NgoMeyi 19, 2022, I-China's National Medical Products Administration (NMPA) igunyaze isicelo sokumaketha se-Bayer's Vericiguat (2.5 mg, 5 mg, kanye no-10 mg) ngaphansi kwegama lomkhiqizo i-Verquvo™.
Lesi sidakamizwa sisetshenziswa ezigulini ezikhulile ezinezimpawu zokuhluleka kwenhliziyo okungapheli kanye nengxenye ye-ejection encishisiwe (ingxenye ye-ejection <45%) ezinzile ngemva komcimbi wakamuva wokubola ngokwelashwa nge-intravenous, ukunciphisa ingozi yokulaliswa esibhedlela ngenxa yokwehluleka kwenhliziyo noma ukwelashwa okuphuthumayo kwe-intravenous diuretic.
Ukugunyazwa kwe-Vericiguat kwakusekelwe emiphumeleni emihle evela ocwaningweni lwe-VICTORIA, olubonise ukuthi i-Vericiguat ingaqhubeka nokunciphisa ingozi ephelele yokufa kwenhliziyo nemithambo yegazi kanye nokulaliswa esibhedlela ngenxa yokwehluleka kwenhliziyo ngo-4.2% (umcimbi wokunciphisa ngokuphelele ubungozi/iminyaka eyi-100 yesiguli) ezigulini ezinenhliziyo. ukwehluleka okube nomcimbi wakamuva wokunciphisa ukuhluleka kwenhliziyo futhi bezinzile ekwelapheni nge-intravenous nge-fraction encishisiwe yokukhipha (i-ejection fraction <45%).
NgoJanuwari 2021, I-Vericiguat yamukelwa e-United States yokwelashwa kwesifo senhliziyo esingapheli esinezimpawu ezigulini ezinengxenyana ye-ejection ngaphansi kwe-45% ngemva kokubhekana nesenzakalo sokuhluleka kwenhliziyo esibi kakhulu.
Ngo-Agasti 2021, isicelo esisha somuthi we-Vericiguat samukelwa yi-CDE futhi ngemva kwalokho safakwa ekubuyekezweni okubalulekile kanye nenqubo yokugunyazwa ngezizathu “zezidakamizwa eziphuthumayo, izidakamizwa ezintsha kanye nemithi emisha ethuthukisiwe yokuvimbela nokwelashwa kwezifo ezithathelwanayo ezinkulu nezifo ezingandile” .
Ngo-Ephreli 2022, I-2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure, ekhishwe ngokuhlanganyela yi-American College of Cardiology (ACC), i-American Heart Association (AHA), kanye ne-Heart Failure Society of America (HFSA), ibuyekeziwe. ukwelashwa kwe-pharmacologic yokwehluleka kwenhliziyo nge-ejection fraction encishisiwe (HFrEF) futhi yafaka i-Vericiguat emithini esetshenziselwa ukwelapha iziguli ezine-HFrEF enobungozi obukhulu kanye nokuhluleka kwenhliziyo ukukhushulwa okusekelwe ekwelapheni okujwayelekile.
I-Vericiguat iyisikhuthazi se-sGC (i-soluble guanylate cyclase) esinomshini wenoveli othuthukiswe ngokuhlanganyela yi-Bayer kanye ne-Merck Sharp & Dohme (MSD).Ingangenelela ngokuqondile ekuphazamisekeni kwendlela yokubonisa amaseli futhi ilungise indlela ye-NO-sGC-cGMP.
Ucwaningo lwangaphambi kweklinikhi nolwemitholampilo lubonise ukuthi indlela yokusayina ye-NO-soluble guanylate cyclase (sGC) -cyclic guanosine monophosphate (cGMP) iyithagethi engaba khona yokuqhubekela phambili kokuhluleka kwenhliziyo okungapheli kanye nokwelashwa kokuhluleka kwenhliziyo.Ngaphansi kwezimo zomzimba, le ndlela yokubonisa iyindlela eyinhloko yokulawula i-myocardial mechanics, umsebenzi wenhliziyo, nomsebenzi we-vascular endothelial.
Ngaphansi kwezimo ze-pathophysiological zokuhluleka kwenhliziyo, ukwanda kokuvuvukala kanye nokungasebenzi kahle kwe-vascular kunciphisa i-NO bioavailability kanye nokuhlanganiswa kwe-cGMP engezansi.Ukuntuleka kwe-cGMP kuholela ekulimazeni ukuqina kwemithambo, i-vascular and cardiac sclerosis, i-fibrosis ne-hypertrophy, kanye nokungasebenzi kahle kwe-coronary kanye ne-renal microcirculatory, ngaleyo ndlela kuholele ekulimaleni okuqhubekayo kwe-myocardial, ukuvuvukala okwandayo kanye nokwehla okuqhubekayo ekusebenzeni kwenhliziyo nezinso.
Isikhathi sokuthumela: May-19-2022