Boehringer Ingelheim GmbH
Corporate Division Communications
Dr Reinhard Malin
New studies show benefits of Micardis® (telmisartan) in combination with amlodipine and hydrochlorothiazide
For medical media, outside the US only
Berlin, Germany, 18 June, 2008 – The results of two new studies of Micardis® (telmisartan) in free combination with amlodipine or fixed combination with hydrochlorothiazide (HCTZ) 25 mg confirm that a telmisartan-based approach to treating hypertensive patients at risk of cardiovascular events can provide powerful and sustained blood pressure control in a broad range of people, including those who are difficult-to-treat.1-5 The study results were presented today at the 18th Scientific Meeting of the European Society of Hypertension and the 22nd Scientific Meeting of the International Society of Hypertension, held in Berlin, Germany.
Commenting on the results, Professor Thomas Unger, Chair of Pharmacology and Director of the Institute of Pharmacology at the Charité – Universitätsmedizin Berlin, said “Controlling patients’ blood pressure is a challenge that usually needs more than one antihypertensive to achieve optimal control. Telmisartan already provides proven effective blood pressure lowering and cardio & vascular protection in a broad range of patients at high-risk of cardiovascular disease. These new blood pressure studies now show that combining telmisartan with other antihypertensive treatments - amlodipine and hydrochlorothiazide - that act via different mechanisms, may reduce the risk of heart attack or stroke even further”.
"Round the clock" powerful blood pressure lowering with telmisartan and amlodipine combination
In a study combining telmisartan (a modern angiotensin II receptor blocker, ARB) and amlodipine (the most widely-used calcium channel blocker, CCB) 1,461 patients were randomized to receive treatment with a combination of telmisartan 0 (placebo), 20, 40, or 80 mg plus amlodipine 0 (placebo), 2.5, 5 or 10 mg.1
After 8 weeks, significant blood pressure reductions were observed for all combinations of clinical interest (telmisartan 40 or 80 mg plus amlodipine 5 or 10 mg; p<0.05) with the greatest reductions (-26.4/-20.1 mmHg) shown and greatest blood pressure control rate (76.5% patients) achieved by telmisartan 80 mg in combination with amlodipine 10 mg.1 All treatment combinations were well tolerated.4
A substudy of 562 patients confirmed that 24-hour “round the clock“ blood pressure control rate (measured by ambulatory blood pressure monitoring) with the combination of telmisartan and amlodipine, including the early morning hours when uncontrolled blood pressure is known to put patients at greatest risk of a heart attack or stroke, was up to twice the rate of that achieved with the monotherapy compounds.2
Difficult-to-treat patients benefit from fixed-dose combination of telmisartan 80 mg / HCTZ 25 mg
In a second long-term study, patients with essential hypertension and whose blood pressure had not previously been adequately controlled, received treatment with either telmisartan 80 mg / HCTZ 25 mg (n=321) or telmisartan 80 mg / HCTZ 12.5 mg (n=318).5
After 24-weeks treatment with telmisartan 80 mg / HCTZ 25 mg, the percentage of patients achieving blood pressure control (DBP <90 mmHg) increased from 52.4% at the study start to 71.4%.5 The increase in control was observed very early (at 4 weeks), was maintained until the study end, at which point most patients (85.6%) did not require additional antihypertensive therapy. Treatment was well tolerated.5
The fixed-dose combination of telmisartan 80 mg / HCTZ 25 mg was recently approved by the European Commission for difficult-to-treat patients whose blood pressure is not adequately controlled with telmisartan / HCTZ lower dose.
Proven cardio & vascular protection and tolerability shown in recent ONTARGET® trial
Telmisartan is the only angiotensin II receptor blocker (ARB) proven to achieve effective blood pressure lowering AND to have proven cardio & vascular protective benefits in a broad range of high-risk cardiovascular patients.6 The first results of the ONTARGET® Trial, presented earlier this year at ACC 2008, demonstrated that telmisartan was as protective as ramipril (the previous gold standard) in terms of reducing the risk of cardiovascular death, myocardial infarction, stroke and hospitalisation for congestive heart failure in a broad cross-section of high-risk patients and was better tolerated. 6
Telmisartan also provides superior blood pressure lowering power compared with the ARBs losartan7 and valsartan8and has also been shown to achieve blood pressure reductions at least as efficacious as leading antihypertensives of other classes, including enalapril, lisinopril, ramipril, amlodipine and atenolol.9-13
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.
Addressing the world’s largest healthcare burden Cardiovascular disease (CVD) is the leading cause of death worldwide, causing over 17.5 million deaths per year.14 7.6 million people die from a heart attack and 5.7 million die from a stroke every year. 4 Global deaths from CVD are predicted to reach approximately 25 million by 2020.15 CVD is also currently a leading cause of disability, and is predicted to be the largest cause of disability worldwide by 2020.15 A major stroke is viewed by more than half of those at risk as being worse than death.16
About telmisartan (Micardis®/Kinzal®/Pritor®)
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®, PROTECTION® and PRoFESS®, over 58,000 patients have been enrolled to investigate the cardiovascular protective effects of telmisartan (for more information please visit www.news-landmarktrials.com ).
Telmisartan was discovered and developed by Boehringer Ingelheim. Under the trademarks Micardis® and MicardisPlus® (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®, Bayer HealthCare promotes telmisartan under the brand names Kinzalmono®, Kinzalkomb® (combination with hydrochlorothiazide), and Pritor® and PritorPlus® (combination with hydrochlorothiazide) in markets across Europe. Pritor® and PritorPlus® is also marketed by GlaxoSmithKline in selected markets.
The ONTARGET® Trial Programme consists of two randomised, double-blind, multicentre international trials: the principle trial, ONTARGET® which has reported its results on 31 March 2008, and a parallel trial TRANSCEND® (Telmisartan Randomized AssessmeNt Study in ACE-I INtolerant subjects with cardiovascular Disease), which is planned to be reported later in the year.6
The treatment arms for the ONTARGET® Trial were telmisartan 80mg, ramipril 10mg, and combination therapy with telmisartan 80mg and ramipril 10mg. In the TRANSCEND® trial the treatment arms are telmisartan 80mg or placebo – both on top of standard blood pressure care, not including an ACE or another ARB.6,17
Patients enrolled in The ONTARGET® Trial Programme were aged ≥ 55 years, had a history of coronary artery disease, stroke or recent (> 7 days, < I 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.17 The ONTARGET® Trial had a four-fold composite endpoint:
Patients intolerant to ACEs were not eligible for the ONTARGET® study. Intolerance to ACE was a requirement for enrolment into TRANSCEND®.
The sponsor of the ONTARGET® 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.
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1. Littlejohn T et al. Superior antihypertensive efficacy of the combination of telmisartan and amlodipine versus respective monotherapies in patients with hypertension: results of a factorial design study. Poster presented at 18th Scientific Meeting of the European Society of Hypertension and the 22nd Scientific Meeting of the International Society of Hypertension; Berlin, Germany, June 18 2008.
2. Littlejohn T et al. Telmisartan and amlodipine combination therapy is powerful at lowering 24 hour blood pressure: findings of an ABPM substudy in hypertensive patients. Poster presented at 18th Scientific Meeting of the European Society of Hypertension and the 22nd Scientific Meeting of the International Society of Hypertension; Berlin, Germany, June 16 2008.
3. Littlejohn T et al.Telmisartan and amlodipine combination provides an effective treatment option for patients with moderate or severe hypertension: subanalysis from a factorial design study Poster presented at 18th Scientific Meeting of the European Society of Hypertension and the 22nd Scientific Meeting of the International Society of Hypertension; Berlin, Germany, June 18 2008.
4. Littlejohn T et al. Effect of telmisartan addition to amlodipine on reduction of incidence of peripheral edema and orthostatic BP changes: safety analysis. Poster presented at 18th Scientific Meeting of the European Society of Hypertension and the 22nd Scientific Meeting of the International Society of Hypertension; Berlin, Germany, June 18 2008.
5. Neldam S et al. Efficacy and safety of telmisartan 80mg/HCTZ 25mg fixed-dose combination, alone or with other antihypertensive medications, during open-label, long-term treatment. Poster presented at 18th Scientific Meeting of the European Society of Hypertension and the 22nd Scientific Meeting of the International Society of Hypertension; Berlin, Germany, June 18 2008.
6. The ONTARGET investigators. N Eng J Med 2008; 358(15):1547-59.
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8. Lacourcière Y et al. Blood Press Monit 2004; 9:203-10.
9. Parati GF et al. Presented at the Annual Meeting of the European Society of Hypertension. June 2006, Madrid, Spain.
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14. World Health Organization, Fact Sheet 317: Cardiovascular Diseases February 2007. http://www.who.int/mediacentre/factsheets/fs317/en/index.html (Accessed June 2008)
15. Murray CJL, Lopez AD. eds. The Global Burden of Disease: A Comprehensive Assessment of Mortality and Disability from Diseases, Injuries, and Risk Factors in 1990 and Projected to 2020. Cambridge; Harvard University Press 2001.
16.Primary Prevention of Ischemic Stroke. A Guideline From the American Heart Association/American Stroke Association Stroke Council. Stroke 2006; 37:1583-1633.
17. The ONTARGET/TRANSCEND Investigators. Am Heart J 2004; 148(1):52-61.