BrigHTN (baxdrostat 0.5 mg)
Trial question
What is the role of low-dose baxdrostat in patients with treatment-resistant hypertension?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 138
138 patients (60 female, 78 male).
Inclusion criteria: patients who had treatment-resistant hypertension, with BP ≥ 130/80 mmHg, and who were receiving stable doses of at least three antihypertensive agents, including a diuretic.
Key exclusion criteria: mean seated SBP of at least 180 mmHg or DBP of at least 110 mmHg; an eGFR of < 45 mL/min/1.73 m²; uncontrolled diabetes.
Interventions
N=69 baxdrostat (at a dose of 0.5 mg daily for 12 weeks).
N=69 placebo (matching placebo for 12 weeks).
Primary outcome
Reduction in mean systolic blood pressure at week 12
12.1 mmHg
9.4 mmHg
12.1 mmHg
9.1 mmHg
6.0 mmHg
3.0 mmHg
0.0 mmHg
Baxdrostat
Placebo
Borderline significant
increase ▲
Borderline significantly greater reduction in mean SBP at week 12 (12.1 mmHg vs. 9.4 mmHg; AD 2.7 mmHg, 95% CI 0 to 5.4).
Secondary outcomes
Borderline significantly lower reduction in DBP at week 12 (8.6 mmHg vs. 9.2 mmHg; AD -0.6 mmHg, 95% CI -1.2 to 0).
Borderline significantly greater reduction in urinary aldosterone levels at 24 hours (187 ng/g vs. -6 ng/g; AD 181 ng/g, 95% CI -0.31 to 362.31).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients who had treatment-resistant hypertension, with BP ≥ 130/80 mmHg, and who were receiving stable doses of at least three antihypertensive agents, including a diuretic, baxdrostat was not superior to placebo with respect to reduction in mean SBP at week 12.
Reference
Mason W Freeman, Yuan-Di Halvorsen, William Marshall et al. Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension. N Engl J Med. 2023 Feb 2;388(5):395-405.
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