Presentation on theme: "חזק בהגנה לבבית Valsartan in Heart Failure"— Presentation transcript:
1 חזק בהגנה לבבית Valsartan in Heart Failure Valsartan Heart Failure Trialה –ARB הראשון שהוכיח תוצאות חיוביות באי-ספיקת לב ב – Mega Trial.
2 Study Overview5010 patients 18 years; EF <40%; NYHA II-IV; LVIDd >2.9 cm/m2Receiving background therapyACE inhibitors, diuretics, digoxin, -blockersRandomized toVal-HeFT, a randomized, double-blind, placebo-controlled study of 5010 HF patients with NYHA class II-IV, was an international collaboration in 16 industrialized countries at 300 centersPatients continued on their standard background therapies, which included ACE inhibitors (n=4644, 92.7%), diuretics (n=4300, 85.5%), digoxin (n=3375, 67.3%), and -blockers (n=1784, 35.6%)Patients were randomized to treatment with valsartan 40 mg bid titrated to 160 mg bid or placeboThe primary endpoints were combined all-cause mortality and morbidity and all-cause mortalityPatients were stratified to each arm according to whether they were on a -blocker or notStudy continued until 906 deaths were reportedValsartan 40 mg bid titrated to 160 mg bidPlaceboCohn JN et al. Eur J Heart Fail. 2000;2:
3 Effect of Valsartan on Combined Morbidity/Mortality Endpoint* 65707580859095100ValsartanPlacebo13.2% Risk ReductionP = 0.009Probability of Event-Free Survival36912151821242730Months*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:
4 HF-Related Hospitalizations* 65707580859095100ValsartanPlaceboEvent-Free Probability27.5% Risk ReductionP < 0.00136912151821242730MonthsHF = heart failure.Cohn JN et al. N Engl J Med. 2001;345:
5 Time Since Randomization (months) Reduction in Combined Morbidity/Mortality Endpoint* with Valsartan (No ACE-I Subgroup)Time Since Randomization (months)40506070809010036912151821242730P < 0.00144.0% Risk reductionValsartan, n=185Placebo, n=181Probability of Event-Free probabilityHazard ratio (Cox model) : 0.560*First morbid event, including death or hospitalizationMaggioni et al. J Am Coll Cardiol 2002;40:
6 Reduction in Mortality with Valsartan (No ACE-I Subgroup) 100Valsartan, n=18590Placebo, n=181Proportion Survived807033% Risk reduction60P = 0.0175036912151821242730Time Since Randomization (months)Maggioni et al. J Am Coll Cardiol 2002;40:
7 Estimated probability of atrial fibrillation Val-HeFT: Diovan® Significantly Reduces Incidence of Atrial Fibrillation Occurrence by 37%0.15Log rank test p=0.00010.10Placebo (n=2499)Estimated probability of atrial fibrillation0.05Diovan 160 mg (n= 2511)24681012141618202224Months of follow-upMaggioni A et al. Am Heart J 2005;149:548–57