Valsartan Heart Failure Trial

1
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Valsartan in Heart Failure
Valsartan Heart Failure Trial
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? Mega Trial.
2
Study Overview
5010 patients ?18 years EF lt40 NYHA II-IV
LVIDd gt2.9 cm/m2
Receiving background therapy
ACE inhibitors, diuretics,digoxin, ?-blockers
Randomized to
Valsartan40 mg bid titrated to160 mg bid
Placebo
Cohn JN et al. Eur J Heart Fail. 20002439-446.
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Effect of Valsartan on Combined
Morbidity/Mortality Endpoint
Valsartan
Placebo
13.2 Risk Reduction
P 0.009
Probability of Event-Free Survival
3
6
9
12
15
18
21
24
27
0
30
Months
All-cause mortality, sudden death with
resuscitation, hospitalization for worsening
heart failure, or therapy with IV inotropes or
vasodilators. Cohn JN et al. N Engl J Med.
20013451667-1675.
4
HF-Related Hospitalizations
Valsartan
Placebo
Event-Free Probability
27.5 Risk Reduction
P lt 0.001
3
6
9
12
15
18
21
24
27
0
30
Months
HF heart failure. Cohn JN et al. N Engl J
Med. 20013451667-1675.
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Reduction in Combined Morbidity/Mortality
Endpoint with Valsartan (No ACE-I Subgroup)
Probability of Event-Free probability
Hazard ratio (Cox model) 0.560 First morbid
event, including death or hospitalization
Maggioni et al. J Am Coll Cardiol 2002401414-21
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Reduction in Mortality with Valsartan (No ACE-I
Subgroup)
100
Valsartan, n185
90
Placebo, n181
Proportion Survived
80
70
33 Risk reduction
60
P 0.017
50
0
3
6
9
12
15
18
21
24
27
30
Time Since Randomization (months)
Maggioni et al. J Am Coll Cardiol 2002401414-21
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Val-HeFT Diovan Significantly Reduces
Incidence of Atrial Fibrillation Occurrence by
37

0.15
Log rank test p0.0001
0.10
Placebo (n2499)
Estimated probability
of atrial fibrillation
0.05
Diovan 160 mg (n 2511)
0
12
0
24
2
4
6
8
10
14
16
18
20
22
Months of follow-up
Maggioni A et al. Am Heart J 200514954857