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European Medicines Agency approves TWYNSTAEeA (telmisartan plus amlodipine) a new single pill combination that delivers powerful and consistent blood pressure reductions throughout 24 hours.

Summary: EMA approval follows review of TWYNSTAEeA trials

Boehringer Ingelheim announced today that the European Commission confirmed the positive opinion of the European Medicines Agency (EMA) approving TWYNSTAEeA. TWYNSTAEeA 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.

TWYNSTAEeA 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

TWYNSTAEeA 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. TWYNSTAEeA 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 BEaA[micro]hm, Director and Chief of Department of Internal Medicine and Cardiology at the University of Saarland in Germany said, EoACA[pounds sterling]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.EoACA[yen]

The approval of TWYNSTAEeA by the European Commission follows a review of three pivotal clinical trials. Results from these studies show that TWYNSTAEeA 2-4,13-15:

EoACAo provided consistent and significantly greater blood pressure reduction compared to the respective monotherapies with the 40-80mg/5-10mg formulations

EoACAo allowed 82.7% of patients to achieve their 24hr blood pressure goal (

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Publication:EMBIN (Emerging Markets Business Information News)
Date:Oct 12, 2010
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