Article

Blood pressure control in Italy: Analysis of clinical data from 2005-2011 surveys on hypertension

IRCCS Neuromed, Pozzilli, Isernia, Italy.
Journal of Hypertension (Impact Factor: 4.72). 06/2012; 30(6):1065-74. DOI: 10.1097/HJH.0b013e3283535993
Source: PubMed

ABSTRACT

Blood pressure (BP) control is poorly achieved in hypertensive patients, worldwide.
We evaluated clinic BP levels and the rate of BP control in hypertensive patients included in observational studies and clinical surveys published between 2005 and 2011 in Italy.
We reviewed the medical literature to identify observational studies and clinical surveys on hypertension between January 2005 and June 2011, which clearly reported information on clinic BP levels, rates of BP control, proportions of treated and untreated patients, who were followed in different clinical settings (mostly in general practice, and also in outpatient clinics and hypertension centres).
The overall sample included 158 876 hypertensive patients (94 907 women, mean age 56.6 ± 9.6 years, BMI 27.2 ± 4.2 kg/m(2), known duration of hypertension 90.2 ± 12.4 months). In the selected studies, average SBP and DBP levels were 145.7 ± 15.9 and 87.5 ± 9.7 mmHg, respectively; BP levels were higher in patients followed in hypertension centres (n = 10 724, 6.7%; 146.5 ± 17.3/88.5 ± 10.3 mmHg) than in those followed by general practitioners (n = 148 152, 93.3%; 143.5 ± 13.9/84.8 ± 8.9 mmHg; P < 0.01). More than half of the patients were treated (n = 91 318, 57.5%); among treated hypertensive patients, only 31 727 (37.0%) had controlled BP levels.
The present analysis confirmed inadequate control of BP in Italy, independently of the clinical setting. Although some improvement was noted compared with a similar analysis performed between 1995 and 2005, these findings highlight the need for a more effective clinical management of hypertension.

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Blood pressure con trol in Italy: analysis of clinical da ta
from 2005^2011surveys on hypertension
Giuliano Tocci
a
, Enrico Agabiti Rosei
b
, Ettore Ambrosioni
c
, Claudio Borghi
c
, Claudio Ferri
d
,
Andrea Ferrucci
e
, Giuseppe Mancia
f
, Alberto Morganti
g
, Roberto Pontremoli
h,i
, Bruno Trimarco
a,j
,
Alberto Zanchetti
k
, and Massimo Volpe
a,e
Introduction: Blood pressure (BP) control is poorly
achieved in hypertensive patients, worldwide.
Aim: We evaluated clinic BP levels and the rate of BP
control in hypertensive patients included in observational
studies and clinical surveys published between 2005 and
2011 in Italy.
Methods: We reviewed the medical literature to identify
observational studies and clinical surveys on hypertension
between January 2005 and June 2011, which clearly
reported information on clinic BP levels, rates of BP
control, proportions of treated and untreated patients,
who were followed in different clinical settings (mostly
in general practice, and also in outpatient clinics and
hypertension centres).
Results: The overall sample included 158 876 hypertensive
patients (94 907 women, mean age 56.6 ! 9.6 years, BMI
27.2 ! 4.2 kg/m
2
, known duration of hypertension
90.2 ! 12.4 months). In the selected studies, average SBP
and DBP levels were 145.7 ! 15.9 and 87.5 ! 9.7 mmHg,
respectively; BP levels were higher in patients followed in
hypertension centres (n ¼ 10 724, 6.7%; 146.5 ! 17.3/
88.5 ! 10.3 mmHg) than in those followed by general
practitioners (n ¼ 148 152, 93.3%; 143.5 ! 13.9/
84.8 ! 8.9 mmHg; P < 0.01). More than half of the
patients were treated (n ¼ 91 318, 57.5%); among treated
hypertensive patients, only 31 727 (37.0%) had controlled
BP levels.
Conclusion: The present analysis confirmed inadequate
control of BP in Italy, independently of the clinical setting.
Although some improvement was noted compared with a
similar analysis performed between 1995 and 2005, these
findings highlight the need for a more effective clinical
management of hypertension.
Keywords: blood pressure control, global cardiovascular
risk, hypertension, hypertension surveys
Abbreviations: ACE, angiotensin-converting enzyme;
ARBs, angiotensin receptor blockers; BP, blood pressure
INTRODUCTION
O
ver the last decades, large observational studies
have consistently reported a persistently inade-
quate level of blood pressure (BP) control in
hypertensive patients [1,2]. Insufficient BP control has
dramatic consequences for Public Health. In turn, effective
BP reduction by means of pharmacological intervention is
one of the most powerful and successful ways to reduce the
incidence of cardiovascular morbidity and mortality [3,4].
Randomized clinical trials, in fact, have consistently
demonstrated significant benefits by lowering high BP
levels in hypertensive patients in different conditions,
including high cardi ovascular risk [57], coronary disease
[8,9], stroke [10,11] or diabetic nephropathy [12,13]. A closer
analysis of these interventional trials, however, showed
that effective BP control (i.e. BP levels <140/90 mmHg
for hypertensive patients and <130/80 mmHg in high-risk
hypertensive patients with diabetes or renal disease) was
achieved only in a few of these randomized clinical trials
[14,15], thus confirming how challenging it is to achieve
adequate BP control.
Poor BP control rates have been reported also by large
observational studies and clinical surveys, performed in
different clinical settings and in different countries. Indeed,
our previous meta-survey of observational studies between
1995 and 2005, and involv ing about 53 000 diagnosed
hypertensive patients in Italy, showed that only 22% of
the patients had their BP levels below the recommended
targets (<140/90 mmHg), whereas about 39% persiste d in
stage 1 hypertension and almost one-third had stage 2
hypertension, despite antihypertensive therapy [16]. A more
Journal of Hypertension 2012, 30:10651074
a
IRCCS Neurom ed, Pozzilli, Isernia,
b
Department of Medical and Surgical Sciences,
II Division of Medicine, Azienda Ospedaliera Spedali Civili, Brescia,
c
Division of Internal
Medicine, University of Bologna, Policlinico Sant’Orsola, Bologna,
d
Department of
Internal Medicine and Public Health, University of L’Aquila, Coppito, L’Aquila,
e
Division of Cardiology, Department of Clinical and Molecular Medicine, Faculty of
Medicine, University of Rome ‘Sapienza’, Sant’Andrea Hospital, Rome,
f
University of
Milano-Bicocca, San Gerardo Hospital, Monza,
g
Chair and Division of Internal Medi-
cine, Hypertension Unit, Ospedale San Giuseppe, Milan,
h
Department of Internal
Medicine, University of Genoa,
i
Department of Cardionephrology, IRCCS Azienda
Ospedaliera Universitaria San Martino-IST, Genoa,
j
Department of Clinical Medicine
and Cardiovascular Sciences, University of Naples ‘Federico II’, Naples and
k
Istituto
Auxologico Italiano and Centro di Fisiologia Clinica e Ipertensione, University of
Milano, Milan, Italy
Correspondence to Massimo Volpe, Professor, University of Rome ‘Sapienza’, Rome
00189, Italy. Tel: +39 06 3377 5654; fax: +39 06 3377 5061; e-mail: massimo.
volpe@uniroma1.it
Received 30 October 2011 Revised 4 February 2012 Accepted 6 March 2012
J Hypertens 30:10651074
! 2012 Wolters Kluwer Health | Lippincott Williams &
Wilkins.
DOI:10.1097/HJH.0b013e3283535993
Journal of Hypertension www.jhypertension.com 1065
Review
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recent international survey, which documented the clinical
profile of more than 20 000 patients with arterial hyper-
tension and cardiovascular risk factors, confirmed that only
22% of diagnosed hypertensive outpatients achieved the
recommended BP control in Italy [17].
In recent years, many observational studies addres sing
the issue of BP control have been performed in Italy. This
gave us the unique opportunity to achieve an updated
appraisal of the clinical managem ent of hypertension,
focusing on high BP treatment and control in Italy. Thus,
in the present article, we analysed the results of observa-
tional studies and clinical surveys to evaluate clinic BP
levels and rates of BP control based on a large, representa-
tive hypertensive population in Italy. The main aim of
our analysis was to report mean BP levels and to determine
the rate of BP control according to the most recent sets
of European guidelines on hypertension [18], that is, to
determine how many patients had BP values less than
140 mmHg for systolic and/or less than 90 mmHg for
diastolic, in different clinical settings.
METHODS
Data search and study selection
The methodology of our analysis has been previously
described [19]. Briefly, we reviewed the medical literature
to identify recent observational studies and clinical surveys
conducted on hypertensive patients in Italy.
In this perspective, a computerized literature search
was carried out using the PubMed, MEDLINE, OVID and
EMBASE databases from January 2005 to June 2011. Only
articles published in English language in peer-reviewed
journals and clinical studies perf ormed in adults (mor e
than 18 years of age) were considered. For study searching,
the following key words were applied: ‘blood pressure’,
‘hypertension’, ‘observational study’ and ‘Italy’. Once
identified, clinical studies were carefully revised by two
investigators (G.T. and M.V.) to be considered for the
present analysis according to the predefined criteria.
We considered the following inclusion criteria: obser-
vational studies or clinical surveys performed in individuals
of both sexes, aimed at evaluating prevalence and/or
clinical characteristics of hypertensive patients, which were
carried out and published between 2005 and 2011;
inclusion of hypertensive patients recruited in Italy; clear
information on average levels of SBP and DBP in each
population sample; and absence of any prospective
pharmacological or nonpharmacological interventions in
the study protocol (interventional, randomized clinical
trials). Hypertensive patients have been evaluated and
clinic BP levels have been measured in all patients included
in the analysis during time intervals predefined in the
individual studies. All clinical data hav e been collected
by the investigators of the various studies during the
observational periods. On the contrary, we considered
the following exclusion criteria: interventional trials or
clinical studies, aimed at evaluating the antihypertensive
efficacy of any pharmacological or nonpharmacological
strategy compared with placebo or active treatment; study
population in which hypertensive patients represented
only a minority (with a cut-off value that was arbitrarily
considered by less than 30% of the population sample);
patients included in national or local registry for evaluating
the efficacy, safety and tolerabil ity of antihypertensive
agents or any other cardiovascular drugs and/or for
administrative purposes.
Clinic blood pressure values and
antihypertensive therapy
Although different criteria were used in the selected studies,
particularly in those published before 2007, BP control was
uniformly regarded as clinic BP values below 140 mmHg for
SBP and/or below 90 mmHg for DBP [18].
In each study, absolute prevalence of treated and
untreated hypertensive patients, as well as prevalence of
controlled and uncontrolled individuals among treated
hypertensive patients were calculated, when available.
In this regard, proportions of treated patients on major
antihypertensive drug class [including ACE inhibitors,
angiotensin receptor blockers (ARBs), beta-blockers,
calcium-channel blockers and diuretics] were also reported.
Cardiovascular risk profile characterization
Sex distribution, mean values of age, BMI, heart rate
and prevalence of cardiovascular major risk factors such
as smoking, hypercholesterolemia and diabetes were
collected for each survey included in the analysis.
Information on hypertension-related organ damage and
associated clinical conditions was also collected, when
available.
Data analysis
According to the study protocol applied to our previous
analysis [19], even in this population sample of hyperten-
sive patients, the BP control was estimated according to
types of studies (population surveys or clinical studies) and
type of clinical setting (hypertension centres or general
practitioners) to which patients were referred.
Because of the descriptive nature of the results, no
statistical test was applied to the collected data. Data
are expressed as mean ! SD and/or as percentage, when
appropriate.
RESULTS
Study selection
Flowchart for study selection is reported in Fig. 1. Among
the 61 st udies initially selected for the analysis, 27 were
excluded because of partial or missing information on BP
levels and 15 because they were already considered in
our previous analysis [19]. Four observational studies were
excluded because they did not provide clear data on
BP levels [2023]. Two additional studies were omitted
because they were published [24] or concluded [25] before
2005. Finally, two studies were not considered because they
primarily focused on patients with metabolic syndrome [26]
or otherwise healthy individuals [27] rather than on hyper-
tension. Thus, on the basis on a strict selection approach
and according to the predefined inclusion and exclusion
criteria, a total of 11 observational studies or clinical surveys
on hypertension in Italy were included the present analysis
Tocci et al.
1066 www.jhypertension.com
Volume 30 # Number 6 # June 2012
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[2838]. A list of these studies with acronyms is reported in
Acknowledgements section.
General characteristics of clinical studies
Table 1 reports the main characteristics of observational
studies and clinical surveys considered for the analysis,
including sample size, year of publication, observational
period, geographical area, type of referring centre (general
practitioners, hypertension clinics, outpatient clinics), type
of population (outpatients or general population) and type
of data collection (single centre or multicentre).
These studies enrolled a total of 158 876 hypertensive
patients, a vast majority of whom were followed by general
practitioners (n ¼ 148 152, 93.3%) [28,32,3739] and only a
minority by specialized centres (mostly hypertension
centres) (n ¼ 10 724, 6.7%) [2931,33,35,36,39]; in addition,
almost all patients were included in multicentre
studies (n ¼ 158 021, 99.5%) [2832,3639], whereas the
proportion of patients included in single-centre studies
was negligible (n ¼ 855, 0.5%) [33,35].
Cardiovascular risk profile
General characteristics of the overall population and
hypertensive patients, which were stratified according to
the type of clinical referrals, are reported in Table 2.
In the overall population, 63 622 (40.0%) were men and
94 907 (60.0%) were women. Patients followed by general
practitioners were predomi nantly women (about 60%),
whereas a more balanced sex distribution was observed
in outpatien ts followed by hypertension centres. Mean age
was 56.6 ! 9.6 years, BMI was 27.2 ! 4.2 kg/m
2
and
heart rate was 73.2 ! 9.8 beats/min; all these parameters
61 potentially relevant studies identified
and screened in medical database
34 surveys retrieved
for detailed assessment
19 potentially appropriate surveys
to be included in the 2005–2011 analysis
27 surveys excluded because of partial or missing
data on overall BP levels or control
15 surveys with usable information to be
used in the 2005–2011 analysis
13 surveys with valuable data
included in the 2005–2011 analysis
11 surveys with valuable data
included in the 2005–2011 analysis
2 surveys excluded because of low proportion of
hypertensive patients included in the sample
2 surveys excluded because of published or
concluded before the target study period
4 surveys excluded because of missing data on BP
levels or control in the overall sample
15 surveys excluded because already included
in the former analysis (2000–2005)
FIGURE 1 Flowchart for study selection.
TABLE 1. General characteristics of observational studies and clinical surveys on hypertension, performed in Italy between 2005 and 2010
Clinical
survey
Population
(n)
Publication
(year)
Observational
period (years) Area
Type of
referring
centre
Type of
population
Study
design
SIMONA 18 326 2005 n.a. Italy GP General population Multicentre
APROS-Diadys 2 545 2007 n.a. Italy HC Outpatient clinic Multicentre
HYPER-PRACT 211 2008 2006 (March) to 2007 (March) Lombardy HC Outpatient clinic Multicentre
IPERDIA 1 397 2008 2001 (March 1 to October 31) Italy HC Outpatient clinic Multicentre
GP survey 119 065 2009 2005 Italy GP General population Multicentre
MAGIC 400 2009 2002 (January) to March (2007) Genoa HC Outpatient clinic Single centre
EFFECTUS 9 904 2009 2006 (May) Italy HC, DC, GP Outpatient clinic Multicentre
REDHY 455 2010 n.a. Palermo HC Outpatient clinic Single centre
IDEMAND 3 534 2010 n.a. Italy HC Outpatient clinic Multicentre
MARTE 1 768 2010 2005 (July) to 2006 (November) Italy GP General population Multicentre
MIRACLES 1 271 2011 2007 (May) to 2008 (May) Italy GP General population Multicentre
OVERALL 158 876
HC, hypertension centre; GP, general practitioner.
Blood pressure control in Italy
Journal of Hypertension www.jhypertension.com 1067
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tended to be higher in patients followed by hyperten-
sion centres rather than in those followed by general
practitioners.
In the overall sample, 6.0% of the patients were smokers,
9.5% had hypercholesterolemia and 11.4% had diabetes.
Of note, and as an index of a greater complexity of patients,
the prevalence of all these risk factors was substantially
higher in the subgroup of patients followed in hypertension
centres as compared with those followed by general
practitioners, as illustrated in Fig. 2.
Blood pressure levels and control rates
As shown in Table 3, in the overall sample, mean SBP and
DBP levels were 145.7 ! 15.9 and 87.5 ! 9.7 mmHg,
respectively. In the majority of the selected studies, SBP
levels exceeded the normal threshold of 140 mmHg,
whereas DBP levels were more frequently below 90 mmHg,
as represented in Fig. 3. Mean BP values were higher in
patients followed in hypertension centres (146.5 ! 17.3/
88.5 ! 10.3 mmHg) than in those followed by general prac-
titioners (143.5 ! 13.9/84.8 ! 8.9 mmHg; P < 0.01) (Fig. 4).
In addition, average BP levels were higher in single-centre
studies than in multicentre studies (155.0 ! 18.0/96.0 ! 12.0
versus 143.7 ! 15.4/85.6 ! 9.2 mmHg; P < 0.01). In some
selected studies which provided information on BP
stratification (n ¼ 4 2 845) [3234], the vast majority of the
patients had grade I (n ¼ 30 456, 71.1%) or grade IIIII
(n ¼ 9340, 21.8%) hypertension and only 2.8% (n ¼ 1182)
TABLE 2. General characteristics of hypertensive patients included in observational studies and clinical surveys on hypertension
Clinical survey
Male
[n (%)]
Female
[n (%)]
Age
(years) BMI
HR
(beats/min) Smoking Dyslipidemia Diabetes
Total centres ¼ 158 876
Hypertension centres (n ¼ 10 724, 6.7%)
APROS-Diadys 1248 (49.0) 1297 (51.0) 70.3 ! 4.5 26.0 ! 2.6 70.1 ! 8.6 n.a. 1364 (61.0) 404 (19.4)
HYPER-PRACT 111 (52.6) 100 (47.4) 56.4 ! 13.8 26.6 ! 3.8 73.2 ! 11.7 47 (22.5) n.a. 21 (9.9)
IPERDIA 690 (49.4) 707 (50.6) 59.0 ! 8,0 28.0 ! 4.5 73.0 ! 10.0 n.a. n.a. 242 (17.3)
MAGIC 260 (65.0) 140 (35.0) 47.0 ! 9.0 26.4 ! 3.5 n.a. 108 (27.0) n.a. 0 (0.0)
EFFECTUS Cardiology 5300 (53.5) 4604 (46.5) 67.0 ! 9.0 28.0 ! 5.0 n.a. 510 (23.4) 861 (59.0) 444 (37.0)
REDHY 246 (54.1) 209 (45.9) 48.3 ! 14.4 28.7 ! 4.8 n.a. 141 (31.0) n.a. n.a.
IDEMAND 1908 (54.0) 1626 (46.0) 61.5 ! 11.6 28.5 ! 4.8 n.a. 1484 (42.0) 2156 (61.0) 1308 (37.0)
Total 5184 (48.3) 5540 (51.7) 58.5 ! 10.0 27.5 ! 4.1 72.1 ! 10.1 2291 (21.4) 4381 (40.8) 2418 (22.6)
General practice (n ¼ 148 152, 93.3%)
SIMONA 0.0 (0.0) 18 326 (100.0) 52.8 ! 4,0 25.1 ! 4.2 75.0 ! 9.4 3848 (21.0) 4582 (25.0) 861 (4.7)
EFFECTUS GPs 4129 (53.5) 3593 (46.5) 67.0 ! 9.0 28.0 ! 5.0 n.a. 2537 (32.9) 4402 (59.0) 2454 (37.0)
GP survey 52 788 (44.3) 66 017 (55.4) n.a. n.a. n.a. n.a. n.a. 11 114 (16.6)
MARTE 843 (47.7) 925 (52.3) 61.1 ! 12.0 27.7 ! 4.3 74.6 ! 9.5 256 (14.5) 660 (37.4) 246 (13.9)
MIRACLES 724 (57.0) 547 (43.0) 43.0 ! 9.7 n.a. n.a. 292 (25.0) 465 (36.6) 166 (13.1)
Total 58 484 (39.5) 89 408 (60.3) 56.0 ! 8.7 26.9 ! 4.5 74.8 ! 9.5 6933 (4.7) 10 109 (6.8) 14 841 (10.0)
Overall 63 668 (40.4) 94 948 (59.8) 56.6 ! 9.6 27.2 ! 4.2 73.2 ! 9.8 9501 (6.0) 15 099 (9.5) 18 043 (11.4)
Since both EFFECTUS [34] and MIRACLES [38] studies included patients followed in different clinical settings, in this table, only those data from hypertensive patients followed by GPs in
the EFFECTUS [34] and by hypertension centres in the EFFECTUS [34] and MIRACLES [38] studies were reported. In the GP Survey [32], sex was not reported for 264 individuals. GP,
general practitioner.
70.0
N = 158 876
60.0
50.0
40.0
30.0
Prevalence (%)
20.0
4.7
GPs (n = 148 152; 93.3%)
Smoking Hypercholesterolemia Diabetes
HT units (n = 10 724; 6.7%) Overall (N = 158 876; 100.0%)
6.8
10.0
21.4
40.8
22.6
6.0
9.5
11.4
10.0
0.0
FIGURE 2 Distribution of major cardiovascular risk factors among hypertensive patients according to referring centres in Italy.
Tocci et al.
1068 www.jhypertension.com
Volume 30 # Number 6 # June 2012
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Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
had high-normal BP values, the remaining proportions
were of patients with normal or optimal BP thresholds
(n ¼ 2317, 4.3%).
About half of the over all patients were treated
(n ¼ 91 318, 57.5%). The proportion of treated patients,
however, was higher in those followed in hypertension
centres (n ¼ 8658, 80.7%) than in those followed by general
practitioners (n ¼ 81 989, 55.3%). BP control rates among
treated hypertensive patients were reported in three
surveys performed by general practitioners (n ¼ 30 801,
40.6%) [32,37,38] and only in one study performed in
hypertension centres (n ¼ 526, 10.7%) [29], with an overall
TABLE 3. Clinic SBP and DBP levels and proportions of treated and untreated patients in observational studies and clinical surveys on
hypertension
Clinic BP levels (mmHg)
Antihypertensive therapy
(% among overall population)
Clinical survey SBP DBP Treated Untreated
Hypertension centres (n ¼ 10 724, 6.7%)
APROS-Diadys 145.2 ! 15.9 84.7 ! 8.5 2393 (94.0) 152 (6.0)
HYPER-PRACT 145.7 ! 19.7 89.1 ! 10.7 168 (79.6) 43 (20.4)
IPERDIA 145.0 ! 16.0 88.0 ! 9.0 1347 (96.4) 50 (3.6)
MAGIC 156.0 ! 15.0 100.0 ! 8.0 0 (0.0) 400 (100.0)
EFFECTUS Cardiology 138.0 ! 14.0 81.0 ! 8.0 6025 (78.0) 1697 (22.0)
REDHY 154.0 ! 21.0 92.0 ! 16.0 345 (75.8) 110 (24.2)
IDEMAND 139.4 ! 16.6 83.8 ! 9.7 3237 (91.6) 297 (8.4)
Total 146.5 ! 17.3 88.5 ! 10.3 8658 (80.7) 2066 (19.3)
General practice (n ¼ 148 152, 93.3%)
SIMONA 136.6 ! 17.6 83.0 ! 10.0 6066 (33.1) 12 260 (66.9)
EFFECTUS GPs 140.0 ! 17.0 82.0 ! 10.0 1168 (53.5) 1014 (46.5)
MARTE 144.0 ! 15.8 85.8 ! 9.6 1768 (100.0) 0 (0.0)
MIRACLES 135.6 ! 12.5 83.4 ! 7.5 1243 (97.8) 28 (2.2)
Total 143.5 ! 13.9 84.8 ! 8.9 81 989 (55.3) 66 163 (44.7)
OVERALL 145.7 ! 15.9 87.5 ! 9.7 91 318 (57.5) 67 558 (42.5)
When available [3234,37], SBP and DBP levels were always within the high-normal values in treated hypertensive patients (135.1 ! 12.0/81.1 ! 7.6 mmHg), whereas they were in stage
2 hypertension thresholds in untreated hypertensive patients (150.0! 12.8/89.6 ! 8.5 mmHg), with the only exception of the EFFECTUS study [34], in which both treated and untreated
BP levels were reported in the high-normal thresholds. BP, blood pressure.
N = 158 876
SIMONA, 2005
APROS-DiaDys, 2007
Hyper-Pract, 2008
IPERDIA, 2008
Italian GP Survey, 2009
MAGIC, 2009
EFFECTUS, 2009
REDHY, 2010
IDEMAND, 2010
MARTE, 2010
MIRACLES, 2011
0.0
Diastolic BP Systolic BP
20.0 40.0 60.0 80.0 100.0 120.0 140.0 160.0 180.0
135.6
144.0
139.4
85.8
84.4
83.8
92.0
154.0
138.0
156.0
163.5
145.0
145.7
145.2
136.6
82.0
100.0
90.8
88.0
89.1
84.7
83.0
FIGURE 3 Clinic blood pressure levels in hypertensive patients included in observational studies or clinical surveys on hypertension between 2005 and 2011 in Italy.
Histograms represent average SBP and DBP levels in each study included in the analysis. Data are expressed as mean ! SD.
Blood pressure control in Italy
Journal of Hypertension www.jhypertension.com 1069
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BP control rate of 37.0% (n ¼ 31.727) among treated
hypertensive patients.
Drugs inhibiting the reninangiotensin system were the
most common therapy prescribed in the overall population
sample, either as a monotherapy or in combination therapy
with thiazide diuretics (n ¼ 41 089, 48.5% among treated
hypertensive patien ts); in particular, 25 150 (29.7%) hyper-
tensive patients were treated with ACE inhibitors and 13 289
(15.7%) with ARBs. In addition, 21 376 (25.2%) hyperten-
sive patients were treated with calciu m antagonists, 18 973
(22.4%) with diuretics and 17 790 (21.0%) with beta-
blockers (Table 4).
DISCUSSION
The present analysis provides one of the largest, updated
and comprehensive available database on the extent to
which BP is controlled by treatment in hypertensive
patients or the hypertensive fra ction of general pop ulations.
This large population sample derives from hypertensive
patients included in observational and clinical studies
performed in Italy and whose results were published
between 2005 and 2011 in Italy. From the large number
of findings provided by the present analysis, we discuss
below some of the main aspects.
First of all, BP control by antihypertensive treatment was
achieved in a relatively small fraction of hypertensive
patients. In fact, among treated hypertensive patients, about
37% achieved the recommended BP values, the others
remaining in the abnormal range of BP. This result is in
line with that of our previous analysis, which collected data
on BP levels reported in clinical studies made available
between 20 00 and 2005 in Italy [19]. This is also in line
with other large observational surveys performed in both
European [17,40] and North American [2,4143] countries,
which reported a disappointingly low rate of BP control
among treated hypertensive patients. Our previous
analysis, however, reported that only 19% (n ¼ 6698) of
treated hypertensive patients (n ¼ 34596) achieved effec-
tive BP control [19], compared with the relatively higher
proportion (37%) observed in the present analysis. A similar
improvement in BP control rates was reported in several
180.0
160.0
140.0
143.5
146.5
145.7
84.8
88.5
87.5
120.0
100.0
BP levels (mmHg)
80.0
60.0
40.0
SBP levels DBP levels
GPs (n = 148 152; 93.3%) HT units (n = 10 724; 6.7%) Overall (N = 158 876; 100.0%)
N = 158 876
FIGURE 4 Clinic blood pressure levels in the overall population sample and in subgroups of patients followed by general practitioners or in hypertension centres. Data are
expressed as mean ! SD.
TABLE 4. Proportions of treated hypertensive patients assuming different antihypertensive drugs in observational studies and clinical
surveys on hypertension
Clinical survey RAS blockers ACEi ARB CCB BB AB Diuretics
APROS-Diadys 1896 (79.2) 1113 (46.5) 783 (32.7) 971 (40.6) 634 (26.5) 258 (10.8) 288 (12.0)
IPERDIA 1029 (76.4) 711 (52.8) 318 (23.6) 520 (38.6) 359 (26.7) 180 (13.4) 604 (44.8)
GP survey 26 134 (39.1) 17 209 (25.7) 8925 (13.3) 16 705 (25.0) 13 778 (20.6) 0 (0.0) 12526 (18.7)
MAGIC 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
EFFECTUS 7011 (89.2) 4825 (61.4) 2186 (27.8) 2335 (29.7) 2138 (27.2) 0 (0.0) 3192 (40.6)
IDEMAND 2650 (81.9) n.a. n.a. n.a. n.a. n.a. 1414 (43.7)
MARTE 1343 (76.0) 797 (45.1) 546 (30.9) 532 (30.1) 563 (31.8) 169 (9.6) 808 (45.7)
MIRACLES 1026 (82.5) 495 (39.8) 531 (42.7) 313 (25.2) 318 (25.6) 0 (0.0) 141 (11.3)
Total 41 089 (48.5) 25 150 (29.7) 13 289 (15.7) 21 376 (25.2) 17 790 (21.0) 607 (0.7) 18 973 (22.4)
The MAGIC study [33] included untreated hypertensive patients, thus information on antihypertensive drug therapies at baseline cannot be produced. ACEi, angiotensin-converting
enzyme inhibitor; ARB, angiotensin receptor blocker; BB, beta-blocker; CCB, calcium-channel blocker; GP, general practitioner; RAS, reninangiotensin system.
Tocci et al.
1070 www.jhypertension.com
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Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Italian surveys [4446]. As an example, in the Gubbio study
[45], the overall BP control rate increased from 10% reported
in the 1980s to 20% in the 1990s to about 40% in the early
2000s; this was paralleled with consistent reductions in both
all-cause and cardiovascular death during the observational
period. Several potential explanations may be advocated in
an attempt to explain this poor BP control rate, including
the relatively high risk of the study population, the con-
comitant presence of associated clinical conditions, the low
proportions of treated patients with diagnosed hyperten-
sion and the use of certain antihypertensive drug therapies
(or dosages). However, the observational nature of our
study did not allow us to provide such explanations.
Second, BP levels and control of treated hypertensive
patients were substantially better in population surveys
than in hypertensive patient-based study. This observation
seems to confirm the hypothesis that these hypertensive
patients have more difficult-to-tr eat hypertension, which
may be at least, in part, due to the relatively higher pre-
valence of cardiovascular risk factors (obesity, smoking,
dyslipidemia, diabetes) reported in the former than in the
latter group. However, it also differs from the results of our
previous analysis [19], in which BP control was somewhat
better in patients seen by specialists than in those seen by
general practitioners. In this latter regard, when comparing
average BP levels between our previous [19] and current
analyses, we observed a substantial reduction in BP levels
only in the subgroup of patients followed by general
practitioners (from 154.1/90.9 to 143.5/84.8 mmHg),
whereas no relevant difference was observed in outpatients
followed by hypertension clinics (from 147.2/89.6 to 146.5/
88.5 mmHg). Several explanations may be advocated for
explaining these apparently contrasting results. Among
these, the different proportions of hypertensive patients
followed by specialized physicians (which was lower in the
current than in the former analysis), the availability of new
sets of guidelines [18,47] and several interventional clinical
trials [6,4853] (which further emphasize the importance
of strict BP control both in the general hypertensive
population and in specific subgroups of patients) during
the observational period of our analysis can be cited.
In addition, the larger use of electronic support [54] and
automated 24-h and home BP monitoring devices [55,56]
(which may help in promoting hypertension awareness,
treatment and control among treated and untreated hyper-
tensive patients) may also have an impact on our results.
Third, the different rates of BP control reported in
hypertensive patients followed by hypertension centres
compared with that reported by general practitioners
may be at least, in part, due to relatively higher prevalence
of additional cardiovascular risk factors and h igher cardio-
vascular risk profile in the former than in the latter group.
This is of particular relevance for the healthcare policies in
Italy, becaus e it may imply a proper selection of high-risk
hypertensive patients from general practice towards hyper-
tension clinics, in which challenging hypertension should
be referred.
Fourthly, to our knowledge, this is the first and largest
analysis on hypertension, which include a considerably
higher proportion of female rather than male individuals.
Among other observations made in Italy, only one st udy, in
fact, was specifically designed and carried out in postme-
nopausal women, aimed at evaluating high BP prevalence
and control [28]. In view of the largest and updated
population sample, the analysis allows us to provide a
current appraisal of the BP treatment and control of a
gender-balanced population sample in Italy.
On the basis of these findings, the analysis allows us to
conclude that in Italy effective treatment of hypertension
continues to remain largely unsuccessful, because the over-
all percentage of treated hypertensive patients is small,
particularly among general practitioners.
Several other aspects deserve to be discussed. First of all,
data included in the analysis were collected over the entire
Italian territory, which means that the conclusion on the
unsatisfactory rates of BP control, particularly for the SBP
levels, may reflect the overall situation of Italy.
BP control is much more rarely achieved for SBP than for
DBP values. This is particularly the case for hypertensive
patients followed by hypertension centres than for those
followed by general practitioners, despite the smaller
sample size and the larger use of antihypertensive drug
therapies in the former than in the latter group. This result
confirms that there is a generally greater difficulty to effec-
tively lower SBP levels, as also reported by other independ-
ent analyses performed on interventional randomized
clinical trials [15,57], which calls for research and clinical
efforts focused on this specific issue. This may also imply
that acting on physicians’ information and motivation and
treatment approach holds promise for improvement.
Our results substantially confirm that also in Italy hyper-
tension rarely comes as an isolated risk factor. In this regard,
11% of the patients had diabetes mellitus and about 10%
had dyslipidemia; in addition, about 20% had evidence of
left ventricular hypertrophy, 30% had metabolic syndrome
and 15% had microalbuminuria. With regard to associated
clinical conditions (when available), about 12% had history
of coronary artery disease, 6% previous myocardial infarc-
tion and 5% stroke. This means that the possibility of a high-
risk condition in hypertensive patients seen in the clinical
practice should not be lightly dismissed. It also implies that
search for associated risk factors as well as for markers of
organ damage should be implemented. It finally means that
efforts towards a more rigorous control of BP should be
even more stringent because of the greater event-saving
effect of BP control when the cardiovascular risk is high.
Potential limitations
The present study is based on a cross-sectional, desc riptive
analysis of large observational studies and clinical surveys
and, as such, it can only identify associations but cannot
provide insights into causation. In view of the relatively
large sample size of our study, even the possibility of
sampling bias has to be considered, although proven
methods were applied to avoid this. The large sample size
and different distribution of involved physicians may also
mean that the views expressed by respondents may not be
fully representative of opinions of the wider physician
community in Italy. In most clinical studies, dependence
on physician self-reporting throughout standardized ques-
tionnaires, rather than more objective measures or quanti-
fications, may also create potential biases. Our analysis
Blood pressure control in Italy
Journal of Hypertension www.jhypertension.com 1071
Page 7
Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
cannot provide information about whether physicians’
practices were located in rural or urban areas. Access
to medical healthcare in rural areas may be more difficult
than in urban areas, and this aspect should be acknow-
ledged when considering the higher prevalence of major
cardiovascular risk factors, including diabetes, and associ-
ated clinical conditions in different areas of Italy. At the
same time, we cannot provide data on the socio-economic
position of individual patients. The relatively low pr eva-
lence of smoking in this hypertensive high-risk population
is probably due to the lack of this information in several
studies considered in our analysis. Also, information on
home or 24-h ambulatory BP levels, as well as those on
the proportions of treated hypertensive patients on com-
bination therapy, was not available in the selected clinical
surveys or observational studies. Finally, because of the
different type of the studies and the different outpatients
populations included in the present analysis, no statistical
analyses were per formed in comparisons with data
provided from our previous analysis of Italian surveys on
hypertension [19].
In conclusion, our analysis of the most large, represen-
tative and updated sample of hypertensive patients derived
from the most recent observational studies available in
Italy over the last 5 years confirmed inadequate control
of BP in Italy, independently of the clinical setting. This
analysis may have major implications for public health
because of the severe impact of uncontrolled BP levels
on the increased risk of cardiovascular diseases in terms
of morbidity, mortality and socio-economic burden. Our
findings also underline the need for more effective and
comprehensive actions to control BP in hypertensive
patients in Italy.
ACKNOW LEDGEMENTS
Conflicts of interest
This work has been endorsed by the Italian Society of
Hypertension (SIIA) and Italian Society of Cardiovascular
Prevention (SIPREC).
No conflict of interest about the work reported in this
paper has been declared by any of the authors.
Appendix: acronyms of surveys include in the
analysis
SIMONA: Study on hypertension prevalence in menopause
in the Italian population [28]. APROS-Diadys: assessment
of prevalence observational study of diastolic dysfunction
[29]. HYPER-PRACT: hypertrophy in clinical practice [30].
IPERDIA: Ipertensione and diabete study [31]. General
Practice survey on hypertension [3 2]. MAGIC: Micro-
albuminuria: A Genoa Investigation on Complications
[33]. EFFECTUS: Evaluation of Final Feasible Effect of
Control Training and Ultra Sensitisation [34]. REDHY: Renal
dysfunction in hypertension [35]. IDEMAND: Italy develop-
ing education and awareness on microalbuminuria in
patients with hypertensive disease [36]. MARTE: Monit or-
aggio della Pressione Arteriosa nella Medicina Territoriale
[37]. MIRACLES: migraine and hypertension relationship:
comorbidity and risk of cerebrovascular events [38].
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Blood pressure control in Italy
Journal of Hypertension www.jhypertension.com 1073
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Reviewers’ Summary Evaluations
Reviewer 1
Blood pressure control is known to be too low in Europe
and worldwide. The present paper illustrates that this is
also the case in Italy. A mong tr eated hypertensive
patients, only 37% were under control. Unfortunately,
no data are given whether this i nsufficient control is
confirmed by ambulatory or home blood pressure. In
any way, the question today is no longer ‘‘how to control
blood pressure’’, but rather ‘‘How to ensure that patients
get antihypertensive treatment and remain compliant
to it?’’
Reviewer 2
This study is a meta-analysis of published literature
between 2005 and 2011 on the treatment of hypertension
in Italy. Out of 61 potentially relevant studies, the authors
selected 11 surveys with adequate data. These surveys
comprised over 150,000 patients, thereby representing
one of the largest cohorts studied thus far. In this cohort,
control of BP was inadequate in the great majority of
the patients. The studies are based on intention-to-treat
principles rather than actual measurement of drug use. The
data should be judged in the light of the notoriously low
adherence of patients to antihyperten sive drug use.
Tocci et al.
1074 www.jhypertension.com
Volume 30 # Number 6 # June 2012
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  • Source
    • "Similar rates of control are also present in the minority of the European countries, such as Denmark, where 57% of treated patients are controlled [4]. In Italy the current control rate is 35% [5]. Despite these improvements, it is clear that hypertension treatment is still far from acceptable, although it is not known how many patients can be controlled in every-day clinical practice. "
    [Show abstract] [Hide abstract] ABSTRACT: It is well known that hypertension control is non-satisfactory, but it is not clear how many hypertensive patients can be controlled in real life. We addressed this question implementing a simple, multifaceted improvement strategy in family practice. Eighteen General Practitioner (GPs) agreed upon a simple improvement strategy including: 1) the use of occasional direct/indirect contacts (prescription refilling) to decrease missing blood pressure (BP) recording, and to increase therapeutic adherence, 2) the use of home BP measurements in non-controlled patients , 3) the addition of a new drug in non-controlled, but adequately adherent patients. Results were assessed after one year by automatic data extraction from the clinical records of all hypertensive subjects. The patients with a diagnosis of hypertension increased from 6.309 (age 58.5 +/- 12.4; M 45.5%) to 6.717 (age 58.6 +/- 12.9; M 45.7%): prevalence 25.3% to 27.0%. The BP recording increased: 4,305 patients (68.2%) vs 4,948 patients (78.4%) (+ 10.2%, ci 9.4%-10.9%; p < 0.001), as well as the BP control: 3,203 (50.8% of all the diagnosed hypertensive patients and 74.4% of the subjects with recorded BP value) vs 4,043 (64.1% of all the diagnosed hypertensive patients and 81.7% of the subjects with recorded BP value) (+ 13.3%, ci 12.5%-14.2%; p < 0.001 and + 7.3%, ci 6.7%-8.0%; p < 0.001). Almost 82% of hypertensive subjects who contact their doctors can be easily controlled. Most non-controlled patients simply don't see their GPs; in almost all the remaining non-controlled patients GPs fail to increase drug therapy. A further improvement is therefore possible.
    Full-text · Article · Dec 2013 · BMC Family Practice
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    • "First, increasing age was associated with a significantly augmented prevalence of most major cardiovascular risk factors, with the exception of diabetes, probably because of the very limited number of diabetics included in our sample. These results are in accordance with those of previous studies in Italian27,28,30,31,34 and North-American populations.37–41 Also, the proportion of subjects treated for arterial hypertension, dyslipidemia, or diabetes increased with age, but the chance of being controlled did not display a favorable trend. "
    [Show abstract] [Hide abstract] ABSTRACT: Hypertension, hypercholesterolemia, and diabetes are the main causes of cardiovascular diseases in developed countries. However, these conditions are still poorly recognized and treated. This study aimed at estimating the prevalence, awareness, treatment, and control rates of major cardiovascular risk factors in an unselected sample of individuals of a small community located in northern Italy. We screened 344 sequential subjects in this study. Data collection included family and clinical history, anthropometric data, blood pressure, blood glucose, and serum cholesterol values. Individual cardiovascular risk profiles were assessed by risk charts of the Progetto Cuore. Based on personal history and/or measured values, 78.2% of subjects had hypercholesterolemia (total cholesterol levels > 190 mg/dL), 61.0% had central obesity (waist circumference ≥ 94 cm for men and ≥80 cm for women), 51.2% had arterial hypertension (blood pressure ≥ 140/90 mmHg), 8.1% had diabetes (blood glucose ≥ 126 mg/dL), 22.7% had impaired fasting glucose (blood glucose 100-125 mg/dL), and 35.5% were overweight (body mass index 25-29 kg/m(2)). Alcohol drinkers and smokers accounted for 46.2% and 22.4% of subjects, respectively. Awareness of hypertension, hypercholesterolemia, and diabetes was poor, and control of these risk factors, except for diabetes, was even worse. Prevalence of high blood pressure, high serum cholesterol, overweight, and obesity significantly increased with aging. Hypercholesterolemia and obesity were significantly more common in women, while overweight and diabetes in men. In 15.4% of participants, the risk of a major cardiovascular event in the next 10 years was either high or very high. In a small community in a wealthy region of Italy, the prevalence of major cardiovascular risk factors is high, while awareness, treatment, and control are poor. Such a result highlights the importance of screening campaigns as a strategy to improve early diagnosis and access to treatment, and thus effective prevention of cardiovascular diseases in the general population.
    Full-text · Article · Apr 2013 · Vascular Health and Risk Management
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    [Show abstract] [Hide abstract] ABSTRACT: Observational clinical studies have demonstrated that only 30–40 % of patients with arterial hypertension achieve the recommended blood pressure goals (below 140/90 mmHg). In contrast, interventional trials consistently showed that it is possible to achieve effective blood pressure targets in about 70 % of treated hypertensive patients with different cardiovascular risk profiles, especially through the use of rational, effective and well tolerated combination therapies. In order to bridge the gap between current and desired blood pressure control and to achieve more effective prevention of cardiovascular diseases, the Italian Society of Hypertension (SIIA) has developed an interventional strategy aimed at reaching nearly 70 % of treated controlled hypertensive patients by 2015. This ambitious goal can be realistically achieved by a more rational use of modern tools and supports, and also through the use of combination therapy in hypertension in daily clinical practice, especially if this approach can be simplified into a single pill (fixed combination therapy), which is a therapeutic option now also available in Italy. Since about 70–80 % of treated hypertensive patients require a combination therapy based on at least two classes of drugs in order to achieve the recommended blood pressure goals, it is of key importance to implement this strategy in routine clinical practice. Amongst the various combination therapies currently available for hypertension treatment and control, the use of those strategies based on drugs that antagonize the renin-angiotensin system, such as angiotensin II type 1 receptor antagonists (angiotensin receptor blockers) and ACE inhibitors, in combination with diuretics and/or calcium channel blockers, has been shown to significantly reduce the risk of major cardiovascular events and to improve patient compliance to treatment, resulting in a greater antihypertensive efficacy and better tolerability compared with monotherapy. The present document of the Italian Society of Arterial Hypertension (SIIA) aims to gather the main indications for the implementation of combination therapy in the treatment of hypertension, in order to improve blood pressure control in Italy.
    Full-text · Article · Mar 2013 · High Blood Pressure & Cardiovascular Prevention
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