Early treatment of stroke with monosialoganglioside GM-1. Efficacy and safety results of the Early Stroke Trial
| Autor: | Lenzi, G. L., Grigoletto, F, Gent, M, Roberts, R. S., Walker, M. D., Easton, J. D., Carolei, Antonio, Dorsey, F. C., Rocca, W. A., Bruno, R, Patarnello, F, Fieschi, C, AND THE EARLY STROKE TRIAL GROUP |
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| Rok vydání: | 1994 |
| Předmět: |
Adult
Male medicine.medical_specialty medicine.medical_treatment G(M1) Ganglioside Placebo law.invention Central nervous system disease Double-Blind Method Randomized controlled trial law medicine Humans In patient Stroke Aged Aged 80 and over Advanced and Specialized Nursing Chemotherapy business.industry Vascular disease Middle Aged medicine.disease Surgery Clinical trial Cerebrovascular Disorders Anesthesia Female Neurology (clinical) Safety Cardiology and Cardiovascular Medicine business |
| Zdroj: | Stroke. 25:1552-1558 |
| ISSN: | 1524-4628 0039-2499 |
| Popis: | The Early Stroke Trial (EST) is a randomized, double-blind, placebo-controlled trial to assess the effect of monosialoganglioside GM-1 in improving recovery in patients who experienced an ischemic supratentorial stroke. Sixteen clinical centers recruited 805 patients, of whom 792 were confirmed to be eligible. Treatment, consisting of a first dose of either 200 mg GM-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. 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 = .06). 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. 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. |
| Databáze: | OpenAIRE |
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