FDA Approves Amturnide for Treatment of High Blood Pressure

The US Food and Drug Administration (FDA) has approved Amturnide, a new treatment for high blood pressure, which combines the direct renin inhibitor Tekturna, the calcium channel blocker amlodipine, and the diuretic hydrochlorothiazide in a single-pill. The approval was based on data from a double-blind, active controlled study that showed Amturnide provided significantly greater reductions in blood pressure compared to all dual combinations of its components.

Key Takeaways:

• 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.
• 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) and achieved greater systolic and diastolic blood pressure reductions with Amturnide compared to dual combination treatment.
• 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.
• Amturnide is only the third high blood pressure treatment to combine three drugs in a single-pill, providing an important treatment option to help address the complex needs of patients with high blood pressure.

Statistics:

• High blood pressure affects nearly 75 million adults in the United States and about one billion adults worldwide.
• An estimated 31% of adults being treated with antihypertensive medications are not at their blood pressure goal.
• Large-scale clinical trials suggest that up to 85% of patients may need multiple medicines to achieve target levels of blood pressure control, and hypertensive patients with lower blood pressure goals or with substantially elevated blood pressure may require three or more medications.
• Amturnide is available in five strengths as once-daily tablets containing aliskiren, amlodipine, and hydrochlorothiazide: 150 mg/5 mg/12.5 mg, 300 mg/5 mg/12.5 mg, 300 mg/5 mg/25 mg, 300 mg/10 mg/12.5 mg, and 300 mg/10 mg/25 mg tablets.

Sources:

• Novartis Pharmaceuticals Corporation
• Clinical Trials Week editors
• NewsRx.com
• U.S. Food and Drug Administration (FDA)