GM1 ganglioside therapy in acute ischemic stroke. Italian Acute Stroke Study--Hemodilution + Drug.
Eleven of 31 clinical centers participating in the Italian Acute Stroke Study--Hemodilution carried out a preliminary study on the effectiveness of ganglioside GM1 in acute stroke; 502 patients were randomized to GM1 (GM1, n = 121), GM1 plus hemodilution (GM1 + H, n = 128), placebo (P, n = 130), or placebo plus hemodilution (P + H, n = 123) groups less than or equal to 12 hours after onset of a hemispheric cerebral infarct. The patients were treated for 15 days and were evaluated on Days 21 and 120 after the onset of stroke. Intention-to-treat analysis failed to show any differences in neurologic deficit, mortality, or neurologic disability among the groups. Efficacy analysis showed a significantly higher degree of neurologic improvement in GM1 group patients compared with patients in the P group during the first 15 days. GM1-treated patients (GM1 and GM1 + H groups) showed a significantly higher degree of neurologic improvement during the first 10 days compared with the placebo-treated patients (P and P + H groups). These differences were no longer statistically significant at Day 120. Our results provide a rationale for the planning of a larger, multicenter trial of GM1 ganglioside in acute stroke.
Argentino
C
C
Dipartimento di Scienze Neurologiche, Roma, Italy.
Sacchetti
M L
ML
Toni
D
D
Savoini
G
G
D'Arcangelo
E
E
Erminio
F
F
Federico
F
F
Milone
F F
FF
Gallai
V
V
Gambi
D
D
D000368:Aged; D002561:Cerebrovascular Disorders / Q000628:therapy*; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D005260:Female; D005677:G(M1) Ganglioside / Q000627:therapeutic use*; D006438:Hemodilution; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011897:Random Allocation
D005677:G(M1) Ganglioside