JOURNAL ANALYSIS ENGLISH NON-MODUL MEDICAL

FACULTY OF UNISSULA

NAME : LINTANG LAILA RIZQY

NIM: 30101306976
CLASS : 17

TITLE : Irbersartan in Patient with Heart failure and Peserved ejection Fraction
1. Identify the PICO of the jounal.
P = Patient with heart failure
I = Irbesartan
C = Placebo
O = Primary : reduce need for hospitalization;secondary : reduce mortality
2. How was the problem identified & formulated?
- Patients blinded : use single blind placebo for 1 to 2 weeks before randomization
- Randomization : randomly assigned in a 1:1 ratio to receive irbesartan or
matching placebo. the randomizationn shedule was implemented with the use of
an interactive voice-response system.randomizaton of patients who were taking an
ACE inhibitor at baseline was capped at 33% at each site.
- Treated the same : patient were started on 75 mg of irbesartan or placebo once
daily, and was doubled to 150 mg after 1 to 2 weeks and was double again to 300
mg after in additional 1 to 2 weeks with a titration visit, patient were seen 8
weeks, 14 weeks and 6 months thereafter and do the mesurrement of serum
creatinin and potassium and at weeks 2 and 8, at month 6 and anually thereafter
and, along with NT-proBNP.
- Meta analysis blinded : the executive commitee designed and oversaw the trialinn
collaboration with representatives of the study sponsor.
- Investigator blinded : all investigator and committee members who were invoved
in the conduct of the study were unaware of study –group as signments.
- Adjudicators blinded : the primary outcome, reasons for such hospitalization
including worsening heart failure, myocardial infarction, stroke, unstable angina,
ventricular or artrial disritmia, or myodial infraction or stroke that ocurred during
any hospitalization. The secondary outcomes were the components of the primary
outcome, a composite heart failure outcome a change in the plasma level of NT-
proBNP at 6 months, a composite vaskular –event outcome and death from
cardiovaskular causes. Deaths and hosppitalizationns were adjudicated by
members of a independent end-point committee who were unaware of study group
as signments and used prepecified criteria.
- Intention to treat : data from all patients who underwent randomization were
analyzed according to the intention to treat principle
- Treated the same : at the end of titration phase, 84% patient in the irbesartan group
and 88% of those in placebo group had reached the 300 mg dose
 - Follow up : at the end of stusy, vital-status data were not available for 29 patients
(1%) in the irbesartan group and 44 patient(2%) in the placebo group. If contact
could not be made at nd of study, data for these patient were censored from the
analysis at the date they were last known to be alive
3. What was the objective of the study?
To analyze death and hospitalization of patient with hearth failure can be decrease by
irbesartan or not
4. What was the hypothesis of the study?
Irbersartan did not improve the outcomes of patients with heart failure and a peserved
left ventricular ejection fraction.
5. Formulated the clinical question of the study.
- What is heart failure with ejection fraction?
- What is the irbesartan?
- What are effects of ibesartan in patients with this syndrome?
- How to analyze effect of irbesartan to patient with heart failure?
- How are the outcome of patient with heart failure?
- What are requirement of irbesartan to be able improve the outcome of patient with
hert failure?
- Where the study be held?
- Who are participated to analyze?
- How method to get the patient with heart failure to researc?
- What kind irbesartan be used?
- How are the outcome of patient with heart failure and with irbesartan?
6. What was / were study design (s) used by the researcher?
The researcher use the study design of RCT>cohort>case control> case series
7. When and where was the study conducted?
On december 4,2008 and the study be held in california, San Fransisco and
Washington DC
8. How were the seting and subject determined? How was the sample drawn?
The seting and subject determined by the patient with heart failure and ejection
fraction. And the sample was drawn by randomization with single blind, all patient
written inform consent, randomly assigned in a 1:1 ratio to receive irbesartan or
matcing placebo.
9. What types of instruments were used in the study?
The type instruments is therapy, such as irbesartan with ACE inhibitor and without
ACE inhibitor, NT-proBNP
10. Mention the inclusion and exclusion criteria of the patients.
- Inclusiuon : at least 60 years of age and had heart failure symptoms and a left
ventricular ajection fraction of at least 45%.
- Exclusion : exclution criteria included previous intolerance to an angiotensin-
receptor blocker ; an alternative probable cause of the patent’s symptoms ; any
previous left ventricular ejection fraction below 40%; a history of acute coronary
syndrome, coronary revaskularization, or stroke within the previous 3 month;
subtantial valvular abnormalities; hypertropic or restrctive cardiomyopati;
pericardial disease; cor pilmonale or other cause of isolated rightheart failure; a
systolic blood pressure of less than 100 mm Hg or more than 95 mmHg despite
 antihypertensive therapy; other systemic disease limiting life expectancy to less
than 3 years; substantial laboratory abnormalities (such as a hemoglobin level of
less than 11 g per deciliter or liver function abnormalities); or characteristics that
might interfere with complience with the study protocol.
11. How was the study procedure conducted?
12. How was the data gathered? Who gathered the data?
13. What technique of analysis was/were used by researcher?
14. What was/were the result like?
15. What was/were the strength (s) and weakness(es) of the study?
16. Was/ were there any side effect(s)