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New Powerful Antihypertensive MicardisPlus(R) 80/25 (80mg telmisartan/25mg hydrochlorothiazide) Approved by EU Commission

Ingelheim, Germany (ots/PRNewswire)

- For Medical Media, Outside the US Only
Boehringer Ingelheim today announced that the European Commission
has granted marketing authorisation of the new powerful strength of
their fixed dose combination antihypertensive drug MicardisPlus(R)
80/25 in all 27 EU member states. It will be launched in Germany and
Denmark in the coming weeks, followed soon by Ireland, the United
Kingdom and the rest of EU, and when approved also in other countries
around the world.
The product is licensed for the treatment of essential
hypertension in patients whose blood pressure is not adequately
controlled on MicardisPlus(R) 80/12.5 (80 mg telmisartan/12.5 mg
hydrochlorothiazide) or patients who have been previously stabilized
on telmisartan and hydrochlorothiazide separately at the same dosages
(1),(2).
The new strength will be marketed by Boehringer Ingelheim in all
27 countries of the European Union under the brand name
MicardisPlus(R) 80/25 Its co-marketing partners will market the new
drug in selected countries under their own brands.
"The approval of MicardisPlus(R) 80/25 provides physicians with a
powerful new drug for patients with difficult to treat essential
hypertension", said Dr Andreas Barner, Member of the Board of
Boehringer Ingelheim and responsible for Research, Development and
Medicine.
European approval of MicardisPlus(R) 80/25 follows the submission
of efficacy and safety data from 12 clinical trials performed in
patients with mild to moderate hypertension. The core clinical
development programme consisted of two consecutive trials designed to
demonstrate the superiority of the fixed dose combination 80 mg
telmisartan/25 mg hydrochlorothiazide (T80/H25) versus 80 mg
telmisartan/12.5 mg hydrochlorothiazide  (T80/H12.5)(2). 971
patients, who were inadequately controlled for their  blood pressure
(BP) on existing antihypertensive treatment, were enrolled  in the
programme. Treatment with T80/H25 provided superior diastolic and
systolic blood pressure lowering power(x) after 8 weeks of
treatment(1)  compared to T80/H12.5. In the consecutive follow up
trial 639 patients  (633 patients evaluated for efficacy) were
treated with the T80/H25 for  further 6 months. At the end of this
treatment interval the proportion of  patients achieving DBP control
had increased from 52.4% to 71.4% (2).
No clinically meaningful differences in the adverse event
profiles of T80/H25 and T80/H12.5 were detected. No specific
increased incidence was identified for all adverse events. No
additional specific safety issues have been identified (1,2). Other
studies considered by the EMEA showed clearly superior clinical
benefits for a T80/H25-based treatment compared with 160 mg valsartan
/25 mg hydrochlorothiazide, the market leading ARBs high strength
combination (3).
Landmark trial ONTARGET(R) proves cardio & vascular protective
effects of telmisartan
Boehringer Ingelheim continues to explore new strategies to
improve cardiovascular therapy: The results of ONTARGET(R) (The
ONgoing Telmisartan Alone and in Combination with Ramipril Global
Endpoint Trial) with 25,620 patients have recently proven that
telmisartan is as protective as the current gold standard, ramipril,
in reducing the risk of cardiovascular death, myocardial infarction,
stroke and hospitalisation for congestive heart failure in a broad
cross section of high-risk cardiovascular patients (4). With 25,620
high-risk patients followed up for up to 6 years ONTARGET(R) was the
largest ARB outcome trial ever. "The ONTARGET(R)results have
important implications for the management of patients with
cardiovascular diseases. We now have a new treatment option for
high-risk patients which is effective and better tolerated," comments
Professor Salim Yusuf, lead investigator of the ONTARGET(R) Trial
Programme and Director of the Population Health Research Institute at
McMaster University, Hamilton, Canada.
Evidence for renal protective effects of telmisartan Further
evidence of the exceptional properties of telmisartan has already
been seen in previous trials. In 2007, the AMADEO(R) trial showed
that telmisartan achieved significantly greater reduction in
proteinuria compared with the ARB losartan beyond blood pressure
reduction effects, demonstrating the potential for renal protection
with telmisartan in diabetic patients (5).
Proven powerful antihypertensive efficacy
In addition, in 2006 the PRISMA(TM) trials in hypertensive
patients demonstrated that telmisartan achieved more powerful blood
pressure reductions over the full 24-hour period compared with the
ACE-inhibitor ramipril (6),(7).
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.
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 (3).
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 (3).
Patients enrolled in The ONTARGET(R) Trial Programme were aged
greater  than or equal to 55 years, had a history of coronary artery
disease, stroke  or recent (> 7 days, < 1 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 (8).
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
References
(x) -1.6 mmHg, 95% CI from -2.5 to -0.6 mmHg (p=0.0012)) and -2.7
mmHg,  95% CI from -4.2 to -1.2 mmHg (p=0.0003) respectively
(1) Trials.Boehringer-Ingelheim.com. Boehringer Ingelheim Trial
Number 502.480
(2) Trials.Boehringer-Ingelheim.com. Boehringer Ingelheim Trial
Number 502.491
(3) White WB, Murwin D, Chrysant SG, Koval SE, Davidai G, Guthrie
R. Blood Press Monit. 2008 Feb;13(1):21-27
(4) The ONTARGET Investigators. Telmisartan, ramipril, or both in
patients at high risk for vascular events. N Eng J Med. Published
online 31 Mar 2008
(5) Bakris G, et al. Influence of glycemic control on proteinuria
in patients with type 2 diabetes and overt nephropathy and
hypertension: results of the AMADEO trial. 67th Sci Sess of the
American Diabetes Association (ADA), Chicago, 22 - 26 Jun 2007
(Poster) 2007.
(6) Williams B, et al. The prospective, randomised investigation
of the safety and efficacy of telmisartan versus ramipril using
ambulatory blood pressure monitoring (PRISMAI). J Hypertens 2006;
24:193-200.
(7) Lacourciere Y, et al. A multicenter, 14-weeks study of
telmisartan and ramipril in patients with mild to moderate
hypertension using ambulatory blood pressure monitoring. Am J
Hypertens 2006; 19:104-12
(8) The ONTARGET/TRANSCEND Investigators. Rationale, design, and
baseline characteristics of 2 large , simple, randomized trials
evaluating telmisartan, ramipril, and their combination in high-risk
patients: The ONgoing Telmisartan Alone and in combination with
Ramipril Global Endpoint Trial/Telmisartan Randomized AssessmeNt
Study in ACE iNtolerant subjects with cardiovascular Disease
(ONTARGET/TRANSCEND) trials Am Heart J 2004; 148(1):52-61.

Contact:

Contact: Dr. Reinhard Malin, CD Communications, Boehringer Ingelheim
GmbH, 55216 Ingelheim am Rhein, GERMANY, Phone: +49-6132-77-90815,
Fax: +49-6132-77-66-01, E-mail: press@boehringer-ingelheim.com

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