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This article originally posted 03 September, 2010 and appeared in  CardiovascularMedicationIssue 537Public Health

Novartis Receives FDA approval of Tekamlo ™, a Combination of Aliskiren and Amlodipine to Treat High Blood Pressure

Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone. 

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Up to 85 percent of patients may need multiple medications to help control their high blood pressure, underscoring the need for effective combination treatments.

Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone.

The FDA approval of Tekamlo was based on clinical trial data involving more than 5,000 patients with mild-to-moderate high blood pressure. An eight-week, randomized, double-blind, placebo-controlled, multi-factorial study showed that the combination of Tekturna and amlodipine resulted in decreases in systolic/diastolic blood pressure at trough of 14-17/9-11 mmHg, compared to 4-9/3-4 mmHg for Tekturna alone, and 9-14/6-8 mmHg for amlodipine alone.

In two additional double-blind, active-controlled studies of similar design evaluating patients with moderate-to-severe high blood pressure (SBP 160 - 200 mmHg), Tekamlo demonstrated significantly greater reductions in systolic and diastolic blood pressures when compared to amlodipine alone. In one study of 443 Black patients the systolic/diastolic treatment difference between Tekamlo and amlodipine was 5.2/3.8 mmHg at the primary endpoint of eight weeks. In the other study of 484 patients the treatment difference between Tekamlo and amlodipine was 7.1/3.8 mmHg at endpoint.

The single-pill combination Tekamlo works to lower blood pressure in two ways. The Tekturna component targets the activity of the renin angiotensin aldosterone system (RAAS), an important regulator of blood pressure [1]. 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 the blood vessel walls through the inhibition of calcium. Both of these medicines enable blood to flow more easily therefore lowering blood pressure. The blood pressure lowering effects of Tekamlo are largely attained within one to two weeks.

It is estimated that about one billion people globally have high blood pressure, and many of these remain either untreated or treated but are not at their blood pressure target. High blood pressure can cause damage to the vital organs of the body, including the heart, brain and kidneys. However, if high blood pressure is properly controlled, the incidence of stroke and heart failure can be reduced by almost half, and heart attacks by one quarter.

References:

1. Tekamlo (aliskiren and amlodipine) Tablets DRAFT Prescribing Information. August 2010.

2. Dahlof B, et al. Cardiovascular Morbidity and Mortality in the Losartan Intervention for Endpoint Reduction in Hypertension Study (LIFE): a Randomised Trial against Atenolol. Lancet 2002;359:995-1003.

3. Pepine CJ, Handberg EM, Cooper-DeHoff RM, et al. A Calcium Antagonist vs. a Non-Calcium Antagonist Hypertension Treatment Strategy for Patients with Coronary Artery Disease. The International Verapamil-Trandolapril Study (INVEST): a Randomized Controlled Trial. JAMA 2003;290:2805-2816.

4. Kearney P, et al. Global Burden of Hypertension: Analysis of Worldwide Data. Lancet 2005;365:217-23.

5. Chobanian AV, et al. Seventh Report of the Joint National Committee on Prevention, Detection Evaluation and Treatment of High Blood Pressure. Hypertension 2003;42:1206-1251.

6. Lloyd-Jones D, Adams R, Brown T, et al. for the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics-2010 update. A report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2010;121;e46-e215.

7. IMS Midas Worldwide Sales Data. December 2009.

Novartis Press Release, August 27, 2010

 

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This article originally posted 03 September, 2010 and appeared in  CardiovascularMedicationIssue 537Public Health

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