ArticleBMJ open2024
Association between exposure to proton pump inhibitors and delirium: a descriptive and disproportionality analysis of VigiBase.
Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05815550 (Association Between Delirium and Use of Proton Pump Inhibitors), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.
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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.
Association Between Delirium and Use of Proton Pump Inhibitors: Analysis of the Global Pharmacovigilance Database
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Proton pump inhibitors and risk of hearing loss; a systematic review.Naunyn-Schmiedeberg's archives of pharmacology · 2025Pooled it
- Medication-safety burden of omeprazole in psychiatric inpatients: A retrospective cross-sectional study.The Journal of international medical research · 2026Article
- Psychiatric symptoms as clinical warning signals of adult anti-LGI-1 encephalitis: an observational cohort study.BMC psychiatry · 2026Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesProton pump inhibitor (PPI) exposure can lead to hyponatraemia, which is a common cause of delirium. An association between PPI exposure and delirium without hyponatraemia has been suggested in the literature. We aimed to describe the association between reports of delirium and PPI exposure and to assess the association between PPI and delirium with and without hyponatraemia.
designA descriptive and disproportionality analysis of claims data.
settingWorld pharmacovigilance database VigiBase between 1 January 1991 and 9 February 2022. PRIMARY AND SECONDARY OUTCOME MEASURES: In the first part, we described reports of delirium for which involvement of a PPI or interactions of PPIs with other drugs were suspected. In the second part, delirium cases and non-cases were used to assess the disproportionality signal using the reporting OR (ROR) for the associations of PPI exposure with delirium or delirium/hyponatraemia co-events.
resultsWe identified 2395 reports of delirium in which involvement of PPI exposure was suspected. Omeprazole, esomeprazole and pantoprazole were the most frequently reported PPIs. Hyponatraemia was present in 11% of the reports. The disproportionality analysis included 1 264 798 reports of adverse drug reactions in patients using PPIs, including 19 081 reports of delirium. We did not find a disproportionality signal for the association between PPI use and delirium (ROR 0.89, 95% CI 0.87 to 0.91). We detected an association of PPI use with delirium/hyponatraemia co-events (ROR 1.53, 95% CI 1.41 to 1.65).
conclusionsMost reports of delirium in which the involvement of PPIs was suspected did not include concomitant hyponatraemia. However, no significant signal of disproportionate reporting of delirium was observed for PPIs compared with other drugs, except in cases of delirium associated with hyponatraemia. Hyponatraemia may be the main mechanism linking PPI exposure with delirium, and this possibility should be further explored in prospective studies. TRIAL REGISTRATION NUMBER: NCT05815550.
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