摘要
AIMTocomparevonoprazan10and20mgvslansoprazole15mgasmaintenancetherapyinhealederosiveesophagitis(EE).METHODSAtotalof607patientsaged≥20years,withendoscopically-confirmedhealedEEfollowing8wkoftreatmentwithvonoprazan20mgoncedaily,wererandomized1:1:1toreceivelansoprazole15mg(n=201),vonoprazan10mg(n=202),orvonoprazan20mg(n=204),oncedaily.Theprimaryendpointofthestudywastherateofendoscopically-confirmedEErecurrenceduringa24-wkmaintenanceperiod.ThesecondaryendpointwastheEErecurrencerateatWeek12duringmaintenancetreatment.Additionalefficacyendpointsincludedtheincidenceofheartburnandacidreflux,andtheEEhealingrate4wkaftertheinitiationofmaintenancetreatment.Safetyendpointscomprisedadverseevents(AEs),vitalsigns,electrocardiogramfindings,clinicallaboratoryresults,serumgastrinandpepsinogenⅠ/Ⅱlevels,andgastricmucosahistopathologyresults.RESULTSRatesofEErecurrenceduringthe24-wkmaintenanceperiodwere16.8%,5.1%,and2.0%withlansoprazole15mg,vonoprazan10mg,andvonoprazan20mg,respectively.Vonoprazanwasshowntobenon-inferiortolansoprazole15mg(P<0.0001forbothdoses).Inapost-hocanalysis,EErecurrenceatWeek24wassignificantlyreducedwithvonoprazanatboththe10mgandthe20mgdosevslansoprazole15mg(5.1%vs16.8%,P=0.0002,and2.0%vs16.8%,P<0.0001,respectively);bycontrast,theEErecurrenceratedidnotdiffersignificantlybetweenthetwodosesofvonoprazan(P=0.1090).Thesafetyprofilesofvonoprazan10and20mgweresimilartothatoflansoprazole15mginpatientswithhealedEE.Treatment-relatedAEswerereportedin11.4%,10.4%,and10.3%ofpatientsinthelansoprazole15mg,vonoprazan10mg,andvonoprazan20mgarms,respectively.CONCLUSIONOurfindingsconfirmthenon-inferiorityofvonoprazan10and20mgtolansoprazole15mgasmaintenancetherapyforpatientswithhealedEE.
出版日期
2018年12月22日（中国期刊网平台首次上网日期，不代表论文的发表时间）
