FDA gives nod to new combination therapy for hypertension

Valturna was more effective at lowering blood pressure than its component monotherapies.

A newhypertension combination therapy targeting the renin angiotensin aldosterone system has received approval from the FDA.

The agency granted approval for Valturna (Novartis), a pill combining aliskiren (Tekturna, Novartis) and valsartan (Diovan, Novartis), on September 17, 2009. The drug is indicated for patients with elevated BP not adequately controlled by either aliskiren or angiotensin receptor blocker monotherapy.

The approval was based in part on results from an eight-week double-blind, randomized, placebo-controlled study that included approximately 1,800 patients, according to a press release. The study researchers compared the effects on BP of 150 mg and 300 mg doses of aliskiren and 160 mg and 320 mg doses of valsartan alone and in combination. The doses were increased to 300 mg of aliskiren and 320 mg of valsartan at four weeks. They reported that the combination aliskiren and valsartan reduced BP to a greater extent than the monotherapies alone or placebo (P<.05). The mean reductions in mean systolic and diastolic BP from baseline were 17.2/12.2 mm Hg for the combination of aliskiren 300 mg and valsartan 320 mg, compared with 12.8/9.7 mm Hg for valsartan 320 mg alone, 13.0/9.0 mm Hg for aliskiren 300 mg alone and 4.6/4.1 mm Hg for placebo.

“When it comes to diagnosing and treating high BP, there is a real need for innovative therapies that help patients get to a healthier blood pressure range," said John Flack, MD, chairman of the department of internal medicine at Wayne State University in Detroit, said in a press release. "For the first time, we have a treatment option in one pill that targets two key points of the renin angiotensin aldosterone system, which may be overactive in many hypertensive patients."