Ngo-Julayi, 2015, i-FDA ivume isidakamizwa esisha i-Entresto (i-Novartis) yokwelashwa kwenhliziyo. Ungafunda mayelana ne-Entresto lapha.
Umdlandla walo muthi omusha uphakeme phakathi kochwepheshe behluleka inhliziyo, futhi ngesizathu esihle. Esivivinyo esikhulu somtholampilo (PARADIGM-HF), i-Entresto ihlukumeze kakhulu i-enalapril, okwamanje iyindlela yokwelapha esemqoka yeziguli ezinokuhluleka kwenhliziyo.
I-Entresto yiyona yokuqala yeqembu le-ARNI yezidakamizwa. Lezi zidakamizwa zihlanganisa i-ARB inhibitor (kulokhu, i-valsartan), ne-neprilysin inhibitor (sacubitril). I-Neprilysin ukuvimbela isici esisha sezidakamizwa ze-ARNI.
Lapho i-neprilysin ye-enzyme ivinjelwa ezigulini zokuhluleka kwenhliziyo, amazinga wegazi ama-peptide angama-natriuretic akhula. Ngenxa yokuthi ama-peptide we-natriuretic angasiza ekuhlulekeni kwenhliziyo, abacwaningi basho ukuthi izidakamizwa ezinjenge-Entresto zingathuthukisa umphumela weziguli ezile nkinga. Imiphumela ye-PARADIGM-HF isifundo sokubonisa ukuthi abacwaningi babelungile.
Ingabe Kukhona I-Downside Ne-Neprilysin Inhibition?
Ngenkathi i-Entresto ibonakala iyasebenza futhi iphephile kuhlolo lwe-PARADIGM-HF, kusekhona izinto ezimbalwa esingazazi mayelana nokuvimbela i-neprilysin yesikhathi eside.
I-Neprilysin inezenzo eziningi ngaphezu kokunciphisa amazinga we-peptides e-natriuretic, kanti ezinye zalezo zenzo zibonakala zizuzisa.
Ngakho-ke ukuvimbela i-neprilysin kungase kungabi yinto enhle yonke yokuyenza.
Ikakhulukazi, i-neprilysin inciphisa ukuqoqwa kwamaprotheni angathandeki emzimbeni, kuhlanganise namaprotheni ahlobene nesifo se-Alzheimer kanye ne- amyloidosis , ngisho nomdlavuza wesicathulo . Eqinisweni, abacwaningi bafuna ngobuqotho izidakamizwa ezingakwandisa umsebenzi we-neprilysin, ngamathemba ukuthi angasiza ukuphatha noma ukuvimbela izimo ezinjengalezi.
Ngakho-ke, naphezu kokuthi ambalwa emiphumela emibi ebikwe ngo-Entresto kuhlolo lwe-PARADIGM-HF, kungenzeka ukuthi kungenzeka kube nemiphumela emibi yesikhathi eside nemithi evimbela i-neprilysin.
Akukho cwaningo lwami olwenziwe ku-Entresto ngangikwazi ukuthola ngisho nokukhulunywa (mhlawumbe ngabacwaningi noma yi-Novartis) yemiphumela engase ibe yingozi ye-neprilysin yokuvimbela ukuvimbela. Ngakho ngathintana noNovotis ukubuza ukuthi inkampani inebufakazi, indlela eyodwa noma enye, ukuthi ukusebenzisa i-Entresto kungathinta ingozi yezifo ezinjenge-Alzheimer's, amyloidosis, noma umdlavuza wesi-prostate.
I-Novartis Impendulo:
Ngemuva kwezinsuku ezimbalwa lapho inkampani ibuza ochwepheshe bayo, ngithole impendulo evela kuNovartis. Lapha sekugcwele:
"I-Neprilysin ibandakanyeka eziningana eziningana zomzimba ngaphakathi kuhlanganise nokuphula izinhlobonhlobo ze-peptide eziphazamisayo, ezithi - ngokukhomba i-neprilysin - i-Entresto isiza ukuthuthukisa, okuholela emiphumeleni enenzuzo ezigulini zokuhluleka kwenhliziyo. I-Neprilysin ingenye ye-enzyme eminingi ehilelekile ekuphukeni ukunciphisa amaprotheni e-amyloid beta. Ulwazi oluvela ohlelweni lwezokuthuthukisa lwe-PARADIGM-HF, oluneziguli ezingaphezu kuka-10 000 ezifundwe, alubonakali noma yimiphi imiphumela emibi ehlobene ne-amyloidosis, umdlavuza we-Alzheimer noma i-prostate ne-Entresto. Kubalulekile ukuqaphela ukuthi iziguli ezinesifo senhliziyo zinama-50 % izinga lokufa eminyakeni emihlanu naphezu kokwelashwa ngemithi yokwelapha engcono kakhulu, izinga lokufa liphakeme kunaningi lamagciwane. I-Entresto inciphisa ukufa, ivimbela ukushona kwabantu futhi yenza abantu abaneHF-REF bazizwe behle. "
Ngashaywa yizinto ezimbalwa mayelana nale mpendulo. Okokuqala, inkampani yayingeyilungele ukuphendula ngokushesha (lokho engikuzwayo) ngumbuzo ocacile futhi obalulekile.
Ngaphezu kwalokho, inkampani ayikwenqabe ukuthi ingozi ye-neprilysin yokuvimbela ingase ibe yingozi kwezinye izinhlobo zezifo ezibi kakhulu. Ukuthi izifundo zabo azikhombisi ubufakazi bokuthi kukhula okunjalo kuyaduduza, kodwa kufanele siqaphele ukuthi izifundo zokungena nge-Entresto ziye zaba nesikhathi esifushane, futhi akucaci ukuthi iziguli ezithintekile nge-Entresto zazibhekwa ngokukhethekile nge-amyloidosis, umdlavuza we-Alzheimer noma i-prostate .
Okokugcina, inkampani ibonisa ukuthi ukuhluleka kwenhliziyo yisimo esibi kangangokuthi ngisho noma izidakamizwa zabo zingabangela noma ziba zimbi kakhulu lezi zifo, ingozi izobanjwa.
Lokhu, kusobala, kuyindaba yokugwetshwa komuntu siqu. Kungakhathaliseki ukuthi isiguli sibheka ingozi njengenzuzo kuxhomeke ekuhloleni kwakhe siqu izingozi kanye nezinzuzo. Lokhu kuyilukhuni olunzima ukwenza, yiqiniso, uma kungezona zonke izingozi ezibizwa ngokuthi ziphuma.
Okubalulekile
I-Entresto ibonakala iyisidakamizwa esicindezelayo kweziguli ezinokuhluleka kwenhliziyo, futhi ngokuqinisekile ngeke zisetshenziswe kakhulu. Ngokungangabazeki kuzosiza iziguli eziningi ngokuhluleka kwenhliziyo ukuba ziphile isikhathi eside, futhi ngezimpawu ezimbalwa.
Kodwa ngokuqondile ngoba i-Entresto inezinhlelo zemithi ye-blockbuster, ngakho-ke izibalo eziningi zeziguli zizokwehliselwa i-neprilysin ukuvimbela okokuqala, kuyoba kubaluleke kakhulu ku-Novartis (no-FDA) ukuqhuba izifundo zokumaketha ngokucophelela, ngakho-ke ukuthi noma yimiphi imiphumela engafanele "engalindelekile" ingabonwa futhi ifakwe ngokushesha ngangokunokwenzeka.
Imithombo:
McMurray JJV, Packer M, Desai AS, et al. Ukuvinjelwa kwe-Angiotensin-neprilysin ngokuhambisana ne-enalapril ekuhlulekeni kwenhliziyo. N Engl J Med 2014; I-DOI: 10.156 / NEJMoa1409077.
Jessup M. Neprilysin ukuvimbela-itravel novel yokuhluleka kwenhliziyo. N Engl J Med 2014; I-DOI: 10.1056 / NEJMe1409898.