Ngomhla we-19 kuCanzibe, ngo-2022, i-China's National Medical Products Administration (NMPA) iphumeze isicelo sentengiso ye-Bayer's.Vericiguat(2.5 mg, 5 mg, kunye ne-10 mg) phantsi kwegama lebhrendi Verquvo™.
Eli chiza lisetyenziselwa izigulane zabantu abadala abaneempawu zokungaphumeleli kwentliziyo kunye nokunciphisa i-fraction ye-ejection (i-ejection fraction <45%) ezizinziswe emva kwesiganeko sokutshatyalaliswa kwamva nje kunye nonyango lwe-intravenous, ukunciphisa umngcipheko wokulaliswa esibhedlele ngenxa yokungaphumeleli kwentliziyo okanye unyango oluphuthumayo lwe-diuretic.
Ukuvunywa kwe-Vericiguat kwakusekelwe kwiziphumo ezilungileyo ezivela kwisifundo se-VICTORIA, esibonise ukuba i-Vericiguat inokunciphisa ngakumbi umngcipheko wokufa kwe-cardiovascular death kunye nokulaliswa esibhedlele ngenxa yokungaphumeleli kwentliziyo nge-4.2% (isiganeko sokunciphisa umngcipheko ngokupheleleyo / iminyaka ye-100 yesigulane) kwizigulane ezinentliziyo. Ukusilela obenesiganeko sokuthotywa kwentliziyo yamva nje kwaye bezinzile kunyango lwe-intravenous kunye neqhezu leejection elincitshisiweyo. (iqhekeza le-ejection <45%).
NgoJanuwari ka-2021, i-Vericiguat yamkelwa e-United States kunyango lwesifo sentliziyo esinganyangekiyo kwizigulane ezineqhezu le-ejection elingaphantsi kwe-45% emva kokufumana isiganeko esibi sentliziyo.
Ngo-Agasti ka-2021, isicelo esitsha sesiyobisi se-Vericiguat samkelwa yi-CDE kwaye emva koko sabandakanywa kuphononongo oluphambili kunye nenkqubo yokuvunywa ngenxa yezizathu "zamachiza angxamisekileyo ekliniki, amachiza amatsha kunye nokuphucula amachiza amatsha othintelo kunye nonyango lwezifo ezosulelayo eziphambili kunye izifo ezingaqhelekanga”.
Ngo-Apreli 2022, i-2022 AHA / ACC / HFSA Isikhokelo soLawulo lweNtliziyo yeNtliziyo, ekhutshwe ngokubambisana yi-American College of Cardiology (ACC), i-American Heart Association (AHA), kunye ne-Heart Failure Society of America (HFSA) ), ihlaziywe unyango lwe-pharmacologic yokungaphumeleli kwentliziyo kunye nokunciphisa i-ejection fraction (HFrEF) kwaye iquka i-Vericiguat kwiziyobisi ezisetyenziselwa unyango lwezigulane ezinomngcipheko ophezulu. I-HFrEF kunye ne-heart failure exacerbations ngokusekelwe kunyango oluqhelekileyo.
Vericiguatsisivuseleli se-sGC (i-soluble guanylate cyclase) esinenoveli indlela ephuhliswe ngokudibeneyo yi-Bayer kunye ne-Merck Sharp & ne-Dohme (MSD). Inokungenelela ngokuthe ngqo kwi-cell-signaling mechanism disorder kunye nokulungisa indlela ye-NO-sGC-cGMP.
Izifundo zangaphambi kweklinikhi kunye nekliniki zibonise ukuba i-NO-soluble guanylate cyclase (sGC) -cyclic guanosine monophosphate (cGMP) indlela yokubonisa indlela yokubonakalisa eyona nto inokuthi ijoliswe kuyo ekuqhubeni kwentliziyo engapheliyo kunye nokunyangwa kwentliziyo. Ngaphantsi kweemeko ze-physiological, le ndlela yomqondiso yindlela ephambili yokulawula i-myocardial mechanics, umsebenzi we-cardiac, kunye ne-vascular endothelial function.
Ngaphantsi kweemeko ze-pathophysiological zokungaphumeleli kwentliziyo, ukunyuka kokuvuvukala kunye nokungasebenzi kwe-vascular kunciphisa i-NO bioavailability kunye ne-lowstream cGMP synthesis. Ukunqongophala kwe-cGMP kukhokelela kwi-dysregulation ye-vascular tension, i-vascular and cardiac sclerosis, i-fibrosis kunye ne-hypertrophy, kunye ne-coronary kunye ne-renal microcirculatory dysfunction, ngaloo ndlela ikhokelela ekuqhubeni kokwenzakala kwe-myocardial, ukunyuka kokuvuvukala kunye nokuhla ngakumbi ekusebenzeni kwentliziyo kunye nezintso.
Ixesha lokuposa: May-30-2022