Dataset Information

Randomised double-blind comparison of placebo and active drugs for effects on risks associated with blood pressure variability in the Systolic Hypertension in Europe trial.

ABSTRACT:

Background

In the Systolic Hypertension in Europe trial (NCT02088450), we investigated whether systolic blood pressure variability determines prognosis over and beyond level.

Methods

Using a computerised random function and a double-blind design, we randomly allocated 4695 patients (?60 years) with isolated systolic hypertension (160-219/<95 mm Hg) to active treatment or matching placebo. Active treatment consisted of nitrendipine (10-40 mg/day) with possible addition of enalapril (5-20 mg/day) and/or hydrochlorothiazide (12.5-25.0 mg/day). We assessed whether on-treatment systolic blood pressure level (SBP), visit-to-visit variability independent of the mean (VIM) or within-visit variability (WVV) predicted total (n?=?286) or cardiovascular (n?=?150) mortality or cardiovascular (n?=?347), cerebrovascular (n?=?133) or cardiac (n?=?217) endpoints.

Findings

At 2 years, mean between-group differences were 10.5 mm Hg (p<0.0001) for SBP, 0.29 units (p?=?0.20) for VIM, and 0.07 mm Hg (p?=?0.47) for WVV. Active treatment reduced (p?0.048) cardiovascular (-28%), cerebrovascular (-40%) and cardiac (-24%) endpoints. In analyses dichotomised by the median, patients with low vs. high VIM had similar event rates (p?0.14). Low vs. high WVV was not associated with event rates (p?0.095), except for total and cardiovascular mortality on active treatment, which were higher with low WVV (p?0.0003). In multivariable-adjusted Cox models, SBP predicted all endpoints (p?0.0043), whereas VIM did not predict any (p?0.058). Except for an inverse association with total mortality (p?=?0.042), WVV was not predictive (p?0.15). Sensitivity analyses, from which we excluded blood pressure readings within 6 months after randomisation, 6 months prior to an event or both were confirmatory.

Conclusions

The double-blind placebo-controlled Syst-Eur trial demonstrated that blood-pressure lowering treatment reduces cardiovascular complications by decreasing level but not variability of SBP. Higher blood pressure level, but not higher variability, predicted risk.

Trial registration

ClinicalTrials.gov NCT02088450.

SUBMITTER: Hara A

PROVIDER: S-EPMC4121168 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomised double-blind comparison of placebo and active drugs for effects on risks associated with blood pressure variability in the Systolic Hypertension in Europe trial.

Hara Azusa A Thijs Lutgarde L Asayama Kei K Jacobs Lotte L Wang Ji-Guang JG Staessen Jan A JA

PloS one 20140804 8

<h4>Background</h4>In the Systolic Hypertension in Europe trial (NCT02088450), we investigated whether systolic blood pressure variability determines prognosis over and beyond level.<h4>Methods</h4>Using a computerised random function and a double-blind design, we randomly allocated 4695 patients (≥60 years) with isolated systolic hypertension (160-219/<95 mm Hg) to active treatment or matching placebo. Active treatment consisted of nitrendipine (10-40 mg/day) with possible addition of enalapril ...[more]

PMID: 25090617

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Project description:Background Nocturnal hypertension, defined by a mean asleep systolic blood pressure (SBP)/diastolic blood pressure (BP) ?120/70 mm Hg, and nondipping SBP, defined by an awake-to-asleep decline in SBP <10%, are each associated with increased risk for cardiovascular disease. Methods and Results We developed predictive equations to identify adults with a high probability of having nocturnal hypertension or nondipping SBP using data from the CARDIA (Coronary Artery Risk Development in Young Adults) study (n=787), JHS (Jackson Heart Study) (n=1063), IDH (Improving the Detection of Hypertension) study (n=395), and MHT (Masked Hypertension) study (n=772) who underwent 24-hour ambulatory BP monitoring. Participants were randomized to derivation (n=2511) or validation (n=506) data sets. The prevalence rates of nocturnal hypertension and nondipping SBP were 39.7% and 44.9% in the derivation data set, respectively, and 36.6% and 44.5% in the validation data set, respectively. The predictive equation for nocturnal hypertension included age, race/ethnicity, smoking status, neck circumference, height, high-density lipoprotein cholesterol, albumin/creatinine ratio, and clinic SBP and diastolic BP. The predictive equation for nondipping SBP included age, sex, race/ethnicity, waist circumference, height, alcohol use, high-density lipoprotein cholesterol, and albumin/creatinine ratio. Concordance statistics (95% CI) for nocturnal hypertension and nondipping SBP predictive equations in the validation data set were 0.84 (0.80-0.87) and 0.73 (0.69-0.78), respectively. Compared with reference models including antihypertensive medication use and clinic SBP and diastolic BP as predictors, the continuous net reclassification improvement (95% CI) values for the nocturnal hypertension and nondipping SBP predictive equations were 0.52 (0.35-0.69) and 0.51 (0.34-0.69), respectively. Conclusions These predictive equations can direct ambulatory BP monitoring toward adults with high probability of having nocturnal hypertension and nondipping SBP.

Dataset Information

Randomised double-blind comparison of placebo and active drugs for effects on risks associated with blood pressure variability in the Systolic Hypertension in Europe trial.

Background

Methods

Findings

Conclusions

Trial registration

Publications

Randomised double-blind comparison of placebo and active drugs for effects on risks associated with blood pressure variability in the Systolic Hypertension in Europe trial.

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