Baxdrostat significantly reduced 24 h ambulatory systolic blood pressure compared to placebo (difference -14.0 mm Hg; 95% CI -17.2 to -10.8; p<0.0001) in patients with resistant hypertension.
RCT (n=217)
Double-blind
1:1
Yes
Does baxdrostat reduce 24 h ambulatory systolic blood pressure in adults with resistant hypertension?
In patients with resistant hypertension, the selective aldosterone synthase inhibitor baxdrostat significantly reduced 24-hour ambulatory systolic blood pressure compared to placebo over 12 weeks.
Effect estimate: difference -14.0 mm Hg (95% CI -17.2 to -10.8)
Absolute Event Rate: -16.6% vs -2.6%
p-value: p=<0.0001
SummaryBackground Aldosterone dysregulation is an important contributor in the pathogenesis of hard-to-control hypertension. We aimed to assess the effect of baxdrostat, a selective aldosterone synthase inhibitor, on ambulatory blood pressure in patients with resistant hypertension. Methods The Bax24 international, phase 3, randomised, double-blind, placebo-controlled trial recruited adults (aged ≥18 years) with seated systolic blood pressure (SBP) ≥140 mm Hg and Findings Between March 1, 2024, and April 16, 2025, 854 patients were screened, 636 were excluded (437 before the placebo run-in and 199 during the placebo run-in) and 217 were randomly assigned to and received baxdrostat (n=108) or placebo (n=109). 140 patients (65%) were male, 77 (35%) patients were female, and 170 patients (78%) were White. The median age was 60·0 years (IQR 51·0–68·0). At 12 weeks, the change from baseline in the least-squares mean 24 h ambulatory SBP was –16·6 mm Hg (95% CI −18·8 to −14·3) in the baxdrostat group (n=89) and −2·6 mm Hg (−4·7 to −0·4) in the placebo group (n=95); the estimated placebo-corrected difference was −14·0 mm Hg (−17·2 to −10·8; pInterpretation Baxdrostat significantly reduced 24 h ambulatory SBP versus placebo in patients with resistant hypertension, providing further evidence of the potential of aldosterone synthase inhibition for treatment of hard-to-control hypertension. Funding AstraZeneca.
“The landmark results from Bax24 Phase III trial demonstrate that patients with the hardest-to-control hypertension treated with baxdrostat achieved a highly clinically meaningful 14 mmHg placebo-adjusted reduction in 24-hour systolic blood pressure, which could transform treatment practice. It's remarkable to see this magnitude of reduction coupled with the fact that just over 70% of baxdrostat patients achieved guideline targets, consistently over 24 hours.”
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Azizi et al. (Sun,) conducted a rct in resistant hypertension (n=217). baxdrostat vs. placebo was evaluated on change in 24 h ambulatory SBP from baseline to week 12 (difference -14.0 mm Hg, 95% CI -17.2 to -10.8, p=<0.0001). Baxdrostat significantly reduced 24 h ambulatory systolic blood pressure compared to placebo (difference -14.0 mm Hg; 95% CI -17.2 to -10.8; p<0.0001) in patients with resistant hypertension.