BACKGROUND:Hypertension is a major global health issue. Aldosterone synthase inhibitors (ASIs) have emerged as a promising therapeutic strategy for blood pressure control. METHODS: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. RESULTS: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]; P<0.0001) and diastolic blood pressure by 2.2 mm Hg ([95% CI, -4.2 to -0.2]; P=0.03). The risk ratio for adverse events was 1.1 ([95% CI, 0.9-1.2]; P=0.3), with a similar trend for serious adverse events (risk ratio, 1.0 [95% CI, 0.5-2.3]; P=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]; P<0.02). CONCLUSIONS: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.

Efficacy and Safety of Aldosterone Synthase Inhibitors for Hypertension: A Meta-Analysis of Randomized Controlled Trials and Systematic Review

Merlo, M
Writing – Original Draft Preparation
;
Martinelli, N
Writing – Review & Editing
;
Pizzolo, F
Writing – Review & Editing
;
Friso, S
Writing – Review & Editing
2025-01-01

Abstract

BACKGROUND:Hypertension is a major global health issue. Aldosterone synthase inhibitors (ASIs) have emerged as a promising therapeutic strategy for blood pressure control. METHODS: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. RESULTS: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]; P<0.0001) and diastolic blood pressure by 2.2 mm Hg ([95% CI, -4.2 to -0.2]; P=0.03). The risk ratio for adverse events was 1.1 ([95% CI, 0.9-1.2]; P=0.3), with a similar trend for serious adverse events (risk ratio, 1.0 [95% CI, 0.5-2.3]; P=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]; P<0.02). CONCLUSIONS: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.
2025
Inglese
STAMPA
Esperti anonimi
82
4
47
56
10
aldosterone
blood pressure
global health
hypertension
middle aged
What Is New? This analysis is among the first to aggregate data from Phase II randomized controlled trials on aldosterone synthase inhibitors (ASIs) specifically for hypertension management, synthesizing findings on dose-related blood pressure reductions and safety signals. Although Phase II trials primarily explore dosage and safety, this meta-analysis provides preliminary evidence of ASIs’ efficacy and identifies hyperkalemia as a safety concern at higher doses. Our work offers a foundation for further research but does not replace the need for Phase III trials, which are essential to establish the efficacy and safety of ASIs in clinical practice. What Is Relevant? ASIs target aldosterone production, providing a distinctive mechanism for blood pressure control that complements existing antihypertensive therapies. This is particularly relevant for patients with resistant hypertension, a group often unresponsive to standard treatments. While promising, our findings should be interpreted cautiously, emphasizing that ASIs remain experimental until validated by Phase III trials and regulatory approval.
https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.124.23962
restricted
info:eu-repo/semantics/article
Marzano, L; Merlo, M; Martinelli, N; Pizzolo, F; Friso, S
5
01 Contributo in rivista::01.01 Articolo in Rivista
262
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11562/1158612
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