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news.The US Food and Drug Administration (FDA) has approved Novartis' high blood pressure treatment, Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets on the basis of the data from a double-blind, active controlled study which showed that Amturnide provided greater reductions in blood pressure compared to all dual combinations of its components.
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Amturnide is approved for patients whose blood pressure is not adequately controlled with any two of its individual components and is not indicated as initial therapy for high blood pressure.
Novartis said that in the trial, Amturnide reduced systolic/diastolic blood pressure by an additional 9.9/6.3mmHg compared to aliskiren/HCTZ; 7.2/3.6mmHg compared to amlodipine/HCTZ; and 6.6/2.6mmHg compared to aliskiren/amlodipine.
In patients with severely elevated blood pressure, these reductions were greater by 16.3/8.2 mmHg, 9.6/4.8 mmHg, and 11.4/4.9mmHg respectively.
Temple University School of Medicine Alan Gradman said that the approval of Amturnide provides physicians with an effective treatment option that combines the benefits of the only approved direct renin inhibitor, a calcium channel blocker and a diuretic in one pill, while offering blood pressure reductions greater than two drugs alone.