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The U.S. Food and Drug Administration (FDA) has approved baxdrostat (Baxfendy) for adults whose hypertension (high blood pressure) isn’t well controlled, even after taking other medicines. It’s meant to be used in combination with other blood pressure medicines, not by itself.
The approval makes baxdrostat the first and only FDA-approved aldosterone synthase inhibitor for adults with high blood pressure. This means the drug works in a new way to help lower blood pressure.
For people whose blood pressure stays high despite taking multiple medications, this new treatment type may give doctors another option to consider.
Baxdrostat is a prescription medication taken as a tablet. It’s approved for adults with high blood pressure who aren’t reaching their blood pressure goals with other medications. The drug belongs to a newer drug class called aldosterone synthase inhibitors.
Aldosterone is a hormone that helps the body control salt, water, and blood volume. When aldosterone levels are too high, the body may hold on to extra sodium and water. This can raise blood pressure and put more strain on the heart and kidneys.
Baxdrostat is designed to block an enzyme involved in making aldosterone. By lowering aldosterone production, the drug may help reduce blood pressure in people whose high blood pressure is partly driven by this hormone pathway.
Other blood pressure medications may work by:
Baxdrostat is different because it targets aldosterone production at its source.
The FDA approval was based on results from the BaxHTN phase 3 clinical trial. The study included 796 adults with uncontrolled or treatment-resistant high blood pressure. These adults were already taking at least two blood pressure medications.
Participants received either 2 milligrams of baxdrostat, 1 milligram of baxdrostat, or a placebo (inactive treatment) once daily, along with their usual standard treatment.
After 12 weeks, people taking 2 milligrams of baxdrostat had an average systolic blood pressure (the top number in a blood pressure reading) drop of 15.7 mm Hg from the start of the study. This was 9.8 mm Hg more than the reduction seen with the placebo.
Participants who received a 1-milligram dose had an average 14.5 mm Hg reduction in systolic blood pressure. This was 8.7 mm Hg more than the reduction seen with the placebo.
Results were consistent among people with uncontrolled high blood pressure and those with treatment-resistant high blood pressure. Treatment-resistant high blood pressure means blood pressure stays high even after treatment with several medications.
All medications can cause side effects. Some people may have mild side effects, while others may have side effects that need medical attention.
According to the drug’s prescribing information, baxdrostat may cause hyperkalemia (high potassium levels) and hyponatremia (low sodium levels). Your doctor may check your potassium and sodium levels before you start baxdrostat and from time to time during treatment.
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What treatments or strategies have you tried to lower your blood pressure? Let others know in the comments below.
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