Visit-to-visit blood pressure variability increases risk of stroke or cardiac events in patients given valsartan or amlodipine in the value trial

Abstract High blood pressure variability has been associated with an increased risk of cardiovascular events. We aimed to assess if increased visit-to-visit variability in systolic blood pressure increases the risk of stroke or cardiac events (fatal/non-fatal coronary or heart failure events) in the VALUE population. The VALUE trial was a randomised-controlled, double-masked investigation of valsartan versus amlodipine in patients 50 years or older with hypertension and high risk of cardiovascular events. Mean follow-up time was 4.2 years. We calculated the standard deviation (SD) of mean systolic blood pressure from visits from 6 months onward, excluding patients with less than 2 visits, or stroke or cardiac events during the first 6 months. In the pooled treatment arms, we grouped SD in quintiles and compared the risk of stroke or cardiac events in the highest and the lowest quintile, using a Cox regression model, adjusting for a number of prognostic variables, including randomised treatment and mean BP from 6 months onwards. Of 14.146 patients included, 1278 (9.0%) experienced a cardiac event and 473 (3.3%) experienced a stroke. Compared to patients with the lowest variability, those in the highest quintile had an increased risk of stroke or cardiac events (HR 1.4, 95% CI 1.0-1.8, p = 0.045 and HR 1.9, 95% CI 1.6-2.3, p