Home » Drug Information » FDA Approved Drugs » 2010
Medical Areas: Cardiology/Vascular Diseases | Family Medicine
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Amturnide (aliskiren + amlodipine + hydrochlorothiazide)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved December 2010
Treatment Area: uncontrolled hypertension
Amturnide is a single tablet combining the direct renin inhibitor Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).
Amturnide is specifically indicated for the treatment of hypertension in patients not adequately controlled with any two of the following: aliskiren, dihydropyridine calcium-channel blockers (DHP-CCB), and thiazide diuretics.
Amturnide is supplied as a tablet designed for oral administration. Amturnide is supplied as once-daily tablets containing aliskiren, amlodipine and hydrochlorothiazide: 150 mg/5 mg/12.5 mg tablets, 300 mg/5 mg/12.5 mg tablets, 300 mg/5 mg/25 mg tablets, 300 mg/10 mg/12.5 mg tablets, and 300 mg/10 mg/25 mg tablets.
The FDA approval of Amturnide was based on a double-blind, active controlled study in 1,181 patients with moderately elevated blood pressure (mean systolic blood pressure [mSBP] 160-179 mmHg) or severely elevated blood pressure (mSBP >/=180 mmHg). The subjects received Amturnide or dual combination treatment of aliskiren/amlodipine 300 mg/10 mg, aliskiren/HCTZ 300 mg/25 mg, and amlodipine/HCTZ 10 mg/25 mg. Both patient populations achieved greater systolic and diastolic blood pressure reductions with Amturnide compared to the dual combinations. 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.
Adverse events associated with the use of Amturnide may include, but are not limited to, the following:
- swelling of ankles, feet and hands
- stuffy or runny nose and sore throat
Mechanism of Action
Amturnide is a single tablet combining the direct renin inhibitor Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ). The aliskiren component targets the activity of the renin angiotensin aldosterone system, an important regulator of blood pressure. Aliskiren 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.
For additional information regarding Amturnide or uncontrolled hypertension, please visit the Novartis web page.