Source: DGNews  |  Posted 2 years ago

NEW YORK -- September 17, 2009 -- The US Food and Drug Administration (FDA) has approved a single pill combination of aliskiren and valsartan (Valturna) for the treatment of hypertension in patients likely to need multiple drugs to achieve their blood pressure goals.

“When it comes to diagnosing and treating high blood pressure, there is a real need for innovative therapies that help patients get to a healthier blood pressure range,” said investigator John Flack, MD, Department of Internal Medicine, Wayne State University, Detroit, Michigan. “Now for the first time, we have a treatment option in one pill that targets two key points of the RAAS (renin angiotensin aldosterone system), which may be overactive in many hypertensive patients.”

This approval was primarily based on a 8-week randomised, double-blind, placebo-controlled clinical trial in approximately 1,800 patients, which studied aliskiren 150 mg and 300 mg and valsartan 160 mg and 320 mg alone and in combination.

The initial doses of aliskiren and valsartan were 150 mg and 160 mg, respectively, and were increased at 4 weeks to 300 mg and 320 mg, respectively.

Blood pressure reductions with the aliskiren/valsartan combination were significantly greater than with the monotherapies or placebo at the 8-week primary endpoint.

Mean systolic and diastolic blood pressure reductions from baseline were 17.2/12.2 mmHg for aliskiren 300 mg/valsartan 320 mg, compared with 12.8/9.7 mmHg for valsartan 320 mg, 13.0/9.0 mmHg for aliskiren 300 mg, and 4.6/4.1 mmHg for placebo (P < .05 for aliskiren/valsartan vs monotherapies or placebo).

SOURCE: Novartis