PEMICU 2

Kelompok 6

VALIDITY
1.a. Yes, randomized placebo controlled study
1.b. Yes, age 66 years old, Men (68%)
Clinical status:
had experience a previous MI (53%)
had current angina (24%)
had heart failure of ischemic etiology (62%)
had diabtes mellitus (28%)
had undergone
percutaneus coronary intervention (16%)

Drug:
ACE Inhibitor (41%)
Beta blocker (55%)
Lipid lowering drug (42%)
Aspirin (56%)
Diuretic (83%)

2.a. Yes, condesartan/ match placebo starting at a dosage of 4 or

8 mg once daily, which was increased as tolerated to target of 32
mg once daily
2.b. Unclear. Study outcome was ascertained according to the
intention to treat principle

3.M. Yes, double blind (a blinded central adjudication process

without knowledge of treatment assignment)

IMPORTANCE OF STUDY
Result

1. How large was the treatment effect

Outcome :
2. CV death or non fatal MI
3. Non fatal MI
4. CV death
5. Fatal MI, sudden death, or non fatal MI
6. Sudden death or fatal MI
7. Hospitalization
a. Unstable angina b. Revascularization procedures

Relative Risk (RR)= Resiko terapi/Resiko placebo

1. Outcome (1): 775/868=0,89
2. Outcome (2): 116/148=0,78
3. Outcome (3): 691/769=0,89
4. Outcome (4): 459/522=0,87
5. Outcome (5): 360/394=0,91
6. Outcome (6a): 394/397=0,99
7. Outcome (6b): 236/241=0,97

RR<1, DECREASE
THE RISK OF
OUTCOME
RR>50%,
CLINICALLY
SIGNIFICANT

Absolute Relative Risk (ARR)= resiko control-resiko treatment

1. Outcome (1): 868-775=93
2. Outcome (2): 148-116=32
3. Outcome (3): 769-691=78
4. Outcome (4): 522-459=63
5. Outcome (5): 394-360=34
6. Outcome (6a): 397-394=3
7. Outcome (6b): 241-236=5

Jika ARR=0,
terapi tidak
berefek

Relative Risk Reduction (RRR)= ARR/resiko control atau 1-RR

1. Outcome (1): 1-0,89= 0,11
2. Outcome (2): 1-0,78= 0,22
3. Outcome (3): 1-0,89= 0,11
4. Outcome (4): 1-0,87= 0,13
5. Outcome (5): 1-0,91= 0,9
6. Outcome (6a): 1-0,99= 0,1
7. Outcome (6b): 1-0,97= 0,3

Number Need to Treat (NNT)= 1/ARR x jml sampel

1. Outcome (1): 1/93 x 3803= 40
2. Outcome (2): 1/32 x 3803= 118
3. Outcome (3): 1/78 x 3803= 48
4. Outcome (4): 1/63 x 3803= 59
5. Outcome (5): 1/34 x 3803= 111 (NA)
6. Outcome (6a): 1/3 x 3803= 1267 (NA)
7. Outcome (6b): 1/5 x 3803= 760 (NA)
(NA) : Not Applicable

MAGNITUDE

variabel

Clinical significant

Statistic
significant

CV death or non fatal MI

Yes

Yes

Non fatal MI

Yes

Yes

CV death

Yes

Yes

Fatal MI, sudden death, or non fatal MI

Yes

Yes

Sudden death or fatal MI

No

No

Hospitalization
a. Unstable angina
b. Revascularization procedures

No

No