In preparation of a trial on the neuroprotective effect of GABAergic activation by a benzodiazepine, we performed a feasibility study in 104 patients with acute (less than 24 h) stroke. 5 mg diazepam twice daily for 5 days (n = 44) was well tolerated, feasible, and appeared to be safe. Testing a dose of 10 mg twice daily for 5 days (n = 17) was stopped early because of drowsiness around day 5, interfering with regular patient care. A dose of 10 mg twice daily for 3 days was well tolerated, despite reported drowsiness in 12 of 43 patients. First-dose application by rectiole was feasible in 97% of the 104 patients. No blood pressure drop or respiratory arrest or insufficiency were detected, whereas the 2-week case fatality rate was similar to that of controls matched for age, sex, and stroke severity. We conclude that testing the GABAergic activity during the acute phase of stroke by 10 mg diazepam twice daily for 3 days is well tolerated and practically feasible, and it does not subject patients to an increased risk of potential serious adverse effects. Preparations for a large randomized trial are in a final stage.
Copyright 2000 S. Karger AG, Basel