As yet unapproved, darusentan works in different way than standard medicines
SUNDAY, Sept. 13 (HealthDay News) -- A new drug for people whose high blood pressure cannot be controlled by existing medications has done well in a pivotal trial, researchers report.
Substantial reductions in blood pressure were achieved with various doses of the drug, darusentan, for people who were still hypertensive despite trying three or more medications, said a report released online Sept. 13 in The Lancet.
An effective new drug against resistant high blood pressure could be "potentially enormously beneficial," said one expert, Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City.
The blood pressure drops seen in the study are highly encouraging, Garratt said. "It only takes small changes in blood pressure readings to confer benefits on patients," he noted. "This drug potentially takes people from a very dangerous place to a very safe place."
The study results will be submitted to the U.S. Food and Drug Administration as part of an application for marketing approval, said Nathan Kaiser, a spokesman for Gilead Sciences, the company that is developing the drug.
"A larger trial completed enrollment earlier this year," Kaiser said. "We expect data from that trial by the end of the year. Pending results of that second study, the earliest time we can apply for approval appears to be the fourth quarter of 2010."
Some studies have said that as many as 30 percent of people with high blood pressure, a major risk factor for cardiovascular problems such as heart attack and stroke, have the resistant form, in which blood pressure cannot be brought down to desired levels despite use of three or more drugs.
Darusentan acts to block the activity of endothelin, an artery-narrowing molecule. Its action involves a different molecular pathway
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