Valsartan Anti-hypertensive Long-term Use Evaluation (VALUE) outcome trial to compare a angiotensin II receptor blocker (ARB), valsartan, with a third-generation calcium channel blocker (CCB), amlodipine, in a general hypertensive population at high cardiovascular risk
participants were mainly previously treated (92%) patients with hypertension
randomisation to low-dose valsartan (80 mg) or amlodipine (5 mg)
this was followed titration of therapy at monthly inter-vals to achieve a target blood pressure < 140/90 mmHg i.e. to valsartan 160 mg or amlodipine 10 mg followed by introduction of diuretic (hydrochlorothiazide) and then free add-on therapy as necessary
15,313 individuals were randomised at 942 sites in 31 countries, and average follow-up was 4.2 years
90 patients were lost to follow-up
on entry to the study: average age of 67 years, BP 155/88 mmHg
nearly 50% had coronary heart disease
one third had diabetes
one third had hypercholesterolaemia
one quarter were smokers
about one in five had proteinuria
about one in five had left ventricular hypertrophy and/or cerebrovascular disease
one in eight had peripheral arterial disease
Results
average blood pressure, 138/79 mmHg, at the end of the study
blood pressure was reduced by around 15/10mmHg during the course of the study
blood pressure levels were significantly lower in the amlodipine-treated patients
initially differences were more than 4/2 mmHg in favour of amlodipine
beyond six months the advantage in favour of amlodipine more than 2 mmHg for systolic blood pressure and 1–2 mmHg for diastolic blood pressure
the incidence of the composite cardiac outcome did not differ between the groups (hazard ratio 1.03, 95% confidence intervals 0.94–1.14; p=0.94) - this is despite the inferior blood pressure control of valsartan in comparison to amlodipine
no significant differences between the treatments for stroke or all-cause mortality
incidence of new-onset diabetes was significantly lower in valsartan-treated patients (23% reduction; p<0.0001)
both treatments were well tolerated - however significantly fewer discontinued therapy due to adverse events in the valsartan group (p=0.045) and peripheral oedema was much more common in the amlodipine group (33% vs. 15%, p<0.0001)
admission to hospital for heart failure was significantly lower with valsartan treated group
reaching blood pressure control (systolic <140 mm Hg) by 6 months, independent of drug type, was associated with significant benefits for subsequent major outcomes; the blood pressure response after just 1 month of treatment predicted events and survival
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