2022
Central vs site outcome adjudication in the IRIS trial
Forman R, Viscoli CM, Bath PM, Furie KL, Guarino P, Inzucchi SE, Young L, Kernan WN. Central vs site outcome adjudication in the IRIS trial. Journal Of Stroke And Cerebrovascular Diseases 2022, 31: 106667. PMID: 35901589, DOI: 10.1016/j.jstrokecerebrovasdis.2022.106667.Peer-Reviewed Original ResearchMeSH KeywordsDouble-Blind MethodHumansHypoglycemic AgentsIschemic Attack, TransientPioglitazoneStrokeTreatment OutcomeConceptsCentral adjudicationHazard ratioStroke definitionsRecent transient ischemic attackInsulin Resistance InterventionMain secondary outcomesShorter symptom durationTransient ischemic attackPrevention of strokeNormal brain imagingClinical trial researchIschemic attackIschemic strokeSecondary outcomesSymptom durationPrimary outcomeStroke trialsIRIS trialMyocardial infarctionOutcome definitionsStroke typeOutcome eventsAdjudicated eventsOutcome adjudicationResistance Intervention
2020
Adherence to study drug in a stroke prevention trial"?>
Kiran A, Viscoli CM, Furie KL, Gorman M, Kernan WN. Adherence to study drug in a stroke prevention trial"?>. Journal Of Stroke And Cerebrovascular Diseases 2020, 29: 105048. PMID: 32912514, PMCID: PMC7487071, DOI: 10.1016/j.jstrokecerebrovasdis.2020.105048.Peer-Reviewed Original ResearchConceptsRate of discontinuationStudy drugDrug holidayTreatment groupsActive study drugAdverse effectsInsulin Resistance InterventionPremature drug discontinuationRecent ischemic strokeStroke Prevention TrialDouble-blind trialTransient ischemic attackClinical trial researchPhases of adherenceDrug discontinuationIschemic attackStroke preventionDiscontinuation ratesIschemic strokeActive therapyMedical therapyPatient adherencePrevention trialsStroke trialsPharmacodynamic effects
2017
Targeting Pioglitazone Hydrochloride Therapy After Stroke or Transient Ischemic Attack According to Pretreatment Risk for Stroke or Myocardial Infarction
Kernan WN, Viscoli CM, Dearborn JL, Kent DM, Conwit R, Fayad P, Furie KL, Gorman M, Guarino PD, Inzucchi SE, Stuart A, Young LH. Targeting Pioglitazone Hydrochloride Therapy After Stroke or Transient Ischemic Attack According to Pretreatment Risk for Stroke or Myocardial Infarction. JAMA Neurology 2017, 74: 1319-1327. PMID: 28975241, PMCID: PMC5710663, DOI: 10.1001/jamaneurol.2017.2136.Peer-Reviewed Original ResearchConceptsTransient ischemic attackIschemic attackMyocardial infarctionIschemic strokeHigh riskPioglitazone groupInsulin resistanceLower riskCox proportional hazards regression modelProportional hazards regression modelsMedian riskEfficacy of pioglitazoneInsulin Resistance InterventionQualifying ischemic strokePlacebo-controlled trialHazards regression modelsLow baseline riskType 2 diabetesGreater absolute benefitDay of entryFuture strokeHydrochloride therapyPlacebo groupHazard ratioSecondary preventionPioglitazone Prevents Stroke in Patients With a Recent Transient Ischemic Attack or Ischemic Stroke
Yaghi S, Furie KL, Viscoli CM, Kamel H, Gorman M, Dearborn J, Young LH, Inzucchi SE, Lovejoy AM, Kasner SE, Conwit R, Kernan WN. Pioglitazone Prevents Stroke in Patients With a Recent Transient Ischemic Attack or Ischemic Stroke. Circulation 2017, 137: 455-463. PMID: 29084736, DOI: 10.1161/circulationaha.117.030458.Peer-Reviewed Original ResearchConceptsTransient ischemic attackIschemic strokeIschemic attackNondiabetic patientsStroke outcomeStroke eventsInsulin resistanceRecent transient ischemic attackCox proportional hazards modelQualifying ischemic strokeEffect of pioglitazoneFirst stroke eventProportional hazards modelPrevents strokeHemorrhagic eventsComposite outcomeSecondary preventionRecent strokeIRIS trialMyocardial infarctionTreatment groupsHazards modelPioglitazoneConsensus criteriaSurvival analysisEffects of pioglitazone on cognitive function in patients with a recent ischaemic stroke or TIA: a report from the IRIS trial
Furie KL, Viscoli CM, Gorman M, Ford GA, Young LH, Inzucchi SE, Guarino PD, Lovejoy AM, Conwit R, Tanne D, Kernan WN. Effects of pioglitazone on cognitive function in patients with a recent ischaemic stroke or TIA: a report from the IRIS trial. Journal Of Neurology Neurosurgery & Psychiatry 2017, 89: 21. PMID: 28939682, DOI: 10.1136/jnnp-2017-316361.Peer-Reviewed Original ResearchConceptsTransient ischemic attackRecent ischemic strokeIschemic strokeCognitive functionHomeostasis model assessment insulin resistance scoreModified Mini-Mental State Examination scoresAssessment-insulin resistance scoreMini-Mental State Examination scoreInsulin Resistance InterventionPoststroke cognitive functionVascular risk factorsEffect of pioglitazoneInsulin-resistant patientsState Examination scoreIschemic attackPioglitazone groupPlacebo groupIRIS trialStroke trialsCerebrovascular diseaseInsulin resistanceRisk factorsCognitive dysfunctionPatientsResistance InterventionCardiac Outcomes After Ischemic Stroke or Transient Ischemic Attack
Young LH, Viscoli CM, Curtis JP, Inzucchi SE, Schwartz GG, Lovejoy AM, Furie KL, Gorman MJ, Conwit R, Abbott JD, Jacoby DL, Kolansky DM, Pfau SE, Ling FS, Kernan WN. Cardiac Outcomes After Ischemic Stroke or Transient Ischemic Attack. Circulation 2017, 135: 1882-1893. PMID: 28246237, PMCID: PMC5511545, DOI: 10.1161/circulationaha.116.024863.Peer-Reviewed Original ResearchConceptsAcute coronary syndromeType 1 myocardial infarctionTransient ischemic attackMyocardial infarctionCoronary syndromeInsulin resistanceIschemic attackIschemic strokeDiabetes mellitusSerum troponinAcute coronary syndrome episodeMean age 63 yearsAcute coronary syndrome eventIndependent clinical events committeeType 2 myocardial infarctionIRIS participantsImpact of pioglitazoneRecent cerebrovascular eventsRecent ischemic strokeClinical events committeeAge 63 yearsEffect of pioglitazoneSmall myocardial infarctionCoronary artery diseaseST-segment elevation
2016
Pioglitazone and Risk for Bone Fracture: Safety Data From a Randomized Clinical Trial
Viscoli CM, Inzucchi SE, Young LH, Insogna KL, Conwit R, Furie KL, Gorman M, Kelly MA, Lovejoy AM, Kernan WN, Investigators F. Pioglitazone and Risk for Bone Fracture: Safety Data From a Randomized Clinical Trial. The Journal Of Clinical Endocrinology & Metabolism 2016, 102: 914-922. PMID: 27935736, PMCID: PMC5460686, DOI: 10.1210/jc.2016-3237.Peer-Reviewed Original ResearchConceptsTransient ischemic attackIschemic strokeFracture riskBone fracturesRisk/benefit ratioAbsolute fracture riskInsulin Resistance InterventionPlacebo-treated patientsIschemic attackNondiabetic patientsPlacebo groupCardiovascular riskBone healthStroke trialsNondiabetic participantsPrevent fallsClinical trialsRelative riskSafety dataFracture classificationQuarterly interviewsPioglitazonePatientsResistance InterventionRisk incrementTaking care of volunteers in a stroke trial: a new assisted-management strategy
Stuart AC, Sico JJ, Viscoli CM, Tayal AH, Inzucchi SE, Ford GA, Furie KL, Cote R, Spence JD, Tanne D, Kernan WN. Taking care of volunteers in a stroke trial: a new assisted-management strategy. Stroke And Vascular Neurology 2016, 1: 108. PMID: 28959471, PMCID: PMC5435205, DOI: 10.1136/svn-2016-000029.Peer-Reviewed Original ResearchMeSH KeywordsAgedAnticholesteremic AgentsAntihypertensive AgentsBiomarkersBlood CoagulationBlood PressureCholesterol, LDLDouble-Blind MethodEuropeFemaleFibrinolytic AgentsHumansHypoglycemic AgentsInsulin ResistanceIschemic Attack, TransientIschemic StrokeIsraelMaleMiddle AgedNorth AmericaPioglitazoneRecurrenceRisk AssessmentRisk FactorsRisk Reduction BehaviorSecondary PreventionTime FactorsTreatment OutcomeConceptsPersonal healthcare providerBlood pressureStroke trialsPreventive careTrial participantsLow-density lipoprotein cholesterolPrevention goalsInsulin Resistance InterventionTransient ischemic attackPrevention of strokeSecondary prevention goalsEvidence-based careProportion of participantsIschemic attackAntithrombotic therapyIschemic strokeLipoprotein cholesterolSecondary preventionAntithrombotic useStroke therapyInsulin sensitisersMyocardial infarctionAnnual visitsHealthcare providersResistance InterventionPioglitazone after Ischemic Stroke or Transient Ischemic Attack.
Viscoli C, Kernan W, Young L. Pioglitazone after Ischemic Stroke or Transient Ischemic Attack. New England Journal Of Medicine 2016, 375: 704. PMID: 27532845, DOI: 10.1056/nejmc1605904.Peer-Reviewed Original ResearchPioglitazone Prevents Diabetes in Patients With Insulin Resistance and Cerebrovascular Disease.
Inzucchi SE, Viscoli CM, Young LH, Furie KL, Gorman M, Lovejoy AM, Dagogo-Jack S, Ismail-Beigi F, Korytkowski MT, Pratley RE, Schwartz GG, Kernan WN. Pioglitazone Prevents Diabetes in Patients With Insulin Resistance and Cerebrovascular Disease. Diabetes Care 2016, 39: 1684-92. PMID: 27465265, PMCID: PMC5033078, DOI: 10.2337/dc16-0798.Peer-Reviewed Original ResearchConceptsTransient ischemic attackRecent ischemic strokeInsulin resistanceIschemic strokeHOMA-IRInsulin Resistance InterventionMajor cardiovascular eventsMean HOMA-IRHistory of diabetesSubsequent ischemic eventsHomeostasis model assessmentRisk of diabetesΜIU/mLFPG testingPioglitazone groupCardiovascular eventsIschemic attackPlacebo groupFirst medicationIschemic eventsMean FPGDiabetes onsetDiabetes preventionCerebrovascular diseaseStroke trialsPioglitazone after Ischemic Stroke or Transient Ischemic Attack
Kernan WN, Viscoli CM, Furie KL, Young LH, Inzucchi SE, Gorman M, Guarino PD, Lovejoy AM, Peduzzi PN, Conwit R, Brass LM, Schwartz GG, Adams HP, Berger L, Carolei A, Clark W, Coull B, Ford GA, Kleindorfer D, O'Leary JR, Parsons MW, Ringleb P, Sen S, Spence JD, Tanne D, Wang D, Winder TR. Pioglitazone after Ischemic Stroke or Transient Ischemic Attack. New England Journal Of Medicine 2016, 374: 1321-1331. PMID: 26886418, PMCID: PMC4887756, DOI: 10.1056/nejmoa1506930.Peer-Reviewed Original ResearchConceptsTransient ischemic attackIschemic strokeInsulin resistanceMyocardial infarctionIschemic attackPrimary outcomeRecent ischemic strokeDouble-blind trialFuture cardiovascular eventsHomeostasis model assessmentInsulin resistance indexRisk of strokeEligible patientsNonfatal strokePioglitazone groupCardiovascular eventsCause mortalityPlacebo groupPreventive therapyCerebrovascular diseaseInsulin sensitivityRisk factorsResistance indexHigh riskLower risk
2014
Litigation Seeking Access to Data From Ongoing Clinical Trials: A Threat to Clinical Research
Kernan WN, Viscoli CM, Varughese MC. Litigation Seeking Access to Data From Ongoing Clinical Trials: A Threat to Clinical Research. JAMA Internal Medicine 2014, 174: 1502-1504. PMID: 25047222, PMCID: PMC5758866, DOI: 10.1001/jamainternmed.2014.3248.Peer-Reviewed Original Research
2003
Pioglitazone Improves Insulin Sensitivity Among Nondiabetic Patients With a Recent Transient Ischemic Attack or Ischemic Stroke
Kernan WN, Inzucchi SE, Viscoli CM, Brass LM, Bravata DM, Shulman GI, McVeety JC, Horwitz RI. Pioglitazone Improves Insulin Sensitivity Among Nondiabetic Patients With a Recent Transient Ischemic Attack or Ischemic Stroke. Stroke 2003, 34: 1431-1436. PMID: 12730556, DOI: 10.1161/01.str.0000071108.00234.0e.Peer-Reviewed Original ResearchConceptsRecent transient ischemic attackTransient ischemic attackGlucose tolerance testOral glucose tolerance testHistory of diabetesInsulin sensitivityTolerance testIschemic attackNondiabetic patientsEligible subjectsIschemic strokeMean C-reactive protein concentrationC-reactive protein concentrationsEffectiveness of pioglitazoneMonths of therapyGlucose blood levelsYears of ageMean proportional increaseIndex eventBlood levelsPatientsPlaceboPioglitazoneStrokeDiabetes