FDA Clears Triple-Comb Hypertension Pill


December 27, 2010

December 27, 2010 – The U.S. Food and Drug Administration (FDA) approved Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure. It combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

The FDA approval was based on data from a double-blind, active controlled study, which showed that Amturnide provided significantly greater reductions in blood pressure compared to all dual combinations of its components. 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. Amturnide is only the third high blood pressure treatment to combine three drugs in a single-pill.

The study involved 1,181 patients with moderately elevated blood pressure (mean systolic blood pressure [mSBP] 160-179 mmHg) or severely elevated blood pressure (mSBP ≥180 mmHg). Both patient populations achieved greater systolic and diastolic blood pressure reductions with Amturnide compared to dual combination treatment of aliskiren/amlodipine 300 mg/10 mg, aliskiren/HCTZ 300 mg/25 mg and amlodipine/HCTZ 10 mg/25 mg.

In the overall patient population, Amturnide reduced systolic/diastolic blood pressure by an additional 9.9/6.3 mmHg compared to aliskiren/HCTZ; 7.2/3.6 mmHg compared to amlodipine/HCTZ; and 6.6/2.6 mmHg 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 11.4/4.9 mmHg respectively.

“Some patients require three or more medications to help manage their high blood pressure, which can be challenging and inconvenient,” said Alan H. Gradman, M.D., professor of medicine at Temple University School of Medicine. “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.”

The single-pill combination Amturnide works to lower blood pressure in three ways. The Tekturna component targets the activity of the renin angiotensin aldosterone system (RAAS), an important regulator of blood pressure. Tekturna directly binds to and inhibits renin, an enzyme produced by the kidneys that starts a process that can make blood vessels narrow and lead to high blood pressure. The calcium channel blocker amlodipine lowers blood pressure by relaxing muscles in the blood vessel walls, and the diuretic hydrochlorothiazide increases the excretion of sodium chloride and water. All three complementary medicines work to relax blood vessels and reduce blood volume, therefore lowering blood pressure.

Amturnide is indicated for the treatment of hypertension. It is not indicated for initial therapy of hypertension. It is designed for use in patients not adequately controlled with any two of the following: aliskiren, dihydropyridine calcium-channel blockers (DHP-CCB), and thiazide diuretics. A patient who experiences dose-limiting adverse reactions attributed to an individual component while on any dual combination of components of Amturnide can be switched to Amturnide at a lower dose of that component and achieve similar blood pressure reductions. Amturnide may be substituted for its titrated components.

Safety and efficacy of Amturnide in pediatric patients have not been established.

For more information: www.novartis.com