VALUE: Valsartan Anti-hypertensive Long-term Use
Evaluation
Purpose
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
Reference
Julius S, Kjeldsen SE, Weber M, et al. Outcomes in hypertensive
patients at high cardiovascular risk treated with regimens based on
valsartan or amlodipine: the VALUE randomised trial. Lancet
2004;363:2022–2031.
VALUE: Valsartan Anti-hypertensive Long-term Use
Evaluation
- TRIAL DESIGN -
Design
Multicenter, multinational, randomized, double-blind
Patients
15,245 patients ≥ 50 yrs with treated or untreated hypertension and high risk of
cardiovascular events
Follow up and primary endpoint
First event: a composite of cardiac morbidity and mortality.
Treatment
Treatment initiated with valsartan (80 mg), or amlodipine (5 mg) and titrated
upwards until a BP < 140/90 mmHg was achieved; other antihypertensive drugs
other than ACE inhibitors or calcium antagonists, could be added if necessary
VALUE: Valsartan Anti-hypertensive Long-term Use
Evaluation
- TRIAL DESIGN continued-
Baseline characteristics
Valsartan Amlodipine
(n=7649) (n=7596)
Age (mean; years) 67.2 67.3
Female 42.4% 42.5%
CHD 45.6% 46.0%
Peripheral arterial 13.8% 14.0%
disease
Stroke or TIA 19.8% 19.8%
LVH with strain pattern 5.9% 6.1%
VALUE: Valsartan Anti-hypertensive Long-term Use
Evaluation
- RESULTS -
No significant difference was observed in cardiac morbidity and
mortality between the two groups
There was a trend for greater heart failure reductions in the valsartan
arm, although this was not statistically significant
VALUE: Valsartan Anti-hypertensive Long-term Use
Evaluation
- RESULTS -
At 72 months, valsartan (80/160 mg per day) and amlodipine (5/10
mg per day) both produced similar blood pressure levels (139.3/79.2
mm Hg vs 137.5/77.7 mm Hg, p<0.0001)
Amlodipine (5/10 mg per day) was more efficacious than valsartan
(80/160 mg per day) at reducing BP in the early months
• At 1 month: BP in the amlodipine arm was reduced more than in the
valsartan arm (4.0/2.1 mm Hg)
• At 6 months: BP in the amlodipine arm was reduced more than in the
valsartan arm (2.1/1.6 mm Hg)
VALUE: Valsartan Anti-hypertensive Long-term Use
Evaluation
- RESULTS continued -
VALUE: Valsartan Anti-hypertensive Long-term Use
Evaluation
- SUMMARY -
The valsartan group had a higher incidence of myocardial
infarction than the amlodipine group, whereas the latter
experienced a significantly higher incidence of new onset
diabetes