Transcript No Slide Title

‫חזק בהגנה לבבית‬
Valsartan in Heart
Failure
Valsartan Heart Failure Trial
‫ספיקת לב‬-‫ הראשון שהוכיח תוצאות חיוביות באי‬ARB– ‫ה‬
.Mega Trial – ‫ב‬
Study Overview
5010 patients
18 years; EF <40%; NYHA II-IV; LVIDd >2.9 cm/m2
Receiving background therapy
ACE inhibitors, diuretics,
digoxin, -blockers
Randomized to
Valsartan
40 mg bid titrated to
160 mg bid
Cohn JN et al. Eur J Heart Fail. 2000;2:439-446.
Placebo
Effect of Valsartan on Combined
Morbidity/Mortality Endpoint*
100
Valsartan
Placebo
95
90
13.2% Risk Reduction
P = 0.009
85
Probability
of EventFree
Survival
80
75
70
65
0
0
3
6
9
12
15
18
21
24
27
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. 2001;345:1667-1675.
30
HF-Related Hospitalizations*
100
Valsartan
Placebo
95
90
85
Event-Free
Probability
80
75
27.5% Risk Reduction
70
P < 0.001
65
0
0
3
6
9
12
15
Months
HF = heart failure.
Cohn JN et al. N Engl J Med. 2001;345:1667-1675.
18
21
24
27
30
Reduction in Combined Morbidity/Mortality
Endpoint* with Valsartan (No ACE-I Subgroup)
100
Valsartan, n=185
Placebo, n=181
90
80
Probability
of Event- 70
Free
60
probability
44.0% Risk reduction
50
P < 0.001
40
0
3
6
9
12 15
18
21
24 27
Time Since Randomization (months)
Hazard ratio (Cox model) : 0.560
*First morbid event, including death or hospitalization
Maggioni et al. J Am Coll Cardiol 2002;40:1414-21
30
Reduction in Mortality with Valsartan
(No ACE-I Subgroup)
100
Valsartan, n=185
Placebo, n=181
90
Proportion
Survived 80
70
33% Risk reduction
60
P = 0.017
50
0
3
6
9
12
15
18
21
24
27
Time Since Randomization (months)
Maggioni et al. J Am Coll Cardiol 2002;40:1414-21
30
Val-HeFT: Diovan® Significantly Reduces
Incidence of Atrial Fibrillation Occurrence by 37%
0.15
Log rank test p=0.0001
0.10
Placebo (n=2499)
Estimated
probability
of atrial
fibrillation
0.05
Diovan 160 mg (n= 2511)
0
0
2
4
6
8
10 12 14 16
Months of follow-up
Maggioni A et al. Am Heart J 2005;149:548–57
18
20
22
24