Lub zog poob phaus tshuaj Tirzepatide tau ua tiav ib zaug ntxiv, zoo kho lub siab rog

Lub zog poob phaus tshuaj Tirzepatide tau ua tiav ib zaug ntxiv, zoo kho lub siab rog

Thaum Lub Rau Hli 12, 2024, lub thoob ntiaj teb sab saum toj kev kho mob phau ntawv xov xwm "New England Journal of Medicine" (NEJM) tau luam tawm ob qhov kev sim tshuaj ntsuam xyuas ntawm GLP-1 cov tshuaj hauv chav kawm rau cov neeg mob metabolic dysfunction-related steatohepatitis (MASH) nrog rau daim siab fibrosis. .

Thawj txoj kev tshawb fawb yog hu ua "Tirzepatide rau Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis." Qhov no yog theem 2, tshuaj-nrhiav, multicenter, ob-dig muag, randomized, placebo-tswj chaw kuaj mob, suav nrog 190 cov neeg mob uas muaj biopsy-confirmed MASH nrog rau daim siab fibrosis F2 lossis F3 (mob nruab nrab lossis hnyav). Tag nrho cov neeg koom tau muab faib ua 4 pawg, tau txais kev txhaj tshuaj subcutaneous txhua lub limtiam ntawm tirzepatide (5mg, 10mg, 15mg koob lossis placebo) rau 52 lub lis piam, nrog rau qhov kawg ntawm qhov tseem ceeb yog kev tshem tawm ntawm MASH thiab tsis muaj kev cuam tshuam ntawm fibrosis ntawm 52 lub lis piam. Cov ntsiab lus tseem ceeb thib ob suav nrog kev txhim kho ntawm fibrosis los ntawm tsawg kawg ib theem, thiab tsis muaj MASH zuj zus.

Cov txiaj ntsig tau pom tias ntawm cov pab pawg placebo, 5mg, 10mg, thiab 15mg cov pab pawg kho mob, qhov feem pua ​​​​ntawm cov neeg koom ua tiav cov txheej txheem ntawm MASH tshem tawm thiab tsis muaj qhov ua rau mob fibrosis yog 10%, 44%, 56%, thiab 62%, feem, thiab qhov kev faib ua feem ntawm cov neeg koom nrog tsawg kawg ib theem kev txhim kho hauv fibrosis thiab tsis muaj MASH yog 30%, 55%, 51%, thiab 51%, feem.

Cov xwm txheej tsis zoo tshaj plaws nyob rau hauv pab pawg kho mob tirzepatide yog cov xwm txheej hauv plab hnyuv, feem ntau yog mob me lossis mob me. Cov ntaub ntawv no qhia tau hais tias nyob rau theem 2 qhov kev sim tshuaj ntsuam xyuas nrog rau cov neeg mob uas muaj mob hnyav lossis mob hnyav ntawm MASH, hais txog MASH regression thiab tsis muaj kev cuam tshuam ntawm fibrosis, kev kho tirzepatide rau 52 lub lis piam tau zoo dua li cov placebo. Qhov txiaj ntsig no txhawb nqa kev coj ua ntawm qhov loj dua, kev sim tshuaj mus sij hawm ntev ntxiv los ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm tirzepatide hauv kev kho mob ntawm MASH.

Txoj kev tshawb fawb thib ob yog hu ua "A Phase 2 Randomized Trial of Survodutide hauv MASH thiab Fibrosis." Qhov no yog 48- lub limtiam theem 2 kev sim tshuaj, uas tau muab 293 tus neeg laus cov neeg mob uas muaj kev kuaj mob MASH thiab fibrosis theem F1-F3 hauv 1: 1: 1: 1 piv, tau txais kev txhaj tshuaj subcutaneous txhua lub lim tiam kev kho mob ntawm survodutide (2.4mg, 4.8mg, 6.0mg lossis placebo) rau 48 lub lis piam, nrog ob theem: a 24- lub lim tiam koob tshuaj nrawm nrawm thiab theem tom ntej 24- lub lim tiam tu.

Lub ntsiab lus kawg yog qhov kev txhim kho histological ntawm MASH thiab tsis muaj qhov ua rau mob fibrosis, thiab cov ntsiab lus thib ob suav nrog kev txo qis tsawg kawg 30% hauv daim siab rog cov ntsiab lus thiab kev txhim kho yam tsawg kawg ib theem ntawm fibrosis soj ntsuam los ntawm biopsy. Cov txiaj ntsig tau pom tias ntawm cov pab pawg placebo, 2.4mg, 4.8mg, thiab 6.0mg pab pawg kho mob, qhov feem pua ​​​​ntawm cov neeg koom nrog MASH kev txhim kho thiab tsis muaj kev cuam tshuam ntawm fibrosis yog 14%, 47%, 62%, thiab 43%, feem; qhov feem pua ​​​​ntawm cov neeg koom nrog txo qis tsawg kawg 30% ntawm daim siab rog cov ntsiab lus yog 14%, 63%, 67%, thiab 57%, feem; Qhov feem pua ​​​​ntawm cov neeg koom nrog tsawg kawg ib theem kev txhim kho hauv fibrosis yog 22%, 34%, 36%, thiab 34%, feem. Qhov tshwm sim ntawm cov xwm txheej tsis zoo hauv pab pawg kho mob survodutide thiab pab pawg placebo yog xeev siab (66% vs. 23%), raws plab (49% vs. 23%), thiab ntuav (41% vs. 4%).

Qhov tshwm sim ntawm cov xwm txheej tsis zoo nyob rau hauv pab pawg kho mob survodutide thiab pab pawg placebo yog 8% thiab 7%, feem. Zuag qhia tag nrho, survodutide tau zoo dua li cov placebo hauv kev txhim kho MASH thiab tsis ua rau mob fibrosis, thiab nws tsim nyog rau kev tshawb fawb ntxiv nyob rau theem loj dua 3 kev sim tshuaj.

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