 8.1 years) showed significant winter morning surge in SBP (+5.0 ± 20.8 mmHg, P < 0.001), while those who lived in temporary housing (n = 113, 76.2 ± 7.6 years) did not. When we divided the winter morning surge in SBP into quintiles, the factors of age ≥75 years and occupant-owned housing were significant determinants for the highest quintile (≥20 mmHg) after adjustment for covariates. The hypertensives aged ≥75 years who lived in their own homes showed a significant risk for the highest quintile (odds ratio 5.21, 95% confidence interval 1.49-18.22, P = 0.010). It is thus crucial to prepare suitable housing conditions for elderly hypertensives following a disaster.

Twenty-Four-Hour Blood Pressure-Lowering Effect of a Sodium-Glucose Cotransporter 2 Inhibitor in Patients With Diabetes and Uncontrolled Nocturnal Hypertension: Results From the Randomized, Placebo-Controlled SACRA Study.

BACKGROUND: The risk of cardiovascular disease and mortality in salt-sensitive patients with diabetes mellitus and uncontrolled nocturnal hypertension is high. The SACRA (Sodium-Glucose Cotransporter 2 [SGLT2] Inhibitor and Angiotensin Receptor Blocker [ARB] Combination Therapy in Patients With Diabetes and Uncontrolled Nocturnal Hypertension) study investigated changes in blood pressure (BP) with empagliflozin plus existing antihypertensive therapy. METHODS: This multicenter, double-blind, parallel study was conducted in Japan. Adult patients with type 2 diabetes mellitus and uncontrolled nocturnal hypertension receiving stable antihypertensive therapy including angiotensin receptor blockers were randomized to 12 weeks' treatment with empagliflozin 10 mg once daily or placebo. Clinic BP was measured at baseline and weeks 4, 8, and 12; 24-hour ambulatory BP monitoring was performed at baseline and week 12; and morning home BP was determined for 5 days before each visit. The primary efficacy end point was change from baseline in nighttime BP (ambulatory BP monitoring). RESULTS: One hundred thirty-two nonobese, older patients with well-controlled blood glucose were randomized (mean age 70 years, mean body mass index 26 kg/m2). Empagliflozin, but not placebo, significantly reduced nighttime systolic BP versus baseline (-6.3 mm Hg; P=0.004); between-group difference in change from baseline was -4.3 mm Hg (P=0.159). Reductions in daytime, 24-hour, morning home, and clinic systolic BP at 12 weeks with empagliflozin were significantly greater than with placebo (-9.5, -7.7, -7.5, and -8.6 mm Hg, respectively; all P≤0.002). Between-group differences in body weight and glycosylated hemoglobin reductions were significant, but small (-1.3 kg and -0.33%; both P<0.001). At 4 weeks, N-terminal pro-B-type natriuretic peptide levels were reduced to a greater extent in the empagliflozin versus placebo group (-12.1%; P=0.013); atrial natriuretic peptide levels decreased with empagliflozin versus placebo at weeks 4 and 12 (-8.2% [P=0.008] and -9.7% [P=0.019]). Changes in antihypertensive medication during the study did not differ significantly between groups. CONCLUSIONS: Nonseverely obese older diabetes patients with uncontrolled nocturnal hypertension showed significant BP reductions without marked reductions in glucose with the addition of empagliflozin to existing antihypertensive and antidiabetic therapy. Use of sodium-glucose cotransporter 2 inhibitors in specific groups (eg, those with nocturnal hypertension, diabetes, and high salt sensitivity) could help reduce the risk of heart failure and cardiovascular mortality. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov. Unique identifier: NCT03050229.

Comparison of different schedules of nocturnal home blood pressure measurement using an information/communication technology-based device in hypertensive patients.

The objective of this study was to test our hypothesis that nocturnal home blood pressure (BP) measurement adapted to the chosen bedtime of participants (measurement at 2, 3, and 4 hour after the chosen bedtime) would be more reliable than measurement at fixed time points (2:00, 3:00, and 4:00 am). Forty-eight hypertensives were randomized to two groups undergoing two seven-night measurement phases in a crossover manner and were asked to measure nocturnal home BP for 14 consecutive nights using a validated automatic information/communication technology-based device. The intraclass correlation coefficients (ICCs) of systolic BP (SBP) obtained by a single measurement per night over two nights showed lower agreement than those of systolic BP obtained by multiple measurements based on a participant-specified bedtime (0.539-0.625 vs 0.675-0.768) and multiple measurements at fixed times (0.468-0.505 vs 0.661-0.790). The ICCs obtained using specific bedtime-based time points and those obtained using fixed time points showed major agreement when SBP was obtained by multiple measurements. The standard errors of measurement for SBP were similar between the bedtime-based measurement phase (1.4-1.7 mm Hg) and the fixed-time measurement phase (1.2-1.6 mm Hg). Neither a fixed bias nor a proportional bias was observed between the SBP values measured by the specific bedtime-based time points and those measured by the fixed-time measurement phase. In conclusion, the reliability of nocturnal home BP measurement appeared to be similar between nocturnal home BP adapted to the chosen bedtime of participants and that measured at fixed time points.