A postmarketing surveillance study of fasudil treatment after aneurysmal subarachnoid hemorrhage.
BACKGROUND
The aim of the present study was, first, to assess safety of fasudil (Eril; Asahi Kasei Pharma Corp, Tokyo, Japan) and, second, to investigate whether the effects of fasudil in the phase 3 trial could be reproduced in a PMS study.


METHODS
Between 1995 and 2000, a total of 1462 patients met the eligibility criteria of the phase 3 trial and were treated with fasudil in a PMS study. Adverse events, low-density areas on CT scans, symptomatic vasospasm, and clinical outcome were all recorded. The results were compared with those in the phase 3 trial. Patients with Fisher grade 3 on admission were selected (subgroup), and the results were also compared with those in the phase 3 trial.


RESULTS
The occurrence of adverse events, including intracranial bleeding and hypotension, low-density areas, and clinical outcomes were similar between the fasudil-treated patients in the phase 3 trial and the patients in the PMS study. The absence of symptomatic vasospasm was more common in the PMS study than in the phase 3 trial. Of the 1462 patients, 842 met the criteria for the subgroup. In the subgroup, the occurrence of low-density areas, the absence of symptomatic vasospasm, and clinical outcomes were similar between the fasudil-treated patients in the phase 3 trial and the patients in the PMS study.


CONCLUSIONS
The present PMS study described the tolerability, safety, and efficacy of fasudil in a large number of patients undergoing surgery for SAH, as demonstrated previously in the phase 3 trial.
Suzuki
Yoshio
Y
Department of Neurosurgery, Nagoya Daini Red Cross Hospital, Nagoya 466-8650, Japan.
Shibuya
Masato
M
Satoh
Shin-Ichi
S
Sugimoto
Yuka
Y
Takakura
Kintomo
K
D019307:1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011859:Radiography; D020127:Recovery of Function; D015203:Reproducibility of Results; D013345:Subarachnoid Hemorrhage / Q000150:complications / Q000000981:diagnostic imaging / Q000188:drug therapy*; D016896:Treatment Outcome; D020301:Vasospasm, Intracranial / Q000000981:diagnostic imaging / Q000209:etiology / Q000517:prevention & control*
D047428:Protein Kinase Inhibitors; D019307:1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine; C049347:fasudil