Valsartan in the Treatment of Hypertension

DOI: 10.5455/medarh.2013.67.174-177
Med Arh. 2013 Jun; 67(3): 174-177
Received: March 21th 2013 | Accepted: May 25th 2013

CONFLICT OF INTEREST: NONE DECLARED

original paper

Valsartan in the Treatment of Hypertension

Salem Alajbegovic1, Aziz Sukalo2, Azra Alajbegovic3, Jasminka Djelilovic Vranic3, Melika Ambeskovic3, Dervis Deljo2, Lejla
Alajbegovic2
Cantonal Hospital Zenica, Bosnia and Herzegovina1
Pharmaceutical Company „Farmavita“, Sarajevo, Bosnia and Herzegovina2
Neurology Clinic, Clinical Center of Sarajevo University, Sarajevo, Bosnia and Herzegovina3

I
ntroduction: Hypertension represents an important public health problem. Effective treatment stroke by 30% and the risk of ischemic
of hypertension is imperative for primary care. Goal: The goal of this study was to examine diseases by 20% (1, 2).
the efficacy of Valsartan in the treatment of hypertension with emphasis on the overall efficacy The majority of patients with hyper-
in reduction of systolic and diastolic blood pressure in a sample of 738 patients. Material and tension have essential or primary hy-
methods: The study lasted for 12 months (from January 1, 2012 until December 31, 2012 year) and pertension, which have unknown cause
conducted in 18 public health institutions in B&H. Parallel follow up of Valsartan antihypertensive and in which the initially high blood
effect through repeated measurements every three months was conducted. Results and discus- pressure is the only manifestations of
sion: Our results indicate that both systolic and diastolic blood pressure decreased significantly after disease. In other patients hypertension
12 weeks of Valsartan treatment. Analysis of adverse effects did not showed statistical significance is caused by disease of some other or-
of side effects for total sample. Statistical analysis by Yates chi-square did not show the presence
gan and therefore is called secondary
of statistically significant differences in adverse effects by gender. Conclusion: We conclude that
hypertension. The degree of clinical
Val or Val plus are effective and safe antihypertensive drugs for the treatment of mild to moderate
severity of hypertension is estimated
hypertension. Key words: hypertension, valsartan.
on the basis of systolic blood pressure
Corresponding author: prof. Salem Alajbegovic, PhD. Cantonal hospital Zenica, Bosnia and and current changes in other organ sys-
herzegovina. tems (1,3).
According to the causes, hyperten-
sion can be:
1. INTRODUCTION evated blood pressure when the level of •• Essential;
Hypertension is the most impor- systolic blood pressure is 140 mmHg •• Renal hypertension;
tant chronic health problem. It is es- (18.7 kPa) or more and/or the level of •• Endocrine hypertension;
timated that hypertension affects ap- diastolic blood pressure is 90 mmHg •• Cardiovascular hypertension;
proximately one billion people and that (12.0 kPa) or more, in repeated mea- •• Neurogenic hypertension;
this number will increase by 60% un- surements. It can occur as isolated sys- •• Hypertension in pregnancy or hy-
til the year 2025. Hypertension is the tolic or diastolic hypertension but most pertension gravitas;
first risk factor for cerebrovascular ac- often both pressures are elevated. Due •• Hypertension induced by drugs or
cidents and cardiovascular disorders. to the changes that occur in large arter- iatrogenic hypertension.
The degree of hypertension based on ies by aging, systolic blood pressure af- Effect of hypertension manifests in
blood pressure as continuous variable ter the fifty year is increasing with each the development of left ventricular hy-
that changes from minute to minute, year of life by about 2 mmHg and dia- pertrophy due to the increased pressure
depending on the patient’s mental and stolic blood pressure by 0.5 to 1 mmHg. load and acceleration of atherosclerosis
physical condition and environmental Men have higher levels of blood pres- in the coronary arteries, as well as in the
factors. Hypertension represents a chal- sure than women until age 60. Later, arteries of the brain, heart, kidneys and
lenge for family physicians because the this difference disappears so in the lower limbs (3, 4).
need of early detection and treatment, older age women have higher values of ​​ Most hypertensive patients have
but also to achieve blood pressure con- blood pressure and higher prevalence no symptoms and such persons are de-
trol. According to the World Health Or- of hypertension. Lowering blood pres- tected only by physical examination.
ganization and the International Soci- sure for 9/5 mmHg reduces the risk of Symptoms that indicate hypertension
ety of Hypertension, it is defined as el-

174 Med Arh. 2013 Jun; 67(3): 174-177 • original paper

 Valsartan in the Treatment of Hypertension

to a doctor can be divided into three changes the blood pressure cannot be considerable further reduction in blood
groups and relate to: maintained in the desired range. pressure.
•• Increase of blood pressure only; •• Diuretics (thiazides); In patients with congestive heart
•• Hypertensive angiopathy; •• Beta-blockers; failure it improves hemodynamics, in-
•• Primary disease in the case of sec- •• ACE inhibitors; cluding pulmonary capillary wedge
ondary hypertension. •• Angiotensin II receptor blockers; pressure, pulmonary artery diastolic
Clear family history of hypertension •• Calcium channel blockers. pressure and systolic blood pressure,
with information about the occasional All these medications can be used systemic vascular resistance and car-
increase of blood pressure in the past as first-line medications for the treat- diac stroke volume. In clinical studies it
goes in favor of the diagnosis of essen- ment of hypertension. Antihyperten- was shown that Valsartan can help re-
tial hypertension. Secondary hyperten- sive effect of thiazides is reflected in the duce the risk of heart failure–patients
sion mostly occurs before 35 or after 55 reduction of plasma volume and beta- treated with Valsartan showed signifi-
years of age. Data on the use of corti- blockers in reducing sympathetic activ- cant improvement in signs and symp-
costeroids or estrogen is obviously very ity and negative inotropic effect on the toms of heart failure including dyspnea,
significant. History of recurrent uri- myocardium. fatigue, edema, compared to placebo.
nary tract infections indicates chronic ACE inhibitors and angiotensin II Valsartan is used to treat hyperten-
pyelonephritis, although this situation receptor blockers are vasodilators be- sion and congestive heart failure. Thera-
develops and asymptomatic, noctu- cause by indirect effect on certain areas peutic doses ranging from 80 to 320 mg.
ria and polydipsia indicate renal or en- of the renin-angiotensin system reduces Pregnant women should not use
docrine disease and lumbar trauma or peripheral vascular resistance. ACE in- Valsartan, while special caution is
episodes of acute pain in the groin can hibitors prevent conversion of angioten- needed in patients who are receiving
be a guideline to kidney damage. Spec- sin I to angiotensin II, and angiotensin high doses of diuretics as symptomatic
ifying weight gain is compatible with receptor blockers block the binding of hypotension may occur. Also, caution is
Cushing’s syndrome and weight loss in- angiotensin II to angiotensin receptors. needed in patients with liver and kidney
dicates pheochromocytoma (2, 4, 5, 6). Calcium channel blockers are pow- damage. Possible side effects are usually
The clinical evaluation of patients erful vasodilators, because they directly dizziness and headache (7, 8, 9, 10, 11).
with hypertension should: reduce tension of blood vessels smooth
•• Confirm the presence of hyper- muscles and thereby reduce peripheral 2. RESEARCH GOALS
tension; vascular resistance. Treatment of sec- To evaluate patients suffering from
•• Determine the presence and ex- ondary hypertension is directed at the hypertension who were treated with
tent of hypertension effects on the cause (7, 8, 9, 10). Valsartan (Val or Val plus), in one of
other organs; Valsartan is competitive angioten- the 18 medical institutions in Bosnia
•• Identify cardiovascular risk fac- sin II receptor antagonist, selective for and Herzegovina, with the emphasis on
tors and other existing diseases their AT1 subtype. Specific selective the effectiveness of antihypertensive ef-
that affect prognosis and treat- blockade of AT1 receptors and consec- fect of Valsartan from pharmaceutical
ment; utive antagonizing of all the effects not company Farmavita.
•• Exclude or confirm the causes of only of angiotensin II, but also other Identify mean systolic blood pres-
secondary hypertension (2, 5, 6). components of the renin-angiotensin- sure in the study group of patients by
Therapeutic approach to the indi- aldosterone system is essential effect measuring blood pressure during the
vidual patient with hypertension de- of valsartan from which derive all of study time period: every three months
pends on associated risk factors that its pharmacodynamics and therapeu- (measured once a month).
favor the development of cardiovascu- tic effects. Identify the differences between the
lar disease, the existence of cardiovas- It is used as monotherapy or in com- patients examined in our study in rela-
cular disease and target organ damage. bination with HCTZ for all types of re- tion to gender, age, age groups.
Essential hypertension cannot be novascular and essential hypertension. Provide a cross section evaluation
cured, but proper treatment can signif- Valsartan is not metabolized in a of the Valsartan side effects.
icantly influence its course. Changing way that it produces active metabolite,
the lifestyle is an important component it is effective for 24 hours and is taken 3. MATERIAL AND METHODS
in the treatment of essential hyperten- once a day. Data used in our study were ob-
sion. Correction of body weight, regu- For the majority of patients after the tained from the studies and analyzes
lar physical activity, diet with limited use of single oral dose antihyperten- conducted in 18 health facilities in
intake of salt (<6g per day), saturated fat sive activity occurs within two hours. the territory of B&H. This study in-
and alcohol and smoking cessation can The greatest reduction in blood pres- cluded 738 patients who underwent
significantly reduce blood pressure and sure with any dose is achieved within three consecutive medical examina-
increase the effectiveness of antihyper- 2-4 weeks and maintained during long- tions after they had been on Valsartan
tensive therapy. term treatment. Co-administration therapy. Patients treated in our study
Treatment with antihypertensive with hydrochlorothiazide produces a completed three examinations in three
medications is indicated if by lifestyle months: one review a month. Inclusion

Med Arh. 2013 Jun; 67(3): 174-177 • original paper 175

Valsartan in the Treatment of Hypertension

criterion was hypertension treated with Gender structure pressure during the initial examination,
Valsartan. N % the first and second follow-up showed
Valsartan which we used in the Male 342 46.3 a linear decrease and statistically sig-
study is a manufactured by Farmavita. Female 396 53.7 nificant difference between the groups
Each doctor treated a group of pa- Total 738 100.0 according to the results of analysis of
tients from 20 to 50 patients by treating Table 1. Gender structure variance (ANOVA) for both systolic
doctor. All doctors keep track of hyper- and diastolic blood pressure. Majority
tension in a specially designed table on of patients have been
Review of the sample by gender and age
the basis of which they drafted the re- 20-40 40-50 50-60 60-70 70>
subjected to the treat-
port. After collecting the data are trans- Total ment of hypertension
yrs. yrs. yrs. yrs. yrs.
formed into the same group study that Male N 24 58 92 83 85 342 for the first time (421
we presented in tables and figures. % 40.0 49.6 47.7 44.1 47.2 46.3 or 57.0%) compared to
Needed data for monitoring the ef- Female N 36 59 101 105 95 396 those who had previ-
fectiveness of Valsartan (Val and Val % 60.0 50.4 52.3 55.9 52.8 53.7 ously treated hyper-
plus) are collected on the basis of med- Total N 60 117 193 188 180 738 tension (317 or 43.0%).
% 8.1 15.9 26.2 25.5 24.3 100.0
ical examinations and notes: Valsartan is non-pep-
•• Anamnesis and previous status. Table 2. Review of the sample by gender and age χ2=2.018; tide ARB that selec-
•• Measuring the blood pressure p=0.7325 tively blocks binding
during first, second and third ex- low-up shows a linear decrease in both of angiotensin II to
amination. systolic and diastolic blood pressure. the angiotensin II type 1. Many clinical
•• Keeping record on side effects It is noticeable that the Valsartan
during the three months. caused side effects in 7.6% of patients Previous hypertension
treatment
•• Laboratory tests. in the total sample (N = 738), while the
N %
•• Diagnostic tests. most frequent was hypotension (2.8%), First hypertension
Study results are presented in tables followed by dizziness (1.6%), fatigue in 421 57.0
treatment
and figures by number of cases, per- 1.1% and other side effects in less than Previously treated
317 43.0
centage and mean with standard devi- 1% of patients. hypertension
ation and range. Analysis of the statisti- Analysis of adverse events by gen- Total 738 100.0

cal significance of the differences is con- der shows that the higher total num- Table 3. Previous hypertension treatment
ducted by Pearson and Yates chi-square ber is recorded among
Review of average BP by treatment duration
test and one-way analysis of variance women as well as hy- Systolic Diastolic
(ANOVA). The results of all these tests potension, dizziness, Mean SD Range Mean SD Range
with p <0.05 or 95% confidence level fatigue, nausea and First 152.36 20.256 118-182 98.24 17,573 86-112
examination
were considered statistically signifi- diarrhea, while diz- First follow-
143.24 14.386 116-170 91.57 12,348 82-105
cant. Analysis was conducted using the ziness, headache and up
statistical package IBM SPSS Statistics abdominal pain were Second 132.26 9.526 110-154 84.26 8,421 69-98
follow-up
v19.0 (Chicago, Illinois, USA). more often reported by F=5.364 F=6.382
men. Given the small p=0.001 p=0.001
4. RESULTS number of side effects Table 4. Review of average BP by treatment duration
Results are presented tables 1-4 statistical analysis us-
and figures 1-2. Review of the gender ing Yates chi-square showed the pres- studies have proven the efficacy, tolera-
structure of the sample indicated that ence of statistically significant dif- bility and safety of Valsartan in reduc-
women were slightly more represented ferences in adverse events by gender ing BP in different groups of patients
with 396 or 53.7% of the respondents (χ2=8.737; p=0.2721). and in improving CV outcomes, as well
in relation to men with 342 or 46.3%. as outcomes of chronic kidney disease.
Analysis of age distribution shows 5. DISCUSSION Our results are comparable to the re-
that the majority of respondents were In our research, we had 738 pa- sults by Mallion and associates (12). In
in the older age groups (over 50 years) tients. Review of the gender structure several studies they evaluated the effi-
and that statistically significant differ- of the sample indicated that women cacy and safety of Valsartan. Reduction
ence by chi-square test is recorded in re- were slightly more represented with in systolic and diastolic blood pressure
lation to gender (p> 0.05). Larger num- 396 or 53.7% of the respondents in re- was clinically and statistically signifi-
ber of patients has been subjected to the lation to men with 342 or 46.3%. Anal- cant and the changes in systolic blood
treatment of hypertension for the first ysis of age distribution shows that the pressure were generally higher than the
time (421 or 57.0%) compared to those majority of respondents were in the diastolic. Our results show a linear re-
who had previously treated hyperten- older age groups (over 50 years) with- duction of both systolic and diastolic
sion (317 or 43.0%). Analysis of the av- out statistically significant difference BP in relation to this study, we can ex-
erage blood pressure during the initial by chi-square test in relation to gen- plain by selective sampling of our sub-
examination, the first and second fol- der (p>0.05). Analysis of average blood jects according to the inclusion crite-

176 Med Arh. 2013 Jun; 67(3): 174-177 • original paper

 p=0.001 p=0.001

Analysis of the average blood pressure during the initial examination, the first and second follow-up
shows a linear decrease in both systolic and diastolic blood pressure. Valsartan in the Treatment of Hypertension

8 7.6
ria (13, 14). In a series of 7 tistically significant side effects for the
large-scale clinical trials 6 total sample. Statistical analysis using
is established the value 5 Yates chi-square showed the presence
4
of Valsartan in reducing 3 2.8 of statistically significant differences
cardiovascular compli- 2 1.6 1.1
in adverse events by gender. Val or Val
0.8
cations and mortality in 1 0.5 0.3 0.3 0.1 plus is an effective and safe antihyper-
0
high-risk patients. Study tensive drug for the treatment of mild
of Val-HeFT and VAL- to moderate hypertension.
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to the resultsdose combination
by Mallion and associates (12).withIn several pertensive patients inadequately controlled
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Med Arh. 2013 Jun; 67(3): 174-177 • original paper 177