Blood Pressure Variability Causes Spurious Identification of Hypertension in Clinical Studies: A Computer Simulation Study

The blood pressure (BP) of an individual varies considerably from day to day. Hypertension is commonly identified based on the average of two BPs taken at each of two visits, a practice consistent with current guidelines. We hypothesized that (i) in the setting of high-normal BP ("prehypertension"), this practice results in frequent spurious detection of hypertension, and (ii) that random, spurious detection of hypertension and flawed study design together explain why in the Trial of Preventing Hypertension (TROPHY) study candesartan appeared to suppress the development of hypertension for 2 years after cessation of therapy.