Asked whether he sees RDN, provided it is established as safe and effective, being used primarily in hypertensive patients who are on or off medication, Dr. Kandzari replied that his personal view is it will have a role in both. Some patients would prefer not to take drugs. For others with uncontrolled hypertension despite multidrug therapy, RDN could serve as adjunctive therapy that reduces their need for medication.
Unanswered questions
Additional studies of both technologies are ongoing, and pivotal large phase 3 trials are being planned, with results expected in the next year or 2. Asked if regulatory agencies are going to require large, long-term trials with hard cardiovascular endpoints as a condition for approval, Dr. Mauri said a strong case can be made for bypassing this step.
“Blood pressure is remarkable,” she replied. “It’s one of the strongest surrogate endpoints that we have in the medical literature. It’s supported by multiple randomized trials of antihypertensive therapies, which have shown that reductions in blood pressure are associated with reductions in mortality from cardiovascular events. That’s really the gold standard for a surrogate endpoint. So I think it’s convincing. That being said, I would be very interested to also see hard endpoints in the long term, but that will take time.”
And time is a luxury in light of the escalating global hypertension pandemic. Dr. Mahfoud noted that it’s estimated that in 2015, 950 million people around the world had a systolic blood pressure in excess of 140 mm Hg. By 2025, that figure is expected to climb to 2.5 billion people. The Centers for Disease Control and Prevention estimates that more than 360,000 deaths per year in the United States have hypertension as the primary or a contributing cause. Blood pressure control rates remain unacceptably low, in the 50% range. Nonadherence is high. So there is a pressing unmet need for new forms of treatment.