| Abstract
| - The Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) Trial is testing the hypothesis that for the same level of BP control, the AT 1-receptor blocker valsartan reduces cardiac morbidity and mortality, with 90% statistical power, by 15% compared to the CCB amlodipine. This is a double-blind, randomized, in 31 countries, prospective comparison of at least 14,400 previously untreated (range SBP 160-210 mmHg, DBP 95-115 mmHg) or treated hypertensives, ≥50 yrs with high risk of CV events (i.e. one or more a priori defined risk or disease factors). Enrollment was concluded by end October 1999. The recruitment goal has been exceeded and more than 15,000 patients were randomized. These patients are characterized by 90% previously treated, 57% male gender, 17.0% age 50-59 yrs, 37.6% 60-69 yrs, 36.4% 70-79 yrs and these risk factors (of total): High cholesterol 32.7% Diabetes (mostly type 2) 31.9% Active smoker 23.1% Proteinuria 22.4% Left ventricular hypertrophy (LVH) 13.8% Increased serum creatinine 3.5%, and the following disease factors (of total): Coronary heart disease 45.1% Previous stroke 19.3% Peripheral arterial disease 13.6% LVH with strain 6.7%.The VALUE Trial has successfully included a large cohort of high risk hypertensives with one or more a priori defined risk or disease factors. This cohort is now being treated aiming at BP <140/90 mmHg for 4-6 years and the occurrence of primary cardiac events in at least 1450 patients.
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