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Boehringer Ingelheim's TWYNSTA approved by FDA for the treatment of hypertension

Published on October 20, 2009 at 12:19 AM · No Comments

Boehringer Ingelheim announced today that the US Food and Drug Administration (FDA) has approved TWYNSTA®, a new highly effective single pill combination therapy of telmisartan (an angiotensin receptor blocker [ARB]) and amlodipine (a calcium-channel blocker [CCB]). TWYNSTA® is indicated for the treatment of hypertension, alone or with other antihypertensive agents, and as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.

This new combination benefits from the complementary modes of action of long-lasting angiotensin receptor- and calcium channel-blockade. This provides powerful efficacy in 24-hour BP reduction and control and combines it with the proven evidence base in cardiovascular (CV) outcomes of both telmisartan and amlodipine. Telmisartan is the only ARB with proven evidence to reduce CV death, myocardial infarction (heart attack) and stroke beyond the effect of BP reduction in a wide range of patients at risk of CV events. In the US, it is the only ARB indicated for CV risk reduction in patients who are unable to take ACE-inhibitors.

Professor Giuseppe Mancia, Professor of Medicine and Chairman of the Department of Clinical Medicine of the University of Milan, Bicocca, Italy said, “In hypertensive patients, treatment tolerance and compliance are significant issues. The data for this combination of telmisartan and amlodipine show that it is effective and well tolerated in a range of more complex, difficult-to-treat patients as well as in those whose BP was previously not controlled on monotherapy. This combination provides a valuable and important new option for patients and physicians, particularly as it includes two components, telmisartan and amlodipine, each with clinically proven CV protection in patients at CV-risk.”

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