AbbVie atogepant: tiv thaiv kev kho mob paroxysmal migraine, siv tau thiab nyab xeeb! --- 2/2

Hauv thaj tsam ntawm mob taub hau, AbbVie tau muag BOTOX (onabotulinumtoxinA) thiab Ubrelvy (ubrogepant). Ntawm lawv, BOTOX yog thawj qhov tshuaj tiv thaiv rau cov neeg laus mob migraine tau pom zoo los ntawm Asmeskas FDA, thiab Ubrelvy yog thawj qhov ncauj CGRP receptor antagonist (gepant) pom zoo los ntawm Asmeskas FDA rau cov neeg laus migraine (nrog lossis tsis muaj Aura) kho mob hnyav.

ADVANCE txoj kev tshawb fawb' thawj qhov kawg tshwm sim (Duab qhov chaw: NEJM)

ADVANCE yog ntau lub chaw, ua piv txwv, muab ob npaug rau qhov muag tsis pom, tswj cov placebo, sib koom ua ke pab pawg theem 3 kev sim tsim los ntsuas qhov ua tau zoo, nyab xeeb thiab tiv taus ntawm qhov ncauj atogepant hauv kev tiv thaiv kev mob taub hau. Tag nrho ntawm 910 tus neeg mob tau muab faib ua 4 pawg kho mob, nrog 3 koob tshuaj (10mg, 30mg, 60mg) ntawm atogepant thiab cov placebo, hais lus ib hnub ib zaug. Kev tshuaj xyuas kev ua tau zoo raws li kev hloov kho lub hom phiaj-rau-kho (mITT) cov pej xeem ntawm 873 tus neeg mob.

Thawj qhov kawg yog kev hloov pauv nruab nrab ntawm cov hnub mob taub hau ib hlis piv rau cov hauv paus hauv kev kho mob 12 lub lis piam. Cov ntaub ntawv qhia pom tias txhua pawg tshuaj atogepant tau mus txog qhov kawg qhov kawg, thiab tus naj npawb nruab nrab ntawm cov mob migraine hnub nyob rau ib hlis tau txheeb cais txo qis piv nrog cov placebo. 10mg/30mg/60mg atogepant pab pawg txo los ntawm 3.7/3.9/4.2 hnub, thiab cov placebo pawg tau txo 2.5 hnub (piv nrog cov placebo pawg hauv txhua pawg tshuaj, p<>

Thaum lub sijhawm kho 12-lub lim tiam, qhov ua ntej tau teev tseg, ntau qhov kev tswj hwm qhov kawg qhov txiaj ntsig tau suav nrog:

Tus naj npawb ntawm hnub mob taub hau hauv ib hlis: 10mg/30mg/60mg atogepant pab pawg txo qis 3.9 (lub hauv paus 8.4), 4.0 (lub hauv paus 8.8), 4.2 (lub hauv paus 9.0) hnub, feem, cov placebo pawg tau txo los ntawm 2.5 hnub (hauv paus 8.4 hnub) (Sib piv nrog pawg placebo hauv txhua pawg tshuaj, p<>

—— Qhov nruab nrab ntawm cov hnub uas siv tshuaj hnyav ib hlis: 10mg/30mg/60mg piv nrog cov pab pawg atogepant pib txo los ntawm 3.7/3.7/3.9 hnub, feem, cov placebo pawg tau txo los ntawm 2.4 hnub (txhua pawg tshuaj piv nrog pawg placebo, p<>

—— Qhov kev faib ua feem ntawm cov neeg mob nrog hnub mob migraine txhua hli txo los ntawm %50%: Hauv 12-lub lim tiam kev kho mob, 55.6%/58.7%/60.8%ntawm cov neeg mob hauv 10mg/30mg/60mg atogepant pab pawg txo los ntawm %50%, thiab qhov kev faib ua feem ntawm cov neeg mob hauv pawg placebo mus txog tus qauv Nws yog 29.0% (txhua pawg tshuaj sib piv nrog cov placebo pawg, p<>

——Migraine-specific quality of life questionnaire version 2.1 (MSQ v2.1) lub luag haujlwm muaj nuj nqis txwv tus qhab nia: hauv lub lim tiam 12, piv nrog pab pawg placebo, 10mg/30mg/60mg atogepant pab pawg tau zoo dua qub (9.9 ntsiab lus, 10.1) cov ntsiab lus, 10.8 cov ntsiab lus; txhua pawg koob tshuaj piv nrog pab pawg placebo, p<>

——AIM-D cov haujlwm niaj hnub sau cov qhab nia hauv qhov nruab nrab txhua hnub mob taub hau: piv rau cov pab pawg placebo, nws tau pom tias qhov nruab nrab txhua hli AIM-D cov haujlwm niaj hnub suav cov qhab nia ntawm 30mg pab pawg thiab 60mg pab pawg tau nce ntau. 30mg pawg yog -2.5 ntsiab lus (p=0.0005), 60mg pawg yog -3.3 ntsiab lus (p<>

—— Zoo ib yam li qhov ua tau zoo hauv kev ua haujlwm niaj hnub, kev raug mob ntawm lub cev hauv AIM-D cov qhab nia qhia tias piv nrog cov pab pawg placebo, 30 mg thiab 60 mg atogepant pawg muaj kev txhim kho zoo dua, thiab 30 mg pab pawg muaj kev txhim kho ntau yam ntawm -2.0 (p=0.0021), kev txhim kho ntau ntawm 60mg pawg yog -2.5 (p=0.0002).

Hauv txoj kev tshawb fawb no, txhua qhov koob tshuaj atogepant tau raug zam zoo. Feem ntau (%5%) cov xwm txheej tsis zoo tau tshaj tawm tsawg kawg ib pab pawg kho mob atogepant tau cem quav (6.9-7.7% hauv txhua pawg tshuaj, 0.5% hauv pawg placebo), xeev siab (4.4-6.1% hauv txhua pawg tshuaj, cov placebo) 1.8% hauv pawg koob tshuaj), kab mob ua pa rau sab saud (3.9-5.7% hauv txhua pawg tshuaj, 4.5% hauv pawg placebo). Feem ntau ntawm cem quav, xeev siab, thiab kab mob ua pa kab mob hauv lub cev tau me me lossis me me hauv qhov hnyav thiab tsis ua rau tsis ua tiav.