2001
Pharmacokinetics and Pharmacodynamics of Recombinant FGF‐2 in a Phase I Trial in Coronary Artery Disease
Bush M, Samara E, Whitehouse MJ, Yoshizawa C, Novicki D, Pike M, Laham R, Simons M, Chronos N. Pharmacokinetics and Pharmacodynamics of Recombinant FGF‐2 in a Phase I Trial in Coronary Artery Disease. The Journal Of Clinical Pharmacology 2001, 41: 378-385. PMID: 11304894, DOI: 10.1177/00912700122010230.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overArea Under CurveCoronary DiseaseEnzyme-Linked Immunosorbent AssayFemaleFibroblast Growth Factor 2Follow-Up StudiesHemodynamicsHeparinHumansInfusions, IntravenousMaleMaximum Tolerated DoseMetabolic Clearance RateMiddle AgedRecombinant ProteinsRegression AnalysisTime FactorsConceptsRecombinant FGF-2Coronary artery diseasePhase I trialFibroblast growth factor-2Artery diseaseI trialSystemic exposureSevere coronary artery diseaseTerminal elimination t1/2Peak plasma concentrationConcentration-time curveMultiple animal modelsDose-response relationshipAcute hemodynamicsGrowth factor 2Chronic ischemiaElimination t1/2Intravenous infusionSingle doseLinear pharmacokineticsDistribution t1/2Plasma concentrationsIntravenous administrationBiphasic eliminationSlow clearance
1999
Local Perivascular Delivery of Basic Fibroblast Growth Factor in Patients Undergoing Coronary Bypass Surgery
Laham R, Sellke F, Edelman E, Pearlman J, Ware J, Brown D, Gold J, Simons M. Local Perivascular Delivery of Basic Fibroblast Growth Factor in Patients Undergoing Coronary Bypass Surgery. Circulation 1999, 100: 1865-1871. PMID: 10545430, DOI: 10.1161/01.cir.100.18.1865.Peer-Reviewed Original ResearchMeSH KeywordsAlginatesCoronary Artery BypassCoronary VesselsDelayed-Action PreparationsDouble-Blind MethodDrug CarriersDrug CompoundingDrug ImplantsFemaleFibroblast Growth Factor 2Follow-Up StudiesGlucuronic AcidHeparinHexuronic AcidsHumansMaleMiddle AgedPatient SelectionPlacebosRecombinant ProteinsConceptsBasic fibroblast growth factorBFGF groupFibroblast growth factorTreatment-related adverse eventsQ-wave myocardial infarctionGrowth factorLocal perivascular deliverySerum bFGF levelsPlacebo-controlled studyCoronary bypass surgerySubset of patientsMode of therapyMagnetic resonance assessmentPromising treatment strategyNuclear perfusionOperative deathsRecurrent anginaStandard revascularizationNew blood vesselsPlacebo groupRepeat revascularizationAdverse eventsBypass surgeryControl patientsPerivascular delivery
1998
Therapeutic Angiogenesis With Basic Fibroblast Growth Factor: Technique and Early Results
Sellke F, Laham R, Edelman E, Pearlman J, Simons M. Therapeutic Angiogenesis With Basic Fibroblast Growth Factor: Technique and Early Results. The Annals Of Thoracic Surgery 1998, 65: 1540-1544. PMID: 9647055, DOI: 10.1016/s0003-4975(98)00340-3.Peer-Reviewed Original ResearchMeSH KeywordsAgedAlginatesAngina PectorisCollateral CirculationCoronary Artery BypassCoronary Artery DiseaseCoronary CirculationCoronary VesselsCreatinineDelayed-Action PreparationsDrug CarriersFeasibility StudiesFemaleFibroblast Growth Factor 2Follow-Up StudiesGlucuronic AcidHeparinHexuronic AcidsHumansMaleMiddle AgedMyocardial ContractionMyocardial InfarctionNeovascularization, PhysiologicPericardiumSafetyStroke VolumeSurvival RateConceptsBasic fibroblast growth factorCoronary artery bypassFibroblast growth factorArtery bypassGrowth factorTherapeutic angiogenesisConventional coronary artery bypassBasic fibroblast growth factor (bFGF) administrationSlow-release devicesStress perfusion scansPerioperative myocardial infarctionSerum creatinine levelsDifficult clinical problemFixed perfusion defectsLong-term resultsMyocardial contractile functionGrowth factor administrationOperative mortalityPatent arteriesMyocardial revascularizationCreatinine levelsEjection fractionClinical efficacyHepatic toxicityPerfusion scan