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

Researcher: Ge Zhang
Chinese name: 张格
ORCID identity anchor: https://orcid.org/0000-0002-3116-3246
Canonical researcher: https://drgezhang.com/#person

Journal: PLOS One
Year: 2026
Type: Article
DOI: 10.1371/journal.pone.0346326
Canonical page: https://drgezhang.com/papers/doi-10-1371-journal-pone-0346326.html
Markdown record: https://drgezhang.com/papers/doi-10-1371-journal-pone-0346326.md

## Full Authors

1. Meirong Shan
2. Qian Guo
3. Ruofei Li
4. Ni Li
5. Yanhua Fu
6. Huanyu Qi
7. Ge Zhang
8. Qian Wang
9. Xingli Xu
10. Jinchuan Lai

## About this record

This is an author-controlled publication record in the Ge Zhang Academic Hub. It identifies this work as part of Ge Zhang’s publication record via ORCID; the publisher version remains the version of record.

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## 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)](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0346326)

### 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](https://journals.plos.org/plosone/article/file?type=supplementary&id=10.1371/journal.pone.0346326.s003)

### 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](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0346326)

### 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](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0346326) — Official publisher or PMC full text reviewed locally. Methods: Data sources and Statistical analysis (sec003, sec005); Results: Tables 1–2 (sec007)
- [Official supplementary material](https://journals.plos.org/plosone/article/file?type=supplementary&id=10.1371/journal.pone.0346326.s003) — Publisher-hosted supplementary document. S3 Table, FAERS Database Mining Report: TABLE 1, Report year rows 2005–2025

Source review: 2026-10-27.

## Cite this paper

Meirong Shan, Qian Guo, Ruofei Li, Ni Li, Yanhua Fu, Huanyu Qi, Ge Zhang, Qian Wang, Xingli Xu, Jinchuan Lai. Real-world safety of aliskiren in primary hypertension: A cross-database study. PLOS One. 2026. https://doi.org/10.1371/journal.pone.0346326

- [BibTeX](https://drgezhang.com/citations/doi-10-1371-journal-pone-0346326.bib)
- [RIS / EndNote](https://drgezhang.com/citations/doi-10-1371-journal-pone-0346326.ris)
- [CSL JSON](https://drgezhang.com/citations/doi-10-1371-journal-pone-0346326.csl.json)

## Links

- DOI: https://doi.org/10.1371/journal.pone.0346326
- HTML page: https://drgezhang.com/papers/doi-10-1371-journal-pone-0346326.html
- Google Scholar query: https://scholar.google.com/scholar?q=%22Real-world%20safety%20of%20aliskiren%20in%20primary%20hypertension%3A%20A%20cross-database%20study%22
- ORCID: https://orcid.org/0000-0002-3116-3246