2016
Safety and efficacy of intravenous glyburide on brain swelling after large hemispheric infarction (GAMES-RP): a randomised, double-blind, placebo-controlled phase 2 trial
Sheth KN, Elm JJ, Molyneaux BJ, Hinson H, Beslow LA, Sze GK, Ostwaldt AC, del Zoppo GJ, Simard JM, Jacobson S, Kimberly WT. Safety and efficacy of intravenous glyburide on brain swelling after large hemispheric infarction (GAMES-RP): a randomised, double-blind, placebo-controlled phase 2 trial. The Lancet Neurology 2016, 15: 1160-1169. PMID: 27567243, DOI: 10.1016/s1474-4422(16)30196-x.Peer-Reviewed Original ResearchConceptsPlacebo-controlled phase 2 trialIntravenous glyburideLarge hemispheric infarctionPhase 2 trialGlyburide groupHemispheric infarctionDecompressive craniectomyPlacebo groupBrain swellingModified Rankin Scale scoreProtocol study populationWeb-based randomisationComposite primary outcomePrimary efficacy outcomeSerious adverse eventsProportion of patientsRankin Scale scoreBolus intravenous injectionLarge hemispheric strokePotential clinical benefitEfficacy outcomesStudy drugAdverse eventsCardiac eventsCerebral edema
2013
Pilot Study of Intravenous Glyburide in Patients With a Large Ischemic Stroke
Sheth KN, Kimberly WT, Elm JJ, Kent TA, Mandava P, Yoo AJ, Thomalla G, Campbell B, Donnan GA, Davis SM, Albers GW, Jacobson S, Simard JM, Stern BJ. Pilot Study of Intravenous Glyburide in Patients With a Large Ischemic Stroke. Stroke 2013, 45: 281-283. PMID: 24193798, PMCID: PMC4235339, DOI: 10.1161/strokeaha.113.003352.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overBlood GlucoseBrain EdemaBrain IschemiaComorbidityFemaleFibrinolytic AgentsGlyburideHumansHypoglycemiaHypoglycemic AgentsInjections, IntravenousMagnetic Resonance ImagingMaleMiddle AgedPatient SafetyPilot ProjectsProspective StudiesStrokeTissue Plasminogen ActivatorTreatment OutcomeWhite PeopleYoung AdultConceptsIschemic strokeLesion volumeIntravenous recombinant tissue-type plasminogen activatorRecombinant tissue-type plasminogen activatorIpsilateral hemisphere volumeLarge ischemic strokeSerious adverse eventsAcute ischemic strokeRetrospective clinical dataFeasibility of recruitingTissue-type plasminogen activatorIntravenous glyburideSevere strokeSymptomatic hypoglycemiaAdverse eventsFocal ischemiaMean ageClinical trialsHemisphere volumeClinical dataDose reductionAge 18PatientsSulfonylurea receptorPlasminogen activator