FDA pom zoo ua pov thawj tshiab rau Somaglutide Txo Cov Kab Mob Ntshav Qab Zib Hauv Cov Neeg Mob Ntshav Qab Zib

Ob peb hnub dhau los, Novo Nordisk tshaj tawm tias Asmeskas FDA tau pom zoo rau kev ntsuas pom tshiab ntawm 0. 5 mg lossis 1 mg ntawm Ozempic (semaglutide, Somalutide) txhaj tshuaj rau txo cov kev mob tseem ceeb ntawm cov neeg mob laus nrog hom 2 mob ntshav qab zib thiab paub mob plawv. Yuav muaj mob tshwm sim hlab plawv (MACE), xws li mob plawv nres, hlab ntsha tawg, lossis tuag. Cov lus qhia ntxaws ntxiv txog kev tshuaj xyuas qhov kawg ntawm PIONEER 6 tau ntxiv rau Rybelsus (qhov ncauj semaglutide) 7 mg lossis 14 mg ntsiav tshuaj.

Somaglutide yog glucagon zoo li peptide-1 (GLP-1) analog. Nws yog ib qho tshuaj hormones uas tsim cov tshuaj insulin zais cia thiab ua lag luam raws li Ozempic. Daim ntawv txhaj tshuaj ib zaug ib asthiv raug pom zoo los ntawm FDA hauv 2017 rau kev kho mob ntawm hom 2 mob ntshav qab zib. Txhawm rau txhim kho kev ua kom tiav thiab cov txiaj ntsig tau ntev ntev, Novo Nordisk tau tsim Rybelsus, kev noj tshuaj ntawm qhov ncauj ntawm somaglutide, uas tau pom zoo los ntawm FDA rau lub Cuaj Hli 2019.

Kab mob plawv (CVD) yog qhov tseem ceeb ua rau tuag thiab xiam oob qhab rau cov neeg mob uas muaj hom 2 mob ntshav qab zib. Cov neeg laus uas muaj ntshav qab zib hom 2 yog ntshav qab zib yog 2 txog rau 4 zaug feem ntau yuav tsim mob CVD ntau dua li cov neeg laus uas tsis muaj ntshav qab zib.

Kev pom zoo rau FDA rau Ozempic yog ua raws li kev soj ntsuam SUSTAIN 6 Kev Tshawb Fawb Lub Plawv Kev Ntsuam Xyuas (CVOT), uas ntsuas xyuas kev mob plawv ntxiv rau Ozempic lossis placebo rau kev kho mob rau cov neeg laus uas muaj hom 2 mob ntshav qab zib thiab kuaj mob plawv kab mob. Hauv qhov kev txiav txim siab {{1 6} - - xyoo SUSTAIN 6 kev sim, Ozempic txo qis kev pheej hmoo ntawm cov hlab plawv tuag, tsis ua kom lub plawv tuag, lossis tsis ua rau lub siab tuag peb qhov sib cuam tshuam MACE kawg. Muab piv rau cov placebo, kwv yees MACE kwv yees kev sib raug zoo yuav txo tau yog 26% (HR 0. {{9}} [95% CI: 0. 58, 0. { {10}}], tsis muaj qhov ua tsis tau zoo, kev soj ntsuam nruab nrab lub sijhawm {{1 6}}. 1 xyoo, p< 0.="" {{1="" 9}}),="" thiab="" lub="" ntsiab="" lus="" sib="" xyaw="" tshwm="" sim="" ntawm="" 6.="" 6%="" ntawm="" ozempic-kho="" cov="" neeg="" mob="" thiab="" 8.="" 9%="" ntawm="" cov="" neeg="" mob="" placebo-kho="" mob.="" thaum="" lub="" sijhawm="" mus="" sib="" hais,="" qhov="" tshwm="" sim="" ntawm="" lub="" plab="" zom="" mov="" tsis="" zoo="" hauv="" ozempic="" pawg="" tau="" siab="" dua="" hauv="" pawg="" placebo.="" yuav="" luag="" mob="" plab="" hnyuv="" feem="" ntau="" tshwm="" sim="" thaum="" thawj="" 30="" lis="">

Novo Nordisk kuj tau tshaj tawm tias nws tau hloov kho ntu 14 (kev tshawb fawb soj ntsuam) ntawm Rybelsus cov ntaub ntawv muab tshuaj kom muaj kev tsom xam ntawm qhov pib qhov kawg ntawm PIONEER 6 CVOT sim, uas qhia qhov phom sij txaus sib piv rau thawj peb feem MACE lub sijhawm (HR 0. 79 [95% CI: 0. 57, 1.

Thaum Lub Rau Hli 2019, Novo Nordisk pib ua kev sim SOUL CVOT ntawm 9, 642 cov neeg laus uas muaj hom 2 ntshav qab zib tau txheeb pom tias muaj kab mob plawv txhawm rau soj ntsuam cov kev mob plawv ntawm Rybelsus ntxiv. Kev sib hais yog tshawb xyuas qhov tshwm sim ntawm Rybelsus ntawm qhov tshwm sim ntawm MACE piv rau cov placebo ntxiv rau kev kho mob txheem.