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.