Marzano Luigi, Merlo Matteo, Martinelli Nicola, Pizzolo Francesca, Friso Simonetta
Department of Medicine, Unit of Internal Medicine B, University of Verona School of Medicine, Azienda Ospedaliera Universitaria Integrata Verona, Policlinico G.B. Rossi, Italy.
Hypertension. 2025 Apr;82(4):e47-e56. doi: 10.1161/HYPERTENSIONAHA.124.23962. Epub 2025 Jan 31.
Hypertension is a major global health issue. Aldosterone synthase inhibitors (ASIs) have emerged as a promising therapeutic strategy for blood pressure control.
A thorough search of the MEDLINE and Embase databases up to March 30, 2024, identified randomized trials comparing ASIs with a placebo for hypertension treatment. Data extraction was done independently by 2 authors. Both random-effects (Restricted maximum likelihood) and fixed-effects meta-analyses were conducted to account for diversity and study size, respectively. Risk ratios for binary outcomes and mean differences for continuous outcomes were calculated.
Seven randomized controlled trials involving 1440 patients (mean age, 60 years; 39% women) were included. The analysis showed that ASIs reduced office systolic blood pressure by 6.3 mm Hg ([95% CI, -8.8 to -3.8]; <0.0001) and diastolic blood pressure by 2.2 mm Hg ([95% CI, -4.2 to -0.2]; =0.03). The risk ratio for adverse events was 1.1 ([95% CI, 0.9-1.2]; =0.3), with a similar trend for serious adverse events (risk ratio, 1.0 [95% CI, 0.5-2.3]; =0.95). No treatment-related deaths occurred. However, the risk of hyperkalemia was higher with ASIs (risk ratio, 2.5 [95% CI, [1.2-5.4]; <0.02).
ASIs effectively reduce systolic and diastolic blood pressure in hypertensive patients and have a tolerable safety profile. The increased risk of hyperkalemia requires careful monitoring. These findings suggest ASIs are a potential treatment option for hypertension, pending further research in larger studies.
高血压是一个重大的全球健康问题。醛固酮合酶抑制剂（ASIs）已成为一种有前景的血压控制治疗策略。
全面检索截至2024年3月30日的MEDLINE和Embase数据库，确定了比较ASIs与安慰剂治疗高血压的随机试验。数据提取由两名作者独立完成。分别进行随机效应（限制最大似然法）和固定效应荟萃分析，以考虑异质性和研究规模。计算二元结局的风险比和连续结局的均值差。
纳入了7项随机对照试验，涉及1440例患者（平均年龄60岁；39%为女性）。分析表明，ASIs使诊室收缩压降低6.3 mmHg（[95%置信区间，-8.8至-3.8]；<0.0001），舒张压降低2.2 mmHg（[95%置信区间，-4.2至-0.2]；=0.03）。不良事件的风险比为1.1（[95%置信区间，0.9 - 1.2]；=0.3），严重不良事件的趋势相似（风险比，1.0 [95%置信区间，0.5 - 2.3]；=0.95）。未发生与治疗相关的死亡。然而，ASIs导致高钾血症的风险更高（风险比，2.5 [95%置信区间，[1.2 - 5.4]；<0.02）。
ASIs可有效降低高血压患者的收缩压和舒张压，且安全性可耐受。高钾血症风险增加需要密切监测。这些发现表明，在更大规模研究进行进一步研究之前，ASIs是高血压的一种潜在治疗选择。
