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FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent
Date:7/20/2009

EAST HANOVER, N.J., July 21 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved Tekturna HCT((R)) (aliskiren and hydrochlorothiazide) tablets as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. Tekturna HCT is a single-pill combination of Tekturna((R)) (aliskiren), the first and only approved direct renin inhibitor, and the diuretic hydrochlorothiazide (HCTZ), one of the most commonly-used high blood pressure medications.

The FDA approval of Tekturna HCT as initial therapy was based on clinical trial data involving more than 2,700 patients, which showed that treatment with the combination of Tekturna and HCTZ offered greater blood pressure reductions than either drug alone.

"Up to 85% of patients will need more than one medication to reach their blood pressure goals," said Alan Gradman, MD, Cardiologist at The Western Pennsylvania Hospital and Professor of Medicine at Temple University. "This approval gives doctors the opportunity to aggressively treat their patients with a single-pill combination of the only approved drug, Tekturna, that works by directly targeting renin and decreasing the activity of the renin angiotensin aldosterone system (RAAS) and, HCTZ, a diuretic. This results in more significant blood pressure reductions, compared to taking either drug alone."

Hypertension affects nearly 74 million US adults and is a major risk factor for cardiovascular disease, the number one leading cause of death in the US. If left untreated, patients with high blood pressure are at risk for cardiovascular events such as stroke, heart attack and heart failure. Of US adults being treated, an estimated 36% are not at their blood pressure goals.

Current US treatment guidelines support the first-line use of combination therapy in appropriate high blood pr
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SOURCE Novartis Pharmaceuticals Corporation
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