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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.
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.
Real-world data from VigiBase, the WHO pharmacovigilance database, was used.
All individual case safety reports with PPI use were included.
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.
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 (41.4%). A significant reporting OR (ROR) was observed for almost all PPIs in both univariable (RORs, 1.32–1.97) and multivariate analyses (aRORs, 1.09–1.35) after adjustments for age group, sex, concurrent antihypertensive medication and drugs known to induce hypertension, with the exception of lansoprazole (aROR 0.99, 95% CI 0.96 to 1.03). A potential trend suggestive of a dose–response relationship was identified, with doses lower than the median associated with a lower aROR for hypertension than doses higher than the median for all PPIs. However, this trend was not statistically significant, potentially due to insufficient statistical power.
This investigation indicates a notable pharmacovigilance safety signal associating PPI usage with hypertension reporting. Although a potential dose–response trend was observed, it was not statistically significant, possibly due to limited statistical power. Further longitudinal studies are warranted.
Este caso clínico presenta la situación de un paciente de 66 años insulino requirente, quien se negó a realizar amputación digital transmetatarsiana en el pie derecho como única opción de tratamiento para el pie diabético, el paciente fue atendido en clínica de heridas donde se elaboró el plan de cuidados utilizando el modelo de enfermería de Virginia Henderson, las taxonomías de la North American Nursing Diagnosis Association (Nanda), Nursing Outcomes Classification (Noc) y Nursing Interventions Classification (Nic). Se establecieron como diagnósticos enfermeros: deterioro de la integridad tisular, perfusión tisular periférica ineficaz y gestión ineficaz de la salud. El desbridamiento mecánico del tejido necrótico bajo la aplicación de procesos de asepsia, el compromiso del grupo multidiscipli-nario de la salud y la educación al paciente, permitieron el salvamento de 2 falanges del dedo y el retorno a la vida normal del paciente en un periodo de 7 meses.
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