Hypertension prevalence, awareness, control and association with metabolic abnormalities in the San...

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Original article 837

Hypertension prevalence, awareness, control and associationwith metabolic abnormalities in the San Marino population:the SMOOTH studyGiuseppe Manciaa,b, Gianfranco Paratia,b, Claudio Borghic, GiuseppeGhironzid, Egidio Andrianie, Liano Marinellif, Mariaconsuelo Valentinia,Francesco Tessarig and Ettore Ambrosionic on behalf of the SMOOTHinvestigators

Background The aim of the SMOOTH (San Marino

Observational Outlooking Trial on Hypertension) study

was to explore hypertension awareness, treatment and

control and the associated metabolic abnormalities and

risk factors in the population of San Marino, a small state

in the Mediterranean area, for which limited evidence is

available.

Methods Nine general practitioners enrolled 4590

consecutive subjects (44% of the San Marino population

age 40–75 years), seen in their office by collecting history,

physical and laboratory data and office blood pressure (BP)

measurements.

Results Of these subjects, 2446 were normotensive and

2144 hypertensive; 62.3% of hypertensive patients were

aware of their condition, 58.6% were treated (monotherapy

31.5%, combination therapy 27.1%), and 21.7% were

controlled. Hypertension awareness and treatment were

more frequent above age 50 and in females; BP control was

similarly low in both genders. As compared to

normotensives, hypertensive subjects were less frequently

smokers (20.1 versus 27.8%), had greater body mass index

(28.1 W 4.5 versus 25.8 W 3.7 g/m2), and a higher

prevalence of diabetes mellitus (15.8 versus 6.3%), lower

high-density lipoprotein (HDL) cholesterol and higher

prevalence of increased blood total cholesterol (66.1

versus 51.3%), triglycerides and serum uric acid. Values of

opyright © Lippincott Williams & Wilkins. Unauth

0263-6352 � 2006 Lippincott Williams & Wilkins

subjects with ‘high-normal’ blood pressure were closer

to those of hypertensive subjects. The prevalence of

metabolic syndrome was higher in hypertensive than in

normotensive subjects, and in treated than in untreated

hypertensives.

Conclusions Even in a small Mediterranean country with

high health-care standards, hypertension awareness,

treatment and control are inadequate and hypertension

clusters with metabolic abnormalities and risk factors as in

non-Mediterranean areas. J Hypertens 24:837–843 Q 2006

Lippincott Williams & Wilkins.

Journal of Hypertension 2006, 24:837–843

Keywords: antihypertensive treatment, epidemiology, hypertension,Mediterranean diet, metabolic factors, risk factors

aClinica Medica and Department Medicina Clinica, Prevenzione e BiotecnologieSanitarie, Universita di Milano-Bicocca, bCardiologia II, Ospedale S.Luca, IstitutoAuxologico Italiano, Milan, Italy, cClinica Medica, Universita di Bologna, dSocietadi Cardiologia, San Marino, eIstituto di Sicurezza Sociale, Repubblica di S.Marino,fUnita di Cardiologia, Ospedale Statale, Repubblica di S. Marino and gCentroElaborazione Dati – Idea 99, Padova, Italy

Correspondence and requests for reprints to Professor Giuseppe Mancia, ClinicaMedica, Ospedale S. Gerardo, via Pergolesi, 3320052 Monza, ItalyTel: +39 00 92333357; e-mail: [email protected]

Sponsorship: This work was supported by Recordati S.p.A.

Received 23 November 2005 Revised 23 February 2006Accepted 23 February 2006

IntroductionSeveral studies performed in European and extra-Euro-

pean countries have shown that awareness of hypertension

in the population is limited. They have also shown that

the percentage of hypertensive patients under medical

treatment is less than that of aware patients, and that

treated patients with adequate blood pressure (BP) con-

trol (i.e. with systolic blood pressure < 140 mmHg and

diastolic blood pressure < 90 mmHg) are no more than

a small fraction of the overall hypertensive population

[1–13].

The present study reports the data obtained in the

SMOOTH (San Marino Observational Outlooking Trial

on Hypertension) study, which was a survey of the

population living in San Marino, a small independent

state within the Italian territory. The purpose of the study

was to determine the status of hypertension awareness,

treatment and control in an enclave characterized by

uniform social characteristics and a high level of health

care. It was also to determine whether hypertension is

associated with metabolic abnormalities, an association

frequently described in populations of northern Europe,

orized reproduction of this article is prohibited.

mailto:[email protected]

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838 Journal of Hypertension 2006, Vol 24 No 5

North America and Australia [14–16], while information

for southern Europe and Mediterranean countries is

limited and in most cases obtained a number of years

ago [17,18].

MethodsThe SMOOTH study is a population-based study, per-

formed in the Republic of San Marino, a European

country with about 27 000 citizens, having demographic

and social characteristics similar to those of the general

Italian population. The study design consisted of a two-

step observation period: a ‘cross-sectional’ phase of 8

months’ duration, focused on screening for hypertensive

subjects and on collecting data on their associated car-

diovascular risk factors; and a subsequent ‘longitudinal’

phase focusing on a 2-year follow-up of the hypertensive

subjects screened in phase 1.

Nine general practitioners belonging to the primary care

service of the Republic of San Marino were asked to enrol

all subjects aged between 40 and 75 years seen in their

office over a period of 8 months. Each general practitioner

was required to obtain from each subject an informed

consent to the study and then: clinical history, focusing

on presence of diabetes mellitus, antidiabetic treatment

and cigarette smoking; physical examination; and labora-

tory data on blood glucose, total, low (LDL) and high-

density lipoprotein (HDL) cholesterol, triglycerides and

uric acid. Blood pressure (BP) was measured by the Riva–

Rocci/Korotkoff sphygmomanometric technique, with

the patient in the sitting position for 10 min before the

measurement. The average of two consecutive measure-

ments, spaced by an interval of 5–10 min, was considered

as the representative BP value of the subject. All

physicians were trained to carefully perform BP measure-

ments according to European Society of Hypertension–

European Society of Cardiology (ESH/ESC) 2003

recommendations [19].

Patients were stratified according to their systolic (SBP)

or diastolic blood pressure (DBP) values in five BP

categories:

(1) o

opy

ptimal (SBP < 120 mmHg, DBP < 80 mmHg);

(2) n
ormal (SBP < 130 mmHg; DBP 80–84 mmHg);
(3) h
igh normal (SBP 130–139 mmHg; DBP 85–89
mmHg);

(4) h
ypertension (SBP� 140 mmHg, DBP� 90 mmHg),
with further subdivision into grades 1, 2 and 3

according to the 1999 World Health Organization–

International Society of Hypertension (WHO/ISH)

and the 2003 ESH/ESC Guidelines [1,19]; and

(5) i
solated systolic hypertension (SBP � 140 mmHg;
DBP < 90 mmHg) [1,2].

Patients were also considered hypertensives if they were

under antihypertensive drug treatment, regardless of the

right © Lippincott Williams & Wilkins. Unautho

BP values obtained. In the case of a discrepancy between

SBP and DBP values, patients were assigned to the

higher BP category. Metabolic abnormalities were con-

sidered to be a blood cholesterol > 200 mg/dl (5.17

mmol/l), triglycerides > 180 mg/dl (> 2.03 mmol/l),

HDL cholesterol < 43 mg/dl (< 1.11 mmol/l) (females)

and < 34 mg/dl (< 0.88 mmol/l) (males); or uric acid � 8

mg/dl (� 474 mmol/l). Diabetes was identified by a blood

glucose � 140 mg/dl (� 7.7 mmol/l), or by use of antidia-

betic drugs. Body mass index (BMI; weight in kg divided

by the squared height value, m2) was regarded to be

increased if � 27 kg/m2. We also assessed the prevalence

of the metabolic syndrome, according to the ATP III

definition [20,21], that is, based on the presence of at least

three out of the following five criteria: abdominal obesity,

elevated serum triglycerides (� 150 mg/dl), low HDL

cholesterol (< 40 mg/dl in men and < 50 mg/dl in

women), elevated BP (office BP � 130/85 mmHg) and

elevated serum fasting glucose (� 110 mg/dl) [22].

Data were collected through an ad-hoc designed chart,

entered into a V-Basic databank program for a Windows-

based personal computer and analysed by means of SAS

Version 6.2 statistical software [23]. Comparisons

between groups were performed by x2 test for dis-

crete/qualitative variables, and by analysis of variance

(ANOVA) whenever suitable. A probability value of

P < 0.05 was considered statistically significant. The

Pearson correlation coefficient was used to test associ-

ation between quantitative variables. Data are shown as

means � standard deviations (SD) for the various groups.

Patients were included after obtaining informed consent

to analysis of their clinical data. The local ethics com-

mittee approved this study which complied with the

Declaration of Helsinki.

ResultsThe present study reports the data collected in the

cross-sectional phase of the survey. 4590 subjects were

enrolled – a large (44%) and age- and gender-represen-

tative sample of the San Marino population aged between

40 and 75 years (Fig. 1).

As shown in Table 1, 2144 (46.7%) subjects were hyper-

tensive, whereas the remaining 2446 (53.3%) were nor-

motensives, 4.8, 21.7 and 26.8% in the high-normal,

normal and optimal BP categories, respectively. Hyper-

tensives had an overall gender distribution similar to, but

an average age greater than normotensive individuals.

As shown in Fig. 2, 62.3% of the hypertensive patients

were aware of their condition and 58.6% were under

antihypertensive drug treatment, with a slight preva-

lence of monotherapy (31.5%) over combination therapy

(27.1%). Angiotensin-converting enzyme (ACE) inhibi-

tors were the most frequently prescribed drugs (29.4%),

rized reproduction of this article is prohibited.

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San Marino hypertension study Mancia et al. 839

Fig. 1

02468

1012141618

%

70-7465-6960-6455-5950-5445-4940-44

Age (years)

San Marino Population SMOOTH

San Marino Population SMOOTH

12141618

12141618

02468

10%

70-7460-6950-5940-49Age (years)

02468

10%

70-7460-6950-5940-49Age (years)

MA

LE

S

FE

MA

LE

S

Comparison of age and gender distribution in the sample of the San Marino Observational Outlooking Trial on Hypertension (SMOOTH) study and inthe San Marino population of the same age range (40–75 years).

followed by diuretics (24.7%) and calcium-channel

blockers (19.8%). Combined control of SBP and DBP

was found in 21.7% of the overall hypertensive group

(corresponding to 37.0% of the treated patients), the

control of SBP alone being much less frequent than

the control of DBP alone (4.1 versus 17.1% of the whole

hypertensive group, corresponding to 6.9 versus 29.2% of

the treated patients). Hypertension awareness and drug

treatment were more frequent in females than in males,

while BP control was similarly low in both genders

(Fig. 3a). Hypertension awareness, drug treatment and

BP control were progressively more frequent from the


Table 1 Age, gender and prevalence, (%) of various blood pressure (BP) care also shown

Class n (%) Age (years) Gender (M/

Hypertensives 2144 (46.7) 60.5 � 9.4 1002/114Normotensives 2446 (53.3) 52.8 � 9.2 1126/132

High normal BP 222 (4.8) 53.2 � 8.5 125/9Normal BP 995 (21.7) 53.9 � 9.2 502/49Optimal BP 1229 (26.8) 51.8 � 9.3 499/73

youngest to the oldest age stratum (Fig. 3b). Isolated

systolic hypertension accounted for 34.5% (n ¼ 740) of

the hypertensive group; in this subgroup 52.2% were

aware of their hypertension while 50% were treated.

Table 2 shows the metabolic abnormalities identified in

the study separately for normotensive and hypertensive

subjects. Compared to the normotensive group, hyper-

tensives showed a lower prevalence of smoking, but a

greater prevalence of increased body mass index, dia-

betes mellitus (for which the difference was marked), and

increased blood cholesterol, triglycerides and uric acid.


ategories. Mean (W SD) of systolic (SBP) and diastolic (DBP) values

F, n) Gender (M/F, %) SBP (mmHg) DBP (mmHg)

2 46.7/53.3 143.4 � 15.2 86.3 � 8.40 46.0/54.0 121.2 � 10.5 77.4 � 6.47 56.0/44.0 133.4 � 2.9 86.1 � 1.33 50.4/49.6 126.8 � 5.4 81.1 � 2.00 40.6/59.4 114.5 � 10.0 72.9 � 5.8

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Fig. 2

0

10

20

30

40

50

60

70A

war

e

Tre

ated

SB

P/D

BP

Co

ntr

ol

com

bin

ed

On

ly S

BP

con

tro

lled

On

ly D

PB

con

tro

lled

62.3%N=1336

58.6%N=1257

21.7%N=465

4.1%N=87

17.1%N=367

%

Hypertension awareness, treatment and control of systolic bloodpressure (SBP) only, diastolic blood pressure (DBP) only, andcombined SBP and DBP in the hypertensive patients of the San MarinoObservational Outlooking Trial on Hypertension (SMOOTH) study.

Table 2 Prevalence (%) of smoking and metabolic abnormalities innormotensive and hypertensive subjects

Normotensives(n ¼ 2446)

Hypertensives(n ¼ 2144) x2 test

Smoking 27.8 20.1 x22 ¼ 40.8(P < 0.0001)

Increased BMI 29.7 55.1 x21 ¼ 302.6(P < 0.0001)

Increased plasmatotal cholesterol

51.3 66.1 x21 ¼ 103.9(P < 0.0001)

Increased plasmatriglycerides

10.0 16.8 x21 ¼ 46.4(P < 0.0001)

Low plasma HDL-cholesterol

6.1 7.0 x21 ¼ 0.90(P ¼ 0.342)

Increased serumuric acid

3.3 8.3 x21 ¼ 52.6(P < 0.0001)

Diabetes mellitus 6.3 15.8 x21 ¼ 15.97(P < 0.0001)

BMI, body mass index; HDL, high-density lipoprotein.

Smoking rate was slightly lower, but other risk factors

(dyslipidaemia and increased serum uric acid) were more

frequent in treated than in untreated hypertensives

(Table 3). Subjects with a ‘high-normal’ BP displayed

a prevalence of diabetes mellitus and increased blood

cholesterol, triglycerides and uric acid that were greater

than those of subjects with a normal or optimal BP.

Values were similar or lower than those of untreated

hypertensive patients (Table 4). The overall prevalence

of metabolic syndrome was 13.4%, being much higher in

hypertensive than in normotensive subjects (24 versus

4%, P < 0.0001). The metabolic syndrome was much

opyright © Lippincott Williams & Wilkins. Unautho

Fig. 3

0

10

20

30

40

50

60

70

%

(a)

ControlledTreatedAware

MalesFemales

56.9%N=570

67.1%N=766

53.0%N=531

63.6%N=726

20.6%N=206

22.7%N=259

(b)

0

10

20

30

40

50

60

70

80

%

Hypertension awareness, treatment and systolic (SBP) and diastolic (DBP)Observational Outlooking Trial on Hypertension (SMOOTH) study accordingDBP combined.

more prevalent in treated than in untreated hypertensive

patients (30 versus 16%, P < 0.0001).

DiscussionOur study shows that in the San Marino Republic,

hypertension, as diagnosed by office SBP � 140 and/or

DBP � 90 mmHg, had a high prevalence (46.7%). It also

shows that about two-thirds of the hypertensive patients

were aware of their condition, that about 60% were taking

antihypertensive drug treatment, and that only slightly

more than 20% of the overall hypertensive population

(i.e. only about one-third of the treated fraction) had

values below 140/90 mmHg. Thus, hypertension preva-

lence is by no means less in this small Mediterranean

country than in large European and extra-European

countries [3–13,24–26].


43.7%N=168

60.2%N=594

74.3%N=574

39.1%N=150

56.1%N=554

71.5%N=553

15.4%N=59

21.1%N=208

25.6%N=198

ControlledTreatedAware

40 – 50

51 – 65

66 – 75

blood pressure control in the hypertensive patients of the San Marinoto (a) gender and (b) age. Controlled rates refers to control of SBP and

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Table 3 Prevalence (%) smoking and metabolic abnormalities inuntreated and treated hypertensive subjects

Untreatedhypertensives

(n ¼ 887)

Treatedhypertensives(n ¼ 1257) x2 test

Smoking 22.2 18.6 x22 ¼ 6.1(P ¼ 0.0485)

Increased BMI 48.9 59.4 x21 ¼ 23.2(P < 0.0001)

Increased plasmatotal cholesterol

60.3 70.3 x21 ¼ 22.9(P < 0.0001)

Increased plasmatriglycerides

14.3 18.5 x21 ¼ 6.6(P ¼ 0.0101)

Low plasma HDL-cholesterol

5.2 7.8 x21 ¼ 3.17(P ¼ 0.075)

Increased serumuric acid

5.3 10.3 x21 ¼ 17.46(P < 0.0001)

Diabetes mellitus 12.1 18.5 x21 ¼ 15.97(P < 0.0001)

BMI, body mass index; HDL, high-density lipoprotein.

Furthermore, despite some important favourable circum-

stances (small geographical size, limited traffic and trans-

portation problems, uniform social characteristics, high

income and health-care level) hypertension control is

affected by the same drawbacks described in studies

on different and much more heterogeneous populations

[1–13,24–26], namely unawareness of the increased BP

condition in a substantial number of patients and inef-

fective BP control in most treated individuals. These

conclusions are of particular interest because the large

sample studied was representative of the San Marino

population within the age-range explored; and our results

offer more up to date information on BP control and

cardiovascular risk factors in a Mediterranean country

than that provided by most surveys so far available.

Several other results of the SMOOTH study on hyper-

tension awareness, treatment and control deserve to be


Table 4 Prevalence of metabolic abnormalities in various normotensiveand smokers, Values are given as numbers (%)

Optimal BP (n ¼ 1229) Normal BP (n ¼ 995)

Non-smokers Smokers Non-smokers Smokers

(N ¼ 559) (N ¼ 670) (N ¼ 499) (N ¼ 495)Increased BMI 135 (24.2) 166 (24.8) 152 (30.5) 177 (35.8)

Increased cholesterol 263 (47.0) 332 (49.6) 262 (52.5) 269 (54.3)

Increased triglycerides 33 (5.9) 65 (9.7)�� 47 (9.4) 72 (14.5)�

Low plasma HDLcholesterol

12 (3.9) 29 (7.8)� 11 (5.9) 15 (6.6)

Increased uric acid 9 (1.6) 20 (3.0) 15 (3.0) 23 (4.6)

Diabetes mellitus 29 (5.2) 34 (5.1) 27 (5.4) 34 (6.9)

BP, blood pressure; BMI, body mass index; HDL, high-density lipoprotein. ��P < 0.0

mentioned because of their similarity or difference with

previous studies addressing a similar issue. First, as in

previous studies [1,2,27,28], the percentage of patients

with unsatisfactory SBP control was greater than that with

unsatisfactory DBP control. This may have been

favoured by the inclusion, in the overall group, of subjects

with isolated systolic hypertension, in whom only SBP is

elevated. However, similar findings were obtained both

in subgroups in which isolated systolic hypertension is

highly prevalent (the elderly) and in subgroups in which

it is not (middle-aged and younger subjects). This allows

us to conclude that, in agreement with previous studies,

target SBP is less frequently obtained than target DBP.

This may be due to greater attention paid by physicians

to DBP rather than SBP control. However, it also prob-

ably reflects the greater difficulty posed by effective SBP

reduction, because in clinical trials average SBP values

have also frequently failed to be reduced to < 140 mmHg

[28]. Second, as in previous studies [29,30], monotherapy

was more common than combination therapy. This can

be one of the reasons for the low rate of BP control,

because clinical trials have shown combinations of two or

more drugs to be necessary to effectively reduce BP

values in the majority of hypertensive patients, presum-

ably because a multiregulated variable such as BP can be

more easily modified by acting on several controlling

factors [8,28–30]. Thirdly, as in previous studies

[1,2,31], women were more frequently aware of their

high BP condition than men. However, at variance from

other studies: the rate of patients with controlled BP was

similar for men and women; this goal was more frequently

achieved in older than in younger patients; and the

percentage of individuals aware of their hypertension

was only slightly greater than the percentage under drug

treatment (62 versus 58%). Thus, in the San Marino

Republic, the health-care system should further improve

the procedures that favour the discovery of a high BP


and untreated hypertensive categories, separately for non-smokers

High-normal BP (n ¼ 222)Untreated hypertensives

(n ¼ 887) x2 test

Non-smokers Smokers Non-smokers SmokersBetween BP

group comparison

(N ¼ 98) (N ¼ 124) (N ¼ 416) (N - 471)39 (39.8) 58 (46.8) 189 (45.4) 245 (52.0)� x2

3 ¼ 144P < 0.0001

59 (60.2) 69 (55.6) 245 (58.9) 290 (61.6) x23 ¼ 30:9P < 0.0001

9 (9.2) 18 (14.5) 39 (9.4) 88 (18.7)�� x23 ¼ 22:4P < 0.0001

1 (2.7) 3 (7.5) 6 (2.9) 18 (7.2)� x23 ¼ 0:57P ¼ 0.90

3 (3.1) 11 (8.9) 11 (2.6) 36 (7.6)�� x23 ¼ 16:1P ¼ 0.001

9 (9.2) 20 (16.1) 43 (10.3) 64 (13.6) x23 ¼ 47:0P < 0.0001

1; �P < 0.05 for the comparison between smokers and non-smokers.

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condition, although once hypertension is identified, drug

treatment is almost always implemented, with no greater

conservative attitude in the elderly. Full success remains

an elusive goal in most of the patients, however, which

has serious adverse consequences because treated hyper-

tensive patients in whom BP is not controlled remain at

higher risk [32]. Furthermore, in treated hypertensive

patients in whom BP was controlled, average values were

141.3 � 16.1/84.8 � 8.6 mmHg. This means that most

patients remained in the high-normal range [1,2,19]

which, given that BP is a risk factor on a continuum

basis [33], carries a risk higher than that accompanying

more ‘normal’ BP.

Our study also aimed to collect data on the association

between hypertension and metabolic abnormalities,

because such information from Mediterranean popu-

lations dates back many years and is much more limited

than that from northern European and extra-European

populations [1,2,17–19]. This is important for clinical

practice because in hypertension calculation of total

cardiovascular risk profile [19,34] guides the timing

and the initiation of drug treatment as well as the BP

values to be reached and the need for multiple risk-factor

correction. The data provided by the SMOOTH study,

however, do not show quantitative differences from those

obtained in the above-mentioned populations. That is,

compared to normotensives, the hypertensive individuals

of the San Marino sample showed a greater prevalence of

dyslipidaemias and increased uric acid levels, together

with a much greater frequency of obesity, diabetes and

metabolic syndrome. Thus, an association between

hypertension and metabolic abnormalities can be seen

in populations that differ for many lifestyle character-

istics, suggesting their origin from an independent and

specific pathophysiological link. Interestingly, metabolic

abnormalities, as well as a metabolic syndrome, were

more common in treated than in untreated hypertensive

patients. This could be accounted for by the dysmeta-

bolic effect of antihypertensive drugs such as diuretics

and beta-blockers; however, these were not largely used.

It is thus more likely for these effects to depend on the

fact that treated hypertensives were those in whom the

high BP condition was more severe, because there is

evidence of a quantitative relationship between BP levels

and metabolic disturbances [34,35].

Two other points should be mentioned. First, in line with

the data obtained in North American populations [36,37]

in subjects with BP values in the so-called ‘high-normal’

range, metabolic abnormalities were either similar or less

frequent than in untreated hypertensives, but more fre-

quent than in subjects with normal or optimal BP. Thus,

regardless of geographical, dietary and other lifestyle

factors, the high-normal BP condition appears to be

characterized by an overall increase in the prevalence

of metabolic abnormalities, accounting for the increased

opyright © Lippincott Williams & Wilkins. Unautho

absolute cardiovascular risk it has been shown to display

in epidemiological studies [36]. This strengthens the

belief that these individuals are not entirely normal

and that they may be considered candidates for active

treatment, although the benefit obtained by BP reduction

strategies from high-normal BP levels has so far been

documented only in those with a very high-risk profile

[19,38,39].

Second, the high prevalence of hypertension seen in the

SMOOTH population may originate from a selection-

bias, that is, from the fact that screening was done via

attendance of the San Marino residents to medical visits.

It may also originate from an alerting reaction that

elicited a pressor response at the time of the doctor’s

visit [40]. This may have been particularly the case

because the study was based on a single visit only.

However, values were derived from the average of two

measurements, following a 10-min rest, a procedure that

minimizes the alerting-dependent BP rise [40]. Further-

more, several studies have shown that BP values obtained

over a single visit are predictive of future cardiovascular

disease and death [41]. In addition, the prevalence of

hypertension in the SMOOTH sample was similar to that

found, for the same age range, in other studies, including

those in northern Italy [18,42]. Finally, hypertensive

patients differed from normotensives on several other

variables, which suggests that their increased BP values

were not just an occasional finding but reflected a stable

hypertensive condition.

AcknowledgementsWe thank the Health Ministry of San Marino Republic

for its cooperation. We also thank Recordati S.p.A for the

unrestricted financial support given to the study.

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AppendixSMOOTH investigators involved in data collection:

Maria Anna Aalders MD, Giuseppe Balducci MD,

Tiziano Bugli MD, Giuseppe Castelli MD, Giorgio De

Luigi MD, Antonella Greco MD, Nelson Lazzari MD,

Arghirios Nikolacopulos MD, Liano Marinelli MD,

Emidio Troiani MD, Giulia Cardinali PhD.


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