WOSCOPS研究课件（PPT18页）BackgroundThisdouble-blindstudywasdesignedtodeterminewhethertheadministrationofpravastatintomenwithhypercholesterolemiaandnohistoryofmyocardialinfarctionreducedthecombinedincidenceofnonfatalmyocardialinfarctionanddeathfromcoronaryheartdiseaseJamesShepherd,etal,NEnglJMed1995;333:1301-7WestofScotlandCoronaryPreventionStudyGroup(WOS)Randomized,double-blind,placebocontrolled6595men,45to64yearsofageAveragefollow-upof4.9years(seenat3monthintervals)Pravastatin(40mgeachevening)vs.placeboJamesShepherd,etal,NEnglJMed1995;333:1301-7WOSBaselineCharacteristicsMeanlipidlevels:TC=272mg/dLLDL=192mg/dLHDL=44mg/dLTrigs=162-164mg/dL5%ofpatientswithangina3%ofpatientswithclaudication8%ofpatientswithabnormalEKG44%currentsmokers,34%ex-smokersJamesShepherd,etal,NEnglJMed1995;333:1301-7WOSCOPS:HighRiskPrimaryPreventionRiskFactors...1riskfactor:100%2riskfactors:44+%3riskfactors:?Familyhistory:?CurrentCHD:5+%?JamesShepherd,etal,NEnglJMed1995;333:1301-7EndpointsPrimaryNon-fatalMIorcoronaryheartdiseasedeathasafirsteventSecondaryNon-fatalMICoronaryheartdiseasedeathJamesShepherd,etal,NEnglJMed1995;333:1301-7OtherEndpointsCardiovascularmortalityTotalmortalityCoronaryrevascularizationproceduresJamesShepherd,etal,NEnglJMed1995;333:1301-7WOSReductioninLipidsPravastatinreducedlipidlevelsby*:20%reductioninTC26%reductioninLDL12%reductioninTrigs5%increaseinHDL*Dataanalyzedaccordingtothetreatmentactuallyreceivednotaccordingtotheintention-to-treatprincipleJamesShepherd,etal,NEnglJMed1995;333:1301-7EffectsofPravastatinTherapyonPlasmaLDLCholesterolLevelsJamesShepherd,etal,NEnglJMed1995;333:1301-7pravastatin(intention-to-treat)pravastatin(actualtreatment)placebo(actualtreatment)placebo(intention-to-treat)NonfatalMIorCHDDeath(PrimaryEndpoint)31%RiskReductionP=0.0001JamesShepherd,etal,NEnglJMed1995;333:1301-7Non-FatalMI(SecondaryEndpoint)31%RiskReductionP=0.0005JamesShepherd,etal,NEnglJMed1995;333:1301-7CHDDeath(SecondaryEndpoint)28%RiskReductionP=0.13JamesShepherd,etal,NEnglJMed1995;333:1301-7CardiovascularDeath32%RiskReductionP=0.033JamesShepherd,etal,NEnglJMed1995;333:1301-7CoronaryInterventionsInterventionPlaceboPravastatinRisk(n=3293)(n=3302)Reductionsp-valueCoronaryAngiography1289031%0.007PTCA/CABG805137%0.009JamesShepherd,etal,NEnglJMed1995;333:1301-7TotalMortalityP=0.05122%RiskReductionJamesShepherd,etal,NEnglJMed1995;333:1301-7WOSResults/ClinicalEventsJamesShepherd,etal,NEnglJMed1995;333:1301-7WOSConclusions“Treatmentwithpravastatinsignificantlyreducedtheincidenceofmyocardialinfarctionanddeathfromcardiovascularcauseswithoutadverselyaffectingtheriskofdeathfromnoncardiovascularcausesinmenwithmoderatehypercholesterolemiaandnohistoryofmyocardialinfarction.”JamesShepherd,etal,NEnglJMed1995;333:1301-7ProjectedBenefitsTreatmentof1000hypercholesterolemicmiddleagedmenwithpravastatinforfiveyearswillavoid:14coronaryangiograms8revascularizationproceduresAndavoid:20nonfatalMIs7CHDdeaths2additionaldeathsJamesShepherd,etal,NEnglJMed1995;333:1301-7
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