/25mg hydrochlorothiazide) Approved by EU Commission
(INGELHEIM, April 15 AsiaNet=연합뉴스)
- 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.
SOURCE: Boehringer Ingelheim GmbH
CONTACT: Dr. Reinhard Malin of CD Communications
for Boehringer Ingelheim GmbH,
+49-6132-77-90815,
Fax: +49-6132-77-66-01,
press@boehringer-ingelheim.com
(끝)
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