Conectar
by Jieyu Zhao, Kota Kurisu, Kazuki Ohashi, Toshiya Osanai, Katsuhiko Ogasawara, Miki Fujimura
In this work, we aimed to assess the impact of clazosentan on clinical labour time costs within Japan’s value-based healthcare system using time-driven activity-based costing. Time-driven activity-based costing was employed to analyse the labour time costs associated with preventing cerebral vasospasm following aneurysmal subarachnoid haemorrhage. Time-driven activity-based costing simplifies cost analysis by utilising time as the primary cost driver. We compared two treatment approaches: conventional therapy with fasudil hydrochloride and postoperative therapy with clazosentan. Scenario and sensitivity analyses were performed to assess the impact of physicians’ costs on the results. The use of clazosentan for the prevention of cerebral vasospasm significantly reduced human resource costs, particularly in cases where symptomatic vasospasm did not occur, yielding savings of approximately 51,343 yen. The greatest cost reductions were observed among nursing staff, with a 30% decrease in the absence of symptomatic vasospasm and a 15% reduction when symptomatic vasospasm was present. The cost reductions for physicians were comparatively smaller, particularly in cases where symptomatic vasospasm occurred. Sensitivity analyses indicated that clazosentan reduced overall costs by approximately 35,000–50,000 yen; however, costs increased in the presence of symptomatic vasospasm. Clazosentan for subarachnoid haemorrhage treatment significantly reduces human resource costs, especially in nursing staff. These findings support the potential of clazosentan for broader clinical use, given its cost-savings and clinical benefits in reducing cerebral vasospasm following aneurysmal subarachnoid haemorrhage.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.
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