US FDA approves novel treatment for hypertension

A novel breakthrough regimen in the treatment of hypertension has been approved by the US Food and Drug Administration as a single-tablet combination of two antihypertensive medicines — aliskiren, the first of its kind in more than a decade, and the diuretic hydrochlorothiazide (HCT).

The aliskiren-HCT combination is the first approved direct renin inhibitor with HCT in a single tablet.

Aliskiren has been shown to consistently lower blood pressure for 24 hours and beyond. It works by targeting renin and decreasing the activity of the renin system as measured by plasma renin activity (PRA). 

Renin is a hormone that triggers the constriction of the arteries, elevating blood pressure. By reducing the effects of renin, aliskiren helps blood vessels to widen so blood pressure is lowered.

HCT, sometimes called a “water pill,” is one of the most commonly used medicines for high blood pressure. As a diuretic, it works to lower blood pressure by ridding the body of unneeded water and salt.

However, diuretics are also known to increase PRA, so the combination with aliskerin is ideal to neutralize the diuretic effect on PRA.

The combination has been shown by clinical data to offer greater blood pressure reductions than either component alone.

The aliskiren-HCT combination is approved for patients not controlled by either medicine alone. Many hypertensive patients are not adequately controlled and most require two or more medicines. Single-tablet combinations simplify treatment by reducing number of pills patients take.

Aliskiren was discovered by Novartis and developed in collaboration with Speedel. Novartis/Speedel won the gold award for aliskiren in The Wall Street Journal’s 7th Annual Technology Innovation Awards contest.