Efficacy and Safety of Aldosterone Synthase Inhibitors in Hypertension: A Systematic Review and Meta‐Analysis

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Abstract
Background: Hypertension remains a major contributor to global cardiovascular morbidity and mortality. Aldosterone, a key hormone in blood pressure regulation, plays a significant role in hypertension pathophysiology. This has led to growing interest in aldosterone synthase inhibitors (ASIs) as a potential treatment. This meta‐analysis aims to evaluate the efficacy and safety of ASIs in managing hypertension. Methods: A systematic search of PubMed, Google Scholar and Cochrane Central was conducted up to 13 July 2025, to identify randomised controlled trials (RCTs) evaluating ASIs in hypertensive adults. Data were analysed using RevMan version 5.4, employing random‐effects models with significance set at p < 0.05. Results: A total of 8 RCTs were included, with a total of 2003 participants in the ASI group and 650 participants in the placebo group. ASIs significantly reduced systolic blood pressure (SBP) compared to placebo (MD: −6.01 mmHg; 95% confidence interval [CI]: −9.31 to −2.71; I 2 = 85%; p = 0.0004); diastolic blood pressure (DBP) was found to be comparable between the two groups (MD: −2.20 mmHg; 95% CI: −4.46 to 0.06; I 2 = 69%; p = 0.06). There was a significant reduction in serum aldosterone levels favouring ASI use (MD: −1.46; 95% CI: −2.76 to −0.16; I 2 = 99%; p < 0.00001). The risk of serious (RD: 0.00; 95% CI: −0.01 to 0.02; I 2 = 30%; p = 0.75) and non‐serious adverse events (RD: 0.05; 95% CI: −0.02 to 0.12; I 2 = 64%; p = 0.20) did not differ significantly between ASI and placebo groups. However, ASI use was associated with a significantly higher risk of hyperkalemia (RD: 0.04; 95% CI: 0.02 to 0.06; I 2 = 70%; p = 0.002). Conclusion: ASIs effectively lower SBP and serum aldosterone in adults with hypertension. They appear safe overall but may increase the risk of hyperkalemia.

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