Berlin (ots/PRNewswire)

• For non-US Healthcare Media and non-UK Healthcare Media
• New Studies Show Benefits of MICARDIS(R) (Telmisartan) in Combination With Amlodipine and Hydrochlorothiazide

The results of two new studies of MICARDIS(R) (telmisartan) in
free combination with amlodipine or fixed combination with
hydrochlorothiazide (HCTZ) 25 mg confirm that a telmisartan-based
approach to treating hypertensive patients at risk of cardiovascular
events can provide powerful and sustained blood pressure control in a
broad range of people, including those who are
difficult-to-treat.(1-5) The study results were presented today at
the 18th Scientific Meeting of the European Society of Hypertension
and  the 22nd Scientific Meeting of the International Society of
Hypertension,  held in Berlin, Germany.

Commenting on the results, Professor Thomas Unger, Chair of
Pharmacology and Director of the Institute of Pharmacology at the
Charite - Universitatsmedizin Berlin, said, "Controlling patients'
blood pressure is a challenge that usually needs more than one
antihypertensive to achieve optimal control. Telmisartan already
provides proven effective blood pressure lowering and cardio &
vascular protection in a broad range of patients at high-risk of
cardiovascular disease. These new blood pressure studies now show
that combining telmisartan with other antihypertensive treatments -
amlodipine and hydrochlorothiazide - that act via different
mechanisms, may reduce the risk of heart attack or stroke even
further."

"Round the clock" powerful blood pressure lowering with
telmisartan and amlodipine combination

In a study combining telmisartan (a modern angiotensin II
receptor blocker, ARB) and amlodipine (the most widely-used calcium
channel blocker, CCB) 1,461 patients were randomized to receive
treatment with a combination of telmisartan 0 (placebo), 20, 40, or
80 mg plus amlodipine 0 (placebo), 2.5, 5 or 10 mg.(1)

After 8 weeks, significant blood pressure reductions were
observed for all combinations of clinical interest (telmisartan 40 or
80 mg plus amlodipine 5 or 10 mg; p<0.05) with the greatest
reductions (-26.4/-20.1 mmHg) shown and greatest blood pressure
control rate (76.5% patients) achieved by telmisartan 80 mg in
combination with amlodipine 10 mg.(1) All treatment combinations were
well tolerated.(4)

A substudy of 562 patients confirmed that 24-hour "round the
clock" blood pressure control rate (measured by ambulatory blood
pressure monitoring) with the combination of telmisartan and
amlodipine, including the early morning hours when uncontrolled blood
pressure is known to put patients at greatest risk of a heart attack
or stroke, was up to twice the rate of that achieved with the
monotherapy compounds.(2)

Difficult-to-treat patients benefit from fixed-dose
combination of telmisartan 80 mg / HCTZ 25 mg

In a second long-term study, patients with essential hypertension
and whose blood pressure had not previously been adequately
controlled, received treatment with either telmisartan 80 mg / HCTZ
25 mg (n=321) or telmisartan 40 mg / HCTZ 12.5 mg (n=318).(5)

After 24-weeks treatment with telmisartan 80 mg / HCTZ 25 mg, the
percentage of patients achieving blood pressure control (DBP <90
mmHg) increased from 52.4% at the study start to 71.4%.(5) The
increase in control was observed very early (at 4 weeks), was
maintained until the study end, at which point most patients (85.6%)
did not require additional antihypertensive therapy. Treatment was
well tolerated.(5)

The fixed-dose combination of telmisartan 80 mg / HCTZ 25 mg was
recently approved by the European Commission for difficult-to-treat
patients whose blood pressure is not adequately controlled with
telmisartan / HCTZ lower dose.

Proven cardio & vascular protection and tolerability shown in
recent ONTARGET(R) trial

Telmisartan is the only angiotensin II receptor blocker (ARB)
proven to achieve effective blood pressure lowering AND to have
proven cardio & vascular protective benefits in a broad range of
high-risk cardiovascular patients.6 The first results of the
ONTARGET(R) Trial, presented earlier this year at ACC 2008,
demonstrated that telmisartan was as protective as ramipril (the
previous gold standard) in terms of reducing the risk of
cardiovascular death, myocardial infarction, stroke and
hospitalisation for congestive heart failure in a broad cross-section
of high-risk patients and was better tolerated. (6)

Telmisartan also provides superior blood pressure lowering power
compared with the ARBs losartan7 and valsartan8and has also been
shown to achieve blood pressure reductions at least as efficacious as
leading antihypertensives of other classes, including enalapril,
lisinopril, ramipril, amlodipine and atenolol.(9-13)

Notes to editors

Please be advised

This release is from Boehringer Ingelheim Corporate Headquarters
in Germany. Please be aware that there may be national differences
between countries regarding specific medical information, including
licensed uses. Please take account of this when referring to the
information provided in this document. This press release is not
intended for distribution within the U.S.A.

Addressing the world's largest healthcare burden

Cardiovascular disease (CVD) is the leading cause of death
worldwide, causing over 17.5 million deaths per year.(14) 7.6 million
people die from a heart attack and 5.7 million die from a stroke
every year. (4) Global deaths from CVD are predicted to reach
approximately 25 million by 2020.(15) CVD is also currently a leading
cause of disability, and is predicted to be the largest cause of
disability worldwide by 2020.(15) A major stroke is viewed  by more
than half of those at risk as being worse than death.(16)

About telmisartan (Micardis(R)/Kinzal(R)/Pritor(R))

Telmisartan is a modern member of the Angiotensin II Receptor
Blocker (ARB) class and is being investigated in the most ambitious
and far-reaching research programme conducted with an ARB. In the
clinical trial programmes ONTARGET(R), PROTECTION(R) and PRoFESS(R),
over 58,000 patients have been enrolled to investigate the
cardiovascular protective effects of telmisartan (for more
information please visit http://www.news-landmarktrials.com).

Telmisartan was discovered and developed by Boehringer Ingelheim.
Under the trademarks MICARDIS(R) and MICARDISPLUS(R) (combination
with hydrochlorothiazide) the company markets telmisartan in 84
countries around the world, including the USA, Japan and European
countries. Telmisartan is marketed in cooperation with Astellas
Pharma Inc. in Japan, Bayer HealthCare in Europe and GlaxoSmithKline
in selected markets.

Astellas Pharma Inc. co-promotes telmisartan under the trademark
MICARDIS(R), Bayer HealthCare promotes telmisartan under the brand
names Kinzalmono(R), Kinzalkomb(R) (combination with
hydrochlorothiazide), and Pritor(R) and PritorPlus(R) (combination
with hydrochlorothiazide) in markets across Europe. Pritor(R) and
PritorPlus(R) is also marketed by GlaxoSmithKline in selected
markets.

About ONTARGET(r)

The ONTARGET(r) Trial Programme consists of two randomised,
double-blind, multicentre international trials: the principle trial,
ONTARGET(r) which has reported its results on 31 March 2008, and a
parallel trial TRANSCEND(r) (Telmisartan Randomized AssessmeNt Study
in ACE-I INtolerant subjects with cardiovascular Disease), which is
planned to be reported later in the year.(6)

The treatment arms for the ONTARGET(r) Trial were telmisartan
80mg, ramipril 10mg, and combination therapy with telmisartan 80mg
and ramipril 10mg. In the TRANSCEND(r) trial the treatment arms are
telmisartan 80mg or placebo - both on top of standard blood pressure
care, not including an ACE or another ARB.(6),(17)

Patients enrolled in The ONTARGET(r) Trial Programme were aged
more than or equal to 55 years, had a history of coronary artery
disease, stroke or recent (> 7 days, < I year) transient ischaemic
attack, peripheral vascular disease, or diabetes mellitus with
target-organ damage such as microalbuminuria, ankle-brachial index <
0.8, or left ventricular hypertrophy.(17)

The ONTARGET(r) Trial had a four-fold composite endpoint:

- cardiovascular death,
    - myocardial infarction,
    - stroke, and
    - hospitalisation for heart failure.

Patients intolerant to ACEs were not eligible for the ONTARGET(r)
study. Intolerance to ACE was a requirement for enrolment into
TRANSCEND(r).

The sponsor of the ONTARGET(r) Trial Programme is Boehringer
Ingelheim; co-funders in selected countries are Bayer HealthCare and
GlaxoSmithKline.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, it
operates globally with 135 affiliates in 47 countries and 39,800
employees. Since it was founded in 1885, the family-owned company has
been committed to researching, developing, manufacturing and
marketing novel products of high therapeutic value for human and
veterinary medicine.

In 2007, Boehringer Ingelheim posted net sales of 10.9 billion
euro while spending one fifth of net sales in its largest business
segment Prescription Medicines on research and development.

For more information please visit
http://www.boehringer-ingelheim.com

Related links:

http://www.news-ontarget.com
    http://www.ontarget-telmisartan.com
    http://www.micardis.com

References

(1). Littlejohn T et al. Superior antihypertensive efficacy of
the combination of telmisartan and amlodipine versus respective
monotherapies in patients with hypertension: results of a factorial
design study. Poster presented at 18th Scientific Meeting of the
European Society of Hypertension and the 22nd Scientific Meeting of
the International Society of Hypertension; Berlin, Germany, June 18
2008.

(2). Littlejohn T et al. Telmisartan and amlodipine combination
therapy is powerful at lowering 24 hour blood pressure: findings of
an ABPM substudy in hypertensive patients. Poster presented at 18th
Scientific Meeting of the European Society of Hypertension and the
22nd Scientific Meeting of the International Society of Hypertension;
Berlin, Germany, June 16 2008.

(3). Littlejohn T et al.Telmisartan and amlodipine combination
provides an effective treatment option for patients with moderate or
severe hypertension: subanalysis from a factorial design study Poster
presented at 18th Scientific Meeting of the European Society of
Hypertension and the 22nd Scientific Meeting of the International
Society of Hypertension; Berlin, Germany, June 18 2008.

(4). Littlejohn T et al. Effect of telmisartan addition to
amlodipine on reduction of incidence of peripheral edema and
orthostatic BP changes: safety analysis. Poster presented at 18th
Scientific Meeting of the European Society of Hypertension and the
22nd Scientific Meeting of the International Society of Hypertension;
Berlin, Germany, June 18 2008.

(5). Neldam S et al. Efficacy and safety of telmisartan 80mg/HCTZ
25mg fixed-dose combination, alone or with other antihypertensive
medications, during open-label, long-term treatment. Poster presented
at 18th Scientific Meeting of the European Society of Hypertension
and the 22nd Scientific Meeting of the International Society of
Hypertension; Berlin, Germany, June 18 2008.

(6). The ONTARGET investigators. N Eng J Med 2008;
358(15):1547-59.

(7). Mallion JM. J Hum Hypertens 1999; 13:657-64.

(8). Lacourciere Y et al. Blood Press Monit 2004; 9:203-10.

(9). Parati GF et al. Presented at the Annual Meeting of the
European Society of Hypertension. June 2006, Madrid, Spain.

(10). Neutel JM et al. Am J Ther 1999; 6:161-6.

(11). Freytag F et al. Clin Ther 2001; 23:108-23.

(12). Lacourciere Y et al. Blood Press Monit 1998; 3:295-302.

(13). Williams B et al. Br J Hypertens 2006; 24:193-200.

(14). World Health Organization, Fact Sheet 317: Cardiovascular
Diseases February 2007.
http://www.who.int/mediacentre/factsheets/fs317/en/index.html
(Accessed June 2008)

(15). Murray CJL, Lopez AD. eds. The Global Burden of Disease: A
Comprehensive Assessment of Mortality and Disability from Diseases,
Injuries, and Risk Factors in 1990 and Projected to 2020. Cambridge;
Harvard University Press 2001.

(16). Primary Prevention of Ischemic Stroke. A Guideline From the
American Heart Association/American Stroke Association Stroke
Council. Stroke 2006; 37:1583-1633.

(17). The ONTARGET/TRANSCEND Investigators. Am Heart J 2004;
148(1):52-61.

Contact:

Contact, Reinhard Malin, Corporate Division Communications,
Boehringer Ingelheim GmbH, 55216 Ingelheim/Germany, Tel.:
+49-6132-77-90815, Fax: +49-6132-72-6601, E-mail:
reinhard.malin@boehringer-ingelheim.com