ArticleCNS neuroscience & therapeutics2023
Updated insights on dementia-related risk of sacubitril/valsartan: A real-world pharmacovigilance analysis.
Article in CNS neuroscience & therapeutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed, 36 citations in OpenAlex.
- Long-term ovarian function risks associated with combined oral contraceptive administration in polycystic ovary syndrome: multisource data integration and protective mechanisms of metformin.Journal of translational medicine · 2026Article
- Association between ranitidine use and thyroid cancer based on FAERS and VigiAccess databases.Discover oncology · 2026Article
- Safety profile of lanreotide: a retrospective post-marketing pharmacovigilance study based on the real-world data from FAERS database.Endocrine · 2025Article
- Association of Vancomycin Plus Piperacillin-Tazobactam With Acute Kidney Injury: Differentiating Pseudo-Injury From True Nephrotoxicity.Clinical and translational science · 2025Article
- The Missing Enzymes: A Call to Update Pharmacological Profiling Practices for Better Drug Safety Assessment.Journal of medicinal chemistry · 2025Review
- Suicidal thoughts and behaviors associated with fluoroquinolone antibiotics: a real-world pharmacovigilance analysis.Frontiers in pharmacology · 2025Article
- Pharmacovigilance Study on Adverse Events of Nicotine Replacement Therapy, Bupropion, and Varenicline in Patients with Chronic Obstructive Pulmonary Disease.International journal of chronic obstructive pulmonary disease · 2025Article
- Adverse drug events associated with tiotropium: a real-world pharmacovigilance study of FDA adverse event reporting system database.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2025Article
- Real-World Pharmacovigilance Analysis of Adverse Events Associated with Liposomal Bupivacaine and Bupivacaine.Journal of pain research · 2025Article
- A real-world pharmacovigilance analysis of potential ototoxicity associated with sacubitril/valsartan based on FDA Adverse Event Reporting System (FAERS).Scientific reports · 2024Article
- Post-marketing safety concerns with rimegepant based on a pharmacovigilance study.The journal of headache and pain · 2024Article
- Subgroup disproportionality analysis of dementia-related adverse events with sacubitril/valsartan across geographical regions.Scientific reports · 2024Article
- Association between treatment with sacubitril/valsartan and the risk of Alzheimer's disease: a clinical update.Alzheimer's research & therapy · 2024Review
- Sacubitril/valsartan and the risk of incident dementia in heart failure: a nationwide propensity-matched cohort study.Clinical research in cardiology : official journal of the German Cardiac Society · 2024Article
- A real-world disproportionality analysis of sacubitril/valsartan: data mining of the FDA adverse event reporting system.Frontiers in pharmacology · 2024Article
- Postmarket safety profile of suicide/self-injury for GLP-1 receptor agonist: a real-world pharmacovigilance analysis.European psychiatry : the journal of the Association of European Psychiatrists · 2023Article
- Updated insights on dementia-related risk of sacubitril/valsartan: A real-world pharmacovigilance analysis.CNS neuroscience & therapeutics · 2023Article
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimSacubitril/valsartan is a new cardiovascular agent characterized by its dual inhibition on the reninangiotensin system (RAS) and the neprilysin. As neprilysin also involved itself in the degradation of amyloid-β, there is an ongoing concern about the effect of sacubitril/valsartan on cognition, especially in case of long-term administration.
methodsThe FDA Adverse Event Reporting System (FAERS) was mined between 2015Q3 and 2022Q4 to analyze the association between sacubitril/valsartan and adverse events (AEs) involving dementia. Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) with "broad" and "narrow" preferred terms (PTs) relevant to dementia was applied to systematically search demented AE reports. The Empirical Bayes Geometric Mean (EBGM) from Multi-Item Gamma Poisson Shrinker (MGPS) and proportional reporting ratio with Chi-square (PRR, χ
resultsWe filtered the query for indication and identified 80,316 reports with heart failure indication in FAERS during the analytical period. Among all the reports, sacubitril/valsartan was listed as primary suspected or secondary suspected drug in 29,269 cases. No significantly elevated reporting rates of narrow dementia were evident with sacubitril/valsartan. The EBGM05 for narrow dementia-related AEs associated with sacubitril/valsartan was 0.88 and the PRR (χ
conclusionThe number of dementia-related cases reported to FAERS generate no safety signal attributable to sacubitril/valsartan in patients with heart failure for now. Further follow-ups are still warranted to address this question.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.