Initial real-world experience of clazosentan for subarachnoid hemorrhage in Japan
BACKGROUND: Cerebral vasospasm (CVS) is one of the most critical factors associated with clinical outcomes of patients with subarachnoid hemorrhage (SAH). Clazosentan has been investigated worldwide as a prophylactic agent to prevent CVS. We evaluated a new CVS management protocol which included cla...
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| Format: | Article |
| Language: | English |
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Elsevier
2024-01-01
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| Series: | World Neurosurgery: X |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2590139723001023 |
| _version_ | 1797320913749803008 |
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| author | Takuma Maeda Mai Okawara Manabu Osakabe Hiroyuki Yamaguchi Takahiro Maeda Hiroki Kurita |
| author_facet | Takuma Maeda Mai Okawara Manabu Osakabe Hiroyuki Yamaguchi Takahiro Maeda Hiroki Kurita |
| author_sort | Takuma Maeda |
| collection | DOAJ |
| description | BACKGROUND: Cerebral vasospasm (CVS) is one of the most critical factors associated with clinical outcomes of patients with subarachnoid hemorrhage (SAH). Clazosentan has been investigated worldwide as a prophylactic agent to prevent CVS. We evaluated a new CVS management protocol which included clazosentan. METHODS: Consecutive 138 patients with SAH, hospitalized in our institution between January 2017 and December 2022, were included in this study. Baseline characteristics, clinical findings, and operative records were analyzed retrospectively. From May 2022, 10 mg/h clazosentan was co-administered with fasudil to all patients according to the indication in the Japanese label. Patients admitted before this date received the conventional combined protocol using the fasudil hydrochloride, nicardipine, and ozagrel. RESULTS: Eighteen (13.0%) patients received the new protocol during the CVS period (defined as day 1 up to day 14 after SAH onset). There were 54 (39.1%) elderly patients aged 75 years or older. Seventy-two (52.2%) patients underwent neurosurgical clipping, whereas 55 (39.9%) patients received endovascular coiling. Among the patients with new protocol, only one patient (5.6%) had symptomatic CVS, compared with 18 patients (15.0%) in those with conventional protocol. More patients who received the new protocol had fluid retention compared with control group (38.9% [7/18] vs. 8.3% [10/120]). Other results did not differ between the two groups. CONCLUSIONS: Clinical outcomes of the new protocol were comparable to those of conventional protocol. Clazosentan may simplify anti-vasospasm treatment. Fluid retention was a specific side-effect of clazosentan, which requires attention especially in the first half of the CVS period. |
| first_indexed | 2024-03-08T04:49:56Z |
| format | Article |
| id | doaj.art-b3f8582c46e84ce0b877fc001aee1c08 |
| institution | Directory Open Access Journal |
| issn | 2590-1397 |
| language | English |
| last_indexed | 2024-03-08T04:49:56Z |
| publishDate | 2024-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | World Neurosurgery: X |
| spelling | doaj.art-b3f8582c46e84ce0b877fc001aee1c082024-02-08T05:15:55ZengElsevierWorld Neurosurgery: X2590-13972024-01-0121100253Initial real-world experience of clazosentan for subarachnoid hemorrhage in JapanTakuma Maeda0Mai Okawara1Manabu Osakabe2Hiroyuki Yamaguchi3Takahiro Maeda4Hiroki Kurita5Department of Cerebrovascular Surgery, Saitama Medical University International Medical Center, Hidaka, Japan; Department of Neurosurgery, Ohkawara Neurosurgical Hospital, Muroran, Japan; Corresponding author. Department of Cerebrovascular Surgery, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka, Saitama, 350-1298, Japan.Department of Neurosurgery, Ohkawara Neurosurgical Hospital, Muroran, JapanDepartment of Neurosurgery, Ohkawara Neurosurgical Hospital, Muroran, JapanDepartment of Neurosurgery, Ohkawara Neurosurgical Hospital, Muroran, JapanDepartment of Neurosurgery, Ohkawara Neurosurgical Hospital, Muroran, JapanDepartment of Cerebrovascular Surgery, Saitama Medical University International Medical Center, Hidaka, JapanBACKGROUND: Cerebral vasospasm (CVS) is one of the most critical factors associated with clinical outcomes of patients with subarachnoid hemorrhage (SAH). Clazosentan has been investigated worldwide as a prophylactic agent to prevent CVS. We evaluated a new CVS management protocol which included clazosentan. METHODS: Consecutive 138 patients with SAH, hospitalized in our institution between January 2017 and December 2022, were included in this study. Baseline characteristics, clinical findings, and operative records were analyzed retrospectively. From May 2022, 10 mg/h clazosentan was co-administered with fasudil to all patients according to the indication in the Japanese label. Patients admitted before this date received the conventional combined protocol using the fasudil hydrochloride, nicardipine, and ozagrel. RESULTS: Eighteen (13.0%) patients received the new protocol during the CVS period (defined as day 1 up to day 14 after SAH onset). There were 54 (39.1%) elderly patients aged 75 years or older. Seventy-two (52.2%) patients underwent neurosurgical clipping, whereas 55 (39.9%) patients received endovascular coiling. Among the patients with new protocol, only one patient (5.6%) had symptomatic CVS, compared with 18 patients (15.0%) in those with conventional protocol. More patients who received the new protocol had fluid retention compared with control group (38.9% [7/18] vs. 8.3% [10/120]). Other results did not differ between the two groups. CONCLUSIONS: Clinical outcomes of the new protocol were comparable to those of conventional protocol. Clazosentan may simplify anti-vasospasm treatment. Fluid retention was a specific side-effect of clazosentan, which requires attention especially in the first half of the CVS period.http://www.sciencedirect.com/science/article/pii/S2590139723001023Cerebral vasospasm (CVS)ClazosentanElderly patientsPIVLAZSubarachnoid hemorrhage (SAH) |
| spellingShingle | Takuma Maeda Mai Okawara Manabu Osakabe Hiroyuki Yamaguchi Takahiro Maeda Hiroki Kurita Initial real-world experience of clazosentan for subarachnoid hemorrhage in Japan World Neurosurgery: X Cerebral vasospasm (CVS) Clazosentan Elderly patients PIVLAZ Subarachnoid hemorrhage (SAH) |
| title | Initial real-world experience of clazosentan for subarachnoid hemorrhage in Japan |
| title_full | Initial real-world experience of clazosentan for subarachnoid hemorrhage in Japan |
| title_fullStr | Initial real-world experience of clazosentan for subarachnoid hemorrhage in Japan |
| title_full_unstemmed | Initial real-world experience of clazosentan for subarachnoid hemorrhage in Japan |
| title_short | Initial real-world experience of clazosentan for subarachnoid hemorrhage in Japan |
| title_sort | initial real world experience of clazosentan for subarachnoid hemorrhage in japan |
| topic | Cerebral vasospasm (CVS) Clazosentan Elderly patients PIVLAZ Subarachnoid hemorrhage (SAH) |
| url | http://www.sciencedirect.com/science/article/pii/S2590139723001023 |
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