The Efficacy and Safety Profile of Baxdrostat (CIN-107) in the Management of Resistant Hypertension: A Systematic Review and Meta-Analysis of Randomized Clinical Trials
摘要
Resistant hypertension remains a major clinical challenge, contributing to increased cardiovascular risk despite multi-drug treatment. Baxdrostat, a selective aldosterone synthase inhibitor, offers a promising fourth-line therapy by reducing aldosterone without affecting cortisol. This systematic review and meta-analysis evaluated the efficacy and safety of Baxdrostat in adults with resistant or uncontrolled hypertension. Randomized controlled trials (RCTs) comparing Baxdrostat at any dose with placebo and reporting blood pressure outcomes were included. A comprehensive search of PubMed, Scopus, Cochrane CENTRAL, and ClinicalTrials.gov was conducted up to May 2025. Two reviewers independently selected studies, extracted data, and assessed bias using Robvis. Meta-analyses used a random-effects model to calculate mean differences (MD) with 95% confidence intervals (CI), and certainty was rated with GRADE. Nine reports from two Phase II RCTs (BrigHTN and HALO) involving 524 participants were included. Baxdrostat 2 mg significantly reduced systolic (−11.0 mmHg; 95% CI −16.4 to −5.5) and diastolic blood pressure (−5.2 mmHg; 95% CI −8.7 to −1.6). The 1 mg dose reduced systolic BP by −8.1 mmHg, while 0.5 mg showed a modest, non-significant effect. Baxdrostat demonstrated a favourable safety profile with dose-dependent aldosterone reductions and minimal adverse events.