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1、A-HeFT Efficacy,Primary Endpoint Composite Score,ScoreDeath(at any time during the trial)3 Alive at end of trial 0First HF hospitalization(adjudicated)1No HF hospitalization 0Change in QoL at 6 mo(or last measurement,if earlier than 6 mo)Improvement 10 units+2Improvement 5 and 10 units+1Change 5 uni
2、ts 0Worsening 5 and 10 units 1Worsening 10 units 2Possible score=6 to+2,DV A HefFT CSR pg 66-67 Taylor_ACC-5,Primary EndpointComposite Score,P=0.016,DV A-HeFT CSR T 24,Composite score range,6 to+2.,0.16,0.47,Mean SEM,Components of Primary Composite EndpointA-HeFT,37,DV A-HeFT CSR T26,All Cause Morta
3、lityEvent Rate,Log-rank P=0.012,n=54,n=32,DV A-HeFT CSR pg 114 and pg 149,BiDil 518463407360314253Placebo532466401340285233,43%Decrease in Relative Risk of Mortality,BiDil,Placebo,HR=0.57(0.37,0.89)P=0.012,DV A-HeFT CSR pg 18,Patients at risk,n,Time since baseline visit date,days,85,90,95,100,0,100,
4、200,300,400,500,Survival,%,Cause-Specific MortalityA-HeFT,DV A-HeFT CSR T31,16,Log-rank P value.,First Hospitalization for HFEvent Rate,Log-rankP 0.001,n=85,n=130,DV A-HeFT CSR T26,T34,BiDil Decreases Relative Risk of First HF Hospitalization by 39%,DV A-HeFT CSR F 5 and Table 32,Placebo,BiDil,HR=0.
5、61(0.46,0.80)P 0.001,BiDil 5184303573052531976Placebo53240732926420316012,Patients at risk,n,Without hospitalization,%,Time since baseline visit date,days,First HF Hospitalization Event Rates and Total Days in Hospital for HF,Log-rank test.Two-sample t test.,A-HeFT CSR T32,HF Hospitalizations,25,DV
6、NitroMed BB T26,Wilcoxon rank-sum test.,CE-11,Time since baseline visit date,days,BiDil Decreases Relative Risk of Mortality or First HF Hospitalization by 37%,DV A-HeFT Fig 6 Pg 119,BiDil 51843336331226120313Placebo53241133727020816415,Patients at risk,n,HR=0.63(0.49,0.81)P 0.001,Placebo,BiDil,MLHF
7、 QuestionnaireChange in QoL Score at 6 Mo,P=0.011,DV TQoL_LHF ptt 16.1,Minnesota Living With HF questionnaire.Lower QoL score indicates better QoL.Mean SEM.,MLHF QuestionnaireChange in QoL From Baseline,DV A-HeFT CSR PTT 16.1,Improvement,P=0.014,Month,P=0.13,P=0.053,P=0.011,P=0.039,P=0.024,P=0.003,4
8、23,441,369,371,198,184,n=,307,305,269,250,226,218,512,528,Subgroup Analyses for the Primary Endpoint Composite Score(1),N,Favors BiDil,Favors placebo,Mean difference in composite score,DVA-HeFT CSR F 2,-1.5,-1,-0.5,0,0.5,1,1.5,Subgroup Analyses for the Primary Endpoint Composite Score(2),DV A-HeFT C
9、SR F 2,Mean difference in composite score,N,-1.5,-1,-0.5,0,0.5,1,1.5,Favors BiDil,Favors placebo,Subgroup Analyses of Hazard Ratio for All-Cause Mortality(1),N,Relative risk(95%CI),0,0.5,1,1.5,2,DV A-HeFT Fig 4,Favors BiDil,Favors placebo,4,Subgroup Analyses of Hazard Ratio for All-Cause Mortality(2
10、),DV Taylor_ACC-17 A-HeFT CSR T 30,N,Favors BiDil,Favors placebo,Relative risk(95%CI),0,0.5,1,1.5,2,7,Subgroup Analyses of HR for First HF Hospitalization(1),0,0.5,1,1.5,2,N,Favors BiDil,Favors placebo,Relative risk(95%CI),DV A-HeFT CSR Fig 4 ptt f7,Subgroup Analyses of HR for First HF Hospitalizati
11、on(2),N,Favors BiDil,Favors placebo,Relative risk(95%CI),0,0.5,1,1.5,2,6,DV Taylor_ A-A-HeFT ptt f7,Change in Blood Pressure From Baseline,DV Data from client;A-HeFT PTT 20,Systolic BP,Change from baseline,mm Hgmean SEM,*,*,*,*,*,*,*,*,*,*,*,Diastolic BP,*P 0.05,-8,-6,-4,-2,0,2,4,0,3,6,9,12,15,18,Bi
12、Dil,Placebo,*,Effect of BP Lowering on BiDil Treatment Effects,23,DV,Summary of BiDil Efficacy,BiDil is efficacious in the treatment of symptomatic heart failure in black patients:Decreases the risk of mortalityDecreases hospitalization for HFRisk for first hospitalizationNumber of hospitalizationDa
13、ys in the hospitalImproves quality of life,DV,A-HeFTClinical Safety,DV,Adverse Events,Favors BiDil.,A-HeFT CSR T 43,46;5-11-05 BD P 85,AEs of Special Interest,DV Pg 143 CSR Table 54/PTT 21.5 by severity,Discontinued study medication due to AEs.,Most Frequent 1%Serious AEsSafety Population,DV A-HeFT
14、CSR T49,P 0.001,16,Patients in the Analysis Populations,DV A-HeFT CSR T13,p 88,16,Of the 301 events in the ITT populations(first HF hospitalization or death)only 40 events remained in the per-protocol population(1 death,39 hospitalizations),Conclusion,Summary of BiDil Efficacy and Safety,A-HeFT conf
15、irms the hypothesis generated from V-HeFT I and V-HeFT IIBiDil is efficacious in the treatment of HF in black patients:Increases survival by 43%Decreases hospitalization for HFRisk for first hospitalization by 39%Number of hospitalizations by 31%Days in the hospital by 42%Improves quality of lifeBiD
16、il has a favorable safety profile for the proposed use,DV NitroMed BB p 120,Summary of BiDil Efficacy and Safety,A-HeFT confirms the hypothesis generated from V-HeFT I and V-HeFT IIBiDil is efficacious in the treatment of HF in black patients:Increases survival by 43%Decreases hospitalization for HFRisk for first hospitalization by 39%Number of hospitalizations by 31%Days in the hospital by 42%Improves quality of lifeBiDil has a favorable safety profile for the proposed use,DV NitroMed BB p 120,
