Nimodipine in traumatic subarachnoid haemorrhage: a re-analysis of the HIT I and HIT II trials.
Two large randomised controlled trials have been performed to study the effect of the calcium antagonist nimodipine on the outcome of severe head injury, HIT I [1] amd HIT II [4]. Both trials showed a modest and statistically non-significant increase in the proportion of favourable outcomes in patients treated with nimodipine. A subgroup analysis of the HIT II trial [4, 5] suggested, however, that there could be a substantial protective effect of nimodipine in patients with traumatic subarachnoid haemorrhage (SAH). This report provides a re-analysis of the HIT I data to see whether it provides a re-analysis of the HIT I data to see whether in HIT II. This involved performing a central review of the CT scans for the HIT I patients, to identify those individuals with evidence of traumatic SAH. The sample size was small, but the HIT I data gave no support to the hypothesis that nimodipine is protective in the traumatic SAH subgroup, where 69% of patients had a poor outcome on placebo and 74% of patients had a poor outcome on nimodipine. The data do not exclude the possibility of a clinically relevant beneficial effect of nimodipine in the traumatic SAH subgroup, but further data are required to provide a definitive answer. In addition, we present a pooled analysis of the data from the two trials, which suggests that the overall benefit of treating unselected head injured patients with nimodipine is unlikely to be clinically relevant.
Murray
G D
GD
Robertson Centre for Biostatistics, University of Glasgow, Federal Republic of Germany.
Teasdale
G M
GM
Schmitz
H
H
D000293:Adolescent; D000328:Adult; D000368:Aged; D001925:Brain Damage, Chronic / Q000188:drug therapy / Q000401:mortality; D001930:Brain Injuries / Q000188:drug therapy* / Q000401:mortality; D002121:Calcium Channel Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D015600:Glasgow Coma Scale; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009553:Nimodipine / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D013345:Subarachnoid Hemorrhage / Q000188:drug therapy* / Q000401:mortality; D016019:Survival Analysis; D016896:Treatment Outcome
D002121:Calcium Channel Blockers; D009553:Nimodipine