Effects of the valsartan/amlodipine combination and nifedipine gastrointestinal therapeutic system monotherapy on brachial pulse pressure and radial augmentation index in hypertensive patients.

OBJECTIVE: In a substudy of a randomized controlled trial, we investigated the effects of the valsartan/amlodipine single-pill combination and nifedipine gastrointestinal therapeutic system (GITS) monotherapy on brachial pulse pressure (bPP) and radial augmentation index (rAI) in patients with previously uncontrolled hypertension. METHODS: We performed measurements of clinic blood pressure (BP) and pulse rate and rAI (n = 63) and ambulatory BP monitoring (n = 42) at baseline and 12-week of follow-up. Analysis of covariance was performed to calculate the least square mean change from baseline and between-group differences [95% confidence interval (CI)]. Correlation analysis was performed to study the interrelationship between the changes in bPP and rAI and in pulse rate. RESULTS: After 12-week treatment, clinic and ambulatory SBP/DBP and pulse rate were not differently changed between the valsartan/amlodipine (n = 29) and nifedipine GITS groups (n = 34, P ≥ 0.06) except daytime SBP (P = 0.01). The reductions in 24-h and daytime ambulatory bPP were significantly greater in the former than the latter group (P ≤ 0.04). rAI increased slightly by 3.5% (P = 0.20) and 5.2% (P = 0.06) in the valsartan/amlodipine and nifedipine groups, respectively, with a between-group difference of -1.7% (95% CI -9.6 to 6.1%, P = 0.66). In the two groups combined, the changes in clinic and ambulatory bPP were not or weakly associated with that in clinic or ambulatory pulse rate (r = -0.14 to 0.36, P = 0.02-0.95), while the changes in rAI were more strongly or significantly associated with that in clinic or ambulatory pulse rate (r = -0.39 to -0.23, P = 0.02-0.16). CONCLUSIONS: Antihypertensive drug-induced changes in rAI but not bPP were dependent on pulse rate.

A randomized multicenter study on ambulatory blood pressure and arterial stiffness in patients treated with valsartan/amlodipine or nifedipine GITS.

In a pre-specified subgroup analysis of a 12-week randomized multicenter study, we investigated effects of valsartan/amlodipine 80/5 mg single-pill combination (n = 75) and nifedipine GITS 30 mg (n = 75) on ambulatory blood pressure (BP) and arterial stiffness assessed by brachial-ankle pulse wave velocity (PWV) in patients with uncontrolled hypertension. At week 12, the between-treatment mean differences in systolic/diastolic BP were smaller for 24-hour and daytime (-2.1/-1.7 and -2.0/-1.5 mm Hg, respectively, P ≥ 0.22) but greater (P < 0.01) for nighttime (-4.0/-2.8 mm Hg, P ≤ 0.09), especially in sustained uncontrolled hypertension (-5.0/-4.1 mm Hg, P ≤ 0.04) and non-dippers (-6.5/-3.7 mm Hg, P ≤ 0.07), in favor of valsartan/amlodipine. At week 12, PWV was significantly reduced from baseline by valsartan/amlodipine (n = 59, P < 0.0001) but not nifedipine (n = 59, P = 0.06). The changes in PWV were significantly associated with that in ambulatory systolic BP and pulse pressure in the nifedipine (P ≤ 0.0008) but not valsartan/amlodipine group (P ≥ 0.57), with a significant interaction (P ≤ 0.045). The valsartan/amlodipine combination was more efficacious than nifedipine GITS in lowering nighttime BP in sustained uncontrolled hypertension and non-dippers, and in lowering arterial stiffness independent of BP lowering.

Association of Anthropometric and Bioelectrical Impedance Analysis Measures of Adiposity with High Molecular Weight Adiponectin Concentration.

OBJECTIVE: To investigate the relationship between adiposity measures and plasma concentration of high molecular weight (HMW) adiponectin. METHODS: In a Chinese sample (n = 1081), we performed measurements of anthropometry and bioelectrical impedance analysis (BIA). We defined overweight and obesity as a body mass index between 24 and 27.4 kg/m² and ≥ 27.5 kg/m², respectively, and central obesity as a waist circumference ≥ 90 cm in men and ≥ 80 cm in women. Plasma HMW adiponectin concentration was measured by the ELISA method. RESULTS: Plasma HMW adiponectin concentration was significantly (P < 0.0001) higher in women (n = 677, 2.47 µg/mL) than men (n = 404, 1.58 µg/mL) and correlated with advancing age in men (r = 0.28) and women (r = 0.29). In adjusted analyses, it was lower in the presence of overweight (n = 159, 1.26 µg/mL in men and n = 227, 2.15µg/mL in women) and obesity (n = 60, 1.31 µg/mL and n = 82, 2.10 µg/mL, respectively) than normal weight subjects (n = 185, 2.07µg/mL and n = 368, 2.94 µg/mL, respectively) and in the presence of central obesity (n = 106, 1.28 µg/mL and n = 331, 2.12 µg/mL, respectively) than subjects with a normal waist circumference (n = 298, 1.74 µg/mL and n = 346, 2.74 µg/mL, respectively). In multiple regression analyses stratified for gender, adjusted for confounders and considered separately each of the adiposity measures, all adiposity measures were significantly (r -0.18 to -0.31, P < 0.001) associated with plasma HMW adiponectin concentration. However, in further stratified and adjusted regression analyses considered stepwise all adiposity measures, only waist-to-hip ratio was significantly (P < 0.05) associated with plasma HMW adiponectin concentration in men (r = -0.10) and women (r = -0.15). CONCLUSIONS: Anthropometric measures of obesity, such as waist-to-hip ratio, but not BIA measures, are independently associated with plasma adiponectin concentration.

The prevalence, incidence, management and risks of atrial fibrillation in an elderly Chinese population: a prospective study.

BACKGROUND: There is limited information on prevalent and incident atrial fibrillation in Chinese. We aimed to investigate the prevalence, incidence, management and risks of atrial fibrillation in an elderly Chinese population. METHODS: In a population--based prospective study in elderly (≥ 60 years) Chinese, we performed cardiovascular health examinations including a 12-lead electrocardiogram at baseline in 3,922 participants and biennially during follow-up in 2,017 participants. We collected information on vital status during the whole follow-up period. RESULTS: The baseline prevalence of atrial fibrillation was 2.0 % (n = 34) in 1718 men and 1.6 % (n = 36) in 2204 women. During a median 3.8 years of follow-up, the incidence rate of atrial fibrillation (n = 34) was 4.9 per 1000 person-years (95 % confidence interval [CI], 3.4-6.9). In univariate analysis, both the prevalence and incidence of atrial fibrillation were higher with age advancing (P < 0.0001) and in the presence of coronary heart disease (P ≤ 0.02). Of the 104 prevalent and incident cases of atrial fibrillation, only 1 (1.0 %) received anticoagulant therapy (warfarin). These patients with atrial fibrillation, compared with those with sinus rhythm, had significantly higher risks of all-cause (n = 261, hazard ratio [HR] 1.87, 95 % CI, 1.09-3.20, P = 0.02), cardiovascular (n = 136, HR 3.78, 95 % CI 2.17-6.58, P < 0.0001) and stroke mortality (n = 44, HR 6.31, 95 % CI 2.81-14.19, P = 0.0003). CONCLUSIONS: Atrial fibrillation was relatively frequent in elderly Chinese, poorly managed and associated with higher risks of mortality.

Validation of the Rossmax CF175 upper-arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

OBJECTIVE: The present study aimed to evaluate the accuracy of the Rossmax CF175 upper-arm blood pressure monitor for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. METHOD: Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (17 women, mean age 46 years) using a mercury sphygmomanometer (two observers) and the Rossmax CF175 device (one supervisor). A total of 99 pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. RESULTS: All the blood pressure requirements were fulfilled. The Rossmax CF175 device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and observers within 5, 10, and 15 mmHg was 78/99, 94/99, and 98/99, respectively, for systolic blood pressure, and 81/99, 96/99, and 97/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Twenty-nine participants, for both of systolic and diastolic blood pressure, had at least two of the three device-observers differences within 5 mmHg (required ≥24). Only one participant for diastolic blood pressure had all three device-observers comparisons greater than 5 mmHg. CONCLUSION: The Rossmax automated oscillometric upper-arm blood pressure monitor CF175 fulfilled the requirements of the International Protocol revision 2010, and hence can be recommended for blood pressure measurement in adults.

Brachial-ankle pulse wave velocity as a predictor of mortality in elderly Chinese.

Pulse wave velocity (PWV) is a measure of arterial stiffness and predicts cardiovascular events and mortality in the general population and various patient populations. In the present study, we investigated the predictive value of brachial-ankle PWV for mortality in an elderly Chinese population. Our study subjects were older (≥60 years) persons living in a suburban town of Shanghai. We measured brachial-ankle PWV using an automated cuff device at baseline and collected vital information till June 30, 2013, during follow-up. The 3876 participants (1713 [44.2%] men; mean [±SD] age, 68.1±7.3 years) included 2292 (59.1%) hypertensive patients. PWV was on average 17.8 (±4.0) m/s and was significantly (P<0.0001) associated with age (r=0.48) and in unadjusted analysis with all-cause (n=316), cardiovascular (n=148), stroke (n=46), and noncardiovascular mortality (n=168) during a median follow-up of 5.9 years. In further adjusted analysis, we studied the risk of mortality according to the decile distributions of PWV. Only the subjects in the top decile (23.3-39.3 m/s) had a significantly (P≤0.003) higher risk of all-cause mortality (hazard ratio relative to the whole study population, 1.56; 95% confidence interval, 1.16-2.08), especially in hypertensive patients (hazard ratio, 1.86; 95% confidence interval, 1.31-2.64; P=0.02 for the interaction between PWV and hypertension). Similar trends were observed for cardiovascular, stroke, and noncardiovascular mortality, although statistical significance was not reached (P≥0.08). In conclusion, brachial-ankle PWV predicts mortality in elderly Chinese on the conditions of markedly increased PWV and hypertension.

Validation of the AVITA BPM15S wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

OBJECTIVE: The present study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor AVITA BPM15S for home blood pressure monitoring according to the International Protocol revision 2010 of the European Society of Hypertension. METHOD: Systolic and diastolic blood pressures were sequentially measured in 33 Chinese adults (15 women, mean age 51 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM15S device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. RESULTS: The AVITA BPM15S device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and observers within 5, 10, and 15 mmHg were 85/99, 94/99, and 98/99, respectively, for systolic blood pressure, and 82/99, 96/99, and 98/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Thirty-two and 28 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥ 24). No participant had all of the three device-observer comparisons greater than 5 mmHg for systolic or diastolic blood pressure. CONCLUSION: The AVITA wrist blood pressure monitor BPM15S fulfilled the requirements of the International Protocol revision 2010 and hence can be recommended for home use in an adult population.

Validation of the AVITA BPM63S upper arm blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

OBJECTIVE: The present study aimed to evaluate the accuracy of the AVITA BPM63S upper arm blood pressure monitor for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. METHODS: Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (14 women, mean age of 47 years) using a mercury sphygmomanometer (two observers) and the AVITA BPM63S device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. RESULTS: All the blood pressure requirements were fulfilled. The AVITA BPM63S device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 68/99, 89/99, and 96/99, respectively, for systolic blood pressure, and 75/99, 95/99, and 97/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Twenty-four and 25 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observers differences within 5 mmHg (required ≥24). One and two participants for systolic and diastolic blood pressure, respectively, had all three device-observers differences greater than 5 mmHg. CONCLUSION: The AVITA BPM63S automated oscillometric upper arm blood pressure monitor has passed the requirements of the International Protocol revision 2010, and hence can be recommended for blood pressure measurement at home in adults.

Validation of the A&D UA-1020 upper-arm blood pressure monitor with six different-shaped or different-sized cuffs according to the British Hypertension Society protocol.

OBJECTIVE: The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure monitor A&D UA-1020 with six different-shaped or different-sized cuffs according to the British Hypertension Society protocol. METHODS: We recruited 136 individuals for four D-ring cuffs (adult, large, small, and medium) and 114 individuals for two cylindrical cuffs (adult and medium). For each participant, we sequentially measured systolic and diastolic blood pressure using a mercury sphygmomanometer (two observers) and UA-1020 (one supervisor) to obtain three pairs of comparisons. RESULTS: For the four D-ring cuffs, the device achieved grade A. The percentage of blood pressure differences within 5, 10, and 15 mmHg was 64, 88, and 96%, respectively, for systolic blood pressure, and 69, 92, and 99%, respectively, for diastolic blood pressure. The average (± SD) of the device-observers differences was -1.2 ± 7.2 mmHg (P = 0.0006) and 1.0 ± 6.0 mmHg (P < 0.0001) for systolic and diastolic blood pressure, respectively. For the two cylindrical cuffs, the device also achieved grade A. The percentage of blood pressure differences within 5, 10, and 15 mmHg was 65, 87, and 96%, respectively, for systolic blood pressure, and 64, 91, and 98%, respectively, for diastolic blood pressure. The average of the device-observers differences was -0.4 ± 7.3 mmHg (P = 0.29) and 2.0 ± 6.1 mmHg (P < 0.0001) for systolic and diastolic blood pressure, respectively. CONCLUSION: The UA-1020 device has passed the requirements of the British Hypertension Society protocol with various sizes of D-ring and cylindrical cuffs, and can be recommended in adults.

Valsartan/amlodipine compared to nifedipine GITS in patients with hypertension inadequately controlled by monotherapy.

INTRODUCTION: Current hypertension guidelines recommend single-pill combinations because they not only improve convenience and compliance to therapy and thus blood pressure (BP) control, but also reduce health-care costs. This study compared the efficacy and safety of valsartan/amlodipine single-pill combination with nifedipine gastrointestinal therapeutic system (GITS) in Chinese patients with hypertension who were inadequately controlled with monotherapy. METHODS: In this multicenter, open-label, active-controlled, parallel-group study, 564 patients with hypertension not adequately controlled by prior monotherapy were randomized to receive valsartan/amlodipine 80/5 mg or nifedipine GITS 30 mg once daily for 12 weeks. RESULTS: In the intention-to-treat analysis (n = 540), valsartan/amlodipine (n = 272) showed a least-square mean reduction of -16.6 versus -10.8 mmHg by nifedipine GITS (n = 268; mean between-treatment difference: -5.8 mmHg; P < 0.0001) from baseline to week 12. The corresponding results for mean sitting diastolic BP were -8.6 and -4.6 mmHg, respectively (difference: -4.0 mmHg; P < 0.0001). The percentage of patients achieving the BP target (<140/90 or <130/80 mmHg in the absence or presence of diabetes mellitus, respectively) was significantly higher with valsartan/amlodipine (79.0%) versus nifedipine GITS (57.4%; P < 0.0001). The overall incidence rate of adverse events was lower with valsartan/amlodipine (19.2%) than with nifedipine GITS (29.4%; P = 0.004). CONCLUSION: The valsartan/amlodipine 80/5 mg single-pill combination is well tolerated and more effective than nifedipine GITS 30 mg for BP control in Chinese patients with hypertension.

A functional common polymorphism of the ABCB1 gene is associated with chronic kidney disease and hypertension in Chinese.

BACKGROUND: Permeability glycoprotein is encoded by the ATP-binding cassette B1 gene (ABCB1) and is an extruder of toxic metabolites in the kidney. A functional common polymorphism (C3435T, rs1045642) in the human ABCB1 gene has been found to be associated with allograft outcome in kidney transplant patients. In this study, we investigated the association of the C3435T polymorphism with renal function and blood pressure (BP) in 2 Chinese populations. METHODS: The discovery and replication populations were recruited from a mountainous area (Zhejiang Province) and a newly urbanized suburban area (Shanghai), respectively. We genotyped all subjects using the ABI SNapShot method. Chronic kidney disease (CKD) was defined as an estimated glomerular filtration rate <60 ml/min × 1.73 m(2) or 24-hour urinary albumin excretion ≥30 mg. RESULTS: In the discovery population of 1,987 subjects, after adjustment for covariables, TT homozygosity (n = 217) was associated with a higher risk of CKD (n = 369; odds ratio (OR) = 1.73; P = 0.003) and with higher systolic BP (+3.1 mm Hg; P = 0.03) and pulse pressure (+3.4 mm Hg; P = 0.001). These associations were dependent on age (Pint ≤ 0.05). In subjects aged ≥60 years (n = 374), the corresponding OR or difference was 2.40 for CKD, 15.1 mm Hg for systolic BP, and 12.4 mm Hg for pulse pressure (P < 0.001). In similar adjusted analyses in the replication population of 2,427 elderly (≥60 years) subjects, TT homozygosity was also associated with a higher risk of CKD (OR = 1.39; P = 0.02) and an enhanced association of hypertension with CKD (OR = 1.50; P = 0.04). CONCLUSIONS: The ABCB1 C3435T polymorphism might predict CKD, especially in the elderly.

Validation of the fully automated A&D TM-2656 blood pressure monitor according to the British Hypertension Society Protocol.

OBJECTIVE: The present study aimed to evaluate the accuracy of the fully automated oscillometric upper-arm blood pressure monitor TM-2656 according to the British Hypertension Society (BHS) Protocol 1993. METHODS: We recruited individuals until there were 85 eligible participants and their blood pressure could meet the blood pressure distribution requirements specified by the BHS Protocol. For each individual, we sequentially measured the systolic and diastolic blood pressures using a mercury sphygmomanometer (two observers) and the TM-2656 device (one supervisor). Data analysis was carried out according to the BHS Protocol. RESULTS: The device achieved grade A. The percentage of blood pressure differences within 5, 10, and 15 mmHg was 62, 85, and 96%, respectively, for systolic blood pressure, and 71, 93, and 99%, respectively, for diastolic blood pressure. The average (±SD) of the device-observer differences was -2.1±7.8 mmHg (P<0.0001) and -1.1±5.8 mmHg (P<0.0001) for systolic and diastolic blood pressures, respectively. CONCLUSION: The A&D upper-arm blood pressure monitor TM-2656 has passed the requirements of the BHS Protocol, and can thus be recommended for blood pressure measurement.

Four-limb blood pressure as predictors of mortality in elderly Chinese.

The predictive value of blood pressure (BP) for cardiovascular morbidity and mortality diminishes in the elderly, which may be confounded and compensated by the BP differences across the 4 limbs, markers of peripheral arterial disease. In a prospective elderly (≥60 years) Chinese study, we performed simultaneous 4-limb BP measurement using an oscillometric device in the supine position, and calculated BP differences between the 4 limbs. At baseline, the mean age of the 3133 participants (1383 men) was 69 years. During 4 years (median) of follow-up, all-cause and cardiovascular deaths occurred in 203 and 93 subjects, respectively. In multiple regression analyses, arm BPs on the higher arm side of systolic BP did not predict mortality (P≥0.06) except for a negative association between mean arterial pressure and total mortality (P=0.04). However, in adjusted analyses, the hazard ratios associated with a 1-SD decrease in ankle-brachial BP index or increase in interarm or interankle BP difference were 1.15 to 1.23 for total mortality (P≤0.01) and 1.17 to 1.24 for cardiovascular mortality (P≤0.04). In categorical analyses, similar results were observed for a decreased ankle-brachial index (≤0.90, ≤0.95, or ≤1.00) or increased interarm or interankle difference (≥15 mm Hg or ≥10 mm Hg). In conclusion, in the elderly, above and beyond arm BP level and together with ankle-brachial index, the interarm and interankle BP differences improve prediction of mortality. Simultaneous 4-limb BP measurement has become feasible with current technology and might be useful in cardiovascular prevention.

Validation of the A&D UA-1020 upper-arm blood pressure monitor for home blood pressure monitoring according to the British Hypertension Society Protocol.

OBJECTIVE: The present study aimed to evaluate the accuracy of the automated oscillometric upper-arm blood pressure (BP) monitor A&D UA-1020 with two different-shaped cuffs for home BP monitoring according to the British Hypertension Society (BHS) Protocol. METHODS: We recruited individuals for each of the two cuffs (D-ring and cylindrical) until there were 85 eligible participants (255 pairs of comparisons) and their BP could meet the BP distribution requirements specified by the BHS Protocol. For each participant, we sequentially measured the systolic and diastolic BP using a mercury sphygmomanometer (two observers) and the UA-1020 device (one supervisor). RESULTS: For the D-ring cuff, the device achieved grade A. The percentage of BP differences within 5, 10, and 15 mmHg was 67, 87, and 96%, respectively, for systolic BP, and 70, 90, and 99%, respectively, for diastolic BP. The average (±SD) of the device-observer differences was -0.2±7.3 mmHg (P=0.64) and 1.7±5.8 mmHg (P<0.0001) for systolic and diastolic BP, respectively. For the cylindrical cuff, the device also achieved grade A. The percentage of BP differences within 5, 10, and 15 mmHg was 67, 88, and 97%, respectively, for systolic BP and 64, 89, and 98%, respectively, for diastolic BP. The average of the device-observer differences was -0.1±7.0 mmHg (P=0.89) and 2.0±6.3 mmHg (P<0.0001) for systolic and diastolic BP, respectively. CONCLUSION: The UA-1020 device has passed the requirements of the BHS Protocol with both the D-ring and the cylindrical cuffs, and hence can be recommended for home use in adults.

Validation of the Rossmax S150 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol revision 2010.

OBJECTIVE: The present study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor Rossmax S150 for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010. METHODS: Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (16 women, mean age of 54 years) using a mercury sphygmomanometer (two observers) and the Rossmax S150 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. Data analysis was carried out using the ESHIP analyzer. RESULTS: The Rossmax S150 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 70/99, 90/99, and 97/99, respectively, for systolic blood pressure, and 84/99, 98/99, and 99/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Twenty-six and 29 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observers differences within 5 mmHg (required ≥ 24). Three and two participants for systolic and diastolic blood pressure, respectively, had all three device-observers comparisons greater than 5 mmHg. CONCLUSION: The Rossmax wrist blood pressure monitor S150 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.

Validation of the Kingyield BP210 wrist blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension-International Protocol.

OBJECTIVE: The present study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor BP210 for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension. METHODS: Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese participants (21 women, 51 years of mean age) using a mercury sphygmomanometer (two observers) and the BP210 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and a further 18 participants in phase 2 of the validation study. Data analysis was conducted using the ESHIP analyzer. RESULTS: The BP210 device successfully passed phase 1 of the validation study with a number of absolute differences between device and observers within 5, 10, and 15 mmHg for at least 33/45, 44/45, and 44/45 measurements, respectively. The device also achieved the targets for phase 2.1, with 77/99, 95/99, and 97/99 differences within 5, 10, and 15 mmHg, respectively for systolic blood pressure, and with 78/99, 97/99, and 99/99 within 5, 10, and 15 mmHg, respectively for diastolic blood pressure. In phase 2.2, 29 and 25 participants had at least two of the three device-observers differences within 5 mmHg (required≥22) for systolic blood pressure and diastolic blood pressure, respectively. CONCLUSION: The Kingyield wrist blood pressure monitor BP210 has passed the International Protocol requirements, and hence can be recommended for home use in adults.

Accuracy of a Novel Non-Invasive technology based EZSCAN system for the diagnosis of diabetes mellitus in Chinese.

BACKGROUND: A new simple technique based on iontophoresis technology (EZSCAN, Impeto Medical, Paris, France) has recently been developed for the screening of diabetes. In the present study, we investigated the accuracy of this system for the diagnosis of diabetes mellitus in Chinese. METHODS: We performed the EZSCAN test in diabetic and non-diabetic subjects. EZSCAN measures electrochemical conductance (EC) at forehead, hands and feet, and derives a diabetes index with a value ranging from 0 to 100. Diabetes mellitus was defined as a plasma glucose concentration of at least 7 mmol/l at fasting or 11.1 mmol/l at 2 hours after glucose load, or as the use of antidiabetic drugs. RESULTS: The 195 study participants (51% men, mean age 52 years) included 75 diabetic patients (use of antidiabetic drugs 81%) and 120 non-diabetic subjects. EC (micro Siemens, µSi) was significantly (P < 0.001) lower in diabetic patients at the hands (44 vs. 61) and feet (51 vs. 69) locations, but not at the forehead (15 vs. 17, P = 0.39). When a diabetes index of 40 (suggested by the manufacturer) was used as the threshold, the sensitivity and specificity for the diagnosis of diabetes mellitus was 85% and 64%, respectively. In 80 patients who underwent an oral glucose tolerance test, EC at hands and feet and the diabetes index were significantly (P < 0.001) associated with both 2-hour post-load plasma glucose and serum glycosylated haemoglobin. CONCLUSIONS: EZSCAN might be useful in screening diabetes mellitus with reasonable sensitivity and specificity.

Validation of the Kingyield BP101H blood pressure monitor for home blood pressure monitoring according to the European Society of Hypertension International Protocol.

OBJECTIVE: This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor BP101H (Kingyield Technology, Shenzhen, China) for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension. METHOD: Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese participants (13 women, 52.6 years of mean age) using a mercury sphygmomanometer (two observers) and the BP101H device (one supervisor). Ninety-nine pairs of comparisons were obtained from 15 participants in phase 1 and further 18 participants in phase 2 of the validation study. Data analysis was done using the ESHIP Analyzer. RESULTS: The BP101H device successfully passed phase 1 of the validation study with a number of absolute differences between device and observers within 5, 10, and 15 mmHg for at least 34/45, 42/45, and 43/45 measurements, respectively. The device also achieved the targets for phase 2.1, with 79/99, 94/99, and 96/99 differences within 5, 10, and 15 mmHg, respectively, for systolic blood pressure, and with 81/99, 94/99, and 98/99 within 5, 10, and 15 mmHg, respectively, for diastolic blood pressure. In phase 2.2, 27 and 28 participants had at least two of the three device-observers differences within 5 mmHg (required ≥22) for systolic blood pressure and diastolic blood pressure, respectively. CONCLUSION: The Kingyield upper arm blood pressure monitor BP101H has passed the International Protocol requirements, and hence can be recommended for home use in adults.