Emerging Drug Options: High Blood Pressure

Hypertension affects approximately 70 million Americans and is a major risk factor for cardiovascular disease. It has been estimated that up to 65% of patients with hypertension do not have their blood pressure (BP) under control. Other studies have demonstrated that as many as 85% of hypertensive patients may need multiple medications to control their BP, underscoring the need for effective combination treatments. In 2009, the FDA approved aliskiren/valsartan (Valturna, Novartis) as a single-pill combination for the treatment of high BP in patients not adequately controlled on aliskiren or valsartan monotherapy. It was also approved as initial therapy in patients likely to need multiple drugs to achieve BP goals. Aliskiren/valsartan targets two key points within the renin-angiotensin aldosterone system (RAAS), which is believed to be an important regulator of BP. Valsartan blocks the action of angiotensin II, a component of the RAAS that causes blood vessels to tighten and narrow. Aliskiren directly inhibits renin, an enzyme that initiates the processes that lead to formation of angiotensin II. By targeting these two points within the RAAS, the agent helps blood vessels relax and widen so BP is lowered. Analyzing Clinical Trial Data A pivotal 8-week randomized, double-blind, placebo-controlled clinical trial involving about 1,800 patients helped lead to the FDA’s approval of aliskiren/valsartan. This trial analyzed use of aliskiren 150 mg and 300 mg and valsartan 160 mg and 320 mg alone and in combination. 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. BP reductions with the aliskiren/valsartan combination were significantly greater than...