The Bad News About Prevalence, the Good News About Treatments -- But Pay Attention to the Details

Linda Brookes, MSc


February 14, 2005

In This Article

Renin Inhibitor Progresses in Clinical Studies for the Treatment of Hypertension

The first phase 3 results for the novel renin inhibitor aliskiren (SPP100) have confirmed its antihypertensive efficacy as monotherapy and in combination with the angiotensin receptor blocker (ARB) valsartan, the company developing the drug, Novartis (Basel, Switzerland, and Bridgewater, New Jersey), has reported.[18] The announcement was made at the company's annual financial results meeting in January. Study no. 2203, carried out in 1064 hypertensive patients, has reconfirmed the blood pressure-lowering effect and safety profile of aliskiren compared with placebo and valsartan. These data are consistent with those of a previous phase 2 study conducted in 650 patients that compared aliskiren with another ARB, irbesartan.

The results were also consistent with those of a phase 2 study in 200 patients that compared aliskiren with yet another ARB, losartan. In that study, patients were treated with a combination of aliskiren and valsartan. The results suggested that there is a trend toward additive benefits, with a dose response for the combination that is to be confirmed in a follow-up study. Aliskiren has also been investigated as combination therapy with an angiotensin-converting enzyme (ACE) inhibitor (ramipril) or with a diuretic (hydrochlorothiazide), and here, too, the drug showed the potential for beneficial effects in combination with these drug classes.

Aliskiren is a novel, completely nonpeptide, orally active renin inhibitor that blocks the first and rate-limiting step of the renin-angiotensin system, the cleavage of angiotensinogen to angiotensin I. Phase 3 trials with aliskiren are ongoing in the United States, Europe, and Japan. Additional phase 3 data are expected to be released later in 2005. A first regulatory submission is planned for early 2006.

Aliskiren has been described as "on track to be the first new treatment for hypertension since 1994." It has been designated "a cardiovascular drug to watch" by Forbes.[19]


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