Introduction: BaxHTN (NCT06034743) is an international, randomised, double-blind, placebo-controlled trial evaluating the efficacy and safety of the aldosterone synthase inhibitor baxdrostat in patients with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). Methods: Participants had a mean seated office systolic blood pressure (seated-SBP) between 140 and <170 mmHg despite treatment with two (uHTN) or 3 (rHTN) antihypertensive treatments (AHT), including a diuretic. Participants with seated-SBP 135 mmHg at the end of a 2-week placebo run-in period were randomised to baxdrostat 2 mg, baxdrostat 1 mg or placebo once daily (QD) for a 12-week doubleblind period. This was followed by a 12-week open-label period of baxdrostat 2 mg QD or standard-of-care, which was followed by an 8week double-blind randomised withdrawal period of baxdrostat 2 mg QD or placebo. There was then a final 20-week open-label period of baxdrostat 2 mg QD. The primary endpoint was change from baseline in seated-SBP at week 12. Results: In total, 796 participants were randomised. 794 received at least one dose of study drug: placebo (n=264), baxdrostat 1 mg (n=264) or baxdrostat 2 mg (n=266). At week 12, the placebo-corrected least-squares mean change from baseline in seated-SBP was -8. 7 mmHg (95% confidence interval, -11. 5 to -5. 8; P<0. 0001) for baxdrostat 1 mg and -9. 8 mmHg (-12. 6 to -7. 0; P<0. 0001) for baxdrostat 2 mg. Treatment was well tolerated with no unanticipated adverse events. Conclusion: The addition of baxdrostat to background AHT led to a reduction in seated-SBP at week 12 compared with placebo in patients with uHTN or rHTN.
Fujino et al. (Wed,) studied this question.