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

Summary

In a multicenter phase 3 RCT of resistant hypertension, baxdrostat reduced 24-hour ambulatory SBP by 16.6 mm Hg versus 2.6 mm Hg with placebo, yielding a placebo-corrected difference of −14.0 mm Hg at 12 weeks. Safety was acceptable with a small incidence of hyperkalemia >6 mmol/L (3%).

Key Findings

• Placebo-corrected reduction in 24-hour ambulatory SBP was −14.0 mm Hg (95% CI −17.2 to −10.8; p<0.0001) at 12 weeks.
• Least-squares mean change: −16.6 mm Hg (baxdrostat, n=89) vs −2.6 mm Hg (placebo, n=95).
• Adverse events occurred in 52% with baxdrostat vs 37% with placebo; confirmed hyperkalemia >6 mmol/L occurred in 3% vs 0%.

Clinical Implications

Baxdrostat may become an add-on option for resistant hypertension with robust ambulatory BP lowering; clinicians should monitor serum potassium and consider patient selection pending longer-term outcomes.

Limitations

• Relatively small randomized sample (n=217) after substantial exclusions during run-in.
• Short treatment duration (12 weeks) without long-term cardiovascular outcome data; modest increase in hyperkalemia risk.

Future Directions

Evaluate long-term efficacy and safety, cardiovascular outcomes, and comparative effectiveness versus mineralocorticoid receptor antagonists; define optimal monitoring protocols and subgroups.