TY - JOUR
T1 - Early treatment of stroke with monosialoganglioside GM-1
T2 - Efficacy and safety results of the early stroke trial
AU - Lenzi, Gian Luigi
AU - Grigoletto, Francesco
AU - Gent, Michael
AU - Roberts, Robin S.
AU - Walker, Michael D.
AU - Donald Easton, J.
AU - Carolei, Antonio
AU - Dorsey, Frank C.
AU - Rocca, Walter A.
AU - Bruno, Roberto
AU - Patarnello, Francesca
AU - Fieschi, Cesare
PY - 1994/8
Y1 - 1994/8
N2 - Background and Purpose The Early Stroke Trial (EST) is a randomized, double-blind, placebo-con trolled trial to assess the effect of monosialoganglioside GM-1 in improving recovery in patients who experienced an ischemic supratentorial stroke. Methods Sixteen clinical centers recruited 805 patients, of whom 792 were confirmed to be eligible. Treatment, consisting of a first dose of either 200 mgGM-1 or placebo, was initiated within 5 hours of the onset of stroke; a second dose of either 100 mg GM-1 or placebo was administered 12 hours later. Thereafter, patients received a daily injection of 100 mg GM-1 or placebo intravenously from day 2 through 10 and intramuscularly from day 11 through 21. Patients were followed up for a total of 4 months. Results Survival was similar in the two treatment groups. Improvement in neurological status, as measured by the change in Canadian Neurological Scale score between baseline and 4-month assessments, was greater in the group receiving GM-1; the observed difference between treatment groups was 0.22 (P =.O6). A post hoc analysis in the subgroup of patients treated within 4 hours showed a statistically significant difference, with Canadian Neurological Scale mean improvement of 0.41 (P =. 016). GM-1 use was not associated with differences in frequency, nature, or severity of adverse experiences. Conclusions These findings suggest that GM-1 is safe in the dose and treatment schedule used and that its efficacy in ischemic stroke is greater when given soon after onset of stroke.
AB - Background and Purpose The Early Stroke Trial (EST) is a randomized, double-blind, placebo-con trolled trial to assess the effect of monosialoganglioside GM-1 in improving recovery in patients who experienced an ischemic supratentorial stroke. Methods Sixteen clinical centers recruited 805 patients, of whom 792 were confirmed to be eligible. Treatment, consisting of a first dose of either 200 mgGM-1 or placebo, was initiated within 5 hours of the onset of stroke; a second dose of either 100 mg GM-1 or placebo was administered 12 hours later. Thereafter, patients received a daily injection of 100 mg GM-1 or placebo intravenously from day 2 through 10 and intramuscularly from day 11 through 21. Patients were followed up for a total of 4 months. Results Survival was similar in the two treatment groups. Improvement in neurological status, as measured by the change in Canadian Neurological Scale score between baseline and 4-month assessments, was greater in the group receiving GM-1; the observed difference between treatment groups was 0.22 (P =.O6). A post hoc analysis in the subgroup of patients treated within 4 hours showed a statistically significant difference, with Canadian Neurological Scale mean improvement of 0.41 (P =. 016). GM-1 use was not associated with differences in frequency, nature, or severity of adverse experiences. Conclusions These findings suggest that GM-1 is safe in the dose and treatment schedule used and that its efficacy in ischemic stroke is greater when given soon after onset of stroke.
KW - Clinical trials
KW - Gangliosides
KW - Stroke management
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U2 - 10.1161/01.STR.25.8.1552
DO - 10.1161/01.STR.25.8.1552
M3 - Article
C2 - 8042206
AN - SCOPUS:0027936299
SN - 0039-2499
VL - 25
SP - 1552
EP - 1558
JO - Stroke
JF - Stroke
IS - 8
ER -