Is low-risk hypertension fact or fiction? Cardiovascular risk profile in the TROPHY study

Background: The Trial of Preventing Hypertension (TROPHY) Study is designed to establish whether treating high normal blood pressure with a low-dose angiotensin receptor blocker, candesartan cilexetil, for 2 years reduces the rate of progression to hypertension compared with placebo treatment over a 4-year observation period. We are presenting the baseline cardiovascular risk factor profile of the 809 subjects randomized in the TROPHY Study. The risk factors in this analysis were as follows: cholesterol >= 200 mg/dl; LDL-cholesterol >= 160 mg/dL; HDL-cholesterol <= 40 mg/dL (for men), <= 50 mg/dL (for women); triglycerides >= 150 mg/dL; body mass index >= 25 kg/m(2) (overweight and obese), fasting insulin >= 20 mU/mL; heart rate >= 80 beats/min; hematocrit >= 43.5% (men) and >= 41.2% (women). Methods: The TROPHY Study is a 4-year randomized, placebo-controlled, multicenter clinical trial of 809 subjects with high normal blood pressure (BP), which is currently in progress. Results: The participants of the TROPHY study (mean age 49 +/- 8.1 years) with high normal BP (mean 134 4/85 +/- 4 mm Hg) had additional cardiovascular risk factors. Of the group, 96% had at least one, 81% had two or more, and 13% had five or more additional risk factors. Conclusions: Our data from individuals with high normal BP suggests clearly that the risk of cardiovascular disease begins to rise before the diagnosis of hypertension is evident. The overall risk in such subjects reflects both the rising BP and other concurring factors. It appears that truly low-risk hypertension only rarely exists.