Har zuwa kwanan nan, yawancin likitoci sun hada da maganin cholesterol-diet-CHD. Na farko, matakan cholesterol a cikin jini ko hypercholesterolemia na haifar da cututtukan zuciya na zuciya (CHD). Na biyu, abun da ke cin abinci mai arziki a cikin kitsen dabba da ƙwayar cholesterol ƙara yawan ƙwayoyin cholesterol cikin jini. Na uku, rage ƙananan cholesterol a cikin jini yana rage haɗari ga cututtukan zuciya.
A darajar fuska, maganin cholesterol-diet-CHD ya zama alama. Bayan haka, "mu ne abin da muke ci," kuma idan muka ci abincin da ke cikin cholesterol da kuma fat (dabbobi), to, za mu iya tashi daga jini. Bugu da ƙari kuma, saboda alamun-wanda ke daɗaɗɗo maganin jini da kuma haifar da CHD da bugun jini-suna cikin ɓangare na cholesterol, ƙananan ƙwayar cholesterol a cikin jini na biyu zuwa cin abinci zai kara yawan haɗarin ga CHD da bugun jini. Kuma, idan kun kasance kuna rage ƙwayoyin cholesterol a jininku ta hanyar amfani da magunguna, to, ku rage yawan hadarin ku na CHD da bugun jini, dama? To, game da duk waɗannan tsammanin, yana da wuya.
Mafi yawan kwanan nan, canjin canji ya kasance a cikin ka'idodin da ke jagorantar kulawar CHD. Ba mu da tabbacin cewa cin abinci mai cike da abinci a cikin cholesterol da fatsari mai mahimmanci shine ke da alhakin ƙara yawan ƙwayar cholesterol a jini. Bugu da ƙari kuma, ba mu da tabbas ko rage yawan ƙwayoyin cholesterol na jini wadanda ke da hatsari ga cututtukan zuciya don taimakawa wajen kawar da bugun jini, angina marar ƙarfi, ciwon zuciya kuma mafi.
Duk abin da muka sani shi ne salon gyaran salon (misali, asarar nauyi, motsa jiki da kuma shan taba) har da statins, ko magungunan kamar Zocor da Crestor, waɗanda suke daidaita lambobi kuma suna ci gaba da rage lipoprotein cholesterol (LDL-C) ko "mummunan" cholesterol, mai yiwuwa taimakawa wajen hana mutuwa da sauran cututtuka na zuciya,
Evolocumab yana cikin sababbin miyagun ƙwayoyi. A cikin gwaje-gwaje na asibiti an nuna cewa an rage yawan LDL-C a yawancin yawan masu halarta - musamman ma wadanda ke da cututtukan kwayoyin da ake kira hypercholesterolemia wanda ke haifar da matakan cyclopean (ainihin gaske) na cholesterol cikin jini. Yanzu ko ko evolocumab zai ba da wani amfãni a yawancin mutane da ke fuskantar hadarin mutuwa da kuma abubuwan da suka faru da cutar cututtukan zuciya ya kasance da za a gani, kuma yana iya dogara ne akan sakamako na tsawon lokaci ko nazarin karatu wanda ke lura da mahalarta a cikin shekarun evolocumab (Repatha ) farfadowa. A wasu kalmomi, kawai lokaci zai gaya ko evolocumab aiki.
Menene Evolocumab?
Evolocumab ya kasance mai cin zarafi na mutumclonal na mutum wanda ke ɗaure kuma ta haka ya hana PCSK9 gina jiki. Wannan furotin yana rikici tare da mai karɓa wanda zai karbi LDL-C don cin hanci da hanta kuma yana tsoma baki da ikon mai karɓa na sake maimaitawa. (Abin sha'awa, bincike ya nuna cewa statins na iya zama kamar yadda ya dace da PCSK9; duk da haka, yayin da aka yi amfani da shi, statins da evolocumab ba daidai ba ne su yi haɗaka ko kuma su yi haɓaka.)
A halin yanzu, Amgen, mai aikatawa na evolocumab, yana gudanar da gwaje-gwajen gwaje-gwaje masu yawa a cikin yawan marasa lafiya a fadin duniya.
Sakamakon waɗannan gwaji sunyi alhaki game da ikon da evolocumab ya rage matakan LDL-C. Alal misali, a cikin gwajin farko na Phase 3, mahalarta tare da mummunan iyali na hypercholesterolemia (homozygous familial hypercholesterolemia) wadanda suke kan farfadowa na statin (wasu sun kasance a kan wata kwayar cutar cholesterol da ake kira Zetia) sun karu da kashi 31 cikin dari a LDL-C matakan a 12 makonni idan aka kwatanta da mutanen da ba su karbi magani ba. (Mahalarta sun samu kashi 23 cikin 100 a apolipoprotein B.) Abu mai mahimmanci, evolocumab ya yi aiki da sauri fiye da wasu sababbin kwayoyi masu saukowa: lomitapide da mipomersen.
Don taya, dangane da illa maras kyau, evolocumab ya fi jituwa fiye da lomitapide da mipomersen.
A cikin wani gwaji na Phase 3, masu halartar da basu yarda da akalla guda biyu ba, kuma sun kasance tare da kawai evolocumab da Zetia sun karu da kashi 53 zuwa 56 cikin LDL-C idan aka kwatanta da kashi 37 zuwa 39 bisa dari a cikin mahalarta Zaria kadai. Bugu da ƙari kuma, evolocumab ya haifar da abubuwa masu ban mamaki fiye da Zetia.
A ƙarshe, a cikin binciken na Phase 2, a cikin mahalarta tare da hypercholesterolemia kuma riga a kan matsakaici- zuwa gagarumin magungunan statin, evolocumab ya rage LDL-C matakan daga 66 zuwa 75 bisa dari lokacin da aka gudanar sau biyu a wata.
Zai iya taimaka wa marasa lafiya?
A wannan batu, shaidun har yanzu ba a kan ko ko evolocumab zai iya ba da wani amfanar kiwon lafiya ga mutanen da ke fuskantar hadarin bugun jini da ciwon zuciya. Hakanan rage rage yawan matakan cholesterol yana nufin kadan a yawancin mutane, ma'anar sabon sharuɗɗa na ACC / AHA an fitar da wani mahimmanci wanda ya kawar da matakan ciwon sukarin cholesterol. Bugu da ƙari kuma, waɗannan sharuɗɗa sun nuna cewa statins, kawai kwayoyi da ke nuna duk wani amfani wajen rage cututtukan zuciya da cututtukan zuciya, ya kamata a sanya su a cikin mutanen da suka riga sun kamu da cutar zuciya (cututtuka ko ciwon zuciya), mutane da LDL-C matakan fiye da 190 ( ƙananan matakan "cholesterol" maras kyau), mutanen da ke da shekaru 40 zuwa 75 da ciwon sukari iri biyu, da kuma mutanen da ke da shekaru 40 zuwa 75 suna fama da cutar na zuciya kashi 7.5 cikin shekaru 10 masu zuwa.
Idan a cikin gwaji na asibitocin da ke bin mahalarta shekaru, evolocumab ya tabbatar da tasiri akan cututtukan cututtuka na zuciya kamar cututtuka da ƙaddarar zuciya, to, muna kallon nasarar da aka samu na magani wanda kawai za'a iya kwatanta da statins. Har ila yau, muna fuskantar tabbacin maganganun cholesterol-diet-CHD wanda ya tabbatar da rashin tabbas dangane da shekarun binciken kimiyya. Ƙarshe, ikon evolocumab na ƙarfin ƙananan layin LDL-C a yawancin masu takara masu yawa yana tunawa da ƙwayar likitancin Zetia, wadda ta tabbatar da zama marar amfani (ko ma dan kadan) don hana ginin rubutu a cikin mahalarta nazarin. A wasu kalmomin, Zetia ya zama kasaci kuma haka zai iya zama evolocumab
> Sources
> "Anti-PCSK9 Antibody yana da kyau ya rage Cholesterol a cikin marasa lafiya tare da tsananin damuwa" by Erik Stroes da abokan aiki da aka wallafa a ranar 11/23/2014 (e-pub kafin bugawa) a cikin Journal of the American College of Cardiology.
> Bersot TP. Babi na 31. Drug Far for Hypercholesterolemia da Dyslipidemia. A cikin: Brunton LL, Chabner BA, Knollmann BC. eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics, 12th . New York, NY: McGraw-Hill; 2011.
> "Hanyoyin evolocumab ko ezetimibe sun kara wa ka'idar LDL-C zuwa matsakaici ko tsaka-tsaki a kan marasa lafiya tare da hypercholesterolemia: gwajin LAPLACE-2 na asibiti" by JG Robinson da abokan aiki da aka buga a JAMA ranar 5/14/2014.
> "Tsarin PCSK9 tare da evolocumab a cikin homozygous iyali hypercholesterolemia (TESLA Sashe na B): ƙaddamarwa, layi biyu, gwajin gwagwarmayar wuri" da FJ Raal da abokan aiki da aka wallafa a The Lancet a ranar 10/2/2014.