A Critical Appraisal of An Article Claiming Effectives of Treatment

The Comparative Effects of Azilsartan Medoxomil and Olmesartan

on Ambulatory and Clinic Blood Pressure
Objectives
1. To establish the validity of the study result that claims Azilsartan Medoxomil has greater BP
lowering effect than the other ARB
2. To contribute credible evidences to the data base of medical literature
3. To apply these valid results in the daily practice
Clinical Scenario
A. E. 56 year old male, married from Iligan City came in for elevated BP.
He is a known hypertensive for 5 years and maintaining Amlodipine 5mg tab 1 tab OD.

Research Question:
There are currently 7 approved Angiotension Receptor Blocker (ARB) in the market and joining
the lineup is the new Azilsartan Medoxomil as the 8th ARB. The main question does azilsartan have
distinguishing features that should motivate choosing it over any of the other sartans for use in clinical
practice?
Citation
Bakris GL, Sica D, Weber MA, et al. The comparative effects of azilsartan medoxomil and olmesartan on
ambulatory and clinic blood pressure. J Clin Hypertension (Greenwich). 2011;13:8188.
Clinical Characteristics of the Study
1. Population
Inclusion Cirteria
1. Men or women > 18 years old
2. Diagnosed with primary hypertension (SBP > 150mmHg and <180 mmHg and 24 hour mean
SBP >130mmHg and <170 mmHg
3. Screening laboratory test were within the reference range
Exclusion Criteria
1. Sitting clinic diastolic BP (DBP) >114mmHg
2. History of major cardiovascular events, significant cardiac conduction defects, secondary
hypertension

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Poor compliance during the placebo run-in period

Severe renal impairment (estimated glomerular filtration rate <30mL/min/1.73m 2)
Known or suspected renal artery stenosis
Type 1 or poorly controlled type 2 diabetes
Significant hepatic abnormalities
Hyperkalmenia
Baseline ABPM reading of insufficient quality

2. Interventions Compared
Azilsartan Medoxomil 20mg, 40mg and 80mg OD versus Olmesartan Medoxomil 40mg
OD and placebo.

3. Outcomes Monitored
Primary Endpoints
a. Change in 24 hour mean systolic BP at week 6
Secondary Endpoints
a. Change in trough sitting clinic systolic BP at week 6
b. Change from baseline 24 hour mean DBP by ABPM

Definition of Terms
1. Primary Hypertension

Study Validity
1. Were the patients randomly assigned to treatment groups?
Yes, the study randomized eligible patients after a 2week placebo controlled run-in trial with a
total of 1275 patients assigned to different groups.
2. Was allocation concealed?

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Yes, the study design was randomized, multicenter, parallel group, double-blind.
Were baseline characteristics similar at the start of the trial
Were patient, caregivers, study personnel blinded to treatment assignment?
Were all patients analyzed under the groups to which they were originally randomized?
Was follow-up adequate?
Aside from the experimental intervention were the groups treated equally?
How large was the treatment effect
Were all clinically important adverse effect considered?

II. Results

Authors Conclusion
The study suggest that Azilsartan Medoxomil 80mg is more effective in reducing SBP than the
higest approved does of Olmesartan Medoxomil, which is considred to be more effective than
others in the ARB class.
Reviewers Concluson

Resolution of the Scenario