6/27/23, 11:49 PM BrigHTN (baxdrostat 0.5 mg) Pathway Feedback Search Clinical Topics Home Studies BrigHTN (baxdrostat 0.5 mg) BrigHTN (baxdrostat 0.5 mg) Disease Hypertension 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 N = 138 57.0% male 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 systolic BP of at least 180 mmHg or diastolic BP of at least 110 mmHg; an eGFR of < 45 mL/min/1.73 m ; 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 12.1 mmHg 9 4 https://web.pathway.md/studies/rec0VuNRDG6vsqvae 1/2 6/27/23, 11:49 PM BrigHTN (baxdrostat 0.5 mg) Pathway 9.4 9.1 mmHg 6.0 mmHg 3.0 mmHg No significant difference 0.0 mmHg Baxdrostat Placebo No significant difference in reduction in mean systolic BP at week 12 (12.1 mmHg vs. 9.4 mmHg; AD 2.7 mmHg, 95% CI 0 to 5.4) Secondary outcomes No significant difference in reduction in diastolic BP at week 12 (8.6 mmHg vs. 9.2 mmHg; AD -0.6 mmHg, 95% CI -1.2 to 0) No significant difference in 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 systolic BP 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. Open reference URL https://web.pathway.md/studies/rec0VuNRDG6vsqvae 2/2