FDA muab Lub Teeb Ntsuab rau AstraZeneca Ticagrelor

AstraZeneca tshaj tawm tias Brilinta (ticagrelor) Tau txais kev pom zoo nyob hauv Tebchaws Meskas kom txo qis kev pheej hmoo ntawm thawj lub plawv lossis mob hlab ntsha tawg hauv cov neeg mob uas muaj kev pheej hmoo mob plawv heev (CAD). CAD yog hom kab mob plawv tshaj plaws. Qhov no yog thawj zaug uas cov koomhaum tswj hwm tau pom zoo cov tshuaj aspirin ua ke nrog ticagrelor, dual antiplatelet therapy rau cov neeg mob uas muaj kev pheej hmoo mob plawv (CV) tab sis tsis muaj keeb kwm ntawm lub plawv nres lossis mob hlab ntsha tawg. Cov tshuaj no tau pom zoo thawj zaug los ntawm FDA rau Lub Xya Hli 20, 2011 rau cov neeg mob uas muaj mob hlab ntsha hlwb (ACS) kom txo qis kev muaj mob plawv dhia ntshav, thiab tau pom zoo los ntawm Tuam Tshoj Food and Drug Administration rau lub Kaum Ib Hlis 22, 2012 rau cov neeg mob nrog mob caj dab mob hlwb (tsis hnov ​​mob angina, tsis-ST-ntu nce myocardial infarction lossis ST-ntu theem myocardial infarction), qhov tshwm sim ntawm thrombotic hlab plawv cov xwm txheej raug txo qis.

Tsoom Fwv Teb Chaws Asmeskas FDA pom zoo raws li kev soj ntsuam Theem 3 kev soj ntsuam kuaj mob THEMIS. Kev sim siab pom tias hauv cov neeg mob plawv thiab mob ntshav qab zib hom 2 mob ntshav qab zib mellitus (T2D) muaj kev pheej hmoo siab los ntawm thawj lub plawv nres lossis mob hlab ntsha tawg, tshuaj aspirin ua ke nrog ticagrelor feem ntau cuam tshuam nrog kev mob plawv tsis zoo ntawm 36 lub hlis piv nrog tshuaj aspirin ib leeg lub ntsiab ntawm qhov kawg ntawm qhov kev tshwm sim muaj qhov kev xav tsawg tsawg. Lub ntsiab sib txuam kawg yog kev txo lub siab thiab mob nkees.

THEMIS yog qhov chaw nyob ntau lub teb chaws, muaj kev xaiv ntau, ob lub qhov muag tsis pom kev hauv qib 3 kev sim kho mob tau tsim los ntsuas qhov kev xav uas qhov sib xyaw ntawmticagrelorthiab cov tshuaj aspirin tuaj yeem txo qhov kev pheej hmoo loj ntawm qhov tshwm sim hlab plawv loj (MACE). Qhov kev sim THEMIS tau pib rau thaum xyoo 2014 thiab yog ib qhov kev tshawb fawb ntau tshaj plaws nyob hauv cov neeg mob uas muaj ntshav qab zib hom 2 rau hnub no. CAD txhais tau tias yog kev kho mob raws li cov leeg ntshav (PCI), kev phais mob hla dhau, lossis txoj hlab ntshav txhaws txog li 50%. Kev sim txiav txim siab THEMIS pom tias hauv CAD thiab T2D cov neeg mob tsis muaj keeb kwm mob plawv lossis mob hlab ntsha tawg, tshuaj aspirin ua ke nrog kev kho mob ticagrelor mus sij hawm ntev txo qis kev sib raug zoo ntawm cov kev mob siab kawg ntawm kev mob plawv, mob stroke, thiab CV tuag piv nrog tshuaj aspirin monotherapy.10% (Kev txo qhov phom sij txaus; 0.8%, 7.7% vs 8.5%).