The FDA approved aliskiren, the first hypertension treatment that inhibits renin.

Aliskiren (Tekturna, Novartis) is also the first, new type of hypertension drug approved by the FDA in more than a decade, according to company officials.

Aliskiren is a once-daily tablet (150 mg and 300 mg) indicated as monotherapy or in combination with other hypertension medications.

Franz Messerli, MD, director of the hypertension program in the division of cardiology at St. Luke's-Roosevelt Hospital, Columbia University, New York, said he is skeptical about where aliskiren fits into the antihypertensive arsenal.

"Is there a need for triple blockade of the renin angiotensin system and if so, what is the risk-benefit ratio?" Messerli, section editor of the Hypertension and Vascular Disease section of Today in Cardiology, said. "As it is introduced now, I don't see the exact place in the therapeutic arsenal".

According to the FDA, researchers evaluated aliskiren's effectiveness through six, placebo-controlled, eight-week clinical trials involving more than 2,000 patients with mild to moderate hypertension.

The antihypertensive effect was maintained for up to one year across all demographic subgroups; however, blacks tended to have smaller reductions in BP than whites and Asians. This is generally true for drugs that affect the renin-angiotensin system, according to the FDA.

Studies showed that when aliskiren was combined with hydrochlorothiazide, further BP reductions were noted.


Posted by: Sandra    Source

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