A RANDOMIZED TRIAL OF 2 DOSES OF NICARDIPINE IN ANEURYSMAL SUBARACHNOID HEMORRHAGE - A REPORT OF THE COOPERATIVE ANEURYSM STUDY

High-dose intravenous nicardipine has been shown to reduce the inciden ce of angiographic and symptomatic vasospasm in patients with aneurysm al subarachnoid hemorrhage (SAH), but treatment may be complicated by side effects, including hypotension or pulmonary edema/azotemia. From August, 1989, to January, 1991, 365 patients at 21 neurosurgical cente rs were entered into a randomized double-blind trial comparing high-do se (0.15 mg/kg/hr) nicardipine with a 50% lower dose (0.075 mg/kg/hr) administered by continuous intravenous infusion for up to 14 days foll owing SAH. Patients in all neurological grades were eligible for the s tudy. During the study period, 184 patients were randomly assigned to receive high-dose nicardipine and 181 to receive the low dose. There w ere no significant differences in patient age, admission neurological condition, or amount and distribution of blood clot on initial compute rized tomography scan. Patients in the high-dose group received a sign ificantly smaller proportion of the planned dose than those in the low -dose group (80% +/- 0.2% vs. 86% +/- 0.2%, p < 0.05), largely because of premature treatment termination after adverse medical events. The incidence of symptomatic vasospasm was 31% in both groups, and the ove rall 3-month outcomes were nearly identical. These data suggest that, from a clinical standpoint, the results of high-dose and low-dose nica rdipine treatment are virtually equivalent, but administration of low- dose nicardipine is attended by fewer side effects.