- Question
- Does adding baxdrostat, an aldosterone synthase inhibitor, to background antihypertensive therapy lower systolic blood pressure in patients with uncontrolled or resistant hypertension?
- Design
- Phase 3, multinational, double-blind, placebo-controlled trial with 1:1:1 randomization of 796 patients after a 2-week placebo run-in. Treatment lasted 12 weeks.
- Population
- Patients with seated systolic blood pressure of 140 mm Hg or more and less than 170 mm Hg despite stable treatment with two antihypertensive drugs (uncontrolled hypertension) or three or more (resistant hypertension), including a diuretic. Randomization required a seated systolic blood pressure of 135 mm Hg or more.
- Intervention
- Baxdrostat 1 mg or 2 mg orally once daily, added to background therapy.
- Control
- Placebo once daily, added to background therapy.
- Primary outcome
- Change in seated systolic blood pressure from baseline to week 12.
- Results
- The least-squares mean change in seated systolic blood pressure was -14.5 mm Hg with 1 mg, -15.7 mm Hg with 2 mg and -5.8 mm Hg with placebo. The placebo-corrected difference was -8.7 mm Hg (95% CI, -11.5 to -5.8) with 1 mg and -9.8 mm Hg (95% CI, -12.6 to -7.0) with 2 mg (P<0.001 for both comparisons).
- Safety
- Serum potassium above 6.0 mmol/L was reported in 6 patients (2.3%) with 1 mg, 8 patients (3.0%) with 2 mg and 1 patient (0.4%) with placebo.
- Conclusion
- In patients with uncontrolled or resistant hypertension, adding baxdrostat to background therapy produced significantly lower seated systolic blood pressure at 12 weeks than placebo.
- Why it matters
- It provided phase 3 evidence that inhibiting aldosterone synthesis is an effective strategy for hard-to-control hypertension, with hyperkalemia as the key safety issue to monitor.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026