Blood Pressure

ISSN: 0803-7051 (Print) 1651-1999 (Online) Journal homepage: www.tandfonline.com/journals/iblo20

The effects of telmisartan alone or in combination

with hydrochlorothiazide on morning home blood
pressure control: The SURGE 2 practice-based
study

Josep Redon, Grzegorz Bilo, Gianfranco Parati & On behalf of the Surge
Steering Committee

To cite this article: Josep Redon, Grzegorz Bilo, Gianfranco Parati & On behalf of the
Surge Steering Committee (2013) The effects of telmisartan alone or in combination with
hydrochlorothiazide on morning home blood pressure control: The SURGE 2 practice-based
study, Blood Pressure, 22:6, 377-385, DOI: 10.3109/08037051.2013.789643

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Blood Pressure, 2013; 22: 377–385

ORIGINAL ARTICLE

The effects of telmisartan alone or in combination with

hydrochlorothiazide on morning home blood pressure control:
The SURGE 2 practice-based study

JOSEP REDON1, GRZEGORZ BILO3 & GIANFRANCO PARATI2,3

ON BEHALF OF THE SURGE STEERING COMMITTEE
1Hypertension Clinic, Hospital Clinico, INCLIVA, University of Valencia, and CIBER of Obesity and Nutrition

CB06/03, Institute of Health Carlos III, Spain, 2Department of Health Sciences, University of Milano-Bicocca,
Milan, Italy, and 3Department of Cardiology, St. Luca Hospital, IRCCS Istituto Auxologico Italiano, Milan, Italy

Abstract
SURGE 2, a large-scale, practice-based study in 10 countries, evaluated the effects of telmisartan alone or with
hydrochlorothiazide (HCTZ) on morning (06:00–11:59) home blood pressure (HBP) control. Hypertensive patients
(clinic blood pressure [BP]  140/90 mmHg) received telmisartan 40 or 80 mg either alone or in combination with HCTZ
12.5 mg for 8 weeks. Treatment could be adjusted if clinic BP remained  140/90 mmHg. Clinic BP was measured in the
morning prior to medication, and seated HBP monitoring was performed, three times per day, 2 days per week. A total
of 25,882 patients were included (71% were previously using antihypertensives). There was a statistically significant
(all p  0.001) reduction in mean morning, lunchtime and evening HBP following treatment with telmisartan/telmisartan
plus HCTZ, and morning HBP control increased from 10.6–19.8% to 51.1–64.6%. Similar improvements were observed
for lunchtime (from 20.6–26.0% to 57.7–70.5%) and evening (from 21.3–31.4% to 59.0–68.8%). The morning HBP
response ranged from 62.6–67.5% (systolic BP) and from 81.4–87.0% (diastolic BP). Adverse events were reported
by 1.2% of patients. Telmisartan alone or with HCTZ improved morning HBP control and maintained a smooth HBP
profile throughout the day in a real-life setting.

Key Words: Home blood pressure monitoring, hydrochlorothiazide, morning blood pressure control, telmisartan

Introduction
sharp increase in the activity of the renin–angiotensin
Ambulatory and home blood pressure monitoring system (RAS) may also be a contributory factor (6).
(HBPM) have enabled physicians to determine Agents that act on the RAS could therefore have a
whether patients with treated hypertension are favourable effect on morning BP control, and may
achieving target blood pressure (BP) goals through- reduce the incidence of MBPS-associated vascular
out the 24-h period. In the Pressioni Arteriose Mon- events.
itorate E Loro Associazioni (PAMELA) study, the To date, a number of surveys have reported that
12-year rate of cardiovascular (CV) death in a popu- control of non-clinic BP is low (7–10). In the Japan
lation of 2051 patients was highest when the home, Home Versus Office Measurement Evaluation
ambulatory and clinic BP were all elevated, which (J-HOME) study, which evaluated 3303 treated
stresses the importance of out-of-office BP control hypertensive patients, 24.6% were found to have
(1). Home and ambulatory measures have also uncontrolled morning BP (9). The AmloDipine
revealed that the peak incidence in vascular events Versus AngiotensiN II receptor blocker; Control
correlates with a morning blood pressure surge of blood pressure Evaluation trial in Diabetics
(MBPS) (2–5). Although the MBPS is largely caused (ADVANCED-J) study showed that systolic morning
by overactivity of the sympathetic nervous system, a home BP, but not systolic clinic BP, was significantly

Correspondence: Josep Redon, Hypertension Clinic, Hospital Clinico, Pavillon B, Avda Blasco Ibanez, 17, 46010 Valencia, Spain. Tel:  34 963862647.
Fax:  34 963862647. E-mail: [email protected]

(Received 24 July 2012 ; accepted 18 February 2013)

ISSN 0803-7051 print/ISSN 1651-1999 online © 2013 Scandinavian Foundation for Cardiovascular Research
DOI: 10.3109/08037051.2013.789643
378 J. Redon et al.

correlated with urinary albumin creatinine excretion Treatments and BP monitoring

rate in 316 hypertensive patients with type 2
Patients with clinic BP  140/90 mmHg were pre-
diabetes (11).
scribed telmisartan (40 or 80 mg) either alone or in
Against this background, SURGE 2 (Study of
combination with HCTZ (12.5 mg) based on the
hypertensive population Under treatment with
decision of the treating physician. Patients using cur-
telmisartan in Real clinical conditions with the Goal
rent antihypertensive treatment could either switch
to control the Early morning blood pressure rise 2)
medications or have these agents added to their
will report the degree of morning home and clinic
regimen. Patients were instructed to take their
BP control after 8 weeks of treatment with telmis-
medication once daily between 07:00 and 10:00 h.
artan (a RAS blocker) either alone or in combina-
During screening, all physicians were instructed
tion with hydrochlorothiazide (HCTZ; a diuretic).
to measure clinic BP using a mercury sphygmoma-
The elimination half-life for telmisartan, at around
nometer, and in accordance with guideline recom-
24 h, is the longest of any of the angiotensin II
mendations (15,16); measures were taken three
receptor blockers. The long plasma half-life of telm-
times, at intervals of 2 min, and the mean was used.
isartan contributes to its prolonged duration of
Patients with uncontrolled hypertension ( 140/
action, as evidenced by the 24-h BP control dem-
90 mmHg) were then supplied with validated home
onstrated in different clinical trials with telmisartan.
BP monitors [according to British Hypertension
Additionally, telmisartan has been shown to reduce
Society guidelines (17)], such as the OMRON 705
target organ damage in a number of clinical studies
IT monitor with data transfer (Omron Healthcare
(12–14).
Europe BV, Hoofddorp, The Netherlands). Devices
were supplied by the study sponsor (Boehringer
Ingelheim International, Ingelheim, Germany).
Materials and Methods Patients were instructed on how to use the devices
by the treating physicians and nurses, who were fol-
Study design
lowing European Society of Hypertension (2003)
SURGE 2 was an 8-week, prospective, open-label, recommendations (16). Brachial artery home BP
phase IV, practice-based study conducted in centres measurements were taken in the seated position,
across 10 countries (Belgium, Canada, Colombia, three times per day: after getting up (before taking
Czech Republic, Indonesia, Jordan, Lebanon, antihypertensive medication), before lunch and
Mexico, Venezuela and Yemen). The main aim of before dinner on 2 days over 1 week. On each occa-
this observational study was to assess the degree of sion, two measurements were performed with an
morning home BP in patients treated with telmis- interval of 3 min between them, and an overall
artan or telmisartan plus HCTZ. Patients were mean was determined for morning, lunchtime and
enrolled between September 2003 and April 2005. evening home BP. Patients were instructed to
All studies were performed in accordance with document the time and values of BP measurements
international and local regulations. The protocol (this was defined as the baseline home BP).
was approved by an independent ethics committee. Within 1 week of performing home BP measure-
All patients provided written informed consent to ments, patients returned to the clinic. Clinic BP was
participate. measured as above (this was defined as baseline clinic
BP). Patients with clinic BP  140/90 mmHg were
treated with telmisartan and/or HCTZ as described.
Population Patients could then attend the clinic after 4 weeks
(optional visit) where medication could be adjusted
Males or females aged between 18 and 80 years with
according to clinic BP control ( 140/90 mmHg or
mild to moderate essential hypertension, who were
 140/90 mmHg). Home BP measurement was per-
either untreated or had uncontrolled clinic BP
formed again by the patient after 8 weeks of treat-
( 140/90 mmHg) on their current antihypertensive
ment and clinic BP was measured during week 8
regimen were included. Patients were excluded if
(Figure 1).
they had congestive heart failure, unstable angina,
acute myocardial infarction, heart surgery or stroke
within the previous 6 months, arrhythmia, angio-
Calculations and reference values
oedema associated with RAS blockade, advanced
hepatic or renal impairment or any other condition Considering that approximately one third of patients
that would not allow for safe completion of the pro- would be previously untreated, and one quarter of
tocol. Other exclusion criteria included chronic these previously untreated patients would receive
administration of oral anticoagulants or digoxin and the telmisartan/HCTZ combination, and around
known hypersensitivity to telmisartan or HCTZ. half of these patients would have data available, for
Pregnant, nursing or pre-menopausal women not at least one endpoint, for analysis at the final visit, a
using birth control were also excluded. total sample size of 25,000 patients would therefore
 Telmisartan/HCTZ and morning BP control 379

Figure 1. Study design and patient disposition. BP, blood pressure; DBP, diastolic blood pressure; HCTZ, hydrochlorothiazide; SBP,
systolic blood pressure.

result in approximately 1000 previously untreated analysed using the Student’s t-test for paired data.
patients in the smallest, telmisartan/HCTZ group All patients who received telmisartan either alone or
with available data. Furthermore, only one quarter in combination with HCTZ with no other therapy at
(250) of these patients would have valid data avail- final visit, and had morning home BP data available
able for all relevant endpoints (i.e. in-clinic BP, at week 8, were included in the analyses.
morning, lunchtime, evening HBP) in this smallest
group of interest. With an intra-individual standard
deviation of 20 mmHg for systolic blood pressure Results
(SBP), the total sample size of 25000 patients guar-
Population
anteed a power of 90% to detect a reduction of
5 mmHg at a two-sided alpha-level of 0.01 in any A total of 25,882 subjects were included; mean age
of the subgroups of interest. was 55 years (previously untreated patients) and 59
The change from mean baseline morning SBP years (previously treated patients), 48.0% of previ-
and diastolic BP (DBP) home BP (06:00–11:59) and ously untreated patients were male and 42.7% of
the degree of morning home BP control (defined as previously treated patients were male. The patient
the percentage of patients with home BP  135/85 characteristics are shown in Table I. The patients
mmHg at baseline and during week 8) were reported. were from Canada (50%; n  12,952/25,882),
Lunchtime (12:00–14:00) and evening (18:00– Mexico (26.5%; n  6848/25,882), Belgium
22:00) home BP control (home BP  135/85 mmHg (8.1%; n  2096/25,882), Lebanon (4.7%; n  1212/
at baseline and during week 8), clinic BP control 25,882), Columbia (4.6%; n  1182/25,882), Czech
( 140/90 mmHg at baseline and during week 8) and Republic (3%; n  769/25,882), Jordan (1.9%;
the mean SBP/DBP reductions during these periods n  496/25,882), Indonesia ( 1%; n  189/25,882),
were also reported. The response rates (defined as Venezuela ( 1%; n  79/25,882) and Yemen ( 1%;
percentage of patients with  10 mmHg reduction n  59/25,882). CV risk factors were documented.
in SBP or DBP from baseline HBP or baseline The most common risk factor was hyperchole-
clinic BP) to telmisartan-based treatments were also sterolaemia [26.7% (previously untreated); 40.0%
documented. (previously treated)]. Diabetes was present in 14.3%
Tolerability was assessed by adverse events, which of previously untreated patients and in 24.5% of
were collected, documented and reported in case previously treated patients, and electrocardiogram-
report forms, and patients were asked to rate the based diagnosis of left ventricular hypertrophy was
tolerability and efficacy of telmisartan either alone or present in 2.2% of previously untreated patients and
in combination with HCTZ, based on a scale of in 8.7% of previously treated patients. The majority
“very good” to “bad”. Change from baseline was of patients (71%; n  18,364/25,882) were taking at
380 J. Redon et al.

Table I. Mean (standard deviation)a baseline characteristics according to previous

therapy.

Previously Previously treated

untreated patients patients
(n  7518) (n  18,364)

Age (years) 55 (12.5) 59 (12.4)

Body mass index (kg/m2) 30.2 (9.69) 29.8 (9.31)
Clinic SBP (mmHg) 155 (18.5) 158 (18.5)
Clinic DBP (mmHg) 92 (11.0) 92 (11.3)
Heart rate (beats/min) 78 (9.5) 76 (10.8)
Male, n (%) 3609 (48.0) 7842 (42.7)
Family history of CV disease, n (%) 1851 (24.6) 5372 (29.3)
Hypercholesterolaemia, n (%) 2008 (26.7) 7342 (40.0)
Diabetes, n (%) 1073 (14.3) 4503 (24.5)
Coronary heart disease, n (%) 241 (3.2) 2267 (12.3)
Left ventricular hypertrophy, n (%) 162 (2.2) 1599 (8.7)
Transient ischaemic attack/stroke, n (%) 108 (1.4) 773 (4.2)
Heart failure, n (%) 48 (0.6) 579 (3.2)
Albuminuria, n (%) 120 (1.6) 700 (3.8)
Antihypertensive therapyb, n (%)
ARB, n (%) 2994 (16.3)
Diuretic, n (%) 5946 (32.4)
ACE inhibitor, n (%) 6733 (36.7)
Beta-blocker, n (%) 5415 (29.5)
Calcium antagonist, n (%) 4327 (23.6)
Other, n (%) 1570 (8.5)

SBP, systolic blood pressure; DBP, diastolic blood pressure; CV, cardiovascular;
ARB, angiotensin II receptor blocker; ACE, angiotensin-converting enzyme.
aUnless otherwise stated. b One antihypertensive agent.

least one antihypertensive; the most commonly pre- A total of 10,121 patients had clinic SBP measures
scribed were angiotensin-converting enzyme inhibi- available at final visit and 10,110 had clinic DBP
tors (36.7%) and diuretics (32.4%). measures available at final visit (Figure 1).
Initially, 70.8% (n  18,319/25,882) of patients
were given telmisartan and 25.8% (n  6688/25,882)
Reduction in home and clinic BP
were given telmisartan plus HCTZ (drug choice was
not recorded for 3.4% [n  875/25,882] of patients). Statistically significant (all p  0.001) reductions in
At final visit, 61.9% (n  16,039/25,882) were mean morning, lunchtime and evening home BP
receiving telmisartan and 31.7% (n  8193/25,882) were observed after 8 weeks of treatment with
were receiving telmisartan plus HCTZ (drug choice telmisartan either alone or in combination with
was not recorded for 6.4% [n  1650/25,882] of HCTZ for both previously untreated and previously
patients. At final visit, 64.8% (n  4872/7518) of treated patients (Figure 2). For previously untreated
previously untreated patients were receiving tel- patients, the mean standard deviation (SD) reduc-
misartan and 20.6% (n  1547/7518) of previously tion in morning home SBP/DBP for telmisartan-
untreated patients were receiving telmisartan plus treated patients was 17.13  17.51/ 8.91  10.22
HCTZ and no other therapy. In previously treated mmHg; p  0.001) and for telmisartan plus HCTZ
patients, 37.3% (n  6851/18,364) received telmis- treated patients it was 20.55  19.39/ 10.60 
artan and 22.6% (n  4144/18,364) received telmis- 11.03 mmHg; p  0.001). For previously treated
artan plus HCTZ and no other therapy at final visit patients, the mean  SD reduction in morning
(Table II). Only patients who received telmisartan home SBP/DBP for telmisartan-treated patients was
or telmisartan plus HCTZ and no other therapy 17.92  17.35/ 9.32  9.94 mmHg; p  0.001
were included in the final analyses. and for telmisartan plus HCTZ-treated patients
Overall, a total of 1552 patients discontinued it was  19.47  19.04/ 10.05  10.77 mmHg;
treatment. Patients could withdraw for more than p  0.001. The overall mean  SD reduction for
one reason. The main reasons were insufficient morning home SBP/DBP was 18.24  18.32/
decrease of BP (n  251) and no further contact with 9.30  10.31 mmHg; p  0.001. The greatest BP
the patient (n  234). Patients who discontinued reductions were observed for clinic BP; the mean
treatment were not included in the final analyses. A SD clinic SBP/DBP reduction was23.43 
total of 16,589 patients had morning home SBP 19.05/11.99  11.15 mmHg; p  0.001 for all
measures available at final visit and 16,560 had telmisartan and telmisartan plus HCTZ-treated
morning home DBP measures available at final visit. patients.
 Telmisartan/HCTZ and morning BP control 381

Table II. Treatment allocation at final visit (n  25,882). SBP reduction  10 mmHg assessed by either clinic
Subgroup Patients, n or HBPM) were more than 48.8% in all patients
following telmisartan-based treatment (Table IV).
Previously untreated (n  7518) The morning home SBP response rate ranged from
Telmisartan only 4872
62.6–67.5% and the morning DBP response rate
Telmisartan and other antihypertensive medication 285
Telmisartan and HCTZ only 1547 ranged from 81.4–87.0%. The clinic SBP response
Telmisartan and HCTZ and other antihypertensive 214 rate ranged from 76.7–82.0%, and the clinic DBP
medication response rate ranged from 77.4–80.2%.
Data on treatment allocation missing 600
Previously treated (n  18,364)
Telmisartan only 6851 Tolerability
Telmisartan and other antihypertensive medication 4031
Telmisartan and HCTZ only 4144 The tolerability of telmisartan either alone or in
Telmisartan and HCTZ and other antihypertensive 2288 combination with HCTZ was rated as “very good”
medication
Data on treatment allocation missing 1050
in the majority of patients (63.6%; n  16,472/
25,882); as “good” in 14.0% (n  3612/25,882) and
HCTZ, hydrochlorothiazide. as “moderate” in 1.1% (n  291/25,882). Less than
1% (n  246/25,882) rated the tolerability as “bad”.
BP control and response rates It was not assessable in  1% (n  212/25,882) and
data were missing for 19.5% (n  5049/25,882)
The improvements in morning, lunchtime and eve-
patients. Adverse events were reported by 1.2% of
ning home and clinic BP control in patients treated
patients (n  301/25,882). Overall, the most fre-
with telmisartan either alone or in combination with
quently reported adverse events were headache,
HCTZ are shown in Table III. Morning home BP
dizziness and diarrhoea (all 0.2%) as shown in
control increased from 10.6–19.8% to 51.1–64.6%,
Table V.
lunchtime home BP increased from 20.6–26.0% to
57.7–70.5% and evening home BP increased from
21.3–31.4% to 59.0–68.8%, which indicates that BP
Discussion
control remained consistent throughout the day
across all treatment groups. Clinic BP control also This practice-based SURGE 2 study, which was
increased from 5.4–10.8% to 63.5–72.1% following conducted in more than 25,000 patients, showed
telmisartan treatment. The response rates (DBP or that telmisartan monotherapy or in combination

Figure 2. Blood pressure reduction in (A) previously untreated and (B) previously treated patients following 8 weeks of treatment
with telmisartan either alone or in combination with HCTZ. HCTZ, hydrochlorothiazide; DBP, diastolic blood pressure; SBP, systolic
blood pressure.
382 J. Redon et al.

Figure 2. (Continued ).

with HCTZ, given to previously untreated or treated by 63.6% of patients and only 1.2% of patients
patients with uncontrolled hypertension, significantly reported adverse events.
reduced SBP and DBP in the morning hours as The daytime home BP profile obtained (shown
evaluated by HBPM. Between 51.1% and 64.6% of by home BP control  50% during morning,
all patients achieved morning home BP control lunchtime and evening measures) with telmisartan
( 135/85 mmHg) compared with 10.6–19.8% at either alone or with HCTZ in both previously
baseline. Similar findings were observed for lunch- untreated and previously treated patients firstly
time and evening home BP control. Clinic BP con- indicates that the morning BP surge was partially
trol also increased from 5.4–10.8% to 63.5–72.1% blunted by telmisartan/telmisartan plus HCTZ treat-
following addition of telmisartan either alone or with ments either alone or when added to other antihy-
HCTZ. At final visit, the majority of previously pertensive therapy. Secondly, it is an indication of the
untreated patients were taking telmisartan only reduction in daytime BP variability, which is also
(64.8%), and a number of previously treated patients known to contribute to CV risk. The impact of vari-
had switched to either telmisartan only (37.3%) ability on organ damage and on the prognosis of
or telmisartan plus HCTZ (22.6%). The findings long-term outcomes has been described previously
also show that telmisartan-based regimens were well (18,19). Even considering the relative small number
tolerated; the tolerability was rated as “very good” of home BP values obtained during the daytime

Table III. Blood pressure (BP) control rates (%) initially and after 8 weeks of treatment with telmisartan either alone or in combination
with HCTZ.

Previously treated patients Previously untreated patients

Telmisartan, Telmisartan plus Telmisartan, Telmisartan plus

BP initial/final HCTZ, initial/final initial/final HCTZ, initial/final

Clinic  140/90 mmHg (n) 10.8/72.1a (n  3097) 5.5/63.5a (n  2017) 10.0/70.8a (n  552) 5.4/63.8a (n  221)
Morning home BP 16.8/58.0a (n  4788) 13.1/51.1a (n  3005) 19.8/64.6a (n  2874) 10.6/53.7a (n  977)
 135/85 mmHg (n)
Lunchtime home BP 21.6/64.3a (n  1882) 20.6/57.7a (n  1077) 26.0/70.5 (n  766) 20.8/66.5b (n  284)
 135/85 mmHg (n)
Evening home BP 24.8/64.0a (n  1876) 21.3/59.0a (n  1077) 31.4/67.8 (n  768) 25.2/68.8 (n  282)
 135/85 mmHg (n)

HCTZ, hydrochlorothiazide. ap  0.0001. bp  0.01 versus initial measurements.

 Telmisartan/HCTZ and morning BP control 383

Table IV. Response rates (%) after 8 weeks of treatment with telmisartan either alone or in combination with HCTZ.

Previously treated patients Previously untreated patients

Telmisartan Telmisartan
BP Telmisartan plus HCTZ Telmisartan plus HCTZ

Clinic
Systolic 76.7 (n  3106) 78.1 (n  2029) 78.1 (n  553) 82.0 (n  222)
Diastolic 80.2 (n  3102) 78.4 (n  2022) 77.8 (n  553) 77.4 (n  221)
Morning home BP
Systolic 63.6 (n  4795) 66.4 (n  3016) 62.6 (n  2879) 67.5 (n  978)
Diastolic 82.1 (n  4788) 81.4 (n  3005) 87.0 (n  2874) 82.5 (n  977)
Lunchtime home BP
Systolic 58.0 (n  1882) 59.1 (n  1080) 56.1 (n  766) 60.4 (n  285)
Diastolic 81.9 (n  1883) 83.3 (n  1077) 84.1 (n  766) 84.2 (n  284)
Evening home BP
Systolic 50.8 (n  1877) 53.9 (n  1080) 48.8 (n  768) 51.8 (n  282)
Diastolic 82.8 (n  1876) 82.3 (n  1077) 84.9 (n  768) 83.0 (n  282)

BP, blood pressure; HCTZ, hydrochlorothiazide.

period (e.g. n  1050 for home BP values obtained the 24 h in treated hypertensive patients. The
at lunchtime in previously untreated patients Finn-HOME study, which assessed 2051 subjects
[Table II]), the reduction in variability achieved with from the adult Finnish population, showed that the
telmisartan/telmisartan plus HCTZ in our study mean difference between home and clinic BP was
may reduce long-term CV risk. The Jichi Morning 7.7/3.4 mmHg, which indicates a discrepancy
Hypertension Research (J-MORE) study, which between the two measures (23). In the Analysis of
assessed 969 treated hypertensive patients, showed a the Control of blood pressure using AMbulatory
difference between morning and evening BP control; blood Pressure monitoring (ACAMPA) study,
the average difference was 7.9 mmHg, and this dif- more than 50% of 240 treated patients with clinic
ference was related to age, beta-blocker use and BP control (BP  140/90 mmHg) still had elevated
regular alcohol consumption (20). Agents such as morning home BP measurements (24). These obser-
telmisartan that are able to maintain a smooth vations strongly emphasize the importance of regu-
24-h BP control (21) may reduce the impact of other larly implementing home BP measurements in
factors such as age and diet on BP variability. A routine clinical practice, aimed at improving BP
recent meta-analysis of 24-h ambulatory BP data control in the hypertensive population.
obtained in 4392 patients showed that the smooth- Our findings are consistent with previous
ness index, a measure of BP homogeneity, and the telmisartan-based studies, including the
effectiveness of treatments over 24 h was highest MICARDIS® Community AccessTrial (MICCAT-2),
for telmisartan 80 mg (SBP, 1.13; DBP, 0.97) and which show that telmisartan 80 mg either alone or
lowest for losartan 50 mg (SBP, 0.66; DBP, 0.57). in combination with HCTZ maintains morning
These results indeed support the hypothesis that and smooth 24-h SBP and DBP control compared
telmisartan reduces BP variability (22). with other agents (25). There is evidence that a
Several other issues also need to be discussed in reduction in home BP of 2–10 mmHg significantly
relation to our findings. A number of previous stud- reduces the risk of CV events (26,27). In the current
ies have demonstrated some discrepancy between study, the percentage of patients achieving a reduc-
home-based and clinic BP measurements; this tion in home SBP or DBP  10 mmHg was high, with
may, in part, be attributable to the use of agents more than 77% of patients achieving a DBP reduction
that cannot maintain smooth BP control throughout  10 mmHg, and more than 48% of patients achiev-
ing a SBP reduction  10 mmHg. These significant
Table V. Most frequently reported (1%) adverse events
reductions in SBP and DBP achieved with telmisar-
(n  25,882). tan-based treatment may favourably affect patients’
prognosis, an issue that will be further addressed in
Total, n (%)
the ongoing Multicenter PROBE Study Comparing
Any adverse event 301 (1.2) the Effects of Angiotensin II Type-1 Receptor Blockers
Back pain 18 (0.1) on Self-Monitored Home Blood Pressure in Patients
Diarrhoea 50 (0.2)
Dizziness 50 (0.2)
with Morning Hypertension (MUSCAT) study (28).
Fatigue 17 (0.1) Although our study was of a short duration and
Headache 55 (0.2) did not directly assess CV outcomes, it showed the
Hypotension 38 (0.1) “real-world” effectiveness of treatments.
Nausea 36 (0.1) An important and favourable feature of our study
Vertigo 29 (0.1)
was the use of home monitoring, which has a number
384 J. Redon et al.

of advantages, including the assessment of morning 3. Marler JR, Price TR, Clark GL, Muller JE, Robertson T,
BP (29). However, HBPM does have some limita- Mohr JP, et al. Morning increase in onset of ischemic stroke.
Stroke. 1989;20:473–476.
tions; devices are not always validated, reliability 4. Muller JE, Stone PH, Turi ZG, Rutherford JD, Czeisler CA,
can be limited and patient training is needed. Fur- Parker C, et al. Circadian variation in the frequency of onset
thermore, there are no consistent references or values of acute myocardial infarction. N Eng J Med. 1985;313:
for target home BP threshold following treatment. 1315–1322.
These potential problems were carefully considered 5. Willich SN, Goldberg RJ, Maclure M, Perriello L, Muller JE.
Increased onset of sudden cardiac death in the first three
in the present study, by using validated devices, hours after awakening. Am J Cardiol. 1992;70:65–68.
by training patients and by referring to the usual con- 6. White WB. Relevance of blood pressure variation in the
trol threshold for HBPM ( 135/85 mmHg), which circadian onset of cardiovascular events. J Hypertens. 2003;
is now recommended by the updated European 21 Suppl:S9–S15.
Society of Hypertension/European Society of Cardi- 7. Omvik P, Gerhardsen G. The Norwegian office-, home-, and
ambulatory blood pressure study (NOHA). Blood Press.
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general practice setting was overall well accepted in in hypertensive patients: A sub-analysis of the Japan
Hypertension Evaluation with Angiotensin II Antagonist
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BP profile throughout the day in both previously 9. Obara T, Ohkubo T, Kikuya M, Asayama K, Metoki H,
treated and previously untreated patients. The reduc- Inoue R, et al. Prevalence of masked uncontrolled and treated
white-coat hypertension defined according to the average of
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Sierra A, de la Cruz JJ, et al; Spanish Society of Hypertension
Ambulatory Blood Pressure Monitoring Registry Investi-
Acknowledgements gators. Effectiveness of blood pressure control outside the
medical setting. Hypertension. 2007;49:62–68.
The authors would like to thank all investigators 11. Tanaka Y, Daida H, Imai Y, Miyauchi K, Sato Y, Hiwatari M,
comprising the SURGE Steering Committee for et al. Morning home blood pressure may be a significant
marker of nephropathy in Japanese patients with type2
their participation, in terms of patient involvement, diabetes: ADVANCED-J study 1. Hypertens Res. 2009;32:
data collection and analyses. Writing and editorial 770–774.
assistance was provided by PAREXEL, which was 12. Burnier M, Brunner HR. Angiotensin II receptor anta-
contracted by Boehringer Ingelheim International gonists. Lancet. 2000;355:637–645.
GmbH for these services. Data analysis was provided 13. Galzerano D, Tammaro P, Cerciello A, Breglio R, Mallardo
M, Lama D, et al. Freehand three-dimensional echo-
by QUINTILES. The authors meet the criteria for cardiographic evaluation of the effect of telmisartan compared
authorship as recommended by the International with hydrochlorothiazide on left ventricular mass in hyper-
Committee of Medical Journal Editors and were fully tensive patients with mild-to-moderate hypertension: A
responsible for all content and editorial decisions, multicentre study. J Hum Hypertens. 2004;18:53–59.
and were involved at all stages of manuscript 14. Barnett AH, Bain SC, Bouter P, Karlberg B, Madsbad S,
Jervell J, et al; Diabetics Exposed to Telmisartan and Enalapril
development. The author received no compensation Study Group. Angiotensin-receptor blockade versus
related to the development of the manuscript. The converting-enzyme inhibition in type 2 diabetes and
SURGE series of trials was sponsored by Boehringer nephropathy. N Eng J Med. 2004;351:1952–1961.
Ingelheim International GmbH. 15. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green
LA, Izzo JL Jr, et al; National Heart, Lung, and Blood
Institute Joint National Committee on Prevention, Detection,
Declaration of interest: Josep Redon, Grzegorz Evaluation, and Treatment of High Blood Pressure; National
Bilo and Gianfranco Parati declare no conflict of High Blood Pressure Education Program Coordinating
interest. No remuneration was received by investiga- Committee. The Seventh Report of the Joint National
tors for participation in this study. Committee on Prevention, Detection, Evaluation, and
Treatment of High Blood Pressure: The JNC7 Report.
JAMA. 2003;289:2560–2572.
16. O’Brien E, Asmar R, Beilin L, Imai Y, Mallion JM, Mancia
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