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HaffnerSM,AlexanderCM,CookTJ,BoccuzziSJ,MuslinerTA,PedersenTR,KjekshusJ,PyoralaKforthe4SGroupReducedCoronaryEventsinSimvastatin-TreatedSubjectswithCHDandDiabetesorImpairedFastingGlucose:SubgroupAnalysesintheScandinavianSimvastatinSurvivalStudy

ArchInternMed1999;159:2661-2667HaffnerSM,AlexanderCM,CookExpanded4SDiabetesAnalysisDiabetesMellitusbyHistory202Subjects(Original4SDiabetesSubgroup)FG>126mg/dl,butNoHistoryofDiabetes281SubjectsImpairedFastingGlucose(FG110-125mg/dl)678SubjectsNormal(FG<110mg/dl)3,237SubjectsHaffnerSM,etal.ArchInternMed1999;159:2661-2667Expanded4SDiabetesAnalysisDRationale&GoalsRationaleNewADADiagnosticCriteriaforDM(FG>126mg/dl)NewCategoryofIFG(FG110-125mg/dl)GoalsConfirmpreviousdataPerformanalysisof4SsubjectswithIFGHaffnerSM,etal.ArchInternMed1999;159:2661-2667Rationale&GoalsRationaleHaffBaselineCharacteristics

Normal IFG DM-FG DM-Hxn 3237 678 281 202Age 59 59 59 60Male(%) 80 84 89 78SBP 138 139 141 147Tot-C 261 261 261 259LDL-C 189 189 186 189HDL-C 46 45 44 44TG 130 137 142 153FG 95 117 136 175HaffnerSM,etal.ArchInternMed1999;159:2661-2667BaselineCharacteristics NormaPercentChangeinLipidsandLipoproteinsin4SHaffnerSM,etal.ArchInternMed1999;159:2661-2667PercentChangeinLipidsandLIncidenceofMajorCHDEventsbyGlucoseStatusinthe4SPlaceboGroupNFG(n=1631)IFG(n=335)DM-FG(n=135)DM-history(n=97)BaselineGlucoseStatusHaffnerSM,etal.ArchInternMed1999;159:2661-2667IncidenceofMajorCHDEvents4S~MajorCoronaryHeartDiseaseEventsRR= 0.68 0.62 0.58pvalue=<0.001 0.003 0.001n= 1631/1606 335/343232/251HaffnerSM,etal.ArchInternMed1999;159:2661-26674S~MajorCoronaryHeartDise4S&RevascularizationsRR= 0.67 0.57 0.52pvalue=<0.001 0.01 0.005n= 1631/1606 335/343232/251HaffnerSM,etal.ArchInternMed1999;159:2661-26674S&RevascularizationsRR= 4S~TotalMortalityRR= 0.72 0.57 0.79pvalue=0.005 0.02 0.34n= 1631/1606 335/343232/251HaffnerSM,etal.ArchInternMed1999;159:2661-26674S~TotalMortalityRR= IFGSubjects(n=678)0.00.20.40.60.81.01.21.4RelativeRiskMCERevascularizationTotMortalityCHDMortalityp=0.003p=0.009p=0.02p=0.0070.620.570.570.45HaffnerSM,etal.ArchInternMed1999;159:2661-2667IFGSubjects(n=678)0.00.20.40DiabeticSubjects(n=483)0.00.20.40.60.81.01.21.4RelativeRiskMCERevascularizationTotMortalityCHDMortalityp=0.001p=0.005p=0.34p=0.260.580.520.790.72HaffnerSM,etal.ArchInternMed1999;159:2661-2667DiabeticSubjects(n=483)0.00.

MajorCHDEventsNFGSimvastatinNFGPlaceboIFGSimvastatinIFGPlaceboDMSimvastatinDMPlaceboArchInternMed1999;159:2661-2667MajorCHDEventsNFGSimvastEffectsofSimvastatinonMajorCoronaryEventsbyGlucoseStatusStratifiedbyLevelofLipidParametersArchInternMed1999;159:2661-2667EffectsofSimvastatinonMajoAbsoluteandRelativeRiskBenefitofSimvastatinTherapybyGlucoseStatusforMajorCoronaryEvents NFG IFG DMSimvastatingroup,No.(%) 299/1606(18.6)67/343(19.5)59/251(23.5)Placebogroup,No.(%) 428/1631(26.2)102/335(30.5)87/232(37.5)Relativerisk 0.68 0.62 0.58Prelativerisk <0.001 0.003 0.001Absolutebenefit(Kaplan-Meieryear6estimate) 8.02/100cases12.11/100cases13.85/100casesNumberneededtotreat 12 8 7HaffnerSM,etal.ArchInternMed1999;159:2661-2667AbsoluteandRelativeRiskBenSummary-DiabetesMellitusHighereventrateindiabetesgroup,byhistory,comparedtoothergroupsIncombinedDMgroup(byhistoryandfastingglucose):MajorCoronaryEventswerereducedby42%(p=0.001)Revascularizationswerereducedby48%(p=0.005)Totalandcoronarymortalitywerereduced,butreductionsnotsignificantduetosmallsamplesizeHaffnerSM,etal.ArchInternMed1999;159:2661-2667Summary-DiabetesMellitusHigSummary-ImpairedFastingGlucoseReducedtotalmortalityby43%(p=0.02)Reducedcoronarymortalityby55%(p=0.007)Reducedmajorcoronaryeventsby38%(p=0.003) Reducedtheneedforrevascularizationproceduresby43%(p=0.009)HaffnerSM,etal.ArchInternMed1999;159:2661-2667Summary-ImpairedFastingGluConclusionsThisanalysisconfirmsandextendsthebenefitofcholesterolloweringwithsimvastatininanexpandedcohortofpatientswithdiabetesandovertCHDCHDpatientswithimpairedfastingglucose

(FG110to125mg/dL)benefitfromtreatmentwithsimvastatinbysignificant&substantialreductionsintotalandcoronarymortality,majorCHDeventsandrevascularizations.HaffnerSM,etal.ArchInternMed1999;159:2661-2667ConclusionsThisanalysisconfiHaffnerSM,AlexanderCM,CookTJ,BoccuzziSJ,MuslinerTA,PedersenTR,KjekshusJ,PyoralaKforthe4SGroupReducedCoronaryEventsinSimvastatin-TreatedSubjectswithCHDandDiabetesorImpairedFastingGlucose:SubgroupAnalysesintheScandinavianSimvastatinSurvivalStudy

ArchInternMed1999;159:2661-2667HaffnerSM,AlexanderCM,CookExpanded4SDiabetesAnalysisDiabetesMellitusbyHistory202Subjects(Original4SDiabetesSubgroup)FG>126mg/dl,butNoHistoryofDiabetes281SubjectsImpairedFastingGlucose(FG110-125mg/dl)678SubjectsNormal(FG<110mg/dl)3,237SubjectsHaffnerSM,etal.ArchInternMed1999;159:2661-2667Expanded4SDiabetesAnalysisDRationale&GoalsRationaleNewADADiagnosticCriteriaforDM(FG>126mg/dl)NewCategoryofIFG(FG110-125mg/dl)GoalsConfirmpreviousdataPerformanalysisof4SsubjectswithIFGHaffnerSM,etal.ArchInternMed1999;159:2661-2667Rationale&GoalsRationaleHaffBaselineCharacteristics

Normal IFG DM-FG DM-Hxn 3237 678 281 202Age 59 59 59 60Male(%) 80 84 89 78SBP 138 139 141 147Tot-C 261 261 261 259LDL-C 189 189 186 189HDL-C 46 45 44 44TG 130 137 142 153FG 95 117 136 175HaffnerSM,etal.ArchInternMed1999;159:2661-2667BaselineCharacteristics NormaPercentChangeinLipidsandLipoproteinsin4SHaffnerSM,etal.ArchInternMed1999;159:2661-2667PercentChangeinLipidsandLIncidenceofMajorCHDEventsbyGlucoseStatusinthe4SPlaceboGroupNFG(n=1631)IFG(n=335)DM-FG(n=135)DM-history(n=97)BaselineGlucoseStatusHaffnerSM,etal.ArchInternMed1999;159:2661-2667IncidenceofMajorCHDEvents4S~MajorCoronaryHeartDiseaseEventsRR= 0.68 0.62 0.58pvalue=<0.001 0.003 0.001n= 1631/1606 335/343232/251HaffnerSM,etal.ArchInternMed1999;159:2661-26674S~MajorCoronaryHeartDise4S&RevascularizationsRR= 0.67 0.57 0.52pvalue=<0.001 0.01 0.005n= 1631/1606 335/343232/251HaffnerSM,etal.ArchInternMed1999;159:2661-26674S&RevascularizationsRR= 4S~TotalMortalityRR= 0.72 0.57 0.79pvalue=0.005 0.02 0.34n= 1631/1606 335/343232/251HaffnerSM,etal.ArchInternMed1999;159:2661-26674S~TotalMortalityRR= IFGSubjects(n=678)0.00.20.40.60.81.01.21.4RelativeRiskMCERevascularizationTotMortalityCHDMortalityp=0.003p=0.009p=0.02p=0.0070.620.570.570.45HaffnerSM,etal.ArchInternMed1999;159:2661-2667IFGSubjects(n=678)0.00.20.40DiabeticSubjects(n=483)0.00.20.40.60.81.01.21.4RelativeRiskMCERevascularizationTotMortalityCHDMortalityp=0.001p=0.005p=0.34p=0.260.580.520.790.72HaffnerSM,etal.ArchInternMed1999;159:2661-2667DiabeticSubjects(n=483)0.00.

MajorCHDEventsNFGSimvastatinNFGPlaceboIFGSimvastatinIFGPlaceboDMSimvastatinDMPlaceboArchInternMed1999;159:2661-2667MajorCHDEventsNFGSimvastEffectsofSimvastatinonMajorCoronaryEventsbyGlucoseStatusStratifiedbyLevelofLipidParametersArchInternMed1999;159:2661-2667EffectsofSimvastatinonMajoAbsoluteandRelativeRiskBenefitofSimvastatinTherapybyGlucoseStatusforMajorCoronaryEvents NFG IFG DMSimvastatingroup,No.(%) 299/1606(18.6)67/343(19.5)59/251(23.5)Placebogroup,No.(%) 428/1631(26.2)102/335(30.5)87/232(37.5)Relativerisk 0.68 0.62 0.58Prelativerisk <0.001 0.003 0.001Absolutebenefit(Kaplan-Meieryear6estimate) 8.02/100cases12.11/100cases13.85/100casesNumberneededtotreat 12 8 7HaffnerSM,etal.ArchInternMed1999;159:2661-2667AbsoluteandRelativeRiskBenSummary-DiabetesMellitusHighereventrateindiabetesgroup,byhistory,comparedtoothergroupsIncombinedDMgroup(byhistoryandfastingglucose):MajorCoronaryEventswe

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