The FDA approved aliskiren, the first high blood pressure therapy that inhibits renin.

Aliskiren (Tekturna, Novartis) is also the first, new type of high blood pressure drug approved by the FDA in more than a decade, as per company officials.

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

Franz Messerli, MD, director of the high blood pressure 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 High blood pressure 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".

As per the FDA, scientists reviewed 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, as per the FDA.

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



Posted by: Emily    Source

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