2025-08-30 ユニバーシティ・カレッジ・ロンドン(UCL)
<関連情報>
- https://www.ucl.ac.uk/news/2025/aug/promising-new-drug-people-stubborn-high-blood-pressure
- https://www.nejm.org/doi/full/10.1056/NEJMoa2507109
制御不能かつ抵抗性高血圧症におけるバクスドロスタットの有効性と安全性 Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension
John M. Flack, M.D., Michel Azizi, M.D., Jenifer M. Brown, M.D., Jamie P. Dwyer, M.D., Jakub Fronczek, M.D., Erika S.W. Jones, M.D., Daniel S. Olsson, M.D., +6 , for the BaxHTN Investigators
New England Journal of Medicine Published: August 30, 2025
DOI: 10.1056/NEJMoa2507109
Abstract
Background
Aldosterone dysregulation plays an important pathogenic role in hard-to-control hypertension. In several studies, baxdrostat, an aldosterone synthase inhibitor, reduced the seated systolic blood pressure of patients with uncontrolled or resistant hypertension.
Methods
In this phase 3, multinational, double-blind, randomized, placebo-controlled trial, we recruited patients with a seated systolic blood pressure of between 140 mm Hg and less than 170 mm Hg despite the receipt of stable treatment with two antihypertensive medications (uncontrolled hypertension) or three or more such medications (resistant hypertension), including a diuretic. After a 2-week placebo run-in period, we randomly assigned patients with a seated systolic blood pressure of 135 mm Hg or more in a 1:1:1 ratio to receive baxdrostat at a dose of 1 mg, baxdrostat at a dose of 2 mg, or placebo once daily for 12 weeks. The primary end point was the change in seated systolic blood pressure from baseline to week 12.
Results
A total of 796 patients underwent randomization and 794 received 1-mg baxdrostat (264 patients), 2-mg baxdrostat (266 patients), or placebo (264 patients) in addition to background therapy. At 12 weeks, the change from baseline in the least-squares mean seated systolic blood pressure was –14.5 mm Hg (95% confidence interval [CI], –16.5 to –12.5) with 1-mg baxdrostat, –15.7 mm Hg (95% CI, –17.6 to –13.7) with 2-mg baxdrostat, and –5.8 mm Hg (95% CI, –7.9 to –3.8) with placebo. The estimated difference from placebo (placebo-corrected difference) was –8.7 mm Hg (95% CI, –11.5 to –5.8) with 1-mg baxdrostat and –9.8 mm Hg (95% CI, –12.6 to –7.0) with 2-mg baxdrostat (P<0.001 for both comparisons). A potassium level of more than 6.0 mmol per liter was reported in 6 patients (2.3%) with 1-mg baxdrostat, in 8 patients (3.0%) with 2-mg baxdrostat, and in 1 patient (0.4%) with placebo.
Conclusions
Among patients with uncontrolled or resistant hypertension, the addition of baxdrostat to background therapy resulted in a significantly lower seated systolic blood pressure at 12 weeks than placebo. (Funded by AstraZeneca and others; BaxHTN ClinicalTrials.gov number, NCT06034743.)
