Phase 2 Trial of Baxdrostat for Treatment-Resistant Hypertension

Freeman, Mason W.; Halvorsen, Yuan-Di C.; Marshall, William; Pater, Mackenzie L.; Isaacsohn, Jon; Pearce, Catherine; Murphy, Brian; Alp, N; Srivastava, Ajay Kumar; Bhatt, Deepak L.; Mj, Brown

doi:10.1056/nejmoa2213169

Cited by 155 publications

(153 citation statements)

References 25 publications

Supporting

Mentioning

134

Contrasting

Unclassified

Order By: Relevance

“…While neither are approved at this time by the US Food and Drug Administration (FDA) for this indication, these agents may represent additional treatment options upon further study. 59,60 Patients should be referred to a hypertension specialist if blood pressure remains uncontrolled despite the above therapies.…”

Section: Yahr and Colleaguesmentioning

confidence: 99%

Resistant hypertension: A stepwise approach

Yahr

Thomas

Calle

et al. 2023

CCJM

View full text Add to dashboard Cite

show abstract

Section: Yahr and Colleaguesmentioning

confidence: 99%

Resistant hypertension: A stepwise approach

Yahr

Thomas

Calle

et al. 2023

CCJM

View full text Add to dashboard Cite

show abstract

“…g o v I d e n t i fi e r : NCT04519658). The results of this clinical trial have been presented by Dr. Mason W. Freeman at the latest Scientific Sessions of the American Heart Association in Chicago (Session "Late-Breaking Science: Resistant Hypertension: A Pressure Cooker") and simultaneously published in The New England Journal of Medicine (10).…”

mentioning

confidence: 99%

“…The trial was stopped early for overwhelming efficacy of the drug: indeed, twelve weeks after randomization, Baxdrostat at 1 and 2 mg significantly lowered systolic BP compared to placebo (meeting the primary outcome of the study). The secondary outcome (differences in diastolic BP), was met at the 2 mg dose (10). Exploratory end points included the demonstration that Baxdrostat reached a maximum plasma level in <4h, leading to a dose-dependent decrease in serum aldosterone, without affecting cortisol levels.…”

mentioning

confidence: 99%

“…In terms of side effects, none of the serious adverse events observed were deemed by the investigators to be related to Baxdrostat. Moreover, none of the patients had to discontinue the trial because of hyperkalemia, which is remarkable: the cases of hyperkalemia observed in a few patients receiving Baxdrostat resolved rapidly with "routine dietary advice" (10); it has to be noted, though, that patients with an estimated glomerular filtration rate >45 ml/min/1.73m 2 , had been excluded. Another noteworthy exclusion criterion, which reduces the generalization of the results of the BrigHTN trial, is having a mean seated systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg.…”

mentioning

confidence: 99%

See 1 more Smart Citation

The selective aldosterone synthase inhibitor Baxdrostat significantly lowers blood pressure in patients with resistant hypertension

et al. 2022

View full text Add to dashboard Cite

Resistant hypertension is defined by blood pressure (BP) targets not achieved despite the use of at least 3 anti-hypertensive drugs of different classes, including a diuretic (1). Diagnosed in more than 10% of hypertensive patients, it represents a high-risk phenotype, leading to an increased risk of cardiovascular disease and all-cause mortality (2). A BP that cannot be controlled with the use of at least 5 antihypertensive agents of different classes, including a long-acting thiazide-like diuretic such as chlorthalidone, and spironolactone is defined refractory hypertension. Substantial evidence indicates that aldosterone excess is very common in patients with resistant hypertension and primary aldosteronism is present in ~20% of patients with confirmed resistant hypertension; intriguingly a positive relationship (more pronounced in men) between weight gain and aldosterone levels has also been demonstrated (3,4). Despite its side effects (5), the mineralocorticoid receptor antagonist spironolactone remains the preferred 4 th line add-on therapy in patients with resistant hypertension. The adverse effects of spironolactone (which include reduced testosterone synthesis, hyperkalemia, gynecomastia, breast tenderness, menstrual irregularities and postmenopausal bleeding) are essentially due to the off-target blockade of several steroid hormone receptors (5). To counteract these obstacles, a different approach has Frontiers in Endocrinology frontiersin.org 01

show abstract

“…Following promising results in preclinical settings ( 8 ), aprocitentan has been tested in a multicenter, blinded, randomized, P a R all E l-group, Phase 3 study with apro CI tentan in S ubjects with Res I stant Hypertensi ON (PRECISION, Clinicaltrials.gov registration ID: NCT03541174). The results of the trial have been presented by Dr. Marcus P. Schlaich at the latest Scientific Sessions of the American Heart Association in Chicago (Session “Late-Breaking Science: Resistant Hypertension: A Pressure Cooker”) and simultaneously published in The Lancet ( 12 ).…”

mentioning

confidence: 99%