title: Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial.
abstract: 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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Michigan, Ann Arbor, USA. sjulius@med.umich.edu
authors.forename: Stevo
authors.initials: S
authors.lastname: Julius
authors.forename: Sverre E
authors.initials: SE
authors.lastname: Kjeldsen
authors.forename: Michael
authors.initials: M
authors.lastname: Weber
authors.forename: Hans R
authors.initials: HR
authors.lastname: Brunner
authors.forename: Steffan
authors.initials: S
authors.lastname: Ekman
authors.forename: Lennart
authors.initials: L
authors.lastname: Hansson
authors.forename: Tsushung
authors.initials: T
authors.lastname: Hua
authors.forename: John
authors.initials: J
authors.lastname: Laragh
authors.forename: Gordon T
authors.initials: GT
authors.lastname: McInnes
authors.forename: Lada
authors.initials: L
authors.lastname: Mitchell
authors.forename: Francis
authors.initials: F
authors.lastname: Plat
authors.forename: Anthony
authors.initials: A
authors.lastname: Schork
authors.forename: Beverly
authors.initials: B
authors.lastname: Smith
authors.forename: Alberto
authors.initials: A
authors.lastname: Zanchetti
mesh_terms: D000368:Aged; D017311:Amlodipine / Q000009:adverse effects / Q000627:therapeutic use*; D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000517:prevention & control; D004232:Diuretics; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D049993:Sodium Chloride Symporter Inhibitors / Q000627:therapeutic use; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014633:Valine / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use*; D000068756:Valsartan
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004232:Diuretics; D049993:Sodium Chloride Symporter Inhibitors; D013777:Tetrazoles; D006852:Hydrochlorothiazide; D017311:Amlodipine; D000068756:Valsartan; D014633:Valine