TROPHY study: Outcomes based on the Seventh Report of the Joint National Committee on Hypertension definition of hypertension

Abstract 

Trial of Preventing Hypertension (TROPHY) investigated whether pharmacological treatment of prehypertension prevents or postpones stage 1 hypertension. Hypertension was originally defined when a participant had blood pressure (BP) ≥140 and/or ≥90 mm Hg at any three clinic visits over 4 years. Contemporary guidelines define hypertension if the BP is ≥140 and/or ≥90 at two consecutive visits. TROPHY results were recalculated based on the current definition. Participants with repeated BP of 130 – 139 and/or 85 – 89 mm Hg were randomly assigned to 2 years of candesartan or placebo, followed by 2 years of placebo for all. All participants received lifestyle counseling at every visit. When participants reached hypertension, antihypertensive treatment was initiated. The 4-year incidence of hypertension was significantly (P < .001) lower than previously reported in the placebo (–11.3%) and candesartan (–11.0%) groups. During the first 2 years, hypertension developed in 162 placebo and 53 candesartan participants (relative risk reduction [RRR], 68%; P < .001; original report 66%; P < .001). After 4 years, hypertension occurred in 197 placebo and 165 candesartan participants (RRR, 18%; P < .009; original report 16%; P < .007). The new definition resulted in a lower incidence of hypertension, but the outcomes were remarkably similar with both definitions and confirmed our original findings.

Keywords: Prehypertension, candesartan, placebo, clinical trials