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VERITAS Trial
Value of Endothelin Receptor Inhibition with
Tezosentan in Acute Heart Failure Studies
Presented at
The American College of Cardiology
Scientific Sessions 2004
Presented by Dr. John J. V. McMurray
VERITAS Trial
1,449 patients with acute heart failure requiring IV therapy
And received at least 1 dose of an IV diuretic, age>18 years, dyspnea at rest, enrollment within
24 hours of hospital admission
40% female, mean age 70 years
68% patients had EF=29% and ischemic heart disease, 99% used IV loop diuretics, 62% used
ACE Inhibitor or angiotensin receptor blockers, 47% used beta-blockers
IV Tezosentan
Placebo
5 mg/hr for 30 minutes followed by 1
mg/hr for 24-72hours
5mg/hr for 30 minutes followed by 1
mg/hr for 24-72 hours
n=727
n=708
Primary Endpoint (VERITAS 1 & 2): Change in dyspnea from baseline over
the first 24 hours, as assessed by area under the curve
Primary Endpoint (pooled trials): Death or worsening heart failure at 7 days
www. Clinical trial results.org
Presented at ACC 2005
VERITAS Trial: Primary Endpoint
Primary endpoint of death or worsening
heart failure at 7 and 30 days
30 days
7 days
35%
30%
p=0.61
p=0.95
31.9%
26.3%
33.2%
• There was no difference in
death or worsening heart failure
between the Tezosentan group
compared to the placebo group
at both 7 and 30 days.
• For the primary endpoint of
dyspnea at 24 hours, there was
no difference between the
treatment groups in either of the
VERITAS trials individually or
together.
26.4%
25%
20%
15%
10%
5%
0%
Tezosentan
www. Clinical trial results.org
Placebo
Presented at ACC 2005
VERITAS Trial: Adverse Events
There was not a significant difference in the
number of serious adverse events that occurred
within the Tezosentan group compared to the
placebo group.
p=NS
50%
40.4%
42.4%
40%
30%
20%
• Hemodynamic
parameters did
improve with the
tezosentan group
group, with a 6mmHg
decline in systolic
blood pressure over
the placebo group at
72 hours and
improvements in
cardiac index.
10%
0%
Serious Adverse Events
Tezosentan
www. Clinical trial results.org
Placebo
•There was no
difference in survival
at 6 months.
Presented at ACC 2005
VERITAS Trial: Summary
Among patients with acute heart failure, treatment with the
endothelin receptor inhibitor tezosentan was associated with
no difference in dyspnea by 24 hours or in death or
worsening heart failure by 7 days compared with placebo,
prompting an early termination of the trials despite no
increase in adverse events.
•
• The lack of clinical benefit occurred despite improvements
in hemodynamic parameters, including systolic blood
pressure and cardiac index.
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