New blood pressure drug Baxdrostat shows promise in clinical trial

almost half of American adults in the US have high blood pressure, and only one in four have it under control. High blood pressure exposes you to serious complications such as heart disease and stroke, which makes this condition serious and important to treat properly.

Now there’s an experimental new drug that’s getting a lot of buzz because of its effectiveness in controlling high blood pressure. It’s called baxdrostat, and the results of a recent phase 2 clinical trial showed that it can reduce blood pressure up to 20 points in patients who have not been able to bring their high blood pressure under control with other medicines.

The trial, which was published in PIT and presented at the annual meeting of the American Heart Association, randomly assigned 248 patients with treatment-resistant high blood pressure to receive 0.5, 1, or 2 milligrams of baxdrostat once a week daily or placebo. The researchers found that patients tolerated the drug well and that people in the 2-milligram group had a 20-point drop in blood pressure. (It’s worth noting: People in the placebo group also saw an 11-point drop, but researchers said in the study that this was likely because they were more diligent about taking other medications during the study period.)

Baxdrostat is not yet available to the masses—it needs to go through phase III clinical trials and get approval from the Food and Drug Administration first. But it’s already getting a lot of attention based on test results.

But what is baxdrostat and who is it good for? Here’s what you need to know.

What is baxdrostat and how does it work?

Baxdrostat is an oral medication that works on the hormone aldosterone that regulates the amount of salt in your body. Baxdrostat blocks an enzyme your body needs to make aldosterone, explains study co-author Morris Brown, MD, professor of endocrine hypertension at Queen Mary University of London.

“Aldosterone is a chemical in your body that will signal your kidney to reabsorb water and sodium,” says Jamie Alan, Ph.D., associate professor of pharmacology and toxicology at Michigan State University.. “When you retain more water, you increase your total blood volume, which increases your blood pressure.”

In a clinical trial, baxdrostat had no side effects that differed from placebo, with the exception of dizziness in some patients when their blood pressure was lowered. Two patients also had elevated potassium levels, which can lead to heart rhythm problems, but still managed to complete the study.

What is high blood pressure again?

Your blood pressure is a measure of the pressure of blood on the walls of the arteries, which carry blood from the heart to other areas of the body, according to center for disease control and prevention (CDC).

It’s normal for your blood pressure to rise and fall throughout the day, the CDC explains, but if it stays high for too long, it can damage your heart and cause health problems. High blood pressure, also known as hypertension, is blood pressure that is higher than normal. People are considered to have hypertension when they have a systolic blood pressure (top number) higher than 130 mmHg or a diastolic blood pressure (bottom number) higher than 80 mmHg, the CDC says. (Anything less than 120 mmHg / 80 mmHg is considered normal blood pressure.)

High blood pressure usually causes no symptoms National Heart, Lung and Blood Institute (NHLBI), but can lead to serious health problems, including aneurysm, stroke, heart attack, and heart failure.

What treatment options are currently available for high blood pressure?

There are several different ways to control high blood pressure, including lifestyle changes and taking certain medications, the NHLBI says.

Lifestyle changes may include:

• Eating heart-healthy foods like those found in DASH dietalong with a low-sodium diet.
• Avoiding or limiting alcohol.
• Regular physical activity.
• Trying to achieve and maintain a healthy weight.
• Avoiding smoking.
• Managing stress levels.
• Get enough sleep.

But for some people, lifestyle changes are not enough. There are several medications that can help lower blood pressure, including:

• Angiotensin-converting enzyme (ACE) inhibitors to prevent excessive narrowing of blood vessels.
• Angiotensin II receptor blockers (ARBs) that prevent narrowing of blood vessels.
• Calcium channel blockers to prevent calcium from entering the muscle cells of your heart and blood vessels.
• Diuretics such as thiazides to remove excess water and sodium from the body and reduce the amount of fluid in the blood.
• Beta blockers that help your heart beat more slowly and with less force.

But for some people even that is not enough. In this case, they are diagnosed with what is known as resistant hypertension, meaning they are on three medications and still haven’t been able to significantly lower their blood pressure. “People who have resistant hypertension should take three medications, including a diuretic, and that may be helpful,” says Dr. Brown. If this does not work, it is currently recommended that they try the so-called spironolactone, which like baxdrostat reduces the effect of aldosterone. “For some patients, that’s enough,” says Dr. Brown. “But the problem is that the dose can be limited by side effects.” (Common side effects of spironolactone include vomiting, diarrhea, increased hair growth, and fatigue, per Medline Plus.)

Why is the drug like need baxdrostat?

Resistant hypertension is a problem and more common than many people realize, says Alan. “You might be surprised at the number of people who have treatment-resistant hypertension,” she says. “It turns out that the body is very good at compensating when you give it a drug that lowers blood pressure. It’s great to have another tool in the arsenal.”

Yu-Ming Ni, MD, cardiologist at MemorialCare Heart and Vascular Institute at Orange Coast Medical Center in Fountain Valley, Calif., agrees, noting that he is “very excited” about the study’s results. “Patients with resistant hypertension have a really high risk of developing cardiovascular disease,” he says. “These patients really need much better treatments, and there are many patients that we’re just fighting to help them get well.”

Thomas Boyden, MD, Corewell Health West’s medical director of preventive cardiology and cardiac rehabilitation, says the results of the study “were really impressive” and “significant when you look at other drugs.” He continues, “this offers a lot of opportunity for patients,” provided future trials also produce good results.

What happens next with baxdrostat?

It will be some time before baxdrostat is available to the masses. “A phase 2 study doesn’t always lead to success,” says Dr. Brown. Still, he says, researchers plan to conduct a phase 3 clinical trial early next year, which typically lasts between 12 and 18 months. “Realistically, the earliest this drug could be licensed would be 2024,” says Dr. Brown.