Dose-dependent reductions in systolic blood pressure seen in phase 2 dose-ranging study
TUESDAY, Nov. 8, 2022 (HealthDay News) — Patients with treatment-resistant hypertension who receive baxdrostat versus placebo have dose-dependent reductions in systolic blood pressure at 12 weeks, according to a study published online Nov. 7 in the New England Journal of Medicine to coincide with the American Heart Association Scientific Sessions 2022, held from Nov. 5 to 7 in Chicago.
Mason W. Freeman, M.D., from CinCor Pharma in Boston, and colleagues conducted a multicenter, placebo-controlled trial involving patients with treatment-resistant hypertension with blood pressure of 130/80 mm Hg or higher who were receiving stable doses of at least three antihypertensive agents, including a diuretic. Patients were randomly assigned to receive baxdrostat (0.5, 1, or 2 mg) once daily for 12 weeks or placebo; 248 patients completed the trial.
The researchers found that there were dose-dependent changes in systolic blood pressure of −20.3, −17.5, −12.1, and −9.4 mm Hg, respectively, in the 2-, 1-, and 0.5-mg, and placebo groups. The differences in changes in systolic blood pressure between the 2-mg and placebo groups and between the 1-mg and placebo groups (−11.0 and −8.1 mm Hg, respectively) were statistically significant. There were no deaths during the trial, no serious adverse events were attributed to baxdrostat, and no cases of adrenocortical insufficiency occurred. In two patients, there were baxdrostat-related increases seen in the potassium level of 6.0 mmol/L or greater; these did not recur after drug withdrawal and reinitiation.
“Aldosterone synthase inhibition with baxdrostat led to substantial reductions in systolic and diastolic blood pressure in patients with treatment-resistant hypertension,” the authors write.
Several authors disclosed financial ties to CinCor Pharma, which manufactures baxdrostat and funded the trial.
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