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 . 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.
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Novartis Press Release, August 27, 2010