Effects of valsartan on morbidity and mortality in patients with heart failure not receiving angiotensin-converting enzyme inhibitors
Key result
Valsartan cuts mortality ~36% vs placebo in HF patients not on ACE inhibitors.
- P=0.017
- n=366
Why the study?
ACE inhibitors reduce morbidity and mortality in HF, but nearly 20% of potentially eligible patients may not receive them.
Key Points
- This study examines how valsartan affects health outcomes in heart failure patients not on ACE inhibitors.
- Randomized trial with patients experiencing heart failure.
- Comparison of morbidity and mortality rates with valsartan treatment.
- Participants not receiving angiotensin-converting enzyme inhibitors.
- Treatment with valsartan resulted in a significant reduction in morbidity rates.
- Mortality rates were lower in the valsartan group compared to the control group.
- Significant improvements in overall health outcomes were observed.
Study Design
Type
RCT (n=366)
Blinding
double-blinded
Randomization
randomized
Multicenter
Yes
PICO
P
Population
366 patients with chronic heart failure not receiving ACE inhibitors at baseline, analyzed as a subgroup of an international randomized trial.
I
Intervention / Comparator
valsartan vs placebo
O
Primary Outcome
all-cause mortality, p=0.017
Main Result
Absolute Event Rate: 17.3% vs 27.1%
p-value: p=0.017
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Val-HeFT identified a critical role for valsartan in the management of heart failure. Despite several potent drugs with proven benefits, impaired quality of life and recurring hospitalization are detrimental to both patients and the healthcare system. Val-HeFT shows that valsartan improves outcomes in patients with this devastating disease.”
“The data from Val-HeFT would suggest that valsartan is a useful drug to add to existing therapy, particularly either an ACE inhibitor or a beta-blocker. I think valsartan is an ideal drug to begin a patient on.”
“Having an agent with a broad range of indications is particularly useful for clinicians because in the 'real world' many causes of cardiovascular disease overlap and one illness predisposes a person for another. Using a lesser number of drugs in patients like this is a good thing for both clinician and patient alike.”
Implication
Supports valsartan in ACEI-intolerant HF; confirms morbidity-mortality benefit in RCT.
Abstract
OBJECTIVES: A subgroup analysis of the Valsartan Heart Failure Trial (Val-HeFT) was performed to evaluate the effects of the angiotensin II receptor blocker, valsartan, in the patients with chronic heart failure (HF) not receiving angiotensin-converting enzyme (ACE) inhibitors. BACKGROUND: The ACE inhibitors reduce mortality and morbidity in patients with HF. Nonetheless, nearly 20% of potentially eligible patients may not be prescribed ACE inhibitors. RESULTS: Val-HeFT was an international, randomized, double-blinded trial that compared valsartan with placebo when added to the prescribed treatment of patients with HF. The two primary end points of the study were all-cause mortality and the composite of all-cause mortality and morbidity (sudden death with resuscitation, hospital admission for HF, or administration of intravenous inotropic or vasodilator drugs for >or=4 h without hospital admission). Of the 5,010 patients enrolled in the trial, 366 (7.3%) were not treated with ACE inhibitors at baseline. The effects of valsartan on the primary and secondary end points of the study were assessed in this subgroup of patients. RESULTS: Both all-cause mortality and combined mortality and morbidity for patients not treated with ACE inhibitors were significantly reduced in the valsartan treatment group compared with the placebo group (17.3% vs. 27.1%, p = 0.017 and 24.9% vs. 42.5%, p < 0.001, respectively). Consistent with the data on clinical events, patients randomized to valsartan showed improvements in physiologic variables, such as ejection fraction, left ventricular internal diameter in diastole, and plasma neurohormone levels. Permanent discontinuation of study treatment because of adverse experiences was comparable between the two groups. CONCLUSIONS: Val-HeFT has provided the first placebo-controlled outcome data demonstrating a favorable effect of an angiotensin receptor blocker on mortality and morbidity in patients with HF not treated with ACE inhibitors. Based on these results, valsartan appears to be an effective therapy in ACE inhibitor-intolerant patients.
Discussion
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Cite This Study
Maggioni et al. (2002) conducted an RCT in chronic heart failure (n=366). valsartan vs. placebo was evaluated on all-cause mortality (p=0.017). Valsartan reduced all-cause mortality (17.3% vs 27.1%, p=0.017) and combined mortality and morbidity (24.9% vs 42.5%, p<0.001) compared to placebo in heart failure patients not on ACE inhibitors.