Efficacy and safety of baxdrostat add-on in uncontrolled and resistant hypertension: a systematic review and meta-analysis of randomized controlled trials with GRADE certainty-of-evidence assessment

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Abstract

Uncontrolled and resistant hypertension continues to be a significant contributor to cardiovascular and renal risk. Baxdrostat is a selective aldosterone synthase inhibitor which has demonstrated a potential blood pressure-lowering effect in randomized controlled trials (RCTs). We performed a systematic literature search across PubMed, Scopus, Web of Science, and Cochrane from their inception to March 2026. The continuous outcomes were reported as mean differences (MDs), and dichotomous outcomes as relative risks (RRs), both with their corresponding 95% confidence intervals (CIs). In four RCTs involving 1481 participants, baxdrostat reduced mean sitting systolic and diastolic blood pressure significantly more than placebo (MD =  - 8.93 mmHg and MD =  - 3.79 mmHg, respectively), with no heterogeneity. Benefits were observed with both 1 mg and 2 mg daily doses. Baxdrostat was associated with a higher incidence of adverse events overall (RR = 1.24; 95% CI, 1.07 to 1.43), higher serum potassium levels (MD = 0.47 mmol per liter), and greater risks of hyperkalemia (RR = 8.64; 95% CI, 3.56 to 20.98) and potassium levels of more than 6 mmol per liter (RR = 6.06; 95% CI, 1.66 to 22.17), whereas serious adverse events were not significantly increased. In patients having uncontrolled or resistant hypertension, baxdrostat reduced sitting systolic and diastolic blood pressure compared to placebo. These results are based on a few RCTs, and the increased risk of hyperkalemia warrants caution. Further studies are required to provide enlightenment on long-term safety and general clinical benefit.

Abstract as published, via PubMed.