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

Azusa Hara, Lutgarde Thijs, Kei Asayama, Lotte Jacobs, Ji-Guang Wang, Jan A. Staessen*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


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/= 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 = 0.058). 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.
Original languageEnglish
Article numbere103169
Issue number8
Publication statusPublished - 4 Aug 2014

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