Tuesday, January 22, 2008

Tekturna HCT Receives US Approval for Treatment of High Blood Pressure

Tekturna HCT® (aliskiren and hydrochlorothiazide) has been approved by the US Food and Drug Administration as a single-tablet combination of two high blood pressure medicines - Tekturna® (aliskiren), the first new type of high blood pressure medicine in more than a decade, and the diuretic hydrochlorothiazide (HCT).

The two medicines in this single-tablet combination work together to lower blood pressure, with clinical data showing that the combination of Tekturna and HCT offers greater blood pressure reductions than either component alone.

This is the first regulatory approval of a single-tablet combination therapy involving Tekturna, known as Rasilez® outside the US, which has been shown to consistently lower blood pressure for 24 hours and beyond. HCT, sometimes called a "water pill", is one of the most commonly used high blood pressure medicines. Tekturna HCT is approved for patients not controlled by either medicine alone.

The efficacy of Tekturna for 24 hours and beyond is important because many high blood pressure medicines fail to work around the clock, especially during the early morning hours when blood pressure often surges. Tekturna has also been shown to maintain blood pressure reductions for up to four days after the last dose.

"Current guidelines call for aggressive treatment of high blood pressure and many patients are still not controlled," said Alan Gradman, MD, Division of Cardiovascular Diseases at the Western Pennsylvania Hospital in Pittsburgh, USA. "Tekturna HCT offers patients an effective new treatment option with significant blood pressure reductions and improved convenience, by combining the complementary mechanisms of action of the first direct renin inhibitor and a diuretic in one tablet."


- Tekturna HCT combines first approved direct renin inhibitor with the diuretic hydrochlorothiazide (HCT) in a single tablet.

- Approved in more than 40 countries, Tekturna used alone lowers blood pressure for 24 hours and beyond.

- Data show combination of Tekturna and HCT resulted in significant additional blood pressure reductions compared to either drug alone.

- Many patients not at goal and most require two or more medicines- single-tablet combinations simplify treatment by reducing number of pills patients take.

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