Problem Hypertension with cardiac RFs
Format Multicenter, double-blind, randomized trial
Treatment Valsartan OR amlodipine
Control -
Population 12,570 patients
Inclusion criteria 50 years old

Subjects had to have a history of cardiovascular disease or at least 3 risk factors in addition to hypertension

Verified coronary disease
Cerebrovascular disease or peripheral arterial occlusive disease
Left ventricular hypertrophy with strain pattern

Risk factors:
Male sex
Age older than 50 years
Current smoker
Left ventricular hypertrophy on ECG
Proteinuria on dipstick
Raised serum creatinine between 150 and 265 µmol/L
Exclusion criteria Renal artery stenosis
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
Follow-up Mean 4.2 years
Primary endpoint Composite measure of cardiac morbidity and mortality, which included:

-Sudden cardiac death
-Fatal/nonfatal myocardial infarction (MI)
-Evidence of recent MI on autopsy
-Emergency thrombolytic/fibrinolytic treatment and/or emergency percutaneous transluminal coronary angioplasty (PTCA)/coronary artery bypass graft (CABG) surgery to avoid MI
-Death during or after PTCA/CABG
-New or chronic congestive heart failure (CHF) requiring hospital management
-Heart failure death
Secondary endpoint(s) Fatal and non-fatal myocardial
Fatal and non-fatal heart
Fatal and non-fatal stroke
All-cause mortality
New-onset diabetes were also prespecified.
Details Subjects were to be randomly assigned to either valsartan or amlodipine 5 mg for 1 month, followed by uptitration to 10 mg of amlodipine or 160 mg of valsartan.

By the end of the third month, subjects could be given additional antihypertensive therapy with hydrochlorothiazide, then other agents (sympatholytics and vasodilators), to try to achieve the target blood pressure of 140/90 mm Hg.
Brief summary: Valsartan inferior BP control vs. amlodipine; similar CV event rate
PAPER: Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial.
Date 19 Jun 2004
Journal Lancet. 2004 Jun 19;363(9426):2022-31.
Information Valsartan vs. Amlodipine in HTN with cardiac RFs
-To assess if renin-angiotensin blockade of benefit, above benefits of BP control
-Target BP 140/90 mm Hg

Significantly lower BPs with amlodipine
-Average 2.2 mm Hg at 60 months
More rapid control of BP in amlodipine group
-Average 4.3 mm Hg lower in early months

No difference in composite endpoints
-?No benefit from RAS blockade...
-...Or just offset by higher BP in ARB group?

N.B. Composite endpoint focused on cardiac outcomes, ignoring strokes