TNT研究和WHS研究PPT课件.ppt

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1、TNTandWHS:Twistsandturnsatthe2005ACCEricJTopolMDProvostandChiefAcademicOfficerChair,DepartmentofCardiovascularMedicineClevelandClinicFoundationCleveland,OHRobertMCaliffMDProfessorofMedicineAssociateViceChancellorforClinicalResearchDirector,DukeClinicalResearchInstituteDukeU

2、niversityMedicalCenterDurham,NCTNTTreatingtoNewTargetsWHSWomen'sHealthStudyTopicsTreatingtoNewTargetsTNTTreatingtonewtargetsParallel-groupstudyrandomizingstableCHDpatientstoadouble-blindtreatmentwithatorvastatin10mgor80mg(NEnglJMed2005;publishedMarch8)StudyaimPrimaryhypothesisof

3、TNTwasthatanincrementalreductioninriskcouldbeachievedbyloweringLDL-cholesterollevelsbeyondthecurrentlyrecommendedminimumtargetsDesign10001patientswithclinicallyevidentCHD,definedaspreviousMI,previousorpresentanginawithevidenceofatheroscleroticCHD,orhavingundergoneacoronaryrevascu

4、larizationprocedureMedianfollow-upof4.9yearsBaselineandfinalLDL-cholesterollevelsLDL-cholesterollevelAtorvastatin10mg(n=5006)Atorvastatin80mg(n=4995)MeanbaselineLDL-cholesterollevels(mg/dL)9897FinalLDL-cholesterollevels(mg/dL)10177PrimaryefficacyoutcomesOutcomeAtorvastatin10mg(n=

5、5006)Atorvastatin80mg(n=4995)Hazardratio(95%CI)pTotalmajorcardiovascularevents(%)10.98.70.78(0.69-0.89)<0.001Deathfromcoronaryheartdisease(%)2.52.00.80(0.61-1.03)0.09NonfatalMI(%)6.24.90.78(0.66-0.93)0.004Resuscitationaftercardiacarrest(%)0.50.50.96(0.56-1.67)0.89Fatalornonfatals

6、troke(%)3.12.30.75(0.59-0.96)0.02Califf'sconclusionsNodifferenceinall-causemortality"IfIdidn'thaveareductionindeath,butIhavealowerriskofheartattackorstroke,I'dtakethat."CaliffSafetySlightlyhigherrateofliver-function-testabnormalities1.2%ofpatientstreatedwith80-mgatorvastatinhadap

7、ersistentelevationinalanineaminotransferase,aspartateaminotransferase,orboth,comparedwith0.2%ofpatientstreatedwith10-mgatorvastatin(p<0.001)CautiouseditorialBertramPitteditorialQuestionedwhethertherewouldbeanyreductionsintotalmortalitywithhigh-dosestatintherapyinstableCHDpatients

8、QuestionedwhetherTNTdataaresufficienttoa