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).
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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.
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.
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
(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.
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