ArticleNeurosurgical review2026
Safety and effectiveness of clazosentan in patients after aneurysmal subarachnoid haemorrhage: a second interim report of a post-marketing surveillance in Japan.
Article in Neurosurgical review, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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.
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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
2 citing papers in PubMed.
- The Clinical Factors Associated with Clazosentan Discontinuation and Exploratory Associations with Discharge and Six-Month Outcomes in Aneurysmal Subarachnoid Hemorrhage: A Multicenter DCI Japan Registry Study.Journal of clinical medicine · 2026Article
- Adjunctive Fasudil Use and Outcomes After Clazosentan Treatment for Aneurysmal Subarachnoid Hemorrhage: A Multicenter DCI Japan Registry Study.Journal of clinical medicine · 2026Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Japanese phase 3 trials demonstrated efficacy and safety of clazosentan for aneurysmal subarachnoid haemorrhage (aSAH) management. However, real-world data remain limited, particularly in elderly, poor-grade, outside of Fisher group 3 patients, or those on concomitant medications. Therefore, this post-marketing surveillance (PMS) programme evaluated safety and effectiveness of clazosentan in Japanese clinical practice. This second interim analysis of an ongoing PMS programme included patients with aSAH who received clazosentan postoperatively in Japan. Safety data included incidence of adverse drug reactions (ADRs) and their severity. Effectiveness endpoints were the incidence of cerebral vasospasm–related events. Exploratory endpoints were prognostic factors for fluid retention–related ADRs and vasospasm-related morbidity/mortality events identified by univariate and multivariate analyses. Of the 2967 included patients, ADRs occurred in 34.5%, serious ADRs in 8.2%, and fluid retention–related ADRs in 20.1%. Cerebral vasospasm was observed in 18.8% of patients, while 7.1% and 10.6% experienced vasospasm-related cerebral infarction and vasospasm-related morbidity/mortality events, respectively. Multivariate analysis identified age ≥ 75 years, thick and diffuse clot size, medical history, comorbidities, and vasodilatory concomitant medication use as key predictors of fluid retention–related ADRs and female sex, age ≥ 75 years, anterior circulation, thick and diffuse clot size, World Federation of Neurosurgical Societies (WFNS) grade IV/V, comorbidities, and cilostazol use (risk reduction factor) as key predictors of vasospasm-related morbidity/mortality events. Patients with fluid retention–related ADRs had a higher incidence of vasospasm-related morbidity/mortality events. This study supports clazosentan use for aSAH, emphasising careful monitoring.
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Registered trials
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