First Orally Active Renin Inhibitor Shows Effective 24-Hour Blood Pressure Control

Data from clinical studies presented today at the 21st Annual Scientific Meeting of the American Society of Hypertension (ASH 2006), show that aliskiren, the first in a new class of orally active renin inhibitors for the treatment of hypertension, provided effective blood pressure control both alone and in combination with a widely-used diuretic. Aliskerin has a novel method of action that targets the point of activation of the renin-angiotensin-aldosterone system (RAAS).

In a study led by Dr. Jerry Mitchell, from the Texas Center for Drug Development in Houston, aliskiren provided effective, smooth 24-hour blood pressure control in patients with hypertension and consistent, significant reductions in 24-hour ambulatory BP. The researchers examined aliskiren’s antihypertensive effect during the 24 hours following dosing and found that aliskiren 150, 300 and 600 mg provided effective, double-digit BP lowering with smooth BP control over the 24 hour dosing period following once-daily administration. The trial was a randomized, double-blind, multicenter, placebo-controlled study of 672 people with mild-to-moderate high blood pressure who were given either one of the doses of aliskiren once-a-day or placebo.

“Sustained, smooth 24-hour control is important,” said Dr. Mitchell, “because blood pressure fluctuates and surges in the early morning and these fluctuations are associated with a marked increase in cardiovascular events. By helping control blood pressure around the clock and preventing blood pressure surges, aliskiren may lower the risks of heart attacks and strokes.”

The latest statistics estimate that one billion people globally and more than 65 million Americans -  one in three adults -  suffer from high blood pressure. Each year, high blood pressure accounts for roughly one in eight deaths.1 Although high blood pressure can be successfully treated, nearly 70 percent of Americans who have this condition do not have it under control.

“Renin inhibition has long been considered a desirable treatment approach and these recent study results provide evidence that aliskiren provides well-tolerated, 24-hour blood pressure control,” said Dr. Mitchell. “Further studies will evaluate whether aliskiren has the potential to provide end-organ protection.”

Another study, led by Dr. Alberto Villamil, from Fundapres in Buenos Aires, Argentina evaluated the antihypertensive efficacy and safety of aliskiren, alone and in combination with the diuretic hydrochlorothiazide (HCTZ). The single-blind trial involving 2,776 patients with hypertension showed that aliskiren significantly reduced high blood pressure when used alone, and contributed to an even greater reduction when used in combination with HCTZ.

“Aliskiren works well when given as monotherapy,” said Dr. Villamil, “but we have found that it also provides significant additional blood pressure reductions when combined with HCTZ treatment.”

Aliskiren demonstrated placebo-like tolerability across the Phase II and III clinical trials. The data showed that aliskerin was safe and effective at lowering blood pressure alone or in combination with the diuretic hydrochlorothiazide (HCTZ).

About the American Society of Hypertension
The American Society of Hypertension (ASH) is the largest US organization devoted exclusively to hypertension and related cardiovascular diseases. ASH is committed to alerting physicians, allied health professionals and the public about new medical options, facts, research findings and treatment choices designed to reduce the risk of cardiovascular disease.

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Revision date: July 3, 2011
Last revised: by Amalia K. Gagarina, M.S., R.D.