Wasu masu ilimin likitan zuciya suna cike da sababbin sababbin magungunan cholesterol.
A Cibiyar Nazarin Harkokin Kimiyya ta Jami'ar Amirka (ACC) ta Cibiyar Nazarin Harkokin Kimiyya (ACC) wadda ta shirya a cikin garin San Diego a tsakiyar watan Maris na 2015, iska ta yi nauyi da magana game da masu hanawa PCSK9. Musamman ma, yawancin masu kwakwalwa a ciki sun kasance suna nuna damuwa game da sakamakon binciken da aka samu na tsawon shekara a kan Repatha na Amgen (evolocumab) . A cikin gwaje-gwaje na asibiti, masu zanga-zangar PCSK9 kamar evolocumab da Regeneron / Sanofi's Praluent (alirocumab) sun nuna cewa rage LDL-C ("bad" cholesterol) akalla kamar yadda statins da watakila more .
( Statins suna da kwayoyi irin su Zocor da Crestor.
Daga qarshe, kawai ragewan LDL cholesterol matakan kawai don rage su bazai iya ba da wani amfani na musamman ba tare da rage haɗarin abubuwan da ke faruwa na zuciya ba kamar yadda annoba da ciwon zuciya suka faru. Kuma don gano ko irin wannan amfanin na tsawon lokaci, muna bukatar nazarin lokaci na tsawon lokaci ... tsawon shekaru fiye da ƙarfafawa, duk da haka, sakamakon shekaru guda da muke shaida yanzu.
Mene ne masu hana PCSK9?
Proprotein convertase subtilisin / Kexin type 9 ko PCSK9 ne wani nau'i wanda ke taka muhimmiyar rawa a cikin cholesterol da fatty acid metabolism. Mutanen da ba su da bambancin kwayoyin cutar PCSK9 an lura da cewa suna da matakan LDL-C ("mummunan cholesterol") wanda ya dace da waɗanda suke a cikin matsanancin ka'ida. Bugu da ƙari kuma, an danganta maye gurbi a cikin jigon jini tare da cin zarafin mahaifa na jini, mummunan cutar wanda ke haifar da matakan da ke cikin lipids ko cholesterol da cututtukan zuciya.
Dangane da irin wannan sanarwa, kamfanonin likitanci Amgen da Regeneron / Sanofi sun kirkiro magunguna guda daya wadanda ke sa ido ga kamfanonin PCSK9 (wanda aka tsara ta hanyar PCSK9): Repatha da Praluent bi da bi.
Sakamako bayan Shekaru ɗaya (ish) na Farfesa tare da Masu Gyara PCSK9
Ranar 17 ga Maris, 2015, New England Journal of Medicine ta buga wasu takardu biyu da ke bayyanewa daga mako-mako na mako-mako na OSLER-1 da OSLER-2 na evolocumab daga sakamakon gwajin gwaji na Regeneron / Sanofi na ODYSSEY.
Wasu sakamako mai mahimmanci daga gwajin OSLER sun haɗa da wadannan:
- Ta hanyar makonni 48 na farfadowa, evolocumab ya ci gaba da rage yawan LDL-C da kashi 61 cikin 100 na mahalarta da matakan da ke dauke da cutar na zuciya.
- Ta hanyar makonni 52 na farfadowa, ƙwayar cututtuka na zuciya (ciwon zuciya, bugun jini, TIA da sauransu) ya kasance kashi 2.18 bisa dari a cikin wadanda ke halartar ba su karɓar evolocumab amma a kan farfadowa na farfadowa (shan kashi) da kashi 0.95 na wadanda ke shan evolocumab kuma a kan farfadowa na farfadowa na kulawa (shan jinsin).
- Ƙananan abubuwa masu ban sha'awa tare da cututtuka masu banƙyama da suka hada da arthralgia, ciwon kai, ciwo mai rauni, da kuma gajiya sun karu da yawa akai-akai a cikin mahalarta ɗauke da evolocumab.
Wasu sakamako masu muhimmanci daga ODYSSEY gwaji sun haɗa da wadannan:
- Ta hanyar makonni 70 na farfadowa, alirocumab ya rage yawan LDL-C da kimanin kashi 60 cikin dari a duk mahalarta ciki har da marasa lafiya marasa lafiya (wadanda ke tare da hypercholesterolemia ko ƙananan cututtuka irin na shan taba, da ciwon sukari da sauransu).
- Abubuwa masu lalacewa da aka samo don magance su tare da kamfanonin kamfanonin kamfanoni sun hada da halayen injection-site, myalgia, neurocognitive da ophthalmologic events.
- Dukkan marasa lafiya a cikin wannan binciken sun riga sun kasance a kan ka'idodin-ko dai kashi biyu ko kashi mafi yawa. A cikin marasa lafiya da ke karɓar kamfanonin alirocumab, yawancin kwayoyin cutar na zuciya sun kasance kashi 1.7 cikin kashi dari 3.3 bisa dari a cikin wadanda ke faruwa.
Shin masu hana PCSK9 ne na sababbin dokoki?
Kwararrun likitocin yanzu suna tambayar yanayin matsayin cholesterol a matsayin mai tantance halitta. Kamar yadda muka koya daga bincike na baya, wasu magungunan da kawai rage LDL-C, karuwar HDL da sauransu zasu iya ba da wani amfani na duniya kamar rigakafin bugun jini ko ciwon zuciya. Hanyar da cholesterol da lipids suke hulɗa a cikin jikinmu sun fi rikitarwa fiye da yadda muke fahimta yanzu.
A halin yanzu, mafi kyawun zaɓi da muke da shi don magance cututtukan zuciya shine statins, wata magungunan magani na musamman wanda zai hana abubuwan da ke faruwa a zuciya na zuciya. Wadannan magungunan na iya aiki ne ta hanyar rage ƙaddarar LDL amma har ma ta hanyar gyaran takardu waɗanda ke kwantar da hankalinmu.
Domin a yi la'akari da masu amfani da PCSK9 da amfani a matsayin statins, muna buƙatar shekaru masu yawa na sakamako, wanda shine dalilin da ya sa Amgen ke aiki tare da binciken FOURIER a halin yanzu. Binciken na FOURIER zai zama bincike na shekaru biyar na gudanar da aikin evolocumab a cikin wadanda ke dauke da kwayoyin da kuma mafi yawan haɗari ga cututtuka na zuciya irin su bugun jini da kuma ciwon zuciya. (Idan kana da sha'awar, AMGEN yana neman masu mahalarta a yanzu don nazarin.) Tare da sakamakon daga binciken FOURIER, masu bincike sunyi fatan mika karuwar yawan abubuwan da ke faruwa a cikin kwayar cutar zuciya a cikin shekara daya zuwa shekaru da dama . Bugu da ƙari, sakamakon daga binciken zai iya taimaka mana mu fahimci abin da yawancin masu haƙuri zai fi amfana daga masu hanawa PCSK9.
A cikin 'yan shekarun nan, idan muka ga kyauta na tsawon lokaci na zuciya, to, zamu iya kallon nasarar Aminiya, mai aikin evolocumab. Irin wannan nasarar yana da matsala domin baya ga rashin sanin tabbas yawan mutanen da ke fama da rashin lafiya zasu iya amfani da su daga evolocumab, akwai wani abu mai ban tsoro game da mai hana PCSK9: Bincike ya nuna cewa a wasu mutane, evolocumab da alirocumab na iya rikici tare da tsarin kulawa na tsakiya. Ƙari musamman, jarrabawar ODYSSEY ya nuna cewa samari na kamfanoni na iya shawo kan ƙwaƙwalwar ajiya, haifar da amnesia ko haifar da rikice.
Sources
Mataki mai taken "PCSK9 hanawa marasa lafiya tare da hypercholesterolemia" na NR Desai da MS Sabatine daga Elsevier a shekarar 2015. An sami damar daga Clinical Key akan 3/15/2015.
Mataki mai suna "Ƙarfafawa da Tsaro na Alirocumab a Rage Rashin Lafiya da Jirgin Lafiya" na JG Robinson da mawallafa daga NEJM 3/17/2015. An sami dama a ranar 3/15/2015.
Mataki mai suna "Ƙarfafawa da Tsaro na Evolocumab a Rage Ruwa da Lafiya" na MS Sabatine da masu marubuta daga NEJM 3/17/2015. An sami dama a ranar 3/15/2015.
Mataki mai taken "Ƙaddamar da LDL Cholesterol Is Good, amma Ta yaya kuma a cikin wanda?" by NJ Stone da DML James daga NEJM 3/17/2015.