Ec. Haley et al., A RANDOMIZED TRIAL OF 2 DOSES OF NICARDIPINE IN ANEURYSMAL SUBARACHNOID HEMORRHAGE - A REPORT OF THE COOPERATIVE ANEURYSM STUDY, Journal of neurosurgery, 80(5), 1994, pp. 788-796
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.