Association between exposure to proton pump inhibitors and hypertension: a descriptive and disproportionality analysis of VigiBase
Abstract
Objectives: The potential link between proton pump inhibitors (PPIs) and hypertension remains unclear. It is uncertain whether such an association exists, whether it represents a class-of-PPI effect and whether a dose-response relationship is involved. This study aimed to investigate the potential class-of-PPI effect associating PPIs with hypertension reporting and evaluate whether the association follows a dose-dependent pattern.
Design: A disproportionality analysis was conducted within VigiBase to identify signals of hypertension reporting associated with individual PPIs by calculating adjusted reporting ORs (aRORs) within a multivariate case/non-case study design. Additionally, the presence of a dose-response relationship was explored.
Setting: Real-world data from VigiBase, the WHO pharmacovigilance database, was used.
Participants: All individual case safety reports with PPI use were included.
Outcome measures: Incident hypertension cases were identified using the Medical Dictionary for Regulatory Activities V.26.1 related to at least one PPI administration that were systematically collected until 28 October 2024. Pharmacovigilance signals between the use of PPIs and hypertension reported and dose dependence between PPI posology and onset or worsening hypertension were analysed.
Results: The database contained 26 587 reports of PPI-associated hypertension (2.3%), predominantly among women (63.3%). Hypertension was most frequently reported in the group aged 45-64 years…
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