A Study of CIN-107 in Adults With Treatment-Resistant Hypertension - BrigHTN
Contribution To Literature:
The BrigHTN trial showed that baxdrostat, a selective inhibitor of aldosterone synthase, improves blood pressure control compared with placebo.
The goal of the trial was to evaluate baxdrostat compared with placebo among patients with treatment-resistant hypertension. Baxdrostat is a selective inhibitor of aldosterone synthase and reduces aldosterone but not cortisol levels.
Patients with treatment-resistant hypertension were randomized to baxdrostat 0.5 mg (n = 69) vs. baxdrostat 1 mg (n = 70) vs. baxdrostat 2 mg (n = 67) vs. placebo (n = 69) once daily for 12 weeks.
- Total number of enrollees: 275
- Duration of follow-up: 12 weeks
- Mean patient age: 62 years
- Percentage female: 39%
- Percentage with diabetes: 41%
- At least 18 years of age
- Use of ≥3 antihypertensive medications
- Mean systolic blood pressure ≥130/80 mm Hg
- Systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥110 mm Hg
- Estimated glomerular filtration rate <45 ml/min/1.73 m2
- Uncontrolled diabetes
The primary outcome, change in systolic blood pressure from baseline to week 12, was -12.1 mm Hg in the baxdrostat 0.5 mg group, vs. -17.5 mm Hg in the baxdrostat 1 mg group, vs. -20.3 mm Hg in the baxdrostat 2 mg group, vs. -9.4 mm Hg in the placebo group (p = 0.003 for baxdrostat 1 mg vs. placebo; p < 0.001 for baxdrostat 2 mg vs. placebo).
- Any serious adverse event: 0% in the baxdrostat 0.5 mg group, vs. 3% in the baxdrostat 1 mg group, vs. 9% in the baxdrostat 2 mg group, vs. 3% in the placebo group
- Potassium level ≥6 mmol/L: 0% in the baxdrostat 0.5 mg group, vs. 3% in the baxdrostat 1 mg group, vs. 2% in the baxdrostat 2 mg group, vs. 0% in the placebo group
Among patients with treatment-resistant hypertension, aldosterone synthase inhibition with baxdrostat led to dose-dependent reductions in systolic blood pressure. Baxdrostat was well tolerated. Phase 3 trials evaluating this agent are warranted.
Presented by Dr. Mason Freeman at the American Heart Association Scientific Sessions, Chicago, IL, November 7, 2022.
Keywords: AHA Annual Scientific Sessions, AHA22, Cytochrome P-450 CYP11B2, Antihypertensive Agents, Blood Pressure, Diabetes Mellitus, Hypertension, Potassium, Primary Prevention
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