Baxdrostat significantly lowers blood pressure (BP) in patients with resistant hypertension, according to results from the phase II BrigHTN study, published in the journal New England Journal of Medicine. Unlike the molecules previously tested, baxdrostat inhibits the synthesis of aldosterone without inhibiting the synthesis of cortisol. If efficacy and safety are confirmed in Phase III, baxdrostat might become the prototype for the first new class of antihypertensive drugs since 2007.
About 10-20% of patients with hypertension resistant to treatment » have a blood pressure that remains high despite treatment with several drugs. Guidelines recommend the addition of spironolactone in these patients, but its use is limited due to its side effects and increased risk of hyperkalemia. In preclinical and phase I studies, baxdrostat showed high selectivity (100:1) for aldosterone synthase inhibition.
In the phase II randomized placebo-controlled trial BrigHTN, 248 patients were randomly assigned to receive baxdrostat once daily, at a dose of 0.5 mg (69 patients), 1 mg (70 patients) or 2 mg (67 patients), or placebo (69 patients) for 12 weeks. The primary endpoint was change in systolic BP at week 12.
Systolic BP was significantly lowered by 11.0 and 8.1 mmHg in patients who received baxdrostat 2 and 1 mg, respectively, compared to placebo. No deaths or serious adverse events attributed to baxdrostat were observed. Two patients treated with baxdrostat developed hyperkalaemia, which resolved following discontinuation of treatment and which did not reappear when treatment was resumed.
This article was originally published in Italian on Univadis Italy.
