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Too little, too late: does tirilazad mesylate reduce fatigue after subarachnoid hemorrhage?
Objective:
Trials assessing drug effectiveness for treatment of subarachnoid hemorrhage (SAH) often use mortality rates and Glasgow Outcome Scale scores as outcome measures. Neuropsychological and psychosocial measures might be more sensitive to outcomes, especially for patients of better-grade status.
Methods:
Eighteen of a total of 31 patients enrolled in the New Zealand arm of the Upjohn international, double-blind, therapeutic trial of tirilazad mesylate for women with SAH were assessed neuropsychologically and psychosocially 3 months after SAH. The 13 not assessed either had died or remained vegetative (9 patients), did not speak English (1 patient), or did not consent (3 patients). The drug code was broken after all assessments had been scored.
Results:
Sixteen of the 31 patients had received the drug and 15 the vehicle. There were no differences between the two groups with respect to age, grades assessed at admission and 14 weeks after SAH, Glasgow Outcome Scale scores assessed at 3 months, or mortality rates. In the subgroup assessed neuropsychologically, nine patients were in each of the drug- and vehicle-treated groups. No differences were found with respect to grades, Glasgow Outcome Scale scores, or values for an index that measured cognitive impairment in all tests, but vehicle-treated patients were more impaired with respect to measures of concentration, sustained attention, and psychomotor speed (P < 0.02), as well as debilitating fatigue (P < 0.01).
Conclusion:
The finding that the patients in the drug-treated group exhibited fewer impairments typical of diffuse cortical damage could be viewed as being consistent with the hypothesis that tirilazad mesylate protects neurons. Given the small size of this study, these results require confirmation with larger patient groups. Future drug trials should consider including neuropsychological tests in assessments of outcomes after SAH. If this is too costly, questions regarding fatigue levels might prove worthwhile.