Effect of Carvedilol on Survival in Severe Chronic Heart Failure

The New England Journal of Medicine

CRP 2

PRESENTED BY: B8

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 betablocker may have adverse effect and worsen the heart failure.

Objective : To prove whether carvedilol (beta-blocker agent) could improve symptoms and reduce the risk of severe chronic heart failure progression. To prove whether carvedilol ( beta-blocker agent ) can interfere with the adverse effect of sympathetic activation through several nonadrenergic mechanisms.

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 standard therapy for heart failure was continued.

Therapy Worksheet
Validity : Are the results of this single preventive 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 entry criteria were randomly signed in a 1:1 ratio,.

 Was the randomization list concealed? Answer: Yes, based on page 1652 Statistical Analysis section par. 3 : An independent data and safety monitoring board was prospectively constituted at the start of the study;.

 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.

 Were all patients analyzed in the groups to which they were randomized? Answer : Yes, based on Statistical analysis section page 1652 : The analyses included all randomized patients and all events were attributed to the patients original randomly assigned treatment group (according to the intentionto-treat principle.

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

Were the groups treated equally, apart from the experimantal treatment? Answer: Yes
Reff: page 1652, Methods : study design, paragraph 1

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

IMPORTANT

Group/ death

no
943

yes 190 1133

1026

130

1156
2289

Relative risk reduction (RRR)

Absolute risk reduction (AAR)

CER - EER

Number needed to treat (NNT)

1/ARR

CER

EER

CER EER/CER

190/1133 = 16,77%

130/1156 = 11,25%

16,77%11,25%/16,77% = 32,90% 95 %

16,77%11,25% = 5,52% 19% - 48%

1/5,52% = 18 2 to 5

Group/ Hospital

no

yes

P C

626 731

507 425

1133 1156
2289

Relative risk reduction (RRR)

Absolute risk reduction (AAR)

CER - EER

Number needed to treat (NNT)

1/ARR

CER

EER

CER EER/CER

507/1133 = 44,75%

425/1156 = 36,76%

44,75%36,76%/44,75% = 17,85% 95 %

44,75%36,76% = 7,99% 13% - 33%

1/7,99% = 13 3 to 8

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).

APPLICABILITY
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 different from those in the study that its results cannot apply? Is the treatment feasible in our setting?
YES NO

YES

What are our patients potential benefits and harms from the therapy?

Method I : f

Risk of the outcome in our patient, relative to patients in the trial. Expressed as a decimal:______ NNT/ f =______/______=______ (NNT for patients like ours)

Method II :
1/(PEER RRR)

Our patients expected event rate if they received the control treatment (PEER) =______ 1/(PEER RRR) = 1/________=______
(NNT for patients like ours)

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

THANK YOU FOR YOUR ATTENTION.