The FDA has approved Valturna (aliskiren and valsartan tablets, from Novartis), a combination agent containing a direct renin inhibitor and an angiotensin receptor blocker, for the treatment of high blood pressure in patients not adequately controlled on aliskiren or angiotensin receptor blocker (ARB) monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. This approval was based on data from an eight-week, randomized, double-blind, placebo-controlled clinical trial in approximately 1,800 patients that demonstrated blood pressure reductions with Valturna to be significantly greater than with aliskiren or valsartan monotherapy or placebo at the eight-week primary endpoint. Mean systolic and diastolic blood pressure reductions from baseline were 17.2/12.2mmHg for aliskiren 300mg/valsartan 320mg, compared with 13/9mmHg for aliskiren 300mg, 12.8/9.7mmHg for valsartan 320mg, and 4.6/4.1mmHg for placebo (p<0.05 for aliskiren/valsartan versus monotherapies or placebo).
Valturna is expected to be available the fourth quarter of 2009 in fixed-dose combination tablets containing aliskiren and valsartan: 150mg/160mg and 300mg/320mg.
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