Efficacy and safety of esaxerenone for the treatment of primary hypertension among adults: A systematic review protocol

Objective: This systematic review aims to evaluate the efficacy and safety of esaxerenone compared to eplerenone or placebo in treating primary hypertension in adult patients. Introduction: Primary hypertension, which lacks a specific identifiable cause, is the most common form and affects over 90% of individuals with hypertension. Esaxerenone is a newly developed nonsteroidal mineralocorticoid antagonist (MR) blocker that has demonstrated some potential in treating primary hypertension. Inclusion criteria: This review will include participants diagnosed with primary hypertension. Intervention involves treatment with esaxerenone, compared with eplerenone or placebo or no comparator, with outcomes including lowering of diastolic and systolic blood pressure, as well as reduction of adverse events. Methods: A comprehensive search will be conducted across multiple databases, including Cochrane CENTRAL, Ovid EMBASE, Ovid MEDLINE, Web of Science Core Collection, and Ovid Scopus, supplemented by grey literature sources such as Google Scholar, ProQuest, and clinical trial registries, to identify published research papers. Two individual reviewers will evaluate the titles, abstracts and full texts based on the inclusion criteria with adjudication by a third reviewer. Critical appraisal will be conducted using standardised JBI appraisal tools. Data extraction will be performed independently by two reviewers. A meta-analysis or network meta-analysis will be conducted for all outcomes where feasible. If a meta-analysis cannot be undertaken, the findings will be reported in a narrative format using Synthesis Without Meta-analysis (SWiM) guidelines. Certainty of evidence will be reported using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.