Baxdrostat use for BP control in patients with uncontrolled hypertension: HALO trial provides insight
USA: Recent data from the HALO trial showed that aldosterone synthase inhibition with baxdrostat was well-tolerated among patients with hypertension but did not achieve the trial's primary endpoint of a statistically significant change in mean seated BP (blood pressure) versus placebo at eight weeks.
The findings from the trial, which represent the second phase 2 study of baxdrostat, were presented at the 2023 Annual Scientific Session of the ACC (American College of Cardiology) Together With the World Congress of Cardiology. Baxdrostat is a highly selective, once daily, oral small-molecule inhibitor of aldosterone synthase.
The phase 2 BrigHTN trial presented at the American Heart Association 2022 Scientific Sessions provided evidence that baxdrostat was well-tolerated and associated with dose-dependent changes in systolic BP of −20.3 mmHg, −17.5 mmHg and −12.1 mmHg were seen in the trials in the 2 mg, 1 mg, and 0.5 mg groups, respectively, compared with the placebo; experiencing a mean change in systolic BP of -9.4 mmHg.
The BrigHTN trial included 248 participants who completed the study, conducted among patients with treatment-resistant hypertension. The trial concluded that dose-related reductions in blood pressure were seen in patients with treatment-resistant hypertension who received baxdrostat.
Treatment-resistant hypertension is defined as blood pressure of 130/80 mmHg or greater and receiving stable doses of at least three antihypertensive agents, including a diuretic.
The findings from the HALO trial presented by Deepak Bhatt, director of Mount Sinai Heart, who also gave the BrigHTN data, provided further insights into the effects of baxdrostat use, with a trial population comprising patients with uncontrolled hypertension despite the use of 1 or 2 antihypertensives at maximally tolerated doses.
In the HALO trial, 249 patients were enrolled, with 60, 62, 63, and 64 patients ere randomized to 2 mg baxdrostat, 1 mg baxdrostat, 0.5 mg baxdrostat, and placebo, respectively.
Patients with a mean seated systolic blood pressure of 140 mmHg or greater, on a stable regimen of an ACE inhibitor or an ARB, an ACEi/ARB plus a calcium channel blocker, or an ACEi/ARB plus a thiazide diuretic were included.
The primary endpoint was the mean seated systolic blood pressure change from baseline after eight weeks of treatment. Secondary endpoints included changes in diastolic blood pressure, renin, and aldosterone levels.
Limitations of the study include modest population size, suboptimal adherence, and assessment of the primary endpoint at eight weeks rather than at 12 weeks.
Reference:
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.
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