Lancet. 2004 Jun 19;363(9426):2022-31. Julius S， Kjeldsen SE， Weber M， Brunner HR， Ekman S， Hansson L， Hua T， Laragh J， McInnes GT， Mitchell L， Plat F， Schork A， Smith B， Zanchetti A; VALUE trial group. University of Michigan， Ann Arbor， USA. sjulius@med.umich.edu
BACKGROUND: The Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial was designed to test the hypothesis that for the same blood-pressure control， valsartan would reduce cardiac morbidity and mortality more than amlodipine in hypertensive patients at high cardiovascular risk.
METHODS: 15?245 patients， aged 50 years or older with treated or untreated hypertension and high risk of cardiac events participated in a randomised， double-blind， parallel-group comparison of therapy based on valsartan or amlodipine. Duration of treatment was event-driven and the trial lasted until at least 1450 patients had reached a primary endpoint， defined as a composite of cardiac mortality and morbidity. Patients from 31 countries were followed up for a mean of 4.2 years.
FINDINGS: Blood pressure was reduced by both treatments， but the effects of the amlodipine-based regimen were more pronounced， especially in the early period (blood pressure 4.0/2.1 mm Hg lower in amlodipine than valsartan group after 1 month; 1.5/1.3 mm Hg after 1 year; p<0.001 between groups). The primary composite endpoint occurred in 810 patients in the valsartan group (10.6%， 25.5 per 1000 patient-years) and 789 in the amlodipine group (10.4%， 24.7 per 1000 patient-years; hazard ratio 1.04， 95% CI 0.94-1.15， p=0.49).
INTERPRETATION: The main outcome of cardiac disease did not differ between the treatment groups. Unequal reductions in blood pressure might account for differences between the groups in cause-specific outcomes. The findings emphasise the importance of prompt blood-pressure control in hypertensive patients at high cardiovascular risk.