Mu Julayi, 2015, a FDA adavomereza mankhwala atsopano Entresto (Novartis) kuti athetse vuto la mtima. Mukhoza kuwerenga za Entresto pano.
Chidwi cha mankhwala atsopanowa ndipamwamba pakati pa akatswiri a mtima olephera, ndipo chifukwa chabwino. Mu mayesero akuluakulu a chipatala (PARADIGM-HF), Entresto inalephera kwambiri kuperewera kwa matenda a enalapril, omwe pakalipano ndi mankhwala othandizira odwala odwala mtima.
Entresto ndiye woyamba wa mankhwala a ARNI. Mankhwalawa amagwirizanitsa ARB inhibitor (panopa, valsartan), ndi neprilysin inhibitor (sacubitril). Neprilysin inhibition ndi chinthu chatsopano cha mankhwala a ARNI.
Pamene enzyme neprissin imalowetsedwa m'maganizo odwala mtima, odwala magazi amatha kuwonjezeka. Chifukwa chakuti peptides ya natriuretic ikhoza kukhala yopindulitsa pamtima, ochita kafukufuku adalemba kuti mankhwala monga Entresto amatha kusintha zotsatira za odwala omwe ali ndi vutoli. Zotsatira za phunziro la PARADIGM-HF likusonyeza kuti ochita kafukufuku anali olondola.
Kodi Pali Kumtunda Kwa Neprilysin Kuletsa?
Ngakhale kuti Entresto inkaoneka ngati yothandiza komanso yotetezeka mu mayesero a PARADIGM-HF, pali zinthu zochepa zomwe sitidziwa za kutaya kwa neprilysin.
Neprilysin ali ndi zochita zambiri kuphatikizapo kuchepetsa kuchuluka kwa masitikiti a natriuretic, ndipo zina mwazochita zikuwoneka zopindulitsa.
Choncho kuletsa neprilysin sikungakhale chinthu chabwino kwambiri padziko lonse.
Makamaka, neprilysin amachepetsa kusungunuka kwa mapuloteni osayenera m'thupi, kuphatikizapo mapuloteni odwala matenda a Alzheimer ndi amyloidosis , ngakhale khansa ya prostate . Ndipotu, ofufuza akufufuza molimbika mankhwala omwe angathe kuwonjezera ntchito ya neprilysin, poganiza kuti akhoza kuthandizira kapena kupewa zinthu monga izi.
Kotero, ngakhale kuti zochepa zovulaza zinalembedwa ndi Entresto mu PARADIGM-HF kuyesa, pangakhalebe kuthekera kwa zotsatira za nthawi yayitali ndi mankhwala omwe amaletsa neprilysin.
Mufukufuku wanga uliwonse ku Entresto ndinkatha kupeza ngakhale kutchulidwa (mwina ndi ochita kafukufuku kapena Novartis) za zotsatira zovuta za matenda osokoneza bongo a neprilysin. Kotero ndinapempha Novartis kuti ndifunse ngati kampaniyo ili ndi umboni, njira imodzi kapena ina, kuti Entresto ingakhudze chiopsezo cha matenda monga Alzheimer's, amyloidosis, kapena kansa ya prostate.
Novartis Replies:
Pambuyo masiku angapo omwe kampaniyo inkafunsira akatswiri ake, ndinalandira yankho ili kuchokera ku Novartis. Pano pali kwathunthu:
"Neprilysin imakhudzidwa ndi njira zingapo m'kati mwa thupi kuphatikizapo kuthana ndi mitundu yambiri ya mapeptidi otchedwa vasoactive, omwe - pogwiritsa ntchito neprilysin - Entresto amathandiza kuwongolera, zomwe zimapangitsa kuti athandizidwe ndi odwala mtima. Neprilysin ndi imodzi mwa mavitamini ambiri omwe akuphwanya mapuloteni otsika a amyloid beta. Chidziwitso cha pulogalamu ya PARADIGM-HF, yomwe ili ndi oposa oposa 10,000, sichisonyeza zotsatira zovuta zokhudzana ndi khansa ya amyloidosis, khansa ya Alzheimer kapena prostate ndi Entresto. % of mortal rate pa zaka zisanu ngakhale kuti akuchiritsidwa ndi mankhwala abwino kwambiri, chiwerengero cha imfa chikuposa chiwerengero cha khansa. Entresto imachepetsa imfa, imaletsa kuchipatala ndikupanga anthu kukhala ndi HF-REF akumverera bwino. "
Ndinakopeka ndi zinthu zingapo za yankho limeneli. Choyamba, kampaniyo sinali yokonzeka ndi yankho yomweyo (zomwe ndimamva) ndi funso lodziwika bwino komanso lofunika.
Komanso, kampaniyo sichikana kuti chiopsezo cha neprilysin chikhoza kuvulaza mitundu yambiri ya matenda aakulu. Mfundo yakuti maphunziro awo sanasonyeze umboni wa kuonongeka kotereku ndikutonthoza, koma tiyenera kuzindikira kuti maphunziro a Entresto onse akhala ochepa, ndipo sizowoneka kuti odwala omwe amachitira ndi Entresto ankayang'aniridwa makamaka ndi amyloidosis, khansa ya Alzheimer kapena prostate .
Pomalizira pake, kampaniyo ikuonetsa kuti vuto la mtima ndi loipa kwambiri ngakhale kuti mankhwalawa amachititsa kuti matendawa awonongeke kapena kuwonjezereka, pangakhale pangozi.
Izi, mwachiwonekere, ndi nkhani yoweruza. Ngati wodwalayo amawona kuti phindu lake ndi lofunika zimadalira payekha kuti adziwe kuopsa kwake ndi zotsatira zake. Izi ndizovuta zofufuza, ndithudi, ngati sizikutchulidwa kuti zoopsa zonse.
Mfundo Yofunika Kwambiri
Entresto ikuwoneka ngati mankhwala okhwima kwa odwala omwe ali ndi mtima wolephera, ndipo mosakayikira adzagwiritsidwa ntchito kwambiri. Mosakayika kuthandiza odwala ambiri omwe ali ndi mtima wosalimba kukhala ndi moyo wautali, ndipo ali ndi zizindikiro zochepa.
Koma makamaka chifukwa Entresto ali ndi mankhwala a blockbuster, ndipo ambiri odwala adzadziwidwa ndi neprilysin kutetezedwa kwa nthawi yoyamba, zidzakhala zofunikira kwambiri kwa Novartis (ndi FDA) kuti azifufuza mosamala kwambiri, choncho kuti zotsatira zilizonse zosayembekezereka zikhoza kuzindikiridwa mofulumira.
Zotsatira:
McMurray JJV, Packer M, Desai AS, ndi al. Angiotensin-neprilysin kulepheretsa kusokoneza mtima kwa mtima. N Engl J Med 2014; DOI: 10.156 / NEJMoa1409077.
Jessup M. Neprilysin chiletso-njira yatsopano yoperewera mtima. N Engl J Med 2014; DOI: 10.1056 / NEJMe1409898.