Data show that treatment with a single-pill combination of telmisartan, an angiotensin receptor blocker, (ARB) and amlodipine, a calcium channel blocker (CCB) results in significant reductions in blood pressure (BP) in patients with severe hypertension.¹ The data, which was presented recently at 20^th Scientific Meeting of the European Society of Hypertension (ESH) in Oslo, and was discussed today at a briefing in Stockholm, also demonstrate the consistently higher BP control/response rates achieved compared to treatment with telmisartan or amlodipine treatment alone.¹

“These latest data confirm that combination therapies provide a valuable treatment option for patients, especially those with severe hypertension. The results demonstrate that the combination of telmisartan and amlodipine provides reliable reduction in blood pressure and offers a more favourable safety profile than the respective individual therapies – an important consideration for improving adherence which is often a barrier to effective blood pressure control,” said Professor Michael Böhm, Director and Chief of Department of Internal Medicine and Cardiology at the University of Saarland in Germany. “Compelling results for the telmisartan and amlodipine combination have resulted in the recent positive opinion adopted by the European Committee for Medicinal Products for Human Use (CHMP).”

Telmisartan and amlodipine are the two longest acting components in their class providing reliable 24 hour reduction in blood pressure. Telmisartan is also the only ARB with an indication of cardiovascular protection in patients at risk of serious cardiovascular events.

Study Results

The telmisartan and amlodipine single-pill combination was investigated in an 8-week, double-blind, parallel group study involving 858 patients with severe hypertension, which was defined as systolic pressure (SBP)≥ 180 mmHg and diastolic blood pressure ≥ 95 mm Hg. Patients were randomised to three treatment arms: telmisartan 80 mg plus amlodipine 10mg, monotherapy with telmisartan 80 mg and monotherapy with amlodipine 10mg.^1,3

Results show that combination treatment with telmisartan 80mg and amlodipine 10mg provides:^1,3

• significantly greater mean systolic BP reductions (up to50 mmHg) than respective monotherapies in patients with severe hypertension, which is among the biggest BP drops seen in antihypertensive trials
• reductions in BP of > 50 mm Hg in 46 % of patients
• superior reductions (-31.9 mm Hg) in systolic BP compared to the respective monotherapies after only one week of treatment
• consistently higher BP control/response rates than individual monotherapies
• a favorable safety and tolerability profile

“High blood pressure is a primary risk factor for a serious cardiovascular event such as a heart attack or stroke. Cardiovascular disease is the number one cause of death worldwide. Well tolerated treatment options that reduce the pill burden for my patients will lead to better management of their hypertension and lead to better outcomes. This is especially important in my patients who are particularly at risk of these serious cardiovascular events because their hypertension is severe, or they suffer from diabetes or metabolic syndrome,” said Dr Sarah Jarvis, General Practitioner and Fellow of the Royal College of General Practitioners and Women’s Health in the UK.

High blood pressure is the number one risk factor for CV disease and responsible for more deaths than any other single CV risk factor including high cholesterol, diabetes or smoking.⁴ Studies show that even a 2 mmHg reduction in systolic blood pressure decreases risk of cardiovascular events (heart attack, stroke etc) by 7-10%.⁵

~ENDS~

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.

About telmisartan plus amlodipine combination

TWYNSTA^® is a once daily, single pill combination of angiotensin II receptor (ARB) telmisartan and the calcium channel blocker (CCB) amlodipine, for the treatment of hypertension.

In October 2009, the US Food and Drug Administration (FDA) approved telmisartan plus amlodipine (marketed as TWYNSTA^®) for use in the treatment of hypertension alone, or with other antihypertensive agents, and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.

In Japan, telmisartan plus amlodipine is marketed as MICAMLO^® and was approved for the treatment of hypertension in July 2010.

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates in 50 countries and more than 41,500 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 2009, Boehringer Ingelheim posted net sales of 12.7 billion euro while spending 21% of net sales in its largest business segment Prescription Medicines on research and development.

For more information please visit www.boehringer-ingelheim.com

Related links:

http://www.boehringer-ingelheim.com/corporate/news/information_packs/hypertension.asp

www.news-ontarget.com

www.ontarget-telmisartan.com

www.micardis.com

References

1. Neutel JM, Mancia G, et al. Single-pill combination of telmisartan 80 mg/amlodipine 10 mg provides superior blood pressure reductions in patients with severe hypertension: TEAMSTA Severe HTN Study. Poster presentation at the European Society of Hypertension (ESH), June 2010.

2. Littlejohn J, et al. Results of treatment with telmisartan-amlodipine in Hypertensive Patients. J Clinl Hypertens 2009;11:4:207-213.

3. White B et al. Effects of telmisartan and amlodipine in combination on ambulatory blood pressure in stages 1 -2 hypertension Blood Pressure. epub Blood Pressure Monitoring 2010.

4. Lopez AD, et al. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. Lancet 2006;367:1747–1757

5. Lewington S, et al. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002;360:1903–13.

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