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Published on 21 July 2009

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FDA approves Tekturna HCT

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The US Food and Drug Administration (FDA) has approved Tekturna HCT (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 (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 Dr Alan Gradman, 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.”

High blood pressure affects nearly one billion individuals globally and is a major risk factor for cardiovascular disease, the number one leading cause of death worldwide. If left untreated, patients with high blood pressure are at risk of cardiovascular events such as stroke, heart attack and heart failure, and of organ damage including kidney failure and vision problems. Up to 65% of patients with high blood pressure do not have the condition under control.

Current US treatment guidelines support the first-line use of combination therapy in appropriate high blood pressure patients. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) recommends that physicians consider starting their high blood pressure patients with two treatment agents, one of which should be a diuretic, if blood pressure is >20/10 mmHg above goal4. The use of multiple medications may help patients achieve blood pressure goals in a more timely fashion.

“We are very pleased the FDA recognises the benefit of Tekturna HCT for the first-line treatment of patients with moderately high blood pressure,” said Trevor Mundel, Global Head of Development at Novartis Pharma AG.

“Novartis is committed to supporting the research and development of effective treatments for high blood pressure that will help patients reach their blood pressure treatment goals.”

Novartis



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