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Effects of Clazosentan on Cerebral Vasospasm–Related Morbidity and All-Cause Mortality after Aneurysmal Subarachnoid Hemorrhage: Two Randomized Phase 3 Trials in Japanese Patients

By Currents Editor posted 30 days ago

  

Effects of Clazosentan on Cerebral Vasospasm–Related Morbidity and All-Cause Mortality after Aneurysmal Subarachnoid Hemorrhage: Two Randomized Phase 3 Trials in Japanese Patients
Journal of Neurosurgery (04/01/22) DOI: 10.3171/2022.2.JNS212914
Endo, Hidenori; Hagihara, Yasushi; Kimura, Naoto; et al.
https://thejns.org/view/journals/j-neurosurg/aop/article-10.3171-2022.2.JNS212914/article-10.3171-2022.2.JNS212914.xml 

New research out of Japan indicates that clazosentan led to significant reductions in the incidence of vasospasm-related morbidity and all-cause morbidity following aneurysmal subarachnoid hemorrhage (aSAH). Investigators conducted two similar Phase 3 studies in patients with aSAH, after their aneurysms were secured by endovascular coiling in one study and by surgical clipping in the second. Patients in each study were randomized to receive intravenous clazosentan (10 mg/hr) or placebo beginning within 48 hours of aSAH and for up to 15 days afterward. A total of 220 patients were included in the full analysis set of the primary analysis for each study, with 109 in each clazosentan group and 111 in each placebo group). After aneurysm coiling, the incidence of vasospasm-related morbidity and all-cause mortality dropped from 28.8% to 13.6% with clazosentan, while the rate after surgical clipping decreased from 39.6% to 16.2%. Clazosentan also resulted in significant reductions in all-cause morbidity/mortality and poor outcome after preplanned study pooling. There were no new safety concerns, as any treatment-emergent adverse events were similar to ones previously reported.

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