A device designed to treat people with resistant hypertension helped lower blood pressure by 33 points, a substantial drop that would otherwise require patients to take an additional three or four drugs, on top of this subgroup's usual regimen of up to five drugs, to control their difficult-to-treat condition.
The device, called the Rheos- System, was tested in a pivotal Phase III study presented today as a late-breaking clinical trial at the American College of Cardiology's Annual Scientific Sessions. It is the first device to be tested in a large-scale clinical trial for the treatment of hypertension and works by activating the body's natural blood flow regulation mechanism to reduce high blood pressure.
Though the therapy led to a considerable drop in blood pressure and had a good safety profile, it did not meet all of the study goals. Another, more focused trial testing the device is needed before the U.S. Food and Drug Administration will consider approving the treatment, according to physicians who led the study.
"The device works extremely well and there is a large group of patients who would benefit from this therapy, but we need to go back and identify this group more clearly," said John Bisognano, M.D., Ph.D., a lead study investigator from the University of Rochester Medical Center. "This outcome is not uncommon. While the initial results are not as crisp as we would expect, it is clear from looking at the data that there are therapeutic benefits to pursue."
The pivotal trial included 265 patients with resistant hypertension treated at 40 medical centers in the United States and two in Europe, and is the latest in a series of studies that have shown the device is beneficial.
People who do not respond to the typical treatment regimen for high blood pressure, which includes one to three medications, coupled with improved nutrition and exercise, have resistant hypertension. These patients are at a far greater risk for stroke, heart attack, heart failure, kidney disease and death, which is why new therapies like Rheos are needed.
"Current drugs and lifestyle modifications can only do so much. I treat a huge number of people who are doing everything right - taking their medications, maintaining a healthy diet, working out - and they still develop resistant hypertension," noted Bisognano, Professor of Medicine and Director of Outpatient Cardiology at the Medical Center.
The prevalence of resistant hypertension is unknown, but current estimates suggest that between 10 and 15 percent of people with high blood pressure are in the truly resistant group. Many people with a family history of high blood pressure have the condition. Older age is also associated with the disorder.