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Aug 27, 2010

FDA Okays Novartis’ Hypertension Combination Therapy

  • FDA approved Novartis’ Tekamlo™ tablets for the treatment of high blood pressure. Tekamlo is a single pill combining the direct renin inhibitor Tekturna® (aliskiren) with the calcium channel blocker amlodipine. It 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.

    "Single-pill combination therapies provide a convenient treatment option while supporting physicians in addressing the complex needs of patients," says Alan H. Gradman, M.D., professor of medicine at Temple University School of Medicine. "This new single-pill combination demonstrated greater blood pressure reductions than either drug alone in clinical studies and therefore provides a new option to consider when choosing appropriate high blood pressure therapies."

    Tekamlo works to lower blood pressure in two ways. The Tekturna component targets the activity of the renin angiotensin aldosterone system (RAAS), a blood pressure regulator. 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, according to Novartis.

    FDA sanction 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 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 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.

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