MediLexicon News - Boehringer Ingelheim Launches New Powerful Blood Pressure Treatment, MicardisPlus 80/25mg (telmisartan/hydrochlorothiazide), In The UK

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Boehringer Ingelheim Launches New Powerful Blood Pressure Treatment, MicardisPlus 80/25mg (telmisartan/hydrochlorothiazide), In The UK

Main Category: Hypertension
Also Included In: Cardiovascular / Cardiology
Article Date: 08 Jul 2008

Boehringer Ingelheim announced that a new formulation of its powerful blood pressure lowering drug, telmisartan (Micardis®) with hydrochlorothiazide (HCTZ), is now available in the UK. The fixed dose combination of 80mg telmisartan and 25mg HCTZ, which will be marketed as MicardisPlus® 80/25mg, is licensed for the treatment of essential hypertension in people whose blood pressure is not adequately controlled on 80mg telmisartan/12.5mg HCTZ or people who have been previously stabilised on telmisartan and HCTZ separately at the same dosages. It gained European approval on 27 March 2008.

An estimated four million adults in the UK have uncontrolled blood pressure,1,2 leaving them vulnerable to cardiovascular problems, such as heart attacks, strokes and kidney disease. Poor blood pressure control is the biggest risk factor for having a cardiovascular event and causes approximately 62,000 deaths every year.3 It is estimated that improved blood pressure control would reduce the cost of managing major cardiovascular events to the NHS by over £97 million a year.1,3

"Improvements in the UK in recent years mean we are very good at identifying and treating people with high blood pressure. However, too many people are still receiving unjustifiably low doses of treatments, leaving them sub-optimally controlled and therefore at risk of cardiovascular problems," explained Dr Sarah Jarvis, GP at Richford Gate Medical Practice, Shepherd's Bush, London. "Many patients are also on a single treatment when evidence shows us that most patients will need multiple drugs to bring their blood pressure under control - but more drugs can mean more tablets. Combination drugs reduce the number of daily tablets patients have to take, which can help improve compliance. We know from recent data that telmisartan 80mg is a very effective and well tolerated treatment - this new combination gives healthcare professionals a powerful weapon in their armoury against uncontrolled blood pressure."

European approval of 80mg telmisartan/25mg HCTZ was based on efficacy and safety data from 12 clinical trials performed in patients with mild to moderate hypertension. These included two pivotal trials which demonstrated that the new combination provided superior blood pressure lowering compared to 80mg telmisartan/12.5mg HCTZ without increased adverse events.4,5 Additional data shows clearly superior clinical benefits with the new higher dose telmisartan/HCTZ combination when compared to another high-dose combination, 160mg valsartan and 25mg HCTZ.6

Dr Charles de Wet, Medical Director, Boehringer Ingelheim, commented, "We are delighted to launch a new version of our established blood pressure treatment, telmisartan, which will benefit people with hard-to-treat hypertension. The ONTARGET study results announced earlier this year showed us that telmisartan is an effective and well tolerated treatment that reduces the risk of heart attacks and strokes for high-risk patients."

New data from the joint European Society of Hypertension-International Society of Hypertension meeting

In ONTARGET, conducted among 25,600 high-risk cardiovascular patients, telmisartan was established as the only antihypertensive in its class to reduce the risk of heart attacks and stroke. Of those receiving telmisartan, 83.3% remained free from an event after five years, equivalent to the 83.5% who remained event-free when treated with the ACE inhibitor ramipril, the current gold standard preventative treatment. However, those patients taking telmisartan experienced significantly fewer side effects, an important consideration when managing long-term conditions such as cardiovascular disease.7

About telmisartan (Micardis®)

Telmisartan, discovered and developed by Boehringer Ingelheim, is a member of the Angiotensin II Receptor Blocker (ARB) class. It is being investigated in the most ambitious and far-reaching research programme conducted with an ARB. In the ongoing clinical trial programmes ONTARGET, PROTECTION and PRoFESS, over 58,000 patients have been enrolled to investigate the cardiovascular protective effects of telmisartan. Telmisartan is indicated for the treatment of essential hypertension.

About ONTARGET7

ONTARGET (the ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) is a randomised, double blind clinical trial, which evaluated over 25,600 high-risk cardiovascular patients with normal or controlled blood pressure. An outcomes-led study, ONTARGET is the largest cardiovascular trial undertaken with an ARB and included the broadest population ever included in this type: high-risk cardiovascular patients with a history of coronary heart disease, stroke, transient ischaemic attack, peripheral vascular disease or diabetes with target organ damage. ONTARGET is an academic-led study managed by the trials centre at McMaster University, Hamilton, Canada and took place in over 700 centres across 40 countries.

About Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and 38,400 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 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. http://www.boehringer-ingelheim.co.uk

References

1. Lloyd A, Schmieder C, Marchant N. Financial and health costs of uncontrolled blood pressure in the United Kingdom. PharmacoEconomics 2003;21:33-41 (Suppl. 1).

2. Colhourn HM, Dong W, Poulter NR. Blood pressure screening, management and control in England: results from the health survey for England 1994. J Hypertens 1998;16(6):747-52.

3. He FJ, MacGregor GA. Cost of poor blood pressure control in the UK: 62000 unnecessary deaths per year. J Hum Hypertens2003;17(7):455-7.

4. Trials.Boehringer-Ingelheim.com. Boehringer Ingelheim Trial Number 502.480

5. Trials.Boehringer-Ingelheim.com. Boehringer Ingelheim Trial Number 502.491

6. White WB, Punzi HA, Murwin D, et al. Effects of the angiotensin II receptor blockers telmisartan vs valsartan in combination with hydrochlorothiazide 25mg once daily for the treatment of hypertension. J Clin Hypertens 2006;8(9):626-33.

7. Yusuf S et al. Telmisartan, Ramipril, or Both in Patients at High Risk for Vascular Events. N Eng J Med 2008; 358:1547-59.

Boehringer Ingelheim

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Boehringer Ingelheim Launches New Powerful Blood Pressure Treatment, MicardisPlus 80/25mg (telmisartan/hydrochlorothiazide), In The UK

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