A cikin Yuli, 2015, FDA ta amince da sabuwar magani ta Entresto (Novartis) don maganin zuciya ta rashin ƙarfi. Za ka iya karanta game da Entresto a nan.
Tsibirin wannan sababbin miyagun ƙwayoyi yana da girma a tsakanin masu fama da rashin lafiya, kuma saboda kyakkyawan dalili. A cikin babban gwajin gwaji (PARADIGM-HF), Entresto ya fi girma a cikin enalapril, wanda a halin yanzu shine babban hanyar maganin marasa lafiya da zuciya daya.
Shigar da shi ne na farko na ƙungiyar ARNI na kwayoyi. Wadannan kwayoyi sun hada wani mai hana ginin ARB (a wannan yanayin, valsartan), tare da mai hana neprilysin (sacubitril). Nunawar Neprilysin shine sabon fasalin kwayoyin ARNI.
Lokacin da kwayar cutar neprilysin ta haramta a cikin marasa lafiya na zuciya, matakan jini na yawan peptides na natriuretic sun karu. Saboda peptides na al'ada zai iya zama da amfani a cikin hasara na zuciya, masu bincike sun ɗauka cewa kwayoyi kamar Entresto zai iya inganta sakamakon marasa lafiya da wannan yanayin. Sakamakon binciken PARADIGM-HF ya nuna cewa masu bincike sun dace.
Shin Akwai Ƙananan Ƙananan zuwa Tsarin Nahiyar Nahiyar Nahiyar Afrika?
Duk da yake Entresto ya zama mai tasiri da lafiya a cikin gwajin PARADIGM-HF, akwai sauran abubuwa da ba mu sani ba game da hanawar neprilysin na dogon lokaci.
Neprilysin yana da ayyuka masu yawa banda su rage girman matakan da ke cikin kullun halitta, kuma wasu daga cikin waɗannan ayyukan suna da amfani.
Sabili da haka hana cikewar neprilysin bazai zama abu mai kyau na duniya ba.
Musamman ma, neprilysin ta rushe kamuwa da sunadaran da ba'a so a cikin jiki, ciki har da sunadaran da ke hade da cutar Alzheimer da amyloidosis , har ma da ciwon ciwon sankara . A gaskiya ma, masu bincike suna neman rayayyun kwayoyi wanda zai iya ƙara aikin neprilysin, cikin fatan cewa zai iya taimakawa wajen magance ko hana yanayin kamar waɗannan.
Saboda haka, duk da cewa an samu rahotanni masu yawa a ciki tare da Entresto a cikin gwajin PARADIGM-HF, har yanzu akwai yiwuwar samun sakamako masu tsawo na tsawon lokaci tare da maganin miyagun ƙwayoyi wanda ke hana neprilysin.
A cikin wani binciken da na yi game da Entresto, na iya samun koyaswa (ko masu bincike ko Novartis) ya nuna game da mummunan sakamakon da ake yi na hana neprilysin na kullum. Don haka sai na tuntube Novartis don tambaya ko kamfanin yana da shaidar, hanyar daya ko daya, ta amfani da Entresto na iya shafar hadarin cututtuka irin su Alzheimer, amyloidosis, ko ciwon daji.
Novartis Sakamakon:
Bayan 'yan kwanaki a lokacin da kamfanin ya shawarci masana, sai na karbi wannan amsa daga Novartis. A nan ya cika:
"Neprilysin yana cikin matakai masu yawa a cikin jiki ciki har da warware wasu nau'o'in kullun da suka dace, wanda - ta hanyar ci gaba da neprilysin - Entresto yana taimakawa wajen bunkasa, yana haifar da tasiri mai amfani a cikin marasa lafiya na zuciya. Neprilysin yana daya daga cikin mahaukacin da ke ciki. Sakamakon shirin shirin ci gaba na PARADIGM-HF, tare da mutane fiye da 10,000 ne suka yi nazarin, ba ya nuna wani mummunan sakamako da ya shafi amyloidosis, Alzheimer's ko kuma prostate cancer tare da Entresto. Yana da muhimmanci a lura cewa marasa lafiya da ciwon zuciya sun sami 50 % yawan mutuwar mutum a shekaru 5 duk da lura da maganin likita mafi kyau yanzu, yawan mutuwa ya fi yadda yawancin cututtuka suke ciki.
Abubuwa nawa sun buge ni game da wannan amsa. Da farko dai, kamfanin bai shirya ba da amsawa da sauri (abin da nake ji) shi ne tambaya mai mahimmanci da muhimmanci.
Bugu da ƙari, kamfanin ba ya ƙin haɗarin cewa hadarin neprilysin zai iya cutar da wasu cututtuka masu tsanani. Gaskiyar cewa nazarin su bai nuna hujjar wannan damuwa ba ne mai ta'aziyya, amma ya kamata mu lura cewa karatu tare da Entresto sun kasance tsawon lokaci kaɗan, kuma ba a bayyana cewa marasa lafiya da aka kula da Entresto sune kula da amyloidosis, Alzheimer's or cancer prostate .
A ƙarshe, kamfanin ya nuna cewa rashin ƙarfi na zuciya shi ne yanayin mummunan yanayin ko da idan miyagun ƙwayoyi ya haifar da cutar da waɗannan cututtuka, hadarin zai zama darajar shan.
Wannan, a bayyane yake, shine batun shari'a na sirri. Ko mai haƙuri yana da haɗari kamar yadda ya dace ya dogara da ƙwarewar kansa na ƙalubalanci tare da amfanin. Wannan ƙari ne mai wuya don yin, ba shakka, idan ba'a kira duk hadarin ba.
Layin Ƙasa
Rikicin yana bayyana ya zama magunguna mai tursasawa ga marasa lafiya da ciwon zuciya, kuma za a yi amfani da shi sosai. Babu shakka zai taimaka wa marasa lafiya da yawa tare da ciwon zuciya na rayuwa tsawon lokaci, kuma tare da ƙananan alamu.
Amma musamman saboda Entresto yana da makirci na magunguna, saboda haka yawancin marasa lafiya za a bayyana su a farkon lokaci, to zai zama mahimmanci ga Novartis (da kuma FDA) don gudanar da karatun bayanan kasuwanci, don haka cewa ana iya gane duk wani sakamako na "wanda ba zato ba tsammani" da kuma halin da sauri.
Sources:
McMurray JJV, Mista M, Desai AS, et al. Angiotensin-neprilysin hanawa zuwa enalapril a cikin zuciya rashin cin nasara. N Engl J Med 2014; DOI: 10.156 / NEJMOA1409077.
Jessup M. Neprilysin ba da izini ba - wani labari ne don rashin nasara. N Engl J Med 2014; DOI: 10.1056 / NEJMe1409898.