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JRheumatol.2002Mar29(3):43646.
Doseresponseandsafetystudyofmeloxicamupto22.5mgdailyin
rheumatoidarthritis:a12weekmulticenter,doubleblind,dose
responsestudyversusplaceboanddiclofenac.
FurstDE1,KolbaKS,FleischmannR,SilverfieldJ,GreenwaldM,RothS,HallDB,RoszkoPJMeloxicam
RheumatoidArthritisInvestigators.
Authorinformation
Abstract
OBJECTIVE: ThisPhaseIII,placeboandactivecontrolled,multicentertrialevaluatedtheefficacy
andsafetyofmeloxicam7.5,15,and22.5mgdailyforthetreatmentofrheumatoidarthritis(RA).
METHODS: A12week,randomized,doubleblind,doubledummy,parallelgrouptrialcompareddaily
oralmeloxicam7.5,15,and22.5mgtoplacebo(negativecontrol)anddiclofenac75mgBID
(positivecontrol).Atotalof894patients(18yearsofagewithconfirmedRAwhoflaredfollowingan
NSAIDfreeperiod)wererandomizedtobetreated.Baselinescoresforallendpointsweresimilar
amongthetreatmentgroups.Patientassessmentswereat0,2,4,8,and12weeksorearly
termination.
RESULTS: Alltreatmentgroupsdemonstratedsignificantimprovementfrombaseline(p<0.001).
Meloxicam7.5and22.5mgwassignificantlysuperiortoplaceboinall5primaryefficacyendpoints
(swollenjointcount,tenderjointcount,patientpain,patientandphysicianglobalallp<0.05).
Diclofenac150mgwassuperiortoplacebofor4of5primaryefficacymeasures(allbutswollenjoint
countp<0.05)andmeloxicam15mgwassuperiorfor3of5primaryendpoints(patientpainand
patientandphysicianglobal).AUCofpatientglobal,patientpain,andmodifiedHealthAssessment
Questionnairedemonstrateddoseresponse(p<0.04),whileAUCACR20showedaqualitative
trendinthesamedirection.Therateofgastrointestinal(GI)eventsduringthe12weektrialforall
dosesofmeloxicamanddiclofenacdidnotdiffersignificantlyfromplacebo(23.232.0%).GI
withdrawalswerecomparableandnotsignificantlydifferentacrossalltreatmentgroups(4.35.7%).
CONCLUSION: Thistrialdemonstratedadoseresponserelationshipformeloxicam7.5,15,and22.5
mgusingAUCmeasurementofresponseforthetreatmentofRA.All3dosesofmeloxicam.and
positivecontrol,wereeffectiveinthetreatmentofRA.TheoverallincidencerateofGIeventsdidnot
differsignificantlyfromplaceboineitherthemeloxicamtreatmentgroupsorthepositivecontrol.
PMID:11908554
[IndexedforMEDLINE]
https://www.ncbi.nlm.nih.gov/pubmed/11908554 1/2
30/3/2017 Doseresponseandsafetystudyofmeloxicamupto22.5mgdailyinrheumatoidarthritis:a12weekmulticenter,doubleblind,doseresponsestudyv...P
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https://www.ncbi.nlm.nih.gov/pubmed/11908554 2/2