BASELINE CHARACTERISTICS OF PARTICIPANTS IN BAXASIA: PHASE 3 STUDY OF THE ALDOSTERONE SYNTHASE INHIBITOR BAXDROSTAT IN ADULTS WITH UNCONTROLLED OR RESISTANT HYPERTENSION PRIMARILY FROM ASIA

 

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https://storage.unitedwebnetwork.com/files/1099/b03ef05b87f53c90d58a5cb4024dde07.pdf
BASELINE CHARACTERISTICS OF PARTICIPANTS IN BAXASIA: PHASE 3 STUDY OF THE ALDOSTERONE SYNTHASE INHIBITOR BAXDROSTAT IN ADULTS WITH UNCONTROLLED OR RESISTANT HYPERTENSION PRIMARILY FROM ASIA

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Hirotaka
Shibata
Hirotaka Shibata Hiro-405@cb3.so-net.ne.jp Oita University Department of Endocrinology, Metabolism, Rheumatology and Nephrology, Faculty of Medicine Oita Japan *
Michel Azizi Michel.azizi@aphp.fr Hôpital Européen Georges Pompidou Hypertension Department Paris France -
Jenifer M. Brown jbrown35@bwh.harvard.edu Brigham and Women’s Hospital Department of Medicine, Division of Cardiovascular Medicine Boston United States -
Wei Duan wei.duan3@astrazeneca.com AstraZeneca R&D China, Biometrics and Data Science Beijing China -
Jamie P. Dwyer Jamie.dwyer@hsc.utah.edu University of Utah Division of Nephrology and Hypertension Salt Lake City United States -
John M. Flack Jflack47@siumed.edu Southern Illinois University and Springfield Memorial Hospital Departments of Medicine and Population Science and Policy, Division of General Internal Medicine, Hypertension Section Springfield United States -
Erika S. W. Jones eswjones@gmail.com Groote Schuur Hospital, University of Cape Town Department of Medicine, Division of Nephrology and Hypertension Cape Town South Africa -
Lei Liu Lylian.Liu1@astrazeneca.com AstraZeneca R&D China, Clinical Science Cardiovascular, Renal and Metabolism (CVRM) Shanghai China -
Shira Perl Shira.perl@astrazeneca.com AstraZeneca R&D BioPharmaceuticals, Late-Stage Development, Cardiovascular, Renal and Metabolism (CVRM) Gaithersburg United States -
Ji-Guang Wang jiguangwang@rjh.com.cn Ruijin Hospital, Shanghai Jiao Tong University School of Medicine The Shanghai Institute of Hypertension Shanghai China -
Junjie Wu jeremy.wu1@astrazeneca.com AstraZeneca R&D China, Clinical Science Cardiovascular, Renal and Metabolism (CVRM) Shanghai China -
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 -
 
 
 

In the Phase 3 BaxHTN study in adults with uncontrolled (uHTN) or resistant (rHTN) hypertension, the selective aldosterone synthase inhibitor, baxdrostat, at 1 and 2 mg/day in addition to background therapy, lowered seated office systolic blood pressure (SBP) by 8.7 and 9.8 mmHg, respectively, vs placebo at 12 weeks. BaxAsia (NCT06344104) has a similar randomised, double-blind design comparing the efficacy and safety of baxdrostat vs placebo in hypertensive patients primarily from Asia. Here, we present the baseline characteristics of participants included in BaxAsia.

Adults aged ≥18 years were eligible if they had: uHTN or rHTN, defined as mean seated SBP between ≥140 and <170 mmHg despite stable treatment with 2 (uHTN) or ≥3 (rHTN) antihypertensive medications (including a diuretic) at maximally tolerated dose; an estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2; and a serum potassium level between ≥3.5 and <5.0 mmol/L. After a 2-week placebo run-in period, participants with a mean seated SBP ≥135 mmHg were randomised 1:1:1 to baxdrostat 1 mg, baxdrostat 2 mg or placebo once daily for a 12-week double-blind period. This was followed by 3 sequential periods: 12-week open-label period (baxdrostat 2 mg); 8-week double-blind randomised withdrawal period (randomised 2:1 to baxdrostat 2 mg or placebo); 20-week open-label period (baxdrostat 2 mg). The primary endpoint is change in seated SBP from baseline to Week 12 with baxdrostat 2 mg vs placebo.

Overall, 666 participants were screened and 326 were randomised; 49.4% had uHTN and 50.6% had rHTN. Mean (standard deviation, SD) age and body mass index were 59.2 (11.5) years and 29.3 (5.3) kg/m2, respectively. Overall, 57.7% were male, 62.3% were Asian and 37.1% were White. Participants were recruited from China mainland (47.9%), Russia (20.6%), Turkey (9.5%), Japan (9.2%), Argentina (4.6%), Australia (3.1%), South Korea (2.1%), Vietnam (1.8%), China Hong Kong (0.9%) and India (0.3%).

At baseline, mean (SD) seated SBP was 149.0 (8.7) mmHg despite treatment with 2–5 antihypertensive medications. Participants with rHTN were on 3 (67.9%), 4 (26.1%) or 5 (6.1%) antihypertensive medications at baseline. Baseline eGFR, serum potassium and sodium levels were 88.2 (17.9) mL/min/1.73 m2, 4.2 (0.4) mmol/L and 140.7 (2.5) mmol/L, respectively. In total, 40.5% of participants had a history of dyslipidaemia, 36.8% obesity, 25.2% type 2 diabetes, 7.1% coronary artery stenosis, 7.4% chronic kidney disease, 4.6% myocardial infarction, 4.6% heart failure and 4.3% stroke. Overall, 99.4% of participants had primary hypertension and 0.6% had secondary hypertension (kidney disease). At baseline, all participants were on diuretic, 96.3% on ACEi, ARB or ARNI, 48.5% on calcium channel blocker, 16.0% on beta blocker and 8.3% on other medications.

Participants randomised in BaxAsia were representative of adults primarily from Asia with uHTN or rHTN with elevated SBP despite multiple antihypertensive medications. A history of dyslipidaemia, type 2 diabetes and/or obesity were the most common comorbidities. BaxAsia will assess the seated office blood pressure-lowering effect and safety of baxdrostat in the study participants.

Kewords