Idatha ePositive yoNyango loThintelo lweMigraine eNgapheliyo

Uphononongo olubalulekileyo lweSigaba se-3 esivavanya ukucamagushela kwizigulane ezikhulileyo ezine-migraine ezingapheliyo zidibana nesiphelo esisisiseko sokunciphisa ngokwezibalo ukusuka kwisiseko kwimihla yenyanga ye-migraine xa kuthelekiswa ne-placebo kwixesha le-12-iveki yonyango.

U-AbbVie namhlanje ubhengeze ukuba iSigaba sesi-3 INKQUBO yovavanyo yokuvavanya i-atogepant (QULIPTA™ eUnited States), i-peptide yomlomo ye-calcitonin ehlobene ne-gene (CGRP) i-receptor antagonist (gepant) yokukhusela unyango lwe-migraine engapheliyo kubantu abadala, yadibana nesiphelo sayo esisisiseko sokunciphisa ngokwezibalo ukusuka kwisiseko kwimihla yenyanga ye-migraine xa kuthelekiswa ne-placebo. , kuzo zombini i-60 mg kanye imihla ngemihla (QD) kunye ne-30 mg kabini imihla ngemihla (BID) iidosi, kwixesha le-12-iveki yonyango. Uphononongo luphinde lwabonisa ukuba unyango nge-atogepant 60 mg QD kunye ne-30 mg BID ibangele uphuculo olubalulekileyo lwezibalo kuzo zonke iiphelo zesibini emva kokulungelelaniswa kothelekiso oluninzi.

Esi sigaba se-3, ihlabathi, i-randomized, i-double-blind-blind, i-placebo-controlled, i-parallel-group study ihlolisise ukusebenza, ukhuseleko, kunye nokunyamezela kwe-atogepant yomlomo ukwenzela unyango olukhuselayo lwe-migraine engapheliyo, isifo se-neurological ephazamisayo apho izigulane zifumana intloko ebuhlungu. kwi-15 okanye ngaphezulu kweentsuku ngenyanga ngaphezu kweenyanga ezintathu, ubuncinane iintsuku ezisibhozo ngenyanga zineempawu zentloko ye-migraine. kumaqela amathathu onyango ukufumana i-2,3 mg QD ye-atogepant, i-778 mg BID ye-atogepant, okanye i-placebo.

Ukusebenza kwahlalutywa kusetyenziswa iinkcazo ezimbini ezahlukeneyo kancinane zabemi besigulane ngokusekelwe kwingxelo ye-arhente elawulayo e-United States kunye ne-European Union. I-United States-igxininise, i-modified intent-to-treat (mITT) yabemi ibandakanya izigulane ze-755 ezineentloko ezivavanywayo ze-eDiary data eqokelelwe ngexesha lokunyanga kabini. I-European Union-focused off-treatment hypothetical estimand (OTHE) yabemi iquka izigulane ze-760 ezineentloko ezivavanywayo idatha ye-eDiary eqokelelwe ngexesha lonyango oluyimfama kabini kunye nexesha lokulandelelana.

Kuzo zonke iiveki ze-12, ngokusekelwe kwinani labantu be-mITT, izigulane kwi-atogepant ye-60 mg QD kunye ne-30 mg BID iingalo zonyango zophononongo, zafumana ukuncipha kwe-6.88 kunye ne-7.46 yeentsuku ze-migraine zenyanga, ngokulandelanayo, xa kuthelekiswa nezigulane kwi-placebo ingalo, ngubani bafumana ukuhla kweentsuku ze-5.05 zenyanga ze-migraine (60 mg QD vs. placebo, p = 0.0009; 30 mg BID vs. placebo, p <0.0001, ilungelelanise ukuthelekisa ezininzi). Ngokusekelwe kwi-OTHE yabemi, kwiiveki ze-12, izigulane kwi-60 mg QD kunye ne-30 mg BID yeengalo zonyango ze-atogepant zophononongo, zafumana ukuhla kwe-6.75 kunye ne-7.33 yeentsuku ze-migraine zenyanga, ngokulandelanayo, xa kuthelekiswa nezigulane kwingalo ye-placebo, owafumana ukuncipha kweentsuku ze-5.09 zenyanga ze-migraine (60 mg QD vs. placebo, p = 0.0024; 30 mg BID vs. placebo, p = 0.0001, ilungelelanise ukuthelekisa ezininzi).

Uphononongo lubonise ukuba unyango nge-atogepant 60 mg QD kunye ne-30 mg BID ibangele uphuculo olubalulekileyo lwezibalo kuzo zonke iziphelo zesibini kuzo zombini uhlalutyo olusebenzayo lwabantu.

Isiphelo esiphambili sesibini silinganisa umlinganiselo wezigulane eziphumelele ubuncinane i-50% yokunciphisa iintsuku zenyanga ze-migraine kwiiveki ze-12. Ngokusekelwe kuluntu lwe-mITT, uvavanyo lubonise ukuba i-41.0% / 42.7% yezigulane kwi-60 mg QD kunye ne-30 mg BID i-atogepant arms, ngokulandelanayo, iphumelele ubuncinane i-50% yokunciphisa, xa kuthelekiswa ne-26.0% yezigulane kwi-placebo ingalo. onke amaqela ethamo ngokuchasene ne-placebo, p≤0.0009, ilungelelaniselwe ukuthelekisa okuninzi). Ngokusekelwe kuluntu lwe-OTHE, ulingo lubonise ukuba i-40.1% / 42.1% yezigulane kwi-60 mg QD kunye ne-30 mg BID i-atogepant arms, ngokulandelanayo, iphumelele ubuncinane i-50% yokunciphisa, xa kuthelekiswa ne-26.5% yezigulane kwi-placebo ingalo. onke amaqela edosi vs. I-placebo, p≤0.0024, ilungelelanise uthelekiso oluninzi). 1

Inkcazo epheleleyo yokhuseleko lweSigaba se-3 PROGRESS yophando yayihambelana neziphumo zokhuseleko ezibonwe kwizifundo zangaphambili kwi-episodic migraine labantu. Iziganeko ezibi kakhulu ezichazwe ngokuphindaphindiweyo ≥ 5% ubuncinane kwingalo yonyango ye-atogepant, kwaye inkulu kune-placebo, yayiyi-constipant (10.0% ye-atogepant 60 mg QD, 10.9% ye-atogepant 30 mg BID, kunye ne-3.1% ye-placebo) , kunye ne-nausea (9.6% ye-atogepant 60 mg QD, i-7.8% ye-atogepant 30 mg BID, kunye ne-3.5% ye-placebo). Uninzi lweziganeko zokuqunjelwa kunye nesicaphucaphu bezithambile okanye ziphakathi ngobungqongqo. Uninzi lweziganeko zokuqunjelwa kunye ne-nausea azizange ziholele ekuyekisweni. Akukho miba yokhuseleko lwe-hepatic ichongiwe. Iziganeko ezimbi kakhulu zenzeke kwi-2.7% yezigulane ezine-atogepant 60 mg QD kunye ne-1.6% yezigulane eziphathwe nge-atogepant 30 mg BID, xa kuthelekiswa ne-1.2% yezigulane ezine-placebo. Akukho nanye kwezi ziganeko ezimbi zonyango eziye zavavanywa njengonyango olunxulumene nomphandi.

"U-AbbVie uphantse abe neminyaka eli-12 yamava ekunyangeni imigraine engapheliyo, isifo esibi. Siyazi ukuba akukho zigulana ezimbini ze-migraine ezifanayo, ngoko kubalulekile ukuba ababoneleli bezempilo babe neendlela ezahlukeneyo zonyango, "kusho uMichael Severino, MD, u-vice-sihlalo kunye nomongameli, u-AbbVie. "Ezi datha kunye nokuhanjiswa okulindileyo okulawulwayo kuqinisa ukuzibophezela kwethu kwipotfoliyo yethu ehamba phambili ye-migraine ukunceda abantu abangaphezu kwebhiliyoni kwihlabathi jikelele abahlala ne-migraine. Sijonge phambili ekuthatheni amanyathelo alandelayo ukuze sikwazi ukwandisa ukusetyenziswa kwe-atogepant e-United States ukubandakanya unyango olukhuselayo lwe-migraine engapheliyo kubantu abadala, kunye nokusebenza kunye nee-arhente ezilawulayo emhlabeni jikelele kwii-submissions ezongezelelweyo. "

Ezi nkcukacha zakha kwiSigaba se-3 ye-ADVANCE yeziphumo zophando, ezivavanya i-atogepant yokukhusela unyango lwe-episodic migraine.4 Isiphelo esiphambili seSigaba se-3 ADVANCE isifundo sasinciphisa ngokwezibalo kwimihla yenyanga ye-migraine kwinyanga ye-12-iveki yonyango xa kuthelekiswa. kwi-placebo.

Ngokusekelwe kwiziphumo zovavanyo lwesigaba se-3 PROGRESS kwi-migraine engapheliyo, u-AbbVie uzimisele ukuhambisa i-spaceal New Drug Application (sNDA) kunye ne-US Food and Drug Administration yokusetyenziswa okwandisiweyo kwe-atogepant ukubandakanya unyango olukhuselayo lwe-migraine engapheliyo. Ukongezelela, iziphumo zokufunda ezivela kwiSigaba sesi-3 solingo lwe-PROGRESS, kunye ne-Phase 3 yedatha ye-ADVANCE yovavanyo, kwi-episodic migraine, iya kwenza isiseko sokungeniswa kokulawulwa kwexesha elizayo kwihlabathi jikelele. Ukusetyenziswa kwe-atogepant yokuthintela unyango lwe-migraine engapheliyo e-United States ayivunywanga kwaye ukhuseleko lwayo kunye nokusebenza kwayo akuzange kuhlolwe ngabasemagunyeni abalawulayo. Ukusetyenziswa kwe-atogepant yokukhusela unyango lwe-episodic migraine kunye ne-migraine engapheliyo ngaphandle kwe-United States ayivunywanga kwaye ukhuseleko lwayo kunye nokusebenza kakuhle akuzange kuhlolwe ngabasemagunyeni abalawulayo.

Malunga nombhali

IAvatar kaJuergen T Steinmetz

UJuergen T Steinmetz

UJuergen Thomas Steinmetz uqhubekile esebenza kwishishini lokuhamba nokhenketho okoko wafikisa eJamani (1977).
Uye waseka eTurboNews ngo-1999 njengephepha leendaba lokuqala kwi-intanethi kushishino lokhenketho lwehlabathi.

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