BAXHTN – EFFICACY AND SAFETY OF THE ALDOSTERONE SYNTHASE INHIBITOR BAXDROSTAT IN PATIENTS WITH UNCONTROLLED OR RESISTANT HYPERTENSION

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Abstract Title *

BAXHTN – EFFICACY AND SAFETY OF THE ALDOSTERONE SYNTHASE INHIBITOR BAXDROSTAT IN PATIENTS WITH UNCONTROLLED OR RESISTANT HYPERTENSION

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Co-author 1

Hirotaka Shibata Hiro-405@cb3.so-net.ne.jp Faculty of Medicine, Oita University Department of Endocrinology, Metabolism, Rheumatology and Nephrology Yufu Japan *

Co-author 2

Michel Azizi michel.azizi@aphp.fr Hôpital Européen Georges Pompidou Hypertension Department Paris France -

Co-author 3

Jenifer Brown jbrown35@bwh.harvard.edu Brigham and Women’s Hospital Department of Medicine, Division of Cardiovascular Medicine Boston United States -

Co-author 4

Jamie Dwyer Jamie.dwyer@hsc.utah.edu University of Utah Division of Nephrology and Hypertension Salt Lake City United States -

Co-author 5

John Flack jflack47@siumed.edu Southern Illinois University Departments of Medicine and Population Science and Policy Springfield United States -

Co-author 6

Jakub Fronczek jakub.fronczek@astrazeneca.com AstraZeneca Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D Warsaw Poland -

Co-author 7

Erika Jones eswjones@gmail.com Groote Schuur Hospital, University of Cape Town Department of Medicine, Division of Nephrology and Hypertension Cape Town South Africa -

Co-author 8

Daniel Olsson daniel.olsson3@astrazeneca.com AstraZeneca R&D BioPharmaceuticals, Late-Stage Development, Cardiovascular, Renal and Metabolism (CVRM) Mölndal Sweden -

Co-author 9

Shira Perl SHIRA.PERL@ASTRAZENECA.COM AstraZeneca R&D BioPharmaceuticals, Late-Stage Development, Cardiovascular, Renal and Metabolism (CVRM) Gaithersburg United States -

Co-author 10

Ji-Guang Wang jiguangwang@rjh.com.cn Ruijin Hospital, Shanghai Jiao Tong University School of Medicine The Shanghai Institute of Hypertension Shanghai China -

Co-author 11

Ulrica Wilderäng ulrica.wilderang@astrazeneca.com AstraZeneca R&D BioPharmaceuticals, Late-Stage Development, Cardiovascular, Renal and Metabolism (CVRM) Mölndal Sweden -

Co-author 12

Janet Wittes janet@wittesllc.com Wittes LLC Wittes LLC Washington DC United States -

Co-author 13

Bryan Williams bryan.williams@ucl.ac.uk UCL Hospitals Biomedical Research Centre, University College London Institute of Cardiovascular Science and National Institute for Health Research London United Kingdom -

Co-author 14

Co-author 15

Introduction

BaxHTN (NCT06034743) is an international, randomised, double-blind, placebo-controlled trial evaluating the efficacy and safety of the aldosterone synthase inhibitor baxdrostat in patients with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN).

Methods

Participants had a mean seated office systolic blood pressure (seated-SBP) between ≥140 and <170 mmHg despite treatment with two (uHTN) or ≥3 (rHTN) antihypertensive treatments (AHT), including a diuretic. Participants with seated-SBP ≥135 mmHg at the end of a 2-week placebo run-in period were randomised to baxdrostat 2 mg, baxdrostat 1 mg or placebo once daily (QD) for a 12-week double-blind period. This was followed by a 12-week open-label period of baxdrostat 2 mg QD or standard-of-care, which was followed by an 8-week double-blind randomised withdrawal period of baxdrostat 2 mg QD or placebo. There was then a final 20-week open-label period of baxdrostat 2 mg QD. The primary endpoint was change from baseline in seated-SBP at week 12.

Results

In total, 796 participants were randomised. 794 received at least one dose of study drug: placebo (n=264), baxdrostat 1 mg (n=264) or baxdrostat 2 mg (n=266). At week 12, the placebo-corrected least-squares mean change from baseline in seated-SBP was –8.7 mmHg (95% confidence interval, –11.5 to –5.8; P<0.0001) for baxdrostat 1 mg and –9.8 mmHg (–12.6 to –7.0; P<0.0001) for baxdrostat 2 mg. Treatment was well tolerated with no unanticipated adverse events.

Conclusion

The addition of baxdrostat to background AHT led to a reduction in seated-SBP at week 12 compared with placebo in patients with uHTN or rHTN.

This abstract was also submitted for the ESC Congress 2025.

Kewords