The Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) Trial
Why the study?
Does valsartan monotherapy reduce primary composite cardiac end points compared to amlodipine monotherapy in high-risk hypertensive patients?
Population
7,080 high-risk hypertensive patients who remained on monotherapy at the end of the initial 6-month drug…
Comparison
Valsartan monotherapy (N=3263) vs Amlodipine monotherapy (N=3817)
Design
RCT
Follow-up
3.2 years (time on monotherapy)
Authors
Discussion
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Implication
Valsartan matches amlodipine for composite events but lowers heart failure in high-risk hypertension; extends ARB versus CCB outcome data.
Key Points
- To compare clinical outcomes and diabetes incidence between valsartan- and amlodipine-based monotherapy regimens in high-risk hypertensive patients.
- Analyzed a subgroup of 7,080 high-risk hypertensive patients from the VALUE trial (valsartan N=3,263; amlodipine N=3,817) who remained on monotherapy after a 6-month adjustment period.
- Tracked patients over an average monotherapy duration of 3.2 years (78% of treatment exposure time).
- Assessed outcomes using both a censored analysis (censoring at monotherapy discontinuation) and an intention-to-treat approach.
- Rates of primary composite cardiac endpoints, stroke, myocardial infarction, and all-cause mortality were comparable between treatment arms in both censored and intention-to-treat analyses.
- Heart failure incidence was lower with valsartan in both the censored (HR 0.63, P=0.004) and intention-to-treat analyses (HR 0.78, P=0.045), with effects amplified by longer monotherapy duration.
- New-onset diabetes occurred less frequently in the valsartan group across both the censored (OR 0.78, P=0.012) and intention-to-treat analyses (OR 0.82, P=0.034).
Structured PICO
Does valsartan monotherapy reduce primary composite cardiac end points compared to amlodipine monotherapy in high-risk hypertensive patients?
P
Population
7,080 high-risk hypertensive patients who remained on monotherapy at the end of the initial 6-month drug adjustment period (from the main 15,245 VALUE trial cohort)
I
Intervention
Valsartan monotherapy (N=3263)
C
Comparator
Amlodipine monotherapy (N=3817)
O
Outcome
Primary composite cardiac end pointscomposite
In high-risk hypertensive patients maintained on monotherapy, valsartan did not reduce composite cardiac endpoints compared to amlodipine, but it significantly reduced the risk of heart failure and new-onset diabetes.
Cite This Study
Julius et al. (2006) studied this question.