Dual Inhibition of the RAAS with Valsartan and Aliskiren, the New Direct Renin Inhibitor

Linda Brookes, MSc


June 12, 2007

In This Article

New clinical study data were presented for aliskiren, the first-in-class, once-daily, orally administered renin inhibitor that received its first regulatory approval, for the treatment of hypertension, in the United States in March. Aliskiren was approved for use as monotherapy based on data from 6 randomized, double-blind, placebo-controlled clinical trials conducted over 8 weeks in patients with mild-to-moderate hypertension. Overall, aliskiren 150-300 mg provided significant blood pressure reductions over 24 hours, with no further blood pressure decrease at a dose of 600 mg. Most (85%-90%) of the blood pressure-lowering effect was seen within 2 weeks, and in patients who continued open-label aliskiren, the effect was maintained up to 1 year.

Aliskiren is also approved for use in combination with other antihypertensive agents and the company that markets the drug, Novartis (Basel, Switzerland), plans to market fixed combinations containing aliskiren plus a thiazide-type diuretic, hydrochlorothiazide (HCTZ), or plus an angiotensin receptor blocker (ARB), valsartan, in the future.

When aliskiren has been studied in combination with either of these drugs, the combination has produced a greater blood pressure reduction than either drug alone.[1,2,3,4] The results of the first large-scale study comparing the effects of aliskiren plus valsartan vs each drug alone in patients with mild-to-moderate (stage 1-2) hypertension were presented at the 2007 American College of Cardiology (ACC) meeting by Suzanne Oparil, MD (University of Alabama at Birmingham School of Medicine).[4] The data are cited in the US prescription data for aliskiren (marketed in the United States as Tekturna).[5]



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