pleno crp b8
TRANSCRIPT
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Effect of Carvedilol on Survival in
Severe Chronic Heart Failure
The New England
Journal of Medicine
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PRESENTED BY: B8
CRP 2
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Artikel: Effect of Carvedilol on Survival
in Severe Chronic Heart Failure
Background :
There was no evidence that beta-blocker
agents may reduce the morbidity and
mortality of patients with severe heart failure.
There is a large scale study shows that beta-
blocker may have adverse effect and worsen
the heart failure.
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Objective :
To prove whether carvedilol (beta-blockeragent) could improve symptoms and reduce
the risk of severe chronic heart failureprogression.
To prove whether carvedilol ( beta-blocker
agent ) can interfere with the adverse effect ofsympathetic activation through severalnonadrenergic mechanisms.
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Method:
From the 2289 patients who had chronic heart
failure by the symptoms of clinically
euvolemic, 1133 patients assigned as a
placebo group and the rest (1156 patients) as
a treatment group with carvedilol for a mean
period of 10.4 months in which standardtherapy for heart failure was continued.
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Therapy Worksheet
Validity : Are the results of this singlepreventive or therapeutic trial valid?
Was the assignment of patients to treatments
randomized? Answer:
Yes, based on page 1652 Study Design section
par 1: Patients who fulfilled all the entrycriteria were randomly signed in a 1:1ratio,.
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Was the randomization list concealed?
Answer:
Yes, based on page 1652 Statistical Analysissection par. 3 : An independent data and
safety monitoring board was prospectively
constituted at the start of the study;.
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Was follow-up of patients sufficiently long and
complete?
Answer:
Yes, the patients were evaluated every 2
months for a period of 10.4 months, based on
page 1653, RESULTS section.
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Were all patients analyzed in the groups towhich they were randomized?
Answer :
Yes, based on Statistical analysis section page1652 : The analyses included all randomizedpatients and all events were attributed to the
patients original randomly assignedtreatment group (according to the intention-to-treat principle.
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Were patients, clinicians and study personnel
kept blind to treatment?
Answer: Yes
Reff : page 1653, results, paragraph 3, line 13-16
Less than 5% knew they were gave beta blocker
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Were the groups treated equally, apart from the
experimantal treatment?
Answer: Yes
Reff: page 1652, Methods : study design,paragraph 1
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They be given the same dose and the
same evaluation
Were the groups similar at the start of the
trial apart from the experimental
therapy?
Answer: Yes
Reff: page 1652, Methods: study patient,
paragraph 2-3
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Group/
death
no yes
P 943 190 1133
C 1026 130 1156
2289
IMPORTANT
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Relative risk
reduction (RRR)
Absolute
risk
reduction(AAR)
Number
needed to
treat (NNT)
CER EER CER EER/CER CER - EER 1/ARR
190/1133
= 16,77%
130/1156
= 11,25%
16,77%-
11,25%/16,77%
= 32,90%
16,77%-
11,25% =
5,52%
1/5,52% =
18
95 % 19% - 48% 2 to 5
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Group/
Hospital
no yes
P 626 507 1133
C 731 425 1156
2289
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Relative risk
reduction (RRR)
Absolute
risk
reduction(AAR)
Number
needed to
treat (NNT)
CER EER CER EER/CER CER - EER 1/ARR
507/1133
= 44,75%
425/1156
= 36,76%
44,75%-
36,76%/44,75%
= 17,85%
44,75%-
36,76% =
7,99%
1/7,99% =
13
95 % 13% - 33% 3 to 8
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INTERPRETATIONS:
RRR? Pasien yang diberi terapi -blocker
33% decrease in the risk of death
17,85% decrease in the risk of
hospitalization and death.
ARR? Perbedaan resiko kematian antara
kelompok kontrol dengan kelompok
eksperimen adalah 5,52% : 7,99%.
NNT? 18 orang (death)
13 orang (hospitalization and death).
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Can you apply this valid, important evidence
about therapy in caring for your patient?
Do these results apply to our patient?
Is our patient so differentfrom those in the study that
its results cannot apply?
Is the treatment feasible in our setting?
APPLICABILITY
YES
NO
YES
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What are our patients potential benefits
and harms from the therapy?
Risk of the outcome in our patient,relative to patients in the trial.
Expressed as a decimal:______
NNT/ f =______/______=______
(NNT for patients like ours)
Our patients expected event rate
if they received
the control treatment (PEER) =______
1/(PEER RRR) = 1/________=______
(NNT for patients like ours)
Method I: f
Method II:1/(PEER RRR)
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Are our patients values and preferences
satisfied by the regimen and its consequences?
Do we and our patient have
a clear assessment
of their values and preferences?
Are they met by this regimen and
its consequences?
YES
YES
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THANK YOU
FOR YOUR
ATTENTION.