Effect of baxdrostat on ambulatory blood pressure in patients with resistant hypertension (Bax24): a phase 3, randomised, double-blind, placebo-controlled trial.

Summary

In an international phase 3 double-blind RCT of resistant hypertension, baxdrostat 2 mg once daily reduced 24-hour ambulatory SBP by 14.0 mm Hg more than placebo over 12 weeks. Adverse events were higher with baxdrostat, with confirmed potassium >6 mmol/L in 3% of treated patients.

Key Findings

• Baxdrostat reduced 24-hour ambulatory SBP by −16.6 mm Hg vs −2.6 mm Hg with placebo; placebo-corrected difference −14.0 mm Hg (95% CI −17.2 to −10.8; p<0.0001).
• Adverse events occurred in 52% with baxdrostat vs 37% with placebo; confirmed serum potassium >6 mmol/L occurred in 3% on baxdrostat and 0% on placebo.
• The study enrolled 217 patients across 22 countries using a rigorous double-blind, placebo-controlled design with ambulatory BP as the primary endpoint.

Clinical Implications

Baxdrostat may become an add-on option for resistant hypertension, with ambulatory BP benefits and the need for potassium monitoring. It supports targeting aldosterone biosynthesis beyond mineralocorticoid receptor antagonism.

Limitations

• Short 12-week duration limits assessment of long-term efficacy, safety, and clinical outcomes
• Generalizability may be limited by demographic composition and exclusion during run-in; missing ABPM data were not imputed

Future Directions

Assess long-term cardiovascular outcomes, durability of BP lowering, and safety; compare with or add to mineralocorticoid receptor antagonists; evaluate diverse populations and biomarkers of aldosterone excess.