LITHUANIAN UNIVERSITY OF HEALTH SCIENCES

FACULTY OF PHARMACY

INSTITUTE of PHYSIOLOGY and PHARMACOLOGY

Leonid, Feigelman

“PATTERNS of USING

ANTIHYPERTENSIVE DRUGS IN

OUTPATIENT SETTINGS”

Master‘s Thesis

Thesis Supervisor: Professor Romaldas Mačiulaitis

Kaunas ‚ 2014

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LITHUANIAN UNIVERSITY OF HEALTH SCIENCES

FACULTY OF PHARMACY

INSTITUTE of PHYSIOLOGY and PHARMACOLOGY

I APPROVE

Dean of the faculty of Pharmacy

Name, Surname, signature

Date (year, month, day)

PATTERNS of USING

ANTIHYPERTENSIVE DRUGS IN

OUTPATIENT SETTINGS

Master‘s Thesis

Thesis Supervisor

Name, Surname, signature

Date (year, month, day)

Reviewer The thesis performed by

Name, Surname, signature Leonid, Feigelman,

Date (year, month, day) Date (year, month, day)

KAUNAS, 2014

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TABLE OF CONTENTS

SUMMARY ............................................................................................................................................. 4

ABBREVIATIONS ................................................................................................................................ 5

1. INTRODUCTION............................... ............................................................................................... 6

1.1 Thesis Aim............................... ...................................................................................................... 8

1.2 Thesis Objectives............................... ........................................................................................... 8

2. LITERATURE SURVEY............................. ..................................................................................... 9

3. RESEARCH METHODOLOGY............................. ....................................................................... 16

3.1 Research Model............................. ............................................................................................. 16

3.2 Thesis methods guidelines and instruction fo the process…………………. ......................... 19

3.3 Research Context…………………. ........................................................................................... 19

3.3 Research Facility............................. ........................................................................................... 19

3.4 The Research Variables………………… ................................................................................. 02

3.5 The Research Course…………………. .................................................................................... 02

3.6 Data Analysis………………….. ................................................................................................ 02

4. THE RESULTS AND THEIR DISCUSSION ……………. .......... Error! Bookmark not defined.

5. CONCLUSIONS…………………. ................................................... Error! Bookmark not defined.

6. RECOMMENDATION FOR FUTURE RESEARCH…………………. ... Error! Bookmark not

defined.

7. REFERENCES…………………. ..................................................... Error! Bookmark not defined.

APPENDIX „A“ ................................................................................................................................... 39

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SUMMARY

Leonid, Feigelman‘s master thesis is presented here with the assistant of Thesis Supervisor. Professor

Romaldas Mačiulaitis from the Lithuanian University of Health Sciences, Faculty of Pharmacy,

INSTITUTE of PHYSIOLOGY and PHARMACOLOGY– Kaunas. The thesis title: PATTERNS of USING ANTIHYPERTENSIVE DRUGS IN

OUTPATIENT SETTINGS

We did not know the patterns of using antihypertensive drugs in outpatient settings in Israel that is

why we raised a research aim to analyze the pattern of use of HBP in outpoint setting.

In order to meet this aim we raised several research objectives:.

1) Does lifestyle modification is important for the patient for blood pressure control?

2) Do the patients need to change their medication at set of time until BP goals reached?

3) Does the use of more than one drug would help achieving better HBP results?

Does the use of single doses combination would have better affect then using fixed dose

combination?

4) How often noncompliance take in HBP control?

5) How many patients suffer from side effects?

Methods: a questionnaire composed of 36 questions and qualitative statistical analysis.

Participants: the participants are people over the 18, who are suffering and taking medication for

HBP.

Results: After analyzing replays of 137 patients 60% stated both lifestyle modification and started to

use prescribed medication. 86( 63.24%) patients had to change medication until they reached the

therapeutic goal while the rest (36.7%) did not need to change them for same reason. 96% of the

patients stated they are taking thier medication ever since they had started, with no stopping.

87% of the patients stated they would need to take thier medication for life.

53% stated they are taking the medication at set hours always, whilest 32% stated they are taking the

medication at set hours most of the time and 15% are not taking it at set hours. 54 (39.71%) stated that

they have sufferd from side affects, such us headeache skin blushing and most comon dry cough from

ACE inhibitors

Conclusions: based on the results of our study we can conclude that most of our patients, who

controlled blood pressure, made the lifestyle modification in addition to taking prescribed medication;

most patients would be required to change their medication at least once before thier BP would be

reduced and reached its goal; by using more than one drug, it would help in amost half of the patients

in achieving better control of the HBP and thus single doses combination would have less effect then

using fixed dose combination; almost half of our patients did not comply with the recommendations

for their treatment; and almost half (40%) of patients have experience side effects from using

medication for HBP control.

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ABBREVIATIONS

Hypertension – HTN

Blood Pressure – BP

High blood pressure – HBP

Multiple Risk Factor Intervention Trial – MRFIT

Cardiovascular Heart Disease – CHD

Systolic Blood Pressure – SBP

Diastolic Blood Pressure – DBP

Left Ventricular Hypertrophy – LVH

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1. INTRODUCTION

PATTERNS of USING ANTIHYPERTENSIVE DRUGS IN

OUTPATIENT SETTINGS in Israel: Hypertension (HTN) are a chronic medical condition in

which the blood pressure in the arteries is elevated. This requires the heart to work harder than normal

to circulate blood through the blood vessels. Normal blood pressure at rest is within the range of 100-

140mmHg systolic (top reading) and 60-90mmHg diastolic (bottom reading). High blood pressure is

said to be present if it is persistently at or above 140/90 mmHg. (Chobanian AV, Bakris GL, Black HR

et al. , August 2004).

High blood pressure can be controlled through healthy lifestyle habits and if that by utself

doesn‘t wirk then by taking medicines, if needed (Nadar S, Lip G, March 2009)

The following are substantial factors that can lead to high blood pressure and people who

have any of them are more likely to suffer from HBP:

Heritage & Family history: parents or other close relatives.

Older age: ≥65 years of age, 55 to 64 years of age and last & least 45 to 54.

Obesity & Overweight.

Current alcohol drinking and smoking status.

Diabetic Status, Albuminuria & TG.

Lack of Physical Activity and Physiological stress.

(Calhoun DA, Jones D, Textor S et al., April 2008)

A blood pressure monitor is the way to know for sure whether your blood pressure is too high.

(Yodfath Y, January 2005). You must check your blood pressure more often; in any case your blood

pressure is higher than it used to be. At that point it is best to purchase high-quality, automated arm

blood pressure cuffs (or ambulatory blood pressure monitor) for self-use and to keep track several

times a day of your numbers. (Sunil N, Gregory L, March 2009)

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The higher the BP and the more severe the retinal changes and other evidence of target-organ

involvement, the worse is the prognosis. A normal blood pressure is less than 120/80. High blood

pressure is 140/90 or higher. If your blood pressure is between 120/80 and 140/90, you have what is

called "Prehypertension", which means that if you don’t take important steps, your elevated blood

pressure can turn into high blood pressure. Hypotension, or low blood pressure, happens when your

systolic pressure is consistently below 90, or 25 points below your normal reading. (Greenhalgh J,

Dickson R & Dundar Y, 2009)

The goal of treatment is to reduce your blood pressure to normal levels with medicine that's

easy to take and has few, if any, side effects. This goal can almost always be achieved. (Rahman M,

May 1993)

The medicines that are being used to treat high blood pressure are called antihypertensive

medicines. (Bakris GL, July 2011) If your blood pressure can only be controlled with medicine, you'll

need to take the medicine for the rest of your life. It is common to need more than one medicine to

help control your blood pressure.

Initially one drug is given, for most hypertensive patients, either a thiazide-like diuretics, a

renin-angiotensin blocker or antagonist, or a Ca channel blocker.

Some antihypertensives are contraindicated in certain disorders (eg, β-blockers in asthma) or are

indicated particularly for certain disorders (eg, β-blockers or Ca channel blockers for angina pectoris,

ACE inhibitors or angiotensin II receptor blockers for diabetes with proteinuria). (Yodfath Y, January

2005)

If the initial drug is ineffective or has intolerable side effects, another drug can be substituted.

If the initial drug is only partly effective but well tolerated, adding a second drug with a different

mechanism is much more likely to achieve BP goal than increasing the dose of the initial drug. (Longo

DL, Fauci AS, Kasper DL et al., January 2013)

“We did not know the patterns of use of antihypertensives in Israel and this is why we raised

an objecitve to analyse the pattern of use of HBP in outpoint setting in Israel“

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THE THESIS AIM is to know the patterns of use of antihypertensives in Israel

1.1 Thesis Aim

Analyzing the pattern of use of HBP in outpoint setting in Israel.

1.2 Thesis Objectives

The objectives we came to with regards to the research aim were also our guidelines in the

relevant questions writing in the questionnaire. There were many other objectives we could

go for, but in the end we had chosen the following as the main and most important ones:

Does lifestyle modification is important for the patient for blood pressure control?

Do the patients need to change their medication at set of time until BP goals reached?

Does the use of more than one drug would help achieving better HBP results?

Does the use of single doses combination would have better affect then using fixed dose

combination?

How often non compliance take in HBP control?

How many paints suffer from side affects?

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2. LITERATURE SURVEY

What is blood pressure?

Blood pressure is the amount of force that the blood puts on the artery walls as it moves through the

body. Here’s how it works: Arteries are blood vessels that carry blood from the heart to the rest of the

body. When the heart beats, it pushes the blood through the arteries. As the blood moves, it puts

pressure on the artery walls. (Lindberg ADB, October 1998)

What is hypertension or High Blood Pressure?

Hypertension (HTN) or high blood pressure, sometimes called arterial hypertension, is

a chronic medical condition in which the blood pressure in the arteries is elevated. This requires the

heart to work harder than normal to circulate blood through the blood vessels. Blood pressure is

summarised by two measurements, systolic and diastolic, which depend on whether the heart muscle is

contracting (systole) or relaxed between beats (diastole) and equate to a maximum and minimum

pressure, respectively. Normal blood pressure at rest is within the range of 100-140mmHg systolic (top

reading) and 60-90mmHg diastolic (bottom reading). High blood pressure is said to be present if it is

persistently at or above 140/90 mmHg. (Chobanian AV, Bakris GL, Black HR et al. , August 2004)

From an epidemiologic perspective, there is no obvious level of blood pressure that defines

hypertension. In adults, there is a continuous, incremental risk of cardiovascular disease, stroke, and

renal disease across levels of both systolic and diastolic blood pressure. The Multiple Risk Factor

Intervention Trial (MRFIT), which included >350,000 male participants, demonstrated a continuous

and graded influence of both systolic and diastolic blood pressure on CHD mortality, extending down

to systolic blood pressures of 120 mmHg. Similarly, results of a meta-analysis involving almost 1

million participants indicate that ischemic heart disease mortality, stroke mortality, and mortality from

other vascular causes are directly related to the height of the blood pressure, beginning at 115/75

mmHg, without evidence of a threshold.

Clinically, hypertension may be defined as that level of blood pressure at which the institution of

therapy reduces blood pressure–related morbidity and mortality. Current clinical criteria for defining

hypertension generally are based on the average of two or more seated blood pressure readings during

each of two or more outpatient visits.

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A recent classification recommends blood pressure criteria for defining normal blood pressure, pre-

hypertension, hypertension (stages I and II), and isolated systolic hypertension, which is a common

occurrence among the elderly. In children and adolescents, hypertension generally is defined as

systolic and/or diastolic blood pressure consistently >95th percentile for age, sex, and height. Blood

pressures between the 90th and 95th percentiles are considered pre-hypertensive and are an indication

for lifestyle interventions. (Longo DL, Fauci AS, Kasper DL et al., January 2013)

What are the symptoms of High Blood Pressure?

Usually, no symptoms develop unless hypertension is severe or long-standing (Bakris GL, July 2011).

This is why it's sometimes called “the silent killer” and why it’s so important to have the blood

pressure checked regularly. High blood pressure can be controlled through healthy lifestyle habits and

taking medicines, if needed (Nadar S, Lip G, March 2009).

What causes High Blood Pressure?

Several different things can cause high blood pressure. In general, there are 2 types of high blood

pressure:

Primary hypertension, also called essential hypertension, is when there is no known cause for the high

blood pressure. This type of blood pressure usually takes many years to develop and probably is a

result of a lifestyle, environment, and aging body changes (Calhoun DA, Jones D, Textor S et al., April

2008).

Secondary hypertension is when a health problem or medicine is causing the high blood pressure.

Such as birth control pills for female, excessive alcohol or licorice intake and sleep apnea mainly for

male, thyroid or adrenal gland problems or Kidney problems or obesity for both sexes. (Sandberg K, Ji

H, March 2012).

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What are the risk factors for high blood pressure?

In studies of the last several years, it is proven that the risk of developing HBP is rising, the incidence

of HBP is high, and SBP of ≥140 mm Hg is the predominant form of HBP. (Bakris GL, July 2011)

The following are substantial factors that can lead to high blood pressure and people who have any of

them are more likely to suffer from HBP:

Heritage & Family history: parents or other close relatives.

Older age: ≥65 years of age, 55 to 64 years of age and last & least 45 to 54.

Obesity & Overweight.

Current alcohol drinking and smoking status.

Diabetic Status, Albuminuria & TG.

Lack of Physical Activity and Physiological stress.

(Calhoun DA, Jones D, Textor S et al., April 2008)

How is high blood pressure being diagnosed?

A blood pressure monitor is the way to know for sure whether your blood pressure is too high.

(Yodfath Y, January 2005)

There is various blood pressure monitors, some of them are for self-use. But when your blood pressure

is first diagnosed as too high, it is best to turn to your doctor or any other Healthcare Professional to

check your blood pressure.

You must check your blood pressure more often; in any case your blood pressure is higher than it used

to be. At that point it is best to purchase high-quality, automated arm blood pressure cuffs (or

ambulatory blood pressure monitor) for self-use and to keep track several times a day of your numbers.

(Sunil N, Gregory L, March 2009)

What are the prognosis of High Blood Pressure? Systolic vs. Diastolic –

what do they mean and what do thier numbers mean?

The higher the BP and the more severe the retinal changes and other evidence of target-organ

involvement, the worse is the prognosis.

The systolic blood pressure is the first number. This is the peak blood pressure when your heart is

squeezing blood out. The diastolic blood pressure is the second number is. It's the pressure when

your heart is filling with blood — relaxing between beats.

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A normal blood pressure is less than 120/80. High blood pressure is 140/90 or higher. If your blood

pressure is between 120/80 and 140/90, you have what is called "Prehypertension", which means that

if you don’t take important steps, your elevated blood pressure can turn into high blood pressure.

Hypotension, or low blood pressure, happens when your systolic pressure is consistently below 90, or

25 points below your normal reading. (Greenhalgh J, Dickson R & Dundar Y, 2009)

How High Blood Pressure is generally treated? Treatment usually begins with changes you can make to your lifestyle to help lower your blood

pressure and reduce your risk of heart disease. If these changes don't work, you may also need to take

medicine. (Calhoun DA, Jones D, Textor S et al., April 2008)

Which Lifestyle modifications are recommended?

The steps to take when you first diagnosed with HBP are: Weight loss and exercise for at least 30min/day.

Smoking cessation.

Diet: Increased fruits and vegetables and low-fat dairy products, decreased salt, limited alcohol.

Try relaxation techniques or biofeedback.

(Various;)

What about drugs & medicine?

The goal of treatment is to reduce your blood pressure to normal levels with medicine that's easy to

take and has few, if any, side effects. This goal can almost always be achieved. (Rahman M, May

1993)

When Antihypertensive Drug is required?

The medicines that are being used to treat high blood pressure are called antihypertensive medicines.

(Bakris GL, July 2011)

If your blood pressure can only be controlled with medicine, you'll need to take the medicine for the

rest of your life. It is common to need more than one medicine to help control your blood pressure.

Don't ever stop taking the medicine without consulting with your doctor, or you may increase your risk

of having a stroke or heart attack. (Greenhalgh J, Dickson R & Dundar Y, 2009)

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Which Antihypertensive Drugs choices there are and what are thier

indications?

Initially one drug is given, for most hypertensive patients, either a thiazide-like diuretics, a renin-

angiotensin blocker or antagonist, or a Ca channel blocker.

Some antihypertensives are contraindicated in certain disorders (eg, β-blockers in asthma) or are

indicated particularly for certain disorders (eg, β-blockers or Ca channel blockers for angina pectoris,

ACE inhibitors or angiotensin II receptor blockers for diabetes with proteinuria). (Yodfath Y, January

2005)

Achieving adequate control often requires several evaluations and changes in drug therapy. The patient

must be very patience & cooperative through all the way and is required to overcome any reluctance to

titrate or add drugs and change of the dosage and distribution of medicines across the day, until BP is

at an acceptable level. Lack of patient adherence, particularly because lifelong treatment is required,

can interfere with adequate BP control. It is important to remember that one of the features of blood

pressure is natural differency during the day, also depending on the activity of the patient. Meanwhile,

some drugs may not match due to some side effects and others.

If the initial drug is ineffective or has intolerable side effects, another drug can be substituted. If the

initial drug is only partly effective but well tolerated, adding a second drug with a different mechanism

is much more likely to achieve BP goal than increasing the dose of the initial drug. (Longo DL, Fauci

AS, Kasper DL et al., January 2013)

If initial systolic BP is > 160 mm Hg, 2 drugs are often used from the start. Options that effectively

reduce hypertensive complications include combining a diuretic with either a β-blocker, an ACE

inhibitor, or an angiotensin II receptor blocker; and combining a Ca channel blocker with either an

ACE inhibitor or an angiotensin II receptor blocker. An appropriate combination and dose are

determined; Hypertension is defined as resistant when BP remains > 160/100 mm Hg despite use of 3

different antihypertensive drugs with complementary mechanisms of action (one of which being a

diuretic).

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According to the latest recommendations, the two main groups of hypertension drugs that delay or

reduces the activity of a protein called angiotensin. This protein has a wide range of roles and effects

on vascular system, kidneys and heart and even the brain. One of the salient characteristics of

angiotensin is shrinking blood vessels, thereby reducing its activities or lifting causes decrease blood

pressure. (Chobanian AV, Bakris GL, Black HR et al. , August 2004)

What can happend if the patient forget to take thier Antihypertensive drugs as they should or if

they omit some doses?

Since the HBP is a long term situation, its treatment must be such as well. In case a patient forget or

omit some doses of the treatment, he is in a risk the his HBP will not be controlled and that can be

sometimes even more risky than not to treat the HBP at all.

What is the difference between the patients who forget or omit taking thier medication in case

they are using fixed dose combination and combinations of single doses?

The fixed dose combination considered to be better for controlling the HBP than the single doses,

however the fixed dose combination also requires much stricked continuity in taking the medication

and in case the continuity is being stopped often, the effect on the patient can be for the worst because

it would be as if he statred the treatment from the beginning and his body would not be able to consist

the medicatino all together and it would not only that the HBP would not be controlled, but it could

also become higher. In the single doses treatment each break would actually bring back the patient to

the period of having HBP without treating it and then the patient risk getting all the side effects he

previously had prior to the treatment and having his HBP skyrocket.

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According to the expected results, we can realize which of the research objectives we might come to

and foritify.

fortified by our questionnaires and confirmed that indeed patients who make lifestyle modification

have more chance to have thier BP controlled quicker with the help of prescribe medication.

We could also realise by Higgins B, Williams B, Williams H, et. Al.(October 2013) that made studies

in different treatment groups and came to the final conclusion that lifestyle interventions in any

treatment group caused reduction of 10mmHg or more is systolic blood pressure.

does patients need to change thier medication at least once before thier BP would be reduced and

reached its goal. That assumption was fortified perfectly by our questionnaire.

Also several articles and researches (Gibbons G H, November 2010 ; Beckerman J, January 2013 ;

James PA, Oparil S, Carter BL, et al., December 2013; Katakam R; Brukamp K; Townsend RR,

September 2008) with regards to the medication for HBP agrees that It may take some trial-and-error

testing to find the combination of high blood pressure medicine that works best for you. Many people

need more than one type of high blood pressure medicine in order to get the best results. Some of these

medicines are combined into one pill.

the use of more than one drug would usually help achieving adequate and faster control of the HBP

and it was also utterly fortified.

According to the the ADA's Clinical Practice Recommendations for 2013 (January 2013) it is

essential to take at least 2 drugs or more in maximal dosages, in order to enable toreach the goal of

reducing the blood pressure of all patients in general and even more in patients that are at high risk

due to diabetic or other kydney diseases.

was our principal assumption that also led us to our research purpose and it indicated if using single

doses combination would have less affect then using fixed dose combination. We cannot really fortify

that assumption as is by the questionnaires, but it is certainly a conclusion that we can make out of the

questionnaires looking at the answers of those patients that are taking the fixed dose combination vs.

the ones that are taking the single dose.

Analyses were also performed by Stanton T & Reid J L (February 2002) concerning using single doses

combination and one of the final conclusions was that a judicious approach to prescribing would

therefore suggest the use of low-dose combination products early in the treatment plan. The benefits of

the combination selected and actual doses used over monotherapy must be proven. The two drugs in

combination must be established to lower blood pressure by a greater amount than each alone. Lower

doses in combination must be as effective as usual monotherapy doses but with fewer side effects.

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3. RESEARCH METHODOLOGY

3.1 Research Model

Independent Variable Dependent Variable

Intervene Variable

3.2 Thesis methods guidelines and instruction of the process

3.2.1 Translation of the prepared questionnaire to Hebrew or Russian. The

prepared questionnaire composed from 36 different questions and needed to be translated

into Hebrew or Russian for the patients in Israel.

3.2.2 Patient selection. Patients should be from 18 years old and with diagnosis of any

HBP at any stage of it and taking medications for it.

3.2.3 Patient questioning. Patients were questioning while they came to pick up their

medications from our pharmacy and other co-workers pharmacies around Israel we had

visited. The researcher and its helpers explained the patients their needs and the patients

gave their consent to participate in our study research.

Prescribe Medication

Side Affects

Set Hours for taking

the Medication

HBP

(Hypertension(

Single doses combination

Vs.

Fixed dose combination

Lifestyle Modification

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3.2.4 Data evaluation. Data from questionnaires should be typed into a standard summary

table. Then data should be calculated and evaluated statistically using Excel software to

find correlations in the various questions.

3.2.5 Translation. All the data of the questionnaires were translated back to English.

3.2.6 Research size. The size we had set was of at least 100 patients that would be randomly

picked from patients taking medication for HBP, according to the lists we had gathered

from our pharmacy.

3.2.7 Possible risks of the participating patients, confidentiality, etc. No

intervention in medical care would performed, therefore there would be no risk of the

participating patients. To ensure confidentiality, each questioned patient will be

numbered and their name would not even be written. The research data will be stored in

the researcher place. No payment will be proposed to the patients. Research will be

performed without any financial or material benefits for the researchers.

3.2.8 Expected results and their meaning. Will help predict the best care for HBP

patients in the shorten time possible and with no side-effects that could prevent from the

patients to go on with thier daily basis routine.

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3.2.9 The actual process of the patient selection and interview during the

research.

In the research, we had interviewed 160 patients. Out of them 24 questionnaires were

disqualified. Therefore, we were left with 136 questionnaires, which out of them 74 were

of females and 62 of males.

The data gathering were done with the help of the questionnaire which was homogenous

and I with the help of 2 other employees had interviewed each patient in a face to face

meeting, while they came to pick up their monthly medications. All those patients are

suffering from some kind and stage of hypertension (HBP) and they all gave their consent

to participate in our study research.

The homogenous questionnaires were filled by us according to the answers each patient had

given in a face to face meeting. The questionnaire did not require the patients to give their

name and therefore we had given a number to each questionnaire.

In order to get some general information, the first part of the questionnaire was about

demographic data and contained 7 questions with multiple choices of answers for each

question.

The second part of the questionnaire was health & Emotional status, which each contained

2 questions with multiple choices of answers.

The third part was the attitude & behavior of the patient and contained 3 questions.

The last and most meaningful part of the questionnaire was the health care which contained

21 questions, which some of them had multiple choices of answers and some the patient

had to answer on their own, since they were questions who required stating dates, periods

of time, name of their medicine etc’.

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3.3 Research Context

The research took place at our work - pharmacy, by interviewing patients with a questionnaire

composed of 36 questions, which we had prepared in advance.

3.4 Research Facility

In the research, we had interviewed 160 patients. Out of them 24 questionnaires were disqualified.

Therefore, we were left with 136 questionnaires, which out of them 74 were of females and 62 of

males.

The data gathering were done with the help of the questionnaire which was homogenous and I with the

help of 2 other employees had interviewed each patient in a face to face meeting, while they came to

pick up their monthly medications. All those patients are suffering from some kind and stage of

hypertension (HBP) and they all gave their consent to participate in our study research.

The homogenous questionnaires were filled by us according to the answers each patient had given in a

face to face meeting. The questionnaire did not require the patient to give their name and therefore we

had given a number to each questionnaire.

In order to get some general information, the first part of the questionnaire was about demographic

data and contained 7 questions with multiple choices of answers for each question.

The second part of the questionnaire was health & Emotional status, which each contained 2 questions

with multiple choices of answers.

The third part was the attitude & behavior of the patient and contained 3 questions.

The last and most meaningful part of the questionnaire was the health care which contained 21

questions, which some of them had multiple choices of answers and some the patient had to answer on

their own, since they were questions who required stating dates, periods of time, name of their

medicine etc’.

The questionnaire is here presented as appendix A.

~20 ~

3.5 The Research Variables

The independent variable of the research is the HBP (hypertension) that we decided not to deal with it

values, because for our research context has no impact.

The dependent variables are Lifestyle Modification, Prescribe Medications, Side-Effects and Set-

Hours of taking the medication which thier values are as appear in the questionnaire and would be

presented in the findingsof the research.

The intervere variable is Single doses combination vs. Fixed dose combination which we would find

their true value according to the findings would be finally determined in the conclusions of the

research.

3.6 The Research Course

The research was held with the help of 160 questionnaires, that 24 of them were disqualified and in the

end we used 136 questionnaires that 74 of them were of females and 62 of them were of males.

The research took place in our work place – the pharmacy and in other co-workers pharmacies around

in Israel. We had inteviewed each patient in a face to face meeting while they came to pick-up thier

medicines without making him/her do any special efforts for answering the questionnaire. In addition,

in order to avoid mistakes and misunderstanding, with each patient – I or one of my 2 employees (after

they had been guided about the questionnaire and its intentions) filled the questionnaire according to

the patients answers, after we made sure they fully understood the questions.

3.7 Data Analysis

We had done the data analysis with the help of Excel software, by entering all the questionnaires data

and using qulitative descriptive statistics calculating the answers and presented them in numeric

terms.

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4. THE RESULTS AND THEIR DISCUSSION

In the Demographic Data the 7 questions asked were:

1. Gender – Out of the patients that had answered the questionnaire 74 were females which come out

as 54.41% and 62 were males which come out as 45.59%.

2. Age – Out of the patients answering the questionnaire: 9 which is 6.62% were up to 35, 34 which

is 25% were between the ages 35-50, 53 which is 38.97% were 50-65 years old and 40 which is

29.41% were 65 & up.

3. Family Status – Out of the patients that had answered the questionnaire 22 were single, which

comes out as 16.18%, 55 were married, which comes out as 40.44%, 28 were divorced which

comes out as 20.59%, 31 were widow which comes out 22.79%.

4. Education – Out of the patients answering the questionnaire: 0 had primary education, 49 had

secondary education which are 36.03%, 30 had 1st degree which is 22.06% and 57 had second

degree which is 41.91%.

5. Employment – Out of the patients that answered the questionnaire 46.32% which are 63 patients

were employee, 18.38% which are 25 patients were unemployed, 2.21% which are 3 patients were

student, and 33.09% which are 45 patients were pensioner.

6. Residence – Out of the patients answering the questionnaire: 47 patients that were 34.56%, 59

patients that were 43.38%, 30 patients that were 22.06%.

7. District – Out of the patients that answered the questionnaire 36.03% which are 49 patients,

34.56% which are 47 patients and 29.41% which are 40 patients.

In the Health Status the 2 questions asked were:

8. General Health before Diagnosis of HBP – 76 (55.88%) patients complained their health was

poor, 57 (41.91%) patients complained their health was fair and 3 (2.21%) patients stated their

health was good. None of the patients stated their health was very good.

~22 ~

9. General Health after Diagnosis of HBP – 4 (2.94%) patients complained their health is poor, 55

(40.44%) patients complained their health is fair, 75 (55.15%) stated their health is good and 2

(1.47%) stated their health is very good.

In the Emotional Status the 2 questions asked were:

10. Feeling before Diagnosis of HBP – 20 (14.71%) patients complained they felt depressed, 40

(29.41%) patients complained they felt sad, 72 (52.94%) patients stated they had no particular

feelings and 4 (2.94%) patients stated they felt happy.

11. Feeling after Diagnosis of HBP – No patients complained they felt depressed, 7 (5.15%) patients

complained they felt sad, 48 (35.29%) patients stated they had no particular feelings and 81

(59.56%) patients stated they felt happy.

In the Attitude & Behavior the 3 questions asked were:

12. Severity of HBP to the opinion of patients – 30 patients which are 22.06% think it is not at all

severe, 46 patients which are 33.82% think it is somewhat severe, 40 patients which are 29.41%

think it is severe and 20 patients which are 14.71% think it is very much severe.

13. Change Daily life due to Diagnosis of HBP – 38 patients which are 27.94% did not change at all

their daily life, 36 patients which are 26.47% did some changes to their daily life, 44 patients

which are 32.35% did changes in their daily life, 18 patients which are 13.24% changed their daily

life very much.

14. Told the surrounding about the Diagnosis of HBP – 41 which are 30.15% patients stated they

told no one, 53 which are 38.97% patients stated they told just the very close people to them, 42

which are 30.88% patients stated they told everybody.

In the Health Care the questions asked were:

15. Symptoms prior to the Diagnosis of HBP – Out of the patients 35.29% which are 48 patients

said they had no symptoms prior to the diagnosis, 19.12% which are 26 patients said they suffered

from headache & dizziness and 45.59% which are 62 patients said they suffered from facial

flushing.

~23 ~

16. Symptoms after to the Diagnosis of HBP – Out of the patients 91.18% which are 124 patients

said they had no symptoms prior to the diagnosis, 2.94% which are 4 patients said they suffered

from headache & dizziness and 5.88% which are 8 patients said they suffered from facial flushing.

17. Measuring Blood Pressure before Diagnostic – Out of the patients answering the questionnaire,

20 patients used to measure the BP every month, 64 measured their BP every year, 2 patients

measured the BP every 2 years and 50 patients had stated they had never measure their BP. That

comes out as 14.71%, 47.06%, 1.47% and 36.76% respectively to the numbers.

18. Measuring Blood Pressure after Diagnostic – Out of the patients answering the questionnaire,

46 patients are measuring their BP every week, 30 patients are measuring the BP every month, 60

measured their BP every year and no patients measured the BP every 2 years. That comes out as

33.82%, 22.06%, and 44.12% respectively to the numbers.

19. Measuring Blood Pressure before Diagnosis by – 38 patients which are 22.62% said they

measured their BP by themselves, 38 patients which are 22.62% said they got their BP measured

by member of their family, 92 patients which are 54.76% said they had their BP measured by

healthcare professional.

20. 1st treatment stage while being diagnosed – 4 patients (2.94%) indicated they made lifestyle

modifications, 54 patients (39.71%) indicated they received prescribe medication and 78 patients

(57.35%) indicated they had both lifestyle modification and prescribe medication.

21. Year of Diagnosed – No analysis needed.

22. Year of starting Medication – No analysis needed. However, we found that only 3 patients

started taking medication bout a year after being diagnosed.

23. Taking Medication from time of Diagnostic – 130 patients had stated they are taking their

medication continuously ever since they had been last diagnosed, 6 patients had stated they are

taking their medication periodically and no patients had stated they are not taking medication.

24. Name of Medication – Since that is an open question, no analysis possible. However, we did

learn that all 24 patients – with no exception, that are taking medication from ACE Inhibitors +

Calcium Channel Blocker group, are using Exforage; 10 of them uses a dosage of 80mg and 14

~24 ~

uses a dosage of 160mg once a day. A common medication for ACE Inhibitors group but mostly

for ACE Inhibitors + Diuretics is being used by 12 patients (10 of them for ACE Inhibitors +

Diuretics), and it is called Tritace; 4 of them use dosage of 2.5mg and 8 patients’ uses a dosage of

5mg. Next common medication again for ACE Inhibitors + Diuretics, but also for ACE

Antagonist is Vector and all patients are using 160mg, but 2 of the patients from group ACE

Inhibitors are taking that dosage twice a day.

25. Dosage of Medication – No analysis possible.

26. Group of Medication – Luckily, we had found out that from all the patients we had interviewed,

there were 20 (14.71%) patients that used medication of Calcium Channel Blockers, 20 (14.71%)

patients that used medication of Beta-Blockers, 26 (19.12%) patients that used medication of ACE

Antagonist, 20 (14.71%) patients that used medication of ACE Inhibitors, 24 (17.65%) patients

that used medication of ACE Inhibitors + Calcium Channel Blocker, 26 (19.12%) patients that

used medication of ACE Inhibitors + Diuretics.

27. Time the Medication made a difference on the HBP condition – No analysis needed here, since

it was an open question. However, out of the patients that did reply that question, they all were

talking on matter of hours.

28. Time the Medication made a change on the patient’s feelings related to the HBP – Here also

no analysis needed here, since it was an open question. However, once again out of the patients

that did reply that question, they all mentioned up to an hour.

29. Taking the medication for the HBP always – 118 patients which are 86.76% said they would

have to take the medication for the HBP always. 16 patients which are 11.76% said they don’t

know if they would have to take the medication. 2 patients which are 1.47% said they would not

have to take the medication always.

30. Side-Effects from the medication – Out of the patients that filled the questionnaires, only 54

patients (39.71%) stated they had or have side-effects from the medications of the HBP while 82

patients (60.29%) stated they never had nor they have side-effects from the medication of the HBP.

~25 ~

31. Type of Side-Effects – That is an open question that the patients who replied question 30 with the

answer Yes, needed to specify which side-effects they had or have from the medication of the

HBP. But the 2 main side-effects that the patients had mentioned were cough & allergy.

32. Change the Medication at some point – 86 patients which are 63.24% said they had to change

their medication at some point, whilst only 50 patients which are 36.76% said they didn’t have to

change their medication.

33. The Medication taken before the Change – It is an open question that the patients had to state

which medication they used to take before the change, therefore no analysis is able. However,

looking at the patient’s answers that taking medication from the Calcium Channel Blockers the

most common medication taken before was lower dosage of Normiten, Normalol or Norvasc;

From the Beta-Blockers group, the most common medication taken before the change was

Norvasc, Enalapril, Enalodex & Cardilog. From the ACE antagonist group, the most common

medication taken before the change was Norvasc, Tritace, Vasodip, Cliaril & Vector.

34. Forgot to take Medication – Out of the answers in the questionnaire, only 40 patients which are

29.41% stated they forget to take the medication and 96 patients which are 70.59% stated they

never forget to take the medication.

35. Frequency of taking Medication – Out of the 40 patients that stated they had forgotten to take the

medication, 24 patients which are 60% stated they forget on a weekly basis whilst 16 patients

which are 40% stated they forget on a monthly basis and no one stated they forget to take their

medication once in a long while.

36. Taking medication at set hours – out of the total136 patients that replied the questionnaire, 72

patients (52.94%) answered they are taking the medication at set hours, 44 patients (32.35%)

answered they are taking the medication most of the times at set hour and 20 patients (14.71%)

answered they aren’t taking the medication at set hours

~26 ~

In the Table 1 we present summary of demographics of our population.

results, which we would not use to determine anything with regards to our current research purpose,

but we might need it for accentuation or for future research.

Table 1. Patients distribution by their gender, age and family status

Gender Age Family Status

No. of

Questionnaires 136 136 136

Numerical Data

74 Females

62 Males

9 Up to 35

34 35-50

53 50-65

40 65 & up

22 Single

55 Married

28 Divorced

31 Widows

Statistic Data in %

54% Females

46% Males

7% Up to 35

25% 35-50

39% 50-65

29% 65 & up

16% Single

40% Married

21% Divorced

23% Widows

In Figure 1, we present summary of educational and geographical status of our population. results,

which can show as level of social status .

Figure 1. Patients distribution by education, employment, residence and district

Education Employment

Residence District

We found no difference between the volume of female and male suffering from HBP.

Specifically, people between the ages 50-65 who are married are suffering more from HBP.

Most people are educated with secondary education or 2nd

degree and are either employee or

pensioner.The dissemination of the residence and district are fairly equal.

~27 ~

In Figure 2 we present health status before they found out about their HBP condition and started

treatment and after.results, which can clearly show us improvement after starting the treatment.

Figure 2. presents patients Health Status results:

Before After

Over 90% stated they felt poor to fair prior to the diagnostic and it changed to fair to good after the

diagnostic, or one would think actually after starting the treatment.

In Figure 3 we present emotional status before they found out about their HBP condition and started

treatment and after.results, which can see influence of HBP on emotional status.

Figure 3. Presents patients Emotional Status findings:

Before After

About half of the patients stated they had no particular emotional feelings prior to the diagnostic

whilest the other half were depressed and sad and it changed after the diagnostic to 60% that stated

they were happy and the rest had no particular emotional feeling except 5% that were still feeling sad.

~28 ~

In Figure 4 we present Attitude & Behavior from patients view after found out about their HBP

condition and who they shared the information about there condition with.

It can show us how the founding about the condition of HBP effect them by there view and whether

they did any lifestyle changing according it.

Figure 4. presents patients Attitude & Behavior results:

The precentage of the patients that from thier point of view the HBP is considered to be severe disease

is fairly even between the answers Somewhat and Yes, not far from them are the patients that

answered Not at All whilest the patients who are considering it to be Very Much severe are quiet low.

The dissemination of the patients that made a change of daily life is also even between the answers

Notat All, Somewhat and Yes whilest the ones that answered Very Much for that question is also down

below. But we can see that 98 (72%) have made lifestyle modification

With regards to telling the surrounding, the distubtion between all answers were fairly even with a tiny

advantage for the answer Just the Very Close.

Severity Daily life Change Told the surrounding

~29 ~

All following Figures here with presents the Health Care findings:

In Figure 5 we present side effect of HBP before the condition was found and after

Figure 5. Symptoms due to High Blood Pressure

Before After

3 times more patients had stated that after the HBP diagnostic, meaning after getting treatment, they

had no symptoms like Headache & dizziness & Facial Flushing comparing to prior to the diagnostic

and obviusly that is all due to the medications they had started to take.

In Figure 6 we check the monitoring of the HBP before and after founding of the condition and by

home it's being monitored by

In Figure 6. Measurement of Blood Pressure

Before After Monitored by

~30 ~

About 50% of the patients had stated they used to measure thier BP prior to the diagnostic Yearly

whilest after the diagnostic roughly 30% had stated they are measring thier BP Daily, Weekly and

Monthly.

More than 50% stated that they had thier BP measured by a health care whilest 23% had stated they

had it done either themselves or by a member of thier family.

In figure 7 we check what was the first treatment stage when diagnosed HBP and when they have

started to intake the medication drugs

Figure 7. Treatment for High Blood Pressure

Change after diagnosed When they started

Most patients, almost 60% stated they did Both Lifestyle Modifications & started taking Prescribe

Medication. The rest stated they started using Prescribe Medication.

The majority, 97.79% stated they started taking the medication the same year they had been diagnosed

when only 2% stated they started using Prescribe Medication about a year after being diagnosed.

~31 ~

In Figure 8. check the compliance of taking the medication

Figure 8. Taking Medication for High Blood Pressure

Taking Medication Medication for Life At Set Hours

96% of the patients stated they are taking thier medication ever since they had started, with no

stopping.

87% of the patients stated they would need to take thier medication for life.

53% stated they are taking the medication at set hours always, whilest 32% stated they are taking the

medication at set hours most of the time and 15% are not taking it at set hours.

In Figure 9 we check the groups of HBP medications the patients use and there side effects

Figure 9 . The Medication Group and its Side-Effects

Anti HPB drug group How many had Side effect

Out of the patients interviewed, there were a nice dissemination between 6 groups, 4of single dose and

2 of fixed dose combination.

Side-effects of the various medications for the HBP are not very common.

~32 ~

In Figure 10 we can see majority of patients had to change their medication at least once in their life ,

we also check compliance and find that 29% forget to take medication and check how often it happen

Figure 10. Change Medication & Forgetting Medication

Change Medication Forget taking Medication How often?

More patients changed thier medication than patients that didn‘t change.

Many more patients never forgot to take thier medication.

From the patients that forget to take thier medication, more forget to do that on a weekly basis than on

a monthly basis and none stated they only forget it once in a while.

~33 ~

In Figure 11 we check the non compliance percentage of the treatment

Figure 11. Non-complinace of the treatment

Forget or not How often? At set time?

Looking at the figures above, we can see that the cases of patients not taking thier medication

according to the instructions are not few (~30%) , and out of them many (40%) forget or omit taking

the medication on a weekly basis and the rest of a monthly basis.

Also, by checking the use of the patients with regards of taking their medication, we had come to learn

that once again a large portion 64 pitents (47%) do not take the medication at set hours.

Those 2 facts can help us better realise that there are possible cases for non-compliances and they are

even fairly common and that is probably the first thing that should be dealt with the patients, in order

to make sure that the medications working properly and that they can control the HBP . using the

combined drug might lower this presentages if the will need to intake less tabs and at a regular time/

~34 ~

Summary of Results & their Discussions

Both female and male suffering equally from HBP. Ages 50-65 are the most common to suffer more

from HBP. There is no importance to residence and district of the patients suffering from HBP.

General heatlh status is changed for the better after starting taking the medication and making lift style

changes.

Also emotional feelings were changed for the better after starting treatment.

Most patients consider the HBP to be quiet severe disease but not as many made daile life change.

There was not any fixed result with regards to telling the surrounding.

Due to the medications the patients started to take, the patients didn‘t have any syptoms of Headache,

dizziness & Facial Flushing.

The majority of the patients increased dramatically the times of measuring thier BP and about half of

them used to measure thier BP by health care.

Most patients did Both Lifestyle Modifications & started taking Prescribe Medication the same year

they had been diagnosed.

Almost all patients stated they are taking thier medication ever since they had started and most of them

realized they would need to take thier medication for life. The majority of them are also taking the

medication at set hours.

Many patients changed thier medication and most of them never forgot to take thier medication.

~35 ~

5. CONCLUSION

In general, if we were to summerize our main conclusions, then they would be presented herewith:

1) Most patients, who control their blood pressure, make lifestyle modification in addition to

taking prescribed medication.

2) Most patients would be required to change thier medication at least once before thier BP would

be reduced and reached its goal.

3) By using more than one drug, it would help 37% in achieving better control of the HBP.

Single doses combination would have less effect then using fixed dose combination.

4) Almost half of the patients (47%) did not compliance

5) Almost half (40%) of patients have suffered from using medication for HBP control.

6. RECOMMENDATION FOR FUTURE RESEARCH Our results and conclusions made possible to propose several recommendations for the future

1. Replicate this study several times to have consistency in the findings and enabling

comprehensive statistical comparative analysis

2. Check for difference in the therapy required for patients in different ages.

3. To check the influence of lifestyle modification on HBP patients and whether it might change

the method of treatment needed.

4. To check the influence of patients mental status on their HPB therapy.

5. Make differentiation in the hypertension condition and by that choose different combination of

medication that would work better.

~36 ~

7. REFERENCES

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MW, Materson BJ, Suzanne Oparil, Jackson, Wright T Jr. The Seventh Report of the: Joint

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Sweden: Department of Physiology, University of Göteborg; July 1990. p. 89-101.

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Blood Institute (NHLBI), 1992, Last Revision: November 2010.

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8. Higgins B, Williams B, Williams H, Northedge J, Crimmins J, Lovibond K, Caulfield M,

Watts M, Stetson N, Miller P, O’Mahony R, McManus R, Mason S, McCormack T, Krause T. Hypertension: Clinical Management of Primary Hypertension in adults on NICE Clinical

Guidelines, CG127. UK: National Clinical Guideline Centre at The Royal College of

Physicians for the National Institute for Health and Care Excellence; August 2011, Last

Revision: October 2013.

~37 ~

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ML, Thomas D. MacKenzie, Olugbenga Ogedegbe, Sidney C. Smith Jr. Laura P. Svetkey,

Taler SJ, Townsend RR, , Wright JT Jr, , Narva AS, Ortiz E. Evidence-based guideline for the

management of high blood pressure in adults: report from the panel members appointed to the

Eighth Joint National Committee (JNC 8). U.S. DEPARTMENT OF HEALTH AND HUMAN

SERVICES, National Institutes of Health, National Heart, Lung, and Blood Institute, National

High Blood Pressure Education Program; 18 December 2013.

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hypertension? Cleveland: Clinic Journal of Medicine; September 2008. Issue 75 (9), p. 663-672

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Online]; McGraw-Hill Global Education Holdings, LLC.; January 2013. Part 10. Disorders of

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Study of Sex Differences in Health, Disease and Aging Georgetown University; March 2012.

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Glasgow, Scotland, UK. Fixed dose combination therapy in the treatment of hypertension. Journal of Human Hypertension, February 2002. Volume 16, Number 2, Pages 75-78

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March 2009. Chapter 1, pp. 3-8; Chapter 5, pp. 29-34.

17. The New Instructions of the ADA for HBP Treatment in Diabetic Patients . The ADA's

Clinical Practice Recommendations; January 2013. Revision 36:S11-S63.

~38 ~

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~39 ~

APENDIX A

Demographic Data:

1. Gender Female O Male O

2. Age Up to 35 O 35 till 50 O 50 till 65 O 65 & up O

3. Family Status Single O Married O Divorced O Widow O

4. Education Primary O Secondary O 1st degree O 2

nd degree O

5. Employment Employee O UnemployeeO Student O Pensioner O

6. Residence Main City O Suburbs O Village O

7. District North O Center O South O

Health Status:

8. In General, before the diagnostic of High Blood Pressure (HBP), your health was:

Poor O Fair O Good O Very Good O

9. In General, after the diagnostic of High Blood Pressure (HBP), your health is:

Poor O Fair O Good O Very Good O

Emotional Status:

10. In General, before the diagnostic of HBP, your feelings were:

Depressed O Sad O None in particular O Happy O

11. In General, after the diagnostic of HBP, your feelings are:

Depressed O Sad O None in particular O Happy O

Attitude & Behavior:

12. In your opinion, the disease of HBP, considered to be severe?

Not at all O Somewhat O Yes O Very much O

13. Did you change your daily life due to the diagnostic of HBP?

Not at all O Somewhat O Yes O Very much O

14. Have you told the surrounding about your HBP diagnostic?

Told no one O Just the very close O To everybody O

Researcher

Leon Feigelman

Place of the research

Pharmacy shavit ltd

Questionnaire No

#

~40 ~

Health Care:

15. What were the symptoms felt prior to the diagnostic of HBP?

None O Headache & dizziness O Facial Flushing O

16. What were the symptoms felt after the diagnostic of HBP?

None O Headache & dizziness O Facial Flushing O

17. Prior to the diagnostic, how often were you measuring your Blood Pressure?

Monthly O Yearly O Every 2 years O Never O

18. After the diagnostic, how often are you measuring your Blood Pressure?

Daily O Weekly O Monthly O Yearly O

19. Who was measuring your Blood Pressure before diagnosing?

Myself O Member of my Family O Healthcare Professional O

20. While being diagnose of HBP, what was the 1st treatment stage?

Lifestyle Modifications O Prescribe Medication O Both O

21. When was your 1st diagnosed of HBP?

Please fill in the date ________________

22. When did you start taking medication for the HBP medication?

Please fill in the date ________________

23. Have you taken the medication for the HBP ever since?

Yes O I’m taking periodically O No O

24. Which medication are you taking for the HBP?

Please fill in the name ________________

25. What is the dosage of the medication you are taking?

Please fill in: No. of Tablets ____ Mg _____ No. of Times a day _____

26. Do you know to which Group your medication for HBP belong?

Calcium channel blockers O Beta-blockers O

ACE inhibitors or antagonist O Diuretics O

27. How long did it take until the medication made a different in your HBP condition?

Please fill in the time________________

28. How long did it take until you felt any change, by taking the medication for HBP?

Please fill in the time________________

~41 ~

29. Would you be required to take the medication always?

Yes O Don’t Know O No O

30. Did you or do you have any side-effects from the medication for the HBP?

Yes O No O

31. If your reply to question 30, was ‘Yes’ – Please state which side-effects?

_________________________________________________________________

32. Did you have to change your medication for HBP at some point?

Yes O No O

33. If your reply to question 32, was ‘Yes’ – Please state which medication you took

before?

_________________________________________________________________

34. Have you ever forgotten to take the medication?

Yes O No O

35. If your reply to question 34, was ‘Yes’ – Please state how often does it happens?

Weekly O Monthly O Once in a long while O

36. Are you taking your medication at set hours?

Yes O Most of the times O No O

Interview assessment (to be filled up by

researcher) Medication is being taken properly

Yes O No O

Comments:_____________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________

_______________________________________________________________________