Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension.
Summary
In a phase 3, double-blind RCT of 794 patients with uncontrolled/resistant hypertension, baxdrostat 1 mg and 2 mg reduced seated systolic blood pressure by 8.7 and 9.8 mmHg more than placebo at 12 weeks. Hyperkalemia (>6.0 mmol/L) occurred infrequently (2.3%–3.0% vs 0.4% with placebo).
Key Findings
- Placebo-corrected seated SBP reduction at 12 weeks: −8.7 mmHg (1 mg) and −9.8 mmHg (2 mg), both P<0.001
- Hyperkalemia >6.0 mmol/L: 2.3% (1 mg), 3.0% (2 mg) vs 0.4% (placebo)
- Consistent BP lowering on top of multi-drug background therapy including a diuretic
Clinical Implications
Baxdrostat could become an add-on option for uncontrolled/resistant hypertension, especially in aldosterone-driven phenotypes, with routine potassium monitoring.
Why It Matters
Introduces a first-in-class aldosterone synthase inhibitor demonstrating clinically meaningful BP reduction in hard-to-treat hypertension, potentially altering therapeutic algorithms.
Limitations
- Short duration (12 weeks) without cardiovascular outcome assessment
- Risk of hyperkalemia requires monitoring; applicability to severe CKD not established
Future Directions
Longer-term trials assessing cardiovascular outcomes, safety in CKD, and head-to-head comparisons with mineralocorticoid receptor antagonists.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized, double-blind, placebo-controlled phase 3 trial provides highest level evidence for efficacy.
- Study Design
- OTHER