A new drug shows promise for hard-to-treat high blood pressure

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A new drug called baxdrostat shows promise for people with resistant hypertension, or high blood pressure that does not respond to existing medications.

Baxdrostat, a new aldosterone synthase inhibitor, significantly lowers resistant hypertension by reducing systolic blood pressure in patients whose blood pressure remains uncontrolled despite multiple medications, with a strong safety profile and sustained effect shown in a large Phase III trial.
Credits: ssbcrack

Key Findings

  • Clinical trial results: Published on August 30 in The New England Journal of Medicine, a Phase III trial tested baxdrostat in nearly 800 patients.

  • Blood pressure reduction: Patients taking 1–2 mg of the drug, along with their usual therapy, experienced an average 9–10 mm Hg greater drop in systolic pressure compared with placebo. A substudy also found about a 15 mm Hg reduction in 24-hour systolic pressure.

  • Mechanism of action: Baxdrostat is an aldosterone synthase inhibitor, which lowers levels of aldosterone — a hormone that drives salt and water retention — thereby reducing blood pressure.

  • Safety profile: The trial reported no major side effects, an encouraging sign for further use.

Context

  • Hypertension affects 1.3 billion people worldwide, but 80% do not receive adequate treatment.

  • Uncontrolled blood pressure raises risks of stroke, heart attack, and heart failure.

  • A healthy reading is below 120/80 mm Hg, while readings at or above 130/80 mm Hg are considered high.

  • The average pressure among trial participants was 149/87 mm Hg, classifying them as significantly hypertensive.

Baxdrostat could become an important alternative therapy for patients whose blood pressure remains uncontrolled despite standard drugs.


Pressure drops

By the end of a trial of patients with resistant or uncontrolled high blood pressure, those taking 1 or 2 milligrams of baxdrostat saw a greater drop in their systolic pressure measured while seated than those on placebo. Systolic pressure, the force of blood on artery walls during heart beats, is measured in millimeters of mercury, or mm Hg.


Baxdrostat may offer a safer and more effective alternative to current treatments for resistant high blood pressure, avoiding common side effects while lowering systolic pressure across diverse patient groups.

Benefits Over Existing Drugs

  • Existing therapies like spironolactone can cause breast tenderness, reduced sexual function in men, and menstrual irregularities in women.

  • According to John Flack of Southern Illinois University, baxdrostat avoids these issues while still reducing blood pressure effectively.

  • About 40% of patients on baxdrostat reached healthy systolic levels (<130 mm Hg) compared with 19% on placebo.

  • The benefit was consistent across men, women, younger and older patients, and those taking two or more medications.

Safety and Tolerability

  • Side effects were generally mild. Small potassium increases occurred but were less significant than with spironolactone.

  • Kidney effects were minor and might even be beneficial by reducing harmful overfiltration.

  • Baxdrostat’s impact extended during an eight-week withdrawal phase: patients who stopped treatment had a 1.4 mm Hg rise, while those who continued saw an additional 3.7 mm Hg drop — showing a prolonged blood pressure–lowering effect unusual for existing drug classes.

Expert Opinions

  • Erica Spatz, a Yale cardiologist, described the results as “impressive and meaningful,” especially for those struggling to control blood pressure.

  • She highlights that sustained drug effects could improve adherence, a common barrier in hypertension treatment.

  • Both experts agree the observed reductions could lower risks of heart attack, stroke, and heart failure.

Broader Implications

  • The American Heart Association guidelines recommend tailoring treatment to overall cardiovascular risk, often estimated using the PREVENT calculator, which factors in blood pressure, cholesterol, age, and other metrics.

  • For high-risk individuals, achieving below 120 mm Hg systolic offers greater protection than just meeting the 130 mm Hg threshold.

  • Baxdrostat could become especially valuable for these patients if approved.

Next Steps

  • Developer AstraZeneca plans to seek U.S. regulatory approval by late 2025.

  • However, more research is needed to confirm whether baxdrostat works as a first- or second-line treatment and whether it provides equivalent heart protection to current drug classes.

  • Experts emphasize that, even if approved, it must be paired with lifestyle changes, regular monitoring, and holistic cardiovascular care for best results.


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