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Ute E. Schmidt
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EMA approval follows review of TWYNSTA® trials that demonstrate:
• powerful blood pressure (BP) reductions of up to 50 mmHg in hypertensive patients with added risk such as those with obesity, metabolic syndrome and diabetes. 1-4
• BP at goal for the full 24-hours in 82.7% of patients. 1-4
• a robust evidence base in cardiovascular (CV) outcomes for both amlodipine and telmisartan - the only angiotensin receptor blocker (ARB) with an indication for CV protection.5,12
For non-US and non-UK Healthcare Media Only
Ingelheim/Germany, 12 October 2010: Boehringer Ingelheim announced today that the European Commission confirmed the positive opinion of the European Medicines Agency (EMA) approving TWYNSTA®. TWYNSTA® is indicated for the treatment of hypertension in adults whose blood pressure is not adequately controlled on amlodipine or as replacement therapy in adult patients receiving telmisartan and amlodipine from separate tablets containing the same component doses.
TWYNSTA® is a new highly effective and well tolerated single pill combination therapy of telmisartan, an angiotensin receptor blocker and amlodipine, a calcium channel blocker, for the treatment of hypertension. It delivers BP reductions of up to 50 mmHg and controls BP for the full 24 hours in up to 83% of patients. 1-4
TWYNSTA consistently reduces blood pressure in a broad range of patients including those with mild, moderate and severe hypertension. In particular, it is effective in hypertensive patients with added risk such as those with obesity, metabolic syndrome and diabetes.
Both telmisartan and amlodipine have a proven evidence base in cardiovascular outcomes. TWYNSTA® combines telmisartan and amlodipine the two longest acting agents in each class. 1-4 Of the ARB class, only telmisartan is indicated to reduce CV morbidity (myocardial infarction [heart attack] and stroke) in a wide range of patients at risk of serious cardiac events.5,12
Professor Michael Böhm, Director and Chief of Department of Internal Medicine and Cardiology at the University of Saarland in Germany said, “For patients at higher risk of cardiovascular disease, that is patients with higher blood pressure, this combination will offer particular efficacy advantages over monotherapies, and possibly over other combination therapies. It is well tolerated and patients may experience less side effects when compared with amlodipine alone. Both factors are highly relevant to the treating physicians because they ensure patients are less likely to discontinue their treatment.”
The approval of TWYNSTA® by the European Commission follows a review of three pivotal clinical trials. Results from these studies show that TWYNSTA® 2-4,13-15:
In addition, results from a recent double-blind, randomised, controlled trial in patients with severe hypertension (TEAMSTA severe HTN) showed that:
Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim, commented: "We are delighted to receive European approval of TWYNSTA®. The data show it is effective and well tolerated in a range of hypertensive patients including those with additional risk factors such as diabetes and obesity and we believe that it will provide an important treatment option for both physicians and patients to achieve good blood pressure control."
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 A large meta-analysis of 61 studies including about 1 million patients (12.7 million patient years) suggests that a reduction of 2 mmHg in systolic blood pressure decreases the risk of CV events such as myocardial infarction and stroke by 7-10%. 16
TWYNSTA® was approved in the US in October 2009 and in Japan in July 2010. Boehringer Ingelheim is committed to make this valuable new therapeutic option available to patients and health care professionals as soon as possible.
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.
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.
On October 2009, the US Food and Drug Administration (FDA) approved TWYNSTA® (telmisartan plus amlodipine) 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.
The single pill combination of telmisartan and amlodipine is also approved as MICAMLO® in Japan.
About telmisartan (Micardis®/Kinzal®/Pritor®)
Telmisartan is a modern member of the Angiotensin II Receptor Blocker (ARB) class and has been 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 were enrolled to investigate the efficacy and 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 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.
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1Neutel 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.
2White B et al. Effects of telmisartan and amlodioine in combination on amulatory blood pressure in stages 1 -2 hypertension Blood Pressure. epub Blood Pressure Monitoring 2010.
3Littlejohn J, et al. Results of treatment with telmisartan-amlodipine in Hypertensive Patients. J Clinl Hypertens 2009;11:4:207-213.
4Neldam S, Lang M, et al. Fixed-dose combination therapy with telmisartan and amlodipine 5 mg in non-responders to amlodipine 5 mg provides superior blood pressure reductions to, and is associated with less peripheral oedema than, amlodipine 10 mg. Poster presentation at the American Society of Hypertension (ASH), May 2009.
5The ONTARGETTM Investigators. Telmisartan, ramipril, or both in patients at high risk for vascular events. New England Journal of Medicine 2008; 358(15):1547-59.
6The TRANSCEND Investigators. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomized controlled trial. Lancet Published online 31 August 2008.
7Pitt B et al. Effect of amlodipine on the progression of atherosclerosis and the occurrence of clinical events. PREVENT Investigators. Circulation 2000;102(13):1503–10.
8Nissen SE, et al. Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure: the CAMELOT study: a randomized controlled trial.JAMA 2004;292(18):2217–25.
9Dahlof B, et al. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised controlled trial. Lancet 2005;366(9489):895–906.
10Williams B, et al. Differential impact of blood pressure-lowering drugs on central aortic pressure and clinical outcomes: principal results of the Conduit Artery Function Evaluation (CAFE) study. Circulation 2006;113(9):1213-25.
11Leenen FH, et al. Clinical events in high-risk hypertensive patients randomly assigned to calcium channel blocker versus angiotensin-converting enzyme inhibitor in the antihypertensive and lipid-lowering treatment to prevent heart attack trial.Hypertension 2006;48(3):374–84.
12MICARDIS SmPC 2010.
13Neldam S, Edwards C, et al. Investigators. Switch to a fixed-dose combination therapy with telmisartan and amlodipine provides significant blood pressure reduction and control in patients not adequately controlled with amlodipine 10 mg. Poster presentation at the American Society of Hypertension (ASH), May 2009.
14Neldam S, Lang M, et al. Long-term safety and efficacy of single-pill combinations of telmisartan 40 - 80 mg plus amlodipine 5 mg in patients initially not controlled on amlodipine 5 mg: open-label follow-up of the TEAMSTA-5 study (TEAMSTA-5 follow-up). Poster presentation at the European Society of Hypertension (ESH), June 2010.
15Neldam S, Edwards C, et al. Long-term safety and efficacy of single-pill combinations of telmisartan 40 - 80 mg plus amlodipine 10 mg in patients not initially controlled on amlodipine 10 mg: open-label follow-up of TEAMSTA-10 study (TEAMSTA-10 follow-up). Poster presentation at the European Society of Hypertension (ESH), June 2010.
16Lewington 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.
17Littlejohn T, Ruilope LM, et al. Telmisartan in combination with amlodipine provides a highly effective and well-tolerated treatment option for hypertensive patients with diabetes: sub-analysis from a factorial design study. Poster presentation at the European Society of Hypertension (ESH), June 2009.