Ukungaphumeleli kwentliziyo kunye neqhezu leejection elincitshisiweyo (HFrEF) luhlobo oluphambili lokungaphumeleli kwentliziyo, kwaye i-China HF Study ibonise ukuba i-42% yokukhubazeka kwentliziyo e-China yi-HFrEF, nangona iiklasi ezininzi zonyango zonyango ziyafumaneka kwi-HFrEF kwaye zinciphise umngcipheko. yokufa kunye nokulaliswa esibhedlele ngenxa yokusilela kwentliziyo kwinqanaba elithile.Nangona kunjalo, abaguli basemngciphekweni omkhulu wokungaphumeleli kwentliziyo okuphindaphindiweyo, ukusweleka kuhleli malunga ne-25% kwaye i-prognosis ihlala imbi.Ngoko ke, kusekho imfuneko engxamisekileyo yee-agent ezintsha zonyango kunyango lwe-HFrEF, kunye ne-Vericiguat, i-novel soluble guanylate cyclase (sGC) stimulator, yafundwa kuphononongo lwe-VICTORIA ukuhlola ukuba i-Vericiguat inokuphucula i-prognosis yezigulane ezine-HFrEF.Uphononongo luyi-multicenter, i-randomized, i-parallel-group, i-placebo-controlled, i-double-blind-blind, i-vent-driven, isigaba se-III seziphumo zekliniki zophononongo.Iqhutywe phantsi kwe-VIGOR Centre eCanada ngokubambisana neDuke Clinical Research Institute, amaziko e-616 kumazwe angama-42 kunye nemimandla, kuquka iYurophu, iJapan, iChina kunye ne-United States, inxaxheba kwisifundo.Isebe lethu lezentliziyo liwongwe ngokuthatha inxaxheba.Iyonke izigulane ze-5,050 ezineentliziyo ezingapheliyo ezineminyaka eyi-≥18 iminyaka, i-NYHA iklasi II-IV, i-EF <45%, kunye namanqanaba aphezulu e-peptide ye-natriuretic (NT-proBNP) kwiintsuku ze-30 ngaphambi kokuba i-randomization, kwaye ngubani oye walaliswa esibhedlele ngenxa yokungaphumeleli kwentliziyo. kwiinyanga ze-6 ngaphambi kwe-randomization okanye i-diuretics elawulwa nge-intravenously ngenxa yokungaphumeleli kwentliziyo kwiinyanga ze-3 ngaphambi kokuba i-randomization ibhaliswe kwisifundo, bonke bafumana i-ESC, i-AHA / ACC, kunye nezikhokelo zesizwe / zengingqi ezicetyiswayo zomgangatho wokunyamekela.Izigulane zahlelwa ngokwe-1: umlinganiselo we-1 kumaqela amabini kwaye zanikwaVericiguat(n = 2526) kunye ne-placebo (n = 2524) phezulu kwonyango oluqhelekileyo, ngokulandelanayo.
Isiphelo esiphambili sophononongo sasiyi-composite endpoint of cardiovascular death or first heart failure in hospitalization;iziphelo zesibini zibandakanya amacandelo okugqibela okuphambili, i-hospitali yokuqala kunye neyokugqibela yokungaphumeleli kwentliziyo (iziganeko zokuqala kunye neziganeko eziphindaphindiweyo), isiphelo esihlanganisiweyo sokufa okanye ukulaliswa kwentliziyo, kunye nokufa konke.Ekulandeleni okuphakathi kweenyanga ze-10.8, kwakukho i-10% yokunciphisa isalamane kwisiphelo sokuqala sokufa kwe-cardiovascular death okanye ukulaliswa kwentliziyo yokuqala esibhedlele kwiqela le-Vericiguat xa kuthelekiswa neqela le-placebo.
Uhlalutyo lweziphelo zesibini lubonise ukunciphisa okukhulu kwisibhedlele sokungaphumeleli kwentliziyo (HR 0.90) kunye nokunciphisa okuphawulekayo kwi-composite endpoint of all-cause death or heart failure (HR 0.90) kwiqela le-Vericiguat xa kuthelekiswa neqela le-placebo.
Iziphumo zophando zibonisa ukuba ukongezwa kweVericiguatukuya kunyango olusemgangathweni lokungaphumeleli kwentliziyo kunciphisa kakhulu ukwenzeka kwamva nje kokuphazamiseka kwentliziyo kunye nokunciphisa umngcipheko we-composite endpoint of cardiovascular death okanye ukulaliswa esibhedlele ngenxa yokusilela kwentliziyo kwizigulane ezine-HFrEF.Ikhono le-Vericiguat ukunciphisa umngcipheko we-composite endpoint of cardiovascular death or heart failure in hospitaling in izigulane ezinomngcipheko ophezulu wokungaphumeleli kwentliziyo kunika indlela entsha yonyango yokungaphumeleli kwentliziyo kwaye ivule iindlela ezintsha zokuphonononga kwikamva lesifo senhliziyo.I-Vericiguat ayivunywanga ngoku ukuba ithengiswe.Ukhuseleko, ukusebenza ngempumelelo kunye nokusebenza kakuhle kwechiza kusafuna ukuvavanywa ngakumbi emarikeni.
Ixesha lokuposa: Feb-09-2022