Real-world safety of aliskiren in primary hypertension: A cross-database study

Research context and source limits

Limited evidence note. Only the source material identified below has been reviewed; this is not a complete Paper GEO V2 assessment.

Spontaneous-report study design, descriptive evidence and explicit corpus/counting uncertainty; no validated adverse-event incidence or causal estimate.

Study and evidence unit

This pharmacovigilance study examines aliskiren-associated spontaneous reports in FAERS and VigiAccess. The article summarizes 5,596 and 5,549 reports, respectively, and describes disproportionality analyses rather than a cohort of exposed patients. Its clinical question concerns possible reporting signals; these databases do not supply the treated-population denominator needed to estimate adverse-event incidence or comparative treatment risk.

Source: Methods: Data sources and Statistical analysis (sec003, sec005); Results: Tables 1–2 (sec007)

What the supplementary report clarifies

The official FAERS mining supplement contains annual entries from 2005 through 2025, alongside report characteristics and signal tables. This directly demonstrates a broader reporting period than the main Table 1 caption, which states Q4 2023–Q4 2024. It does not establish the exact extraction quarters or authorize silently replacing the published caption with the Methods window.

Source: S3 Table, FAERS Database Mining Report: TABLE 1, Report year rows 2005–2025

Evidence boundary

The audit therefore retains study context without endorsing quantitative signal ranking or a clinical safety recommendation. The printed Serious count of 1,037 and Hospitalization count of 1,735 remain unreconciled at the report-versus-outcome level. Author clarification must identify the analytic window and counting rules; reporting associations cannot establish that aliskiren caused an event.

Source: Table 1, AE severity and Serious outcome rows; Discussion limitations

Evidence limits

• Exact FAERS analysis quarters remain unresolved.
• Serious/outcome counting units are not reconciled.
• Spontaneous reporting does not establish incidence or causality.

Provenance

• Article source — Official publisher or PMC full text reviewed locally. Methods: Data sources and Statistical analysis (sec003, sec005); Results: Tables 1–2 (sec007)
• Official supplementary material — Publisher-hosted supplementary document. S3 Table, FAERS Database Mining Report: TABLE 1, Report year rows 2005–2025

Source review: 2026-10-27.

Verify publication identity

These records identify the same original work; database inclusion is not evidence of scientific validity or clinical benefit.