title: GM1 ganglioside therapy in acute ischemic stroke. Italian Acute Stroke Study--Hemodilution + Drug.
abstract: 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.
authors.affiliation: Dipartimento di Scienze Neurologiche, Roma, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Argentino
authors.forename: M L
authors.initials: ML
authors.lastname: Sacchetti
authors.forename: D
authors.initials: D
authors.lastname: Toni
authors.forename: G
authors.initials: G
authors.lastname: Savoini
authors.forename: E
authors.initials: E
authors.lastname: D'Arcangelo
authors.forename: F
authors.initials: F
authors.lastname: Erminio
authors.forename: F
authors.initials: F
authors.lastname: Federico
authors.forename: F F
authors.initials: FF
authors.lastname: Milone
authors.forename: V
authors.initials: V
authors.lastname: Gallai
authors.forename: D
authors.initials: D
authors.lastname: Gambi
mesh_terms: 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
chemical_list: D005677:G(M1) Ganglioside