VALUE, 2004 valsartan versus amlodipine

NCT00129233    Lancet 2004 Jun 19;363:2022-31  

valsartan versus amlodipine in patients, aged 50 years or older with treated or untreated hypertension and high risk of cardiac events




Studied treatment valsartan based regimen
Control treatment amlodipine based regimen
female (%) 42%
Diabetic (%) 32%



Patients patients, aged 50 years or older with treated or untreated hypertension and high risk of cardiac events
Group sizes 7649 / 7596
Inclusion criteriamen or women of any racial background, 50 years of age and older, and presence of cardiovascular risk factors or disease according to an algorithm based on age and sex. The qualifying risk factors were male sex, age older than 50 years, verified diabetes mellitus, current smoking, high total cholesterol, left ventricular hypertrophy by electrocardiogram, proteinuria on dipstick and raised serum creatinine between 150 and 265 µmol/L. The qualifying diseases were verified coronary disease, cerebrovascular disease or peripheral arterial occlusive disease, or left ventricular hypertrophy with strain pattern.
Exclusion criteriarenal artery stenosis, pregnancy, acute myocardial infarction, percutaneous transluminal coronary angioplasty or coronary artery bypass graft within the past 3 months, clinically relevant valvular disease, cerebrovascular accident in the past 3 months, severe hepatic disease, severe chronic renal failure, congestive heart failure requiring ACE inhibitor therapy, patients on monotherapy with blockers for both coronary artery disease and hypertension
SBP (mmHg) 154.8
DBP (mmHg) 87.6



Blindness Double blind Inclusion period Sep 1997 - nov 1999
Follow-up duration 4.2 y (mean) Centers multicentre
Lost to FU 71 (0.47%) geographical localisation 31 countries
Primary endpoint cardiac event Design Parallel groups



EndpointX1N1X0N0TE95% CI cancer occurence(prespecified endpoint) - 7649 - 7596 no data cancer death - 7649 - 7596 no data PAS inférieure à 140 - 7649 - 7596 no data PAD inférieure à 90 - 7649 - 7596 no data PA inférieure à140/90 - 7649 - 7596 no data Cardiovascular death 304 7649 304 7596 0,99[0,84; 1,17] stroke (fatal and non fatal) 322 7649 281 7596 1,14[0,97; 1,34] Myocardial infarction ( fatal and non fatal) 369 7649 313 7596 1,17[1,00; 1,37] cardiovascular death - 7649 - 7596 no data cardiac death 304 7649 304 7596 0,99[0,84; 1,17] all cause death 841 7649 818 7596 1,02[0,92; 1,13] coronary event 810 7649 789 7596 1,02[0,92; 1,13] cardiovascular event 810 7649 789 7596 1,02[0,92; 1,13] apparition d'un premier évènement cardiovasculaire 810 7649 789 7596 1,02[0,92; 1,13] New onset diabetes 690 7649 845 7596 0,81[0,73; 0,90] breast cancer - 7649 - 7596 no data prostate cancer - 7649 - 7596 no data cancer 669 7622 782 7576 0,85[0,76; 0,95] cancer occurence - 7649 - 7596 no data lung cancer - 7649 - 7596 no data0,22,01,0


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 Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet 2004 Jun 19;363:2022-31     [PMID: 15207952]   link to pdf