High blood pressure, also known as hypertension, is a common health problem that can lead to serious conditions like heart disease and stroke. Black adults in the United States are more likely to have high blood pressure than others, and it’s often harder to treat in Black patients. A clinical trial, co-led by Black heart doctor Keith C. Ferdinand, MD, looked at a new drug called aprocitentan to see how well it worked to lower blood pressure in Black patients with resistant hypertension.
What is Resistant Hypertension?
Resistant hypertension, or resistant high blood pressure, means that a person’s blood pressure stays high even when they are taking at least three different blood pressure medications. It’s a serious condition that increases the risk of heart and kidney problems.
“Black individuals frequently present with resistant hypertension and disproportionately increased cardiovascular risk,” Dr. Ferdinand, coauthor of the analysis, said in a press release. “This is possibly related to the activated endothelin system seen in patients prone to developing resistant hypertension and this may explain why existing therapies that do not target the endothelin system have not shown optimal improvement for Black patients. Now, for the first time, we have an approved treatment targeting the endothelin system that may help fulfill an unmet need in Black patients with resistant hypertension.”
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How Was the Trial Done?
The study included 82 Black patients who had resistant hypertension. These patients were already taking a combination of three common blood pressure drugs. The study was divided into three parts:
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Part 1: For the first four weeks, patients were randomly assigned to take either a placebo (a fake pill) or aprocitentan at one of two different doses (12.5 mg or 25 mg) once a day. Neither the patients nor the doctors knew who was getting the drug or the placebo.
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Part 2: For the next 32 weeks, all patients took aprocitentan at the 25 mg dose.
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Part 3: In the final 12 weeks, patients were again randomly assigned to take either the 25 mg dose of aprocitentan or a placebo.
Blood pressure was measured in the office and with 24-hour ambulatory blood pressure monitoring (ABPM). ABPM involves wearing a device that automatically measures blood pressure throughout the day and night.
What Were the Results?
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Part 1: After four weeks, office blood pressure was reduced similarly in all groups, including those taking the placebo. However, the 24-hour ABPM showed that aprocitentan lowered blood pressure more than the placebo.
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Part 2: During the 32 weeks when all patients were taking aprocitentan, their office blood pressure continued to decrease.
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Part 3: When some patients were switched back to the placebo, their blood pressure increased, while those who stayed on aprocitentan maintained lower blood pressure.
The study also found that aprocitentan reduced the amount of protein in the urine, which is a sign of kidney damage. The drug was generally well-tolerated, but some patients experienced swelling in their extremities.
What Do the Results Mean?
The researchers concluded that aprocitentan can effectively lower blood pressure and reduce protein in the urine in Black patients with resistant hypertension. The blood pressure-lowering effect was similar to what was seen in the larger study that included patients of all races.
They believe that aprocitentan could be a valuable new treatment option for Black patients with difficult-to-control high blood pressure.
Why This Clinical Trial Matters
This clinical trial is important because not only is hypertension more common, but it also tends to be more severe and more difficult to treat in Black individuals. This disparity contributes to higher rates of heart disease, stroke, kidney failure, and premature death within the Black community.
The fact that this research focused on Black patients with resistant hypertension is significant. It addresses the urgent need to find effective treatments for vulnerable Black people. The study’s findings suggest that aprocitentan is a strong new approach to managing high blood pressure in Black patients when other medications have not been sufficient. By potentially improving blood pressure control, this treatment could help reduce the risk of serious health complications and improve health outcomes for the Black community, keeping us strong and healthy.
