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Azilsartan in Patients With Mild to Moderate Hypertension Using Clinic and Ambulatory Blood Pressure Measurements.

ABSTRACT: This was a phase 2, multicenter, randomized, parallel-group, double-blind dose-ranging study. Hypertensive adults (n=555) received one of five doses of azilsartan (AZL; 2.5, 5, 10, 20, 40 mg), olmesartan medoxomil (OLM) 20 mg, or placebo once daily. The primary endpoint was change in trough clinic diastolic blood pressure (DBP) at week 8. Compared with placebo, all AZL doses (except 2.5 mg) provided statistically and clinically significant reductions in DBP and systolic blood pressure (SBP) based on both clinic blood pressure (BP) and 24-hour ambulatory BP monitoring (ABPM). AZL 40 mg was statistically superior vs OLM. Clinic BP was associated with a pronounced placebo effect (-6 mm Hg), whereas this was negligible with ABPM (±0.5 mm Hg). Adverse event frequency was similar in the AZL and placebo groups. Based on these and other findings, subsequent trials investigated the commercial AZL medoxomil tablet at doses 20 to 80 mg/d using 24-hour ABPM.

SUBMITTER: Perez A

PROVIDER: S-EPMC8030785 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Azilsartan in Patients With Mild to Moderate Hypertension Using Clinic and Ambulatory Blood Pressure Measurements.

Perez Alfonso A Cao Charlie C

Journal of clinical hypertension (Greenwich, Conn.) 20160715 1

This was a phase 2, multicenter, randomized, parallel-group, double-blind dose-ranging study. Hypertensive adults (n=555) received one of five doses of azilsartan (AZL; 2.5, 5, 10, 20, 40 mg), olmesartan medoxomil (OLM) 20 mg, or placebo once daily. The primary endpoint was change in trough clinic diastolic blood pressure (DBP) at week 8. Compared with placebo, all AZL doses (except 2.5 mg) provided statistically and clinically significant reductions in DBP and systolic blood pressure (SBP) base ...[more]

PMID: 27421242

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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.

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.

Dataset Information

Azilsartan in Patients With Mild to Moderate Hypertension Using Clinic and Ambulatory Blood Pressure Measurements.

Publications

Azilsartan in Patients With Mild to Moderate Hypertension Using Clinic and Ambulatory Blood Pressure Measurements.

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