A phase 3 trial presented at the ESC Congress 2025 reported that the selective aldosterone synthase inhibitor baxdrostat achieved significant reductions in blood pressure in patients with uncontrolled or resistant hypertension.1
Aldosterone dysregulation is known to contribute to the development of difficult-to-control hypertension.2 Baxdrostat, an oral once-daily therapy, has previously shown promise in earlier studies, and the phase 3 BaxHTN trial was designed to confirm its efficacy and safety in a larger, multinational population.
The double-blind, randomized, placebo-controlled study enrolled 796 patients with uncontrolled or resistant hypertension, defined as seated systolic blood pressure (SBP) ≥140 mmHg despite treatment with at least two antihypertensive agents, or ≥135 mmHg despite treatment with three or more agents including a diuretic. After a placebo run-in, participants were assigned to baxdrostat 1 mg, baxdrostat 2 mg, or placebo once daily, in addition to standard therapy, for 12 weeks.
At week 12, baxdrostat demonstrated robust reductions in SBP. The least-squares mean change from baseline was –14.5 mmHg with the 1 mg dose and –15.7 mmHg with the 2 mg dose, compared with –5.8 mmHg for placebo. This translated to placebo-corrected reductions of –8.7 mmHg (95% CI, –11.5 to –5.8) and –9.8 mmHg (95% CI, –12.6 to –7.0) for the 1 mg and 2 mg doses, respectively (both p<0.001). Safety findings were generally consistent with previous studies. Elevated potassium levels (>6.0 mmol/L) occurred in 2.3% of patients receiving baxdrostat 1 mg, 3.0% of those on baxdrostat 2 mg and 0.4% of patients on placebo.
In Madrid, the presentation of these results was met with a warm reception from the cardiology community, drawing strong interest from both clinicians and researchers in attendance. Further studies are expected to be presented at the American Heart Association (AHA) Scientific Sessions later this year.
The full publication is available here.3
References:
- BaxHTN – Efficacy and safety of the aldosterone synthase inhibitor baxdrostat in patients with uncontrolled or resistant hypertension. Prsented at ESC Congress 2025, Madrid, Spain (August 29 – September 1, 2025).
- Brown JM. Adverse Effects of Aldosterone: Beyond Blood Pressure. JAHA. 2024;13. DOI: https://doi.org/10.1161/JAHA.123.03014
- Flack JM, Azizi M, Brown JM, et al. Efficacy and Safety of Baxdrostat in Uncontrolled and Resistant Hypertension. NEJM. 2025. DOI: 10.1056/NEJMoa250710
Editor: Sven Awege, Education Editor
Disclosures: This article was created by the touchCARDIO team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
Cite: Key guideline updates in 2025 so far. touchCARDIO. 9 October 2025.
This content has been developed independently by Touch Medical Media for touchCARDIO. It is not affiliated with the European Society of Cardiology (ESC). Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media.
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