Double‐blind evaluation of monosialoganglioside (GM<sub>1</sub>) therapy in stroke

Bassi, S.; Albizzati, M. G.; Sbacchi, M.; Frattola, L.; Massarotti, M

doi:10.1002/jnr.490120232

Cited by 52 publications

(8 citation statements)

References 11 publications

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“…787 The trial was stopped prematurely in 2011 because of futility; no difference was found in the 90-day global outcome end point (OR, 1.03; 95% CI, 0.86-1.25; P=0.364). 788 Several trials of GM1-ganglioside, which also may stabilize membranes, have not demonstrated improved outcomes with treatment, [789][790][791][792] and a systematic review of this agent did not demonstrate any benefit from treatment. 793 In addition to their low-density lipoprotein cholesterol-lowering effects, statins, or HMG-CoA reductase inhibitors, exert acute neuroprotective properties, including beneficial effects on endothelial function, cerebral blood flow, and inflammation.…”

Section: -784mentioning

confidence: 99%

Guidelines for the Early Management of Patients With Acute Ischemic Stroke

Jauch¹,

Saver²,

Adams³

et al. 2013

Stroke

5,374

1,801

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Background and Purpose-The authors present an overview of the current evidence and management recommendations for evaluation and treatment of adults with acute ischemic stroke. The intended audiences are prehospital care providers, physicians, allied health professionals, and hospital administrators responsible for the care of acute ischemic stroke patients within the first 48 hours from stroke onset. These guidelines supersede the prior 2007 guidelines and 2009 updates. Methods-Members of the writing committee were appointed by the American Stroke Association Stroke Council's Scientific Statement Oversight Committee, representing various areas of medical expertise. Strict adherence to the American Heart Association conflict of interest policy was maintained throughout the consensus process. Panel members were assigned topics relevant to their areas of expertise, reviewed the stroke literature with emphasis on publications since the prior guidelines, and drafted recommendations in accordance with the American Heart Association Stroke Council's Level of Evidence grading algorithm. Results-The goal of these guidelines is to limit the morbidity and mortality associated with stroke. The guidelines support the overarching concept of stroke systems of care and detail aspects of stroke care from patient recognition; emergency medical services activation, transport, and triage; through the initial hours in the emergency department and stroke unit. The guideline discusses early stroke evaluation and general medical care, as well as ischemic stroke, specific interventions such as reperfusion strategies, and general physiological optimization for cerebral resuscitation. The American Heart Association makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest. Guidelines for the Early Management of PatientsThis statement was approved by the American Heart Association Science Advisory and Coordinating Committee on December 12, 2012. A copy of the document is available at http://my.americanheart.org/statements by selecting either the "By Topic" link or the "By Publication Date" link. To purchase additional reprints, call 843-216-2533 or e-mail kelle.ramsay@wolterskluwer.com.The Executive Summary is available as an online-only Data Supplement with this article at http://stroke.ahajournals.org/lookup/suppl/ doi:10.1161/STR.0b013e318284056a/-/DC1.The American Heart Association requests that this document be cited as follows: Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; on behalf of the American Heart Association Stroke Council, Council on Cardio...

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Section: -784mentioning

confidence: 99%

Guidelines for the Early Management of Patients With Acute Ischemic Stroke

Jauch¹,

Saver²,

Adams³

et al. 2013

Stroke

5,374

1,801

View full text Add to dashboard Cite

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“…In vitro and in vivo treatment with GM 1 or GM 1 -L (siagoside) attenuates EAA-related neuronal death in a dose-dependent manner even when administered systemically (for review, see Leon et al 1990). First clinical trials in stroke patients were initiated in the early 1980s (Bassi et al 1984;Battistin et al 1985). However, two large trials were finished in 1994 without convincing evidence of efficiacy for this therapeutic approach (Alter et al 1994;Lenzi et al 1994) Neurotrophic factors and other growth factors Based on the neurotrophic factor hypothesis (Barde 1989), lack of trophic support was suggested to cause secondary neuronal death after neuronal trauma.…”

Section: Gangliosidesmentioning

confidence: 99%

Neuronal death after brain injury

Kermer¹,

Klöcker²,

Bähr³

1999

Cell and Tissue Research

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Neuronal damage in the central nervous system leads to primary cell death, induced directly by the trauma, and delayed secondary death of neurons, the latter depending on environmental changes, lack of metabolic and trophic supply, and altered gene transcription. While primary death of neurons occurring within a short time after trauma is not a realistic target for therapy, secondary cell death might be prevented by new neuroprotective strategies. Although there are increasing data concerning cell rescue after ischemic and traumatic brain injury through the last decade, the mechanisms that underlie secondary death of neurons following lesion are still incompletely understood and are now the subject of a more detailed investigation. In this review, we want to give an overview on what is known about the molecular mechanisms of delayed ischemic and traumatic neuronal death in vivo and about promising neuroprotective treatment strategies that might be of future clinical relevance or have already entered clinical trials.

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“…An electrocardiogram was performed at day 7 and at 4 months. Hematologic tests and urinalyses were performed on days 10 …”

Section: -14mentioning

confidence: 99%

Design and baseline results of the monosialoganglioside early stroke trial. The EST Study Group.

Rocca

Dorsey

Grigoletto

et al. 1992

Stroke

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for the EST Study GroupBackground and Purpose: The Early Stroke Trial is a randomized, placebo-controlled, double-masked, multicenter study to assess the safety and efficacy of monosialoganglioside in patients who have suffered an ischemic stroke of the cerebral hemispheres.Methods: Only patients who could be evaluated and treated within 5 hours after the onset of stroke were considered; within each center, subjects were stratified by age, sex, and clinical severity. Patients were randomly allocated to receive a specified sequence of intravenous and intramuscular doses of either monosialoganglioside or identical-appearing placebo for 21 days. Patients were followed up for 4 months after randomization. Neurological status was measured primarily by using the Canadian Neurological Scale. After assessing the effect of treatment on survival, the principal measure of efficacy will be the change in neurological status between baseline and the 4-month follow-up among survivors.Results: Sixteen clinical centers, IS in Europe and one in North America, entered a total of 792 eligible patients during a 36-month recruitment period (from May 1987 to April 1990). In our series there were more men than women, and the relative frequency of patients increased with advancing age. The most frequently associated cardiovascular conditions were hypertension, atrial fibrillation, and peripheral vascular disease. Approximately 46% of the patients were admitted to a hospital within 1 hour and 81%, within 2 hours after the onset of stroke. About 22% first received the study treatment within 3 hours and 57%, within 4 hours.Conclusions: This study demonstrates the feasibility of large-scale trials with the onset of treatment within 5 hours after an ischemic stroke. (Stroke 1992;23:519-526)

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Double‐blind evaluation of monosialoganglioside (GM₁) therapy in stroke

Cited by 52 publications

References 11 publications

Guidelines for the Early Management of Patients With Acute Ischemic Stroke

Guidelines for the Early Management of Patients With Acute Ischemic Stroke

Neuronal death after brain injury

Design and baseline results of the monosialoganglioside early stroke trial. The EST Study Group.

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Double‐blind evaluation of monosialoganglioside (GM1) therapy in stroke

Cited by 52 publications

References 11 publications

Guidelines for the Early Management of Patients With Acute Ischemic Stroke

Guidelines for the Early Management of Patients With Acute Ischemic Stroke

Neuronal death after brain injury

Design and baseline results of the monosialoganglioside early stroke trial. The EST Study Group.

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Product

Resources

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Double‐blind evaluation of monosialoganglioside (GM₁) therapy in stroke