Download Trial Overview - Clinical Trial Results

Cooperative North Scandinavian
Enalapril Survival Study
(CONSENSUS I)
• Multicenter, randomized, double-blind, placebocontrolled trial
• 253 patients; 126 placebo, 127 enalapril followed for
an average of 188 days
• Patient History:
– Class IV CHF patients
– Conventional treatment for heart failure was continued in
both groups
CONSENSUS Study Group
N Eng J Med 1987
CONSENSUS I
Cumulative Probability of Death in the Placebo
and Enalapril Groups
Cumulative Probability of Death
0.7
Placebo
Enalapril
0.6
0.5
31%
p=0.001 reduction
0.4
p=0.002
0.3
40%
reduction
0.2
0.1
0
0
1
CONSENSUS Study Group
N Eng J Med 1987
2
3
4
5
6
7
Months
8
9
10
11
12
CONSENSUS I
Results
• A significant improvement in NYHA classification was
observed in the enalapril group, together with a reduction
in heart size and a reduced requirement for other
medications for heart failure
• The overall withdrawal rate was similar in both groups,
but hypotension requiring withdrawal occurred in seven
patients in the enalapril group an in no patients in the
placebo group
• After the initial dose of enalapril was reduced to 2.5 mg
daily in high-risk patients, this side effect was less
frequent
CONSENSUS Study Group
N Eng J Med 1987