Vivian Kadus, PharmD

Article 1 Discussion
PGY-1 Pharmacy Resident
2/21/2023 Lutheran Hospital
 OBJECTIVES

01 02 03 04
Interpret Article 1 and Evaluate a patient case Relate the patient case to Develop a patient
summarize the pertinent and assess the important Article 1 medication
information from the patient factors needed to recommendation utilizing
study make a medication the patient specific
recommendation factors, clinical practice
guidelines, and Article 1
Study Design and Execution
Can this study establish a cause-and-effect Yes, randomized and active control
relationship?
What type of randomization was used? Central computer-based service
Was the study evaluating treatment or prevention? Treatment
Was the study parallel or crossover? Parallel
How was the study blinded, if at all? Double-blinded
Should the investigators have used double-dummy? Yes. Which they did, the tablets were placed in
capsules
Was it intention-to-treat or something else? ITT
 Inclusion and Exclusion Criteria

Inclusion Exclusion
• > 18 y/o • No exclusion criteria listed
• Untreated or monotherapy for HTN
• Untreated patients: clinic systolic blood pressure
(SBP) 140-190 mm Hg and diastolic blood pressure
(DBP) 90-109 mm Hg
• Treated patients: clinic systolic blood pressure (SBP)
130-179 mm Hg and diastolic blood pressure (DBP)
85-109 mm Hg

https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12616001144404
Intervention and Control
Intervention
Is the intervention optimal,
considering use, dosing, and
administration, based on tertiary
DI databases?
Quadpill (containing irbesartan
37.5 mg, amlodipine 1.25 mg,
indapamide 0.625 mg, and
bisoprolol 2.5 mg) vs irbesartan
150 mg and placebos tablets , all
treatment was taken once daily
Lowest doses of each medication,
4 drug classes that are
recommended by our CPG
Co-Intervention Control
Are appropriate co-interventions Is placebo the appropriate control
described (HINT: are all patients strategy, considering
receiving gold standard of care?)? inclusion/exclusion criteria?
Based on BP reading additional Irbesartan 150 mg daily plus
medications were able to be added placebo tablet
on at week 6 amlodipine 5 mg was
added to the participant’s regimen This is the recommended dosing
for hypertension per Lexicomp
Outcomes
• Was a “true” primary endpoint described?
• Yes, it was the change in mean unattended office systolic blood pressures at 12 weeks.
• Are the primary and secondary outcome more efficacy or more safety?
• Efficacy, they asses if there are changes in unattended office and office BP readings
• Are the outcomes more clinical or surrogate?
• Surrogate, they are measurable in a lab and serve as disease state markers
• Are they more objective or more subjective?
• Objective, we would all view a patient’s results and interpret them similarly
Enrollment
• Review Figure 1.
• Do they provide everything we’re
looking for under Excluded?
• Does the figure suggest high,
moderate, or low external validity?
• Was this truly an ITT study, or was
it modified somehow?
Baseline Characteristics
Are any demographic or clinical characteristics
imbalanced between groups? What would be the
impact of the imbalance?
What are two or three other things you would you
want to know about the population that is not
included in Table 1? How would you use this
information?
If you had to describe the population using three
clinical (not demographic) characteristics, what
would you say?
More not treated patients in the intervention group
Majority of patient population was white; we know
that other races and ethnicities are at higher risk for
hypertension
What general medications patient’s who were on
monotherapy prior to starting this trial
The population had stage 2 hypertension (BP
>140/90), most of the population was not adequately
treated for their hypertension, and the majority of the
population was overweight (BMI >30)
 Endpoint Results

Statistical significance was found between the groups at 12 weeks in

terms of unattended systolic blood pressure (mean difference = -6 (95%
CI -8 to -4))

However, the study did not meet power, so what does that mean for these
results?
 A. 45 YO smoker, never treated for HTN, with

Which of the an in-office blood pressure of 154/90 mm Hg

patients would B. 55 YO non-smoker, social drinker, being

treated with lisinopril and carvedilol, with an

be most like in-office blood pressure of 141/ 87 mm Hg

the studied C. 55 YO smoker, with T2DM and

hyperlipidemia, on amlodipine and
hydrochlorothiazide, in-office blood pressure of
population in 128/69 mm Hg

Article 1? D. 65 YO smoker, never treated for HTN, in-

office blood pressure of 125/88 mm Hg
Patient Case
 You are on an ambulatory care APPE rotation. The medical resident working in the
family practice office states that he has a new patient who he feels would benefit from
being on multiple hypertension medications to get him at goal ASAP. The patient has
just been diagnosed and never received any medications for hypertension.

 Work in small groups to determine what subjective and objective information you need
to help determine if you would recommend the quad pill for this patient.
 Patient Case
Demographics PMH Allergies

40 YOWM Depression NKDA

Current Medications Key labs and values Social history

Sertraline 50 mg daily, ibuprofen HR 70 BPM, in office blood Social alcohol, walks his dog
200 mg PRN pressure 131/85 mm Hg everyday for 15 minutes as
exercise, smokes 1 ppd, third party
insurance through employer

COLLECT
 Patient Case
 Take a few minutes to work in groups and determine what recommendations are given by our clinical practice guidelines that would apply to
this patient.

 What lifestyle modifications can you recommend for this patient?

 Weight loss 

 Heart healthy diet 

 Decreased sodium intake 

 Smoking cessation 

 What is the recommend blood pressure medications?

 The primary agents used in the treatment of hypertension include thiazide diuretics, ACE inhibitors, ARBs, and CCBs

 When should he follow up with the medical resident?

 One month

 What is his blood pressure goal?

 <130/80

ASSESS
 Article Application to Patient
 In a PubMed panic you locate Article 1:
 Looking at the inclusion criteria, how is this patient similar and different to the study
population?
 Similar: >18YO, untreated HTN
 Different: BP < 140/90 mm Hg
 Looking at the baseline characteristics, how is the patient similar and different from the studied
population
 Similar: white, male, not treated for HTN, smoker
 Different: 40 YO, office BP 131/85 mm Hg

ASSESS
 Article Application to Patient
 What would you recommend for this patient considering the following:
 ACC/AHA clinical practice guideline
 Article 1
 Tertiary DI resources

 Take a few minutes to develop a response for what you would recommend to the
provider and make sure to include what you would monitor to ensure you
recommendation is successful for the patient.

PLAN
MONITOR
 That the pt follow lifestyle

What would modifications such as weight loss,

following a heart healthy diet,
decreasing sodium intake, and
you smoking cessation 

recommend to The pt’s blood pressure is not that

the medical far from goal, his 10-year ASCVD
risk is <10% so he does not need
resident? pharmalogical therapy, however, if
he wants to one of the four classes
would be fine
Key Takeaway Points
A quick review of the abstract would not get you to the level of critical evaluation
we just achieved

The investigators concluded that quadpill demonstrated the efficacy, tolerability,

and simplicity on these results in the abstract

Your ability to incorporate primary literature into patient cases is dependent on how
well you can apply inclusion/exclusion criteria and baseline characteristics to the
patient in front of you
To Do List
Work on your DIQ response. You need to send your
response to your initial email by the end of the day.
Written responses are due Wed, Mar 1.

We begin Handout 2 and STATS next week! Get

started by reviewing Handout 2 in its entirety then
focus on the objectives for the RAQ.