The study, done at 117 sites across the globe, enrolled 379 people with systolic blood pressure (the higher number in a reading) that remained at 140 or higher (130 for those with diabetes or chronic kidney disease). The recommended blood pressure reading is 120/80. All patients received 14 weeks of treatment with daily doses of 50, 100 or 300 milligrams of darusentan, or a placebo, an inactive substance.
On average, the participants' systolic blood pressure dropped 17 points with the 50-milligram dose of darusentan and 18 points with both the 100-milligram and the 300-milligram dose. A 9-point drop was recorded in the placebo group.
"That was a very meaningful reduction in blood pressure," said study lead author Dr. Michael A. Weber, professor of medicine in the cardiology division of State University of New York, Downstate College of Medicine. "Even if you subtract what happened in the placebo group, you still get about a 10-point drop, which is a clinically important finding. It translates into a meaningful reduction in the likelihood of strokes and other cardiovascular outcomes."
The major side effect was edema, excess fluid accumulation, which occurred in 27 percent of people taking the active drug and 14 percent of those taking placebo.
Because of edema, "to be really effective, darusentan probably should be used along with effective diuretic therapy," Weber said. Diuretics, which increase the flow of fluid from the body, are already widely used against high blood pressure.
If darusentan works as hoped, it will be especially useful for older people with resistant high blood pressure, Weber said. "They tend to be middle-aged or older, often with some impairment of kidney function," he said. "It is harder and harder to treat them and even more necessary to get their blood pressure treated, s
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