New hypertension medication OK'd
NEWS IN BRIEF — Posted March 26, 2007
The Food and Drug Administration has approved Tekturna, or aliskiren, a new molecular entity, for the treatment of high blood pressure.
It's the first approved drug that inhibits the kidney enzyme renin, which is associated with the regulation of blood pressure. Tekturna, which comes in tablets, acts at the beginning of the blood pressure regulation process, while other available hypertension medications act at later stages, according to the FDA.
The drug was tested for effectiveness in six placebo-controlled, eight-week clinical trials that enrolled more than 2,000 patients with mild to moderate hypertension. Although it was effective across all population groups, African-Americans tended to have smaller reductions in blood pressure than did whites and Asians.
When the new drug was used with hydrochlorothiazide, additional blood pressure reductions were realized.
Safety was evaluated in trials involving 6,460 patients, the FDA said.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2007/03/26/hlbf0326.htm.