Pleno Crp b8

7/29/2019 Pleno Crp b8

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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.

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