A Study of CIN-107 in Adults With Treatment-Resistant Hypertension - BrigHTN

Feb 02, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
CinCor Pharma
Date Presented:
11/07/2022
Date Published:
02/02/2023
Date Updated:
02/02/2023
Original Posted Date:
11/07/2022
References

Contribution To Literature:

The BrigHTN trial showed that baxdrostat, a selective inhibitor of aldosterone synthase, improves blood pressure control compared with placebo.

Description:

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.

Study Design

  • Randomized
  • Parallel
  • Placebo

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%

Inclusion criteria:

  • At least 18 years of age
  • Use of ≥3 antihypertensive medications
  • Mean systolic blood pressure ≥130/80 mm Hg

Exclusion criteria:

  • 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

Principal Findings:

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).

Secondary outcomes:

  • 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

Interpretation:

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.

References:

Highlighted text has been updated as of February 2, 2023.

Freeman MW, Halvorsen YD, Marshall W, et al., on behalf of the BrigHTN Investigators. Phase 2 Trial of Baxdrostat in Treatment-Resistant Hypertension. N Engl J Med 2023;388:395-405.

Editorial: Azizi M. Decreasing the Effects of Aldosterone in Resistant Hypertension — A Success Story. N Engl J Med 2023;388:461-3.

Editorial: Leopold JA, Ingelfinger JR. Aldosterone and Treatment-Resistant Hypertension. N Engl J Med 2023;388:464-7.

Presented by Dr. Mason Freeman at the American Heart Association Scientific Sessions, Chicago, IL, November 7, 2022.

Clinical Topics: Prevention, Hypertension

Keywords: AHA Annual Scientific Sessions, AHA22, Cytochrome P-450 CYP11B2, Antihypertensive Agents, Blood Pressure, Diabetes Mellitus, Hypertension, Potassium, Primary Prevention


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