BrigHTN (baxdrostat 2 mg)
Trial question
What is the role of high-dose baxdrostat in patients with treatment-resistant hypertension?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 136
136 patients (56 female, 80 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=67 baxdrostat (at a dose of 2 mg daily for 12 weeks).
N=69 placebo (matching placebo for 12 weeks).
Primary outcome
Reduction in systolic blood pressure at week 12
20.3 mmHg
9.4 mmHg
20.3 mmHg
15.2 mmHg
10.2 mmHg
5.1 mmHg
0.0 mmHg
Baxdrostat
Placebo
Significant
increase ▲
Significantly greater reduction in SBP at week 12 (20.3 mmHg vs. 9.4 mmHg; AD 11 mmHg, 95% CI 5.5 to 16.4).
Secondary outcomes
Significantly greater reduction in DBP at week 12 (14.3 mmHg vs. 9.2 mmHg; AD 5.2 mmHg, 95% CI 1.6 to 8.7).
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 superior to placebo with respect to reduction in 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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