Azilsartan in Patients With Mild to Moderate Hypertension Using Clinic and Ambulatory Blood Pressure Measurements.
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SUBMITTER: Perez A
PROVIDER: S-EPMC8030785 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The current study assesses the antihypertensive efficacy and safety of the investigational angiotensin receptor blocker (ARB), azilsartan medoxomil (AZL-M), compared with placebo and the ARB olmesartan medoxomil (OLM-M). This randomized, double-blind, placebo-controlled, multicenter study assessed change from baseline in mean 24-hour ambulatory systolic blood pressure (SBP) following 6 weeks of treatment. Patients with primary hypertension (n=1275) and baseline 24-hour mean ambulatory systolic pressure ≥ 130 mm Hg and ≤ 170 mm Hg were studied; 142 received placebo and the remainder received 20 mg, 40 mg, or 80 mg AZL-M or 40 mg OLM-M. Mean age of participants was 58 ± 11 years, baseline mean 24-hour SBP was 146 mm Hg. Dose-dependent reductions in 24-hour mean SBP at study end occurred in all AZL-M groups. Reduction in 24-hour mean SBP was greater with AZL-M 80 mg than OLM-M 40 mg by 2.1 mm Hg (95% confidence interval, -4.0 to -0.1; P=.038), while AZL-M 40 mg was noninferior to OLM-M 40 mg. The side effect profiles of both ARBs were similar to placebo. AZL-M is well tolerated and more efficacious at its maximal dose than the highest dose of OLM-M.
| S-EPMC8673073 | biostudies-literature
Project description:AIM: The conventional method for analyzing 24-h ambulatory blood pressure monitoring (24-h ABPM) is insufficient to deal with the large amount of data collected. The aim of this study was to develop a novel cyclic fluctuation model for 24-h ABPM in Chinese patients with mild to moderate hypertension. METHODS: The data were obtained from 4 independent antihypertensive drug clinical trials in Chinese patients with mild to moderate hypertension. The measurements of 24-h ABPM at the end of the placebo run-in period in study 1 were used to develop the cyclic fluctuation model. After evaluated, the structural model was used to analyze the measurements in the other 3 studies. Models were fitted using NONMEM software. RESULTS: The cyclic fluctuation model, which consisted of 2 cosine functions with fixed-effect parameters for rhythm-adjusted 24-h mean blood pressure, amplitude and phase shift, successfully described the blood pressure measurements of study 1. Model robustness was validated by the bootstrap method. The measurements in the other 3 studies were well described by the same structural model. Moreover, the parameters from all the 4 studies were very similar. Visual predictive checks demonstrated that the cyclic fluctuation model could predict the blood pressure fluctuations in the 4 studies. CONCLUSION: The cyclic fluctuation model for 24-h ABPM deepens our understanding of blood pressure variability, which will be beneficial for drug development and individual therapy in hypertensive patients.
| S-EPMC4003025 | biostudies-other
Project description:Ambulatory blood pressure (BP) monitoring provides a more precise measure of BP status than clinic BP and is currently recommended in the evaluation of high BP in children and adolescents. However, ambulatory BP monitoring may not always be available. Our aim was to determine the clinic BP percentile most likely to predict ambulatory hypertension. We evaluated clinic and ambulatory BP in 247 adolescents (median age, 15.7 years; 63% white; 54% male). Clinic BP percentile (based on the fourth report and the 2017 American Academy of Pediatrics clinical practice guidelines) and ambulatory BP status (normal versus hypertension) were determined by age-, sex-, and height-specific cut points. Sensitivity and specificity of different clinic BP percentiles and cutoffs to predict ambulatory hypertension were calculated. Forty (16%) and 67 (27%) patients had systolic hypertension based on the fourth report and the 2017 guidelines, respectively, whereas 38 (15%) had wake ambulatory systolic hypertension. The prevalence of ambulatory wake systolic hypertension increased across clinic systolic BP percentiles, from 3% when clinic systolic BP was <50th percentile to 41% when ?95th percentile. The 2017 guidelines' 85th systolic percentile had similar sensitivity (86.8%) and better specificity (57.4% versus 48.1%) than elevated BP (?90th percentile or ?120 mm?Hg) to diagnose ambulatory hypertension. When evaluating adolescents for hypertension, 2017 guidelines' clinic systolic 85th percentile may be the optimal threshold at which to perform ambulatory BP monitoring.
| S-EPMC7202372 | biostudies-literature
Project description:The effect of clinic-based intensive hypertension treatment on ambulatory blood pressure (BP) is unknown. The goal of the SPRINT (Systolic Blood Pressure Intervention Trial) ambulatory BP ancillary study was to evaluate the effect of intensive versus standard clinic-based BP targets on ambulatory BP. Ambulatory BP was obtained within 3 weeks of the 27-month study visit in 897 SPRINT participants. Intensive treatment resulted in lower clinic systolic BP (mean difference between groups=16.0 mm?Hg; 95% confidence interval, 14.1-17.8 mm?Hg), nighttime systolic BP (mean difference=9.6 mm?Hg; 95% confidence interval, 7.7-11.5 mm?Hg), daytime systolic BP (mean difference=12.3 mm?Hg; 95% confidence interval, 10.6-13.9 mm?Hg), and 24-hour systolic BP (mean difference=11.2 mm?Hg; 95% confidence interval, 9.7-12.8 mm?Hg). The night/day systolic BP ratio was similar between the intensive (0.92±0.09) and standard-treatment groups (0.91±0.09). There was considerable lack of agreement within participants between clinic systolic BP and daytime ambulatory systolic BP with wide limits of agreement on Bland-Altman plots. In conclusion, targeting a systolic BP of <120 mm?Hg, when compared with <140 mm?Hg, resulted in lower nighttime, daytime, and 24-hour systolic BP, but did not change the night/day systolic BP ratio. Ambulatory BP monitoring may be required to assess the effect of targeted hypertension therapy on out of office BP. Further studies are needed to assess whether targeting hypertension therapy based on ambulatory BP improves clinical outcomes. CLINICAL TRIAL REGISTRATION:URL: http://www.clinicaltrials.gov. Unique identifier: NCT01835249.
| S-EPMC5145774 | biostudies-literature
Project description:BACKGROUND:and objectives Our objective was to determine whether clinic BPs (taken at either a single visit or two sequential visits) are inferior to ambulatory BPs in their ability to discriminate risk of adverse outcomes in children with CKD. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:We included 513 participants of the CKD in Children Study who had clinic BPs and 24-hour ambulatory BP monitoring performed during similar timeframes. Predictors of interest were systolic BPs taken at a single visit or two repeated visits within a 1-year period compared with mean wake and sleep systolic ambulatory BPs. Outcomes were left ventricular hypertrophy and ESKD. We determined the ability for each BP parameter to provide risk discrimination using c statistics. RESULTS:During mean follow-up of 3.5 years, 123 participants developed ESKD. In cross-sectional unadjusted analysis, every 0.1 increase in systolic BP index was associated with a 2.0 times higher odds of left ventricular hypertrophy (95% confidence interval, 1.5 to 2.8) by clinic BPs versus 1.8 times higher odds (95% confidence interval, 1.3 to 2.4) by ambulatory wake BP. The c statistic was highest for clinic BP (c=0.65; 95% confidence interval, 0.58 to 0.73) but similar to ambulatory wake BP (c=0.64; 95% confidence interval, 0.57 to 0.71) for the discrimination of left ventricular hypertrophy. In longitudinal unadjusted analysis, every 0.1 increase in systolic BP index was associated with a higher risk of ESKD using repeated clinic (hazard ratio, 1.5; 95% confidence interval, 1.3 to 1.8) versus ambulatory wake BP (hazard ratio, 1.6; 95% confidence interval, 1.3 to 2.0). Unadjusted c statistics were the same for wake (c=0.61; 95% confidence interval, 0.56 to 0.67) and clinic systolic BPs (c=0.61; 95% confidence interval, 0.55 to 0.66) for discriminating risk of ESKD. CONCLUSIONS:Clinic BPs taken in a protocol-driven setting are not consistently inferior to ambulatory BP in the discrimination of BP-related adverse outcomes in children with CKD.
| S-EPMC5967676 | biostudies-literature
Project description:Guidelines recommend measuring out-of-clinic blood pressure (BP) to identify masked hypertension (MHT) defined by out-of-clinic BP in the hypertensive range among individuals with clinic-measured BP not in the hypertensive range. The aim of this study was to determine the overlap between ambulatory BP monitoring (ABPM) and home BP monitoring (HBPM) for the detection of MHT. We analyzed data from 333 community-dwelling adults not taking antihypertensive medication with clinic BP <140/90 mm Hg in the IDH study (Improving the Detection of Hypertension). Any MHT was defined by the presence of daytime MHT (mean daytime BP ≥135/85 mm Hg), 24-hour MHT (mean 24-hour BP ≥130/80 mm Hg), or nighttime MHT (mean nighttime BP ≥120/70 mm Hg). Home MHT was defined as mean BP ≥135/85 mm Hg on HBPM. The prevalence of MHT was 25.8% for any MHT and 11.1% for home MHT. Among participants with MHT on either ABPM or HBPM, 29.5% had MHT on both ABPM and HBPM; 61.1% had MHT only on ABPM; and 9.4% of participants had MHT only on HBPM. After multivariable adjustment and compared with participants without MHT on ABPM and HBPM, those with MHT on both ABPM and HBPM and only on ABPM had a higher left ventricular mass index (mean difference [SE], 12.7 [2.9] g/m2, P<0.001; and 4.9 [2.1] g/m2, P=0.022, respectively), whereas participants with MHT only on HBPM did not have an increased left ventricular mass index (mean difference [SE], -1.9 [4.8] g/m2, P=0.693). These data suggest that conducting ABPM will detect many individuals with MHT who have an increased cardiovascular disease risk.
| S-EPMC6207212 | biostudies-literature
Project description:Background Blood pressure ( BP ) varies over time within individual patients and across different BP measurement techniques. The effect of different BP targets on concordance between BP measurements is unknown. The goals of this analysis are to evaluate concordance between (1) clinic and ambulatory BP , (2) clinic visit-to-visit variability and ambulatory BP variability, and (3) first and second ambulatory BP and to evaluate whether different clinic targets affect these relationships. Methods and Results The SPRINT (Systolic Blood Pressure Intervention Trial) ambulatory BP monitoring ancillary study obtained ambulatory BP readings in 897 participants at the 27-month follow-up visit and obtained a second reading in 203 participants 293±84 days afterward. There was considerable lack of agreement between clinic and daytime ambulatory systolic BP with wide limits of agreement in Bland-Altman plots of -21 to 34 mm Hg in the intensive-treatment group and -26 to 32 mm Hg in the standard-treatment group. Overall, there was poor agreement between clinic visit-to-visit variability and ambulatory BP variability with correlation coefficients for systolic and diastolic BP all <0.16. We observed a high correlation between first and second ambulatory BP ; however, the limits of agreement were wide in both the intensive group (-27 to 21 mm Hg) and the standard group (-23 to 20 mm Hg). Conclusions We found low concordance in BP and BP variability between clinic and ambulatory BP and second ambulatory BP . Results did not differ by treatment arm. These results reinforce the need for multiple BP measurements before clinical decision making.
| S-EPMC6662121 | biostudies-literature
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| S-EPMC8516806 | biostudies-literature
Project description:ObjectivesThe aim of this study was to evaluate the cost effectiveness of ambulatory blood pressure monitoring (ABPM) compared with home blood pressure monitoring (HBPM) and clinic blood pressure monitoring (CBPM) in diagnosing hypertension in Australia.MethodsA cohort-based Markov model was built from the Payer's perspective (Australian government) comparing lifetime costs and effectiveness of ABPM, HBPM and CBPM in people aged ≥ 35 years with suspected hypertension who have a CBPM between ≥ 140/90 mmHg and ≤ 180/110 mmHg using a sphygmomanometer and have not yet commenced antihypertensive treatment. The main outcome measures were incremental cost-effectiveness ratio (ICER) assessing cost per quality-adjusted life-year (QALY) and life-years (LYs) gained by ABPM versus HBPM and CBPM. Cost was measured in Australian dollars (A$).ResultsOver a lifetime model, ABPM had lower total costs (A$8,491) compared with HBPM (A$9,648) and CBPM (A$10,206) per person. ABPM was associated with a small but significant improvement in the quality and quantity of life for people with suspected hypertension with 12.872 QALYs and 17.449 LYs compared with 12.857 QALYs and 17.433 LYs with HBPM, and 12.850 QALYs and 17.425 LYs with CBPM. In the base-case analysis, ABPM dominated HBPM and CBPM. In scenario analyses, at 100% specificity of HBPM, ABPM no longer remained cost effective at a A$50,000/QALY threshold. However, in probabilistic sensitivity analysis, over 10,000 iterations, ABPM remained dominant.ConclusionABPM was the dominant strategy for confirming the diagnosis of hypertension among Australian adults aged ≥ 35 years old with suspected hypertension. The findings of this study are important for reimbursement decision makers to support policy change and for clinicians to make practice changes consistent with ABPM recommendations in primary care.
| S-EPMC9929017 | biostudies-literature
Project description:BackgroundAmbulatory blood pressure (ABP) is consistently superior to clinic blood pressure (CBP) as a predictor of cardiovascular morbidity and mortality risk. A common perception is that ABP is usually lower than CBP. The relationship of the CBP minus ABP difference to age has not been examined in the United States.MethodsBetween 2005 and 2012, 888 healthy, employed, middle-aged (mean±SD age, 45±10.4 years) individuals (59% female, 7.4% black, 12% Hispanic) with screening BP <160/105 mm Hg and not taking antihypertensive medication completed 3 separate clinic BP assessments and a 24-hour ABP recording for the Masked Hypertension Study. The distributions of CBP, mean awake ABP (aABP), and the CBP-aABP difference in the full sample and by demographic characteristics were compared. Locally weighted scatterplot smoothing was used to model the relationship of the BP measures to age and body mass index. The prevalence of discrepancies in ABP- versus CBP-defined hypertension status-white-coat hypertension and masked hypertension-were also examined.ResultsAverage systolic/diastolic aABP (123.0/77.4±10.3/7.4 mm Hg) was significantly higher than the average of 9 CBP readings over 3 visits (116.0/75.4±11.6/7.7 mm Hg). aABP exceeded CBP by >10 mm Hg much more frequently than CBP exceeded aABP. The difference (aABP>CBP) was most pronounced in young adults and those with normal body mass index. The systolic difference progressively diminished, but did not disappear, at older ages and higher body mass indexes. The diastolic difference vanished around age 65 and reversed (CBP>aABP) for body mass index >32.5 kg/m2. Whereas 5.3% of participants were hypertensive by CBP, 19.2% were hypertensive by aABP; 15.7% of those with nonelevated CBP had masked hypertension.ConclusionsContrary to a widely held belief, based primarily on cohort studies of patients with elevated CBP, ABP is not usually lower than CBP, at least not among healthy, employed individuals. Furthermore, a substantial proportion of otherwise healthy individuals with nonelevated CBP have masked hypertension. Demonstrated CBP-aABP gradients, if confirmed in representative samples (eg, NHANES [National Health and Nutrition Examination Survey]), could provide guidance for primary care physicians as to when, for a given CBP, 24-hour ABP would be useful to identify or rule out masked hypertension.
| S-EPMC5151173 | biostudies-literature