Emerging Evidence Shows New Type of Hypertension Treatment to be Effective and Well Tolerated

NEW YORK and MANCHESTER , England , August 25/PRNewswire/ --

Studies of Renin-Inhibitor "Aliskiren" are Reviewed in Premier Issue of "Core Evidence" First International Peer-Reviewed Journal Using Evidence-Based Measures to Evaluate Drugs

Data emerging from early studies of aliskiren, a new type of treatment for hypertension, indicate that the new drug is effective as a single treatment for patients with mild-to-moderate uncomplicated essential high blood pressure. Results of initial randomised controlled clinical trials also suggest that the new medication is well tolerated and that patients exhibit good adherence to the once-a-day oral medication.

The evaluation appears in the premier issue of the journal Core Evidence, the first international peer-reviewed publication to assess medications by critically evaluating evidence on clinical effectiveness and outcomes.

Hypertension affects approximately 50 million people in the USA and about 1 billion people worldwide, and the World Health Organization (WHO) estimates that there are 7.1 million deaths each year (13% of all mortality) due to complications of hypertension.

"Despite the availability of many effective, well-tolerated drugs, a significant portion of treated hypertensive patients remain uncontrolled and face serious morbidity and mortality as a consequence," wrote Doris Peter, PhD, the journal's Editor for North America , who authored the review. "The current challenges in the drug treatment of hypertension include adherence to therapy and the need for most patients to take more than one drug to control their hypertension," Dr Peter said.

Current drug therapies for hypertension include diuretics, beta blockers, angiotensin-converting enzyme (ACE) inhibitors, aldosterone receptor blockers (ARBs), calcium channel blockers, and alpha-1 blockers, used individually and in various combinations.

Aliskiren, under development by Novartis, is the first in a new class of antihypertensive drugs called renin inhibitors. Renin is an enzyme which controls the formation of a substance called angiotensin II, the key mediator in the regulation of body fluid volume and blood pressure.

Aliskiren, which has not yet been approved by the US Food and Drug Administration, currently is in phase III trials as a stand-alone therapy and in phase II as combination therapy in patients with mild-to-moderate hypertension, and in phase II trials in patients with diabetic nephropathy.

The Core Evidence review of available phase II data concludes that there is now good evidence that as a stand-alone therapy aliskiren reduces blood pressure significantly compared with placebo and is as effective as two commonly prescribed ARBs with a similar tolerability profile. "For patients whose blood pressure can be controlled with single-agent therapy, aliskiren may offer another well-tolerated, effective alternative," the review concluded.

The article also noted that, although further examination is needed, there is preliminary evidence from one study that adherence to aliskiren therapy is high, averaging more than 95%. The article observed that, "A good tolerability profile together with once-daily administration may be expected to positively influence adherence and quality of life, both of which can be significant barriers to effective disease management in patients with hypertension."

However, the review also noted that, "most patients with hypertension eventually need a second antihypertensive drug" and although "there is some evidence that aliskiren combined with an ARB is effective in reducing blood pressure," the use of aliskiren in combination therapy cannot be recommended without further study.

Published by Core Medical Publishing Ltd (www.coremedicalpublishing.com)

(19/10/05)