Tsoom Fwv Teb Chaws Asmeskas FDA tso cai rau Boehringer / Eli Lilly SGLT2 inhibitor Jardiance (Enpagliflozin) khiav ceev kev tsim nyog!

Lub tuam txhab Eli Lilly-Boehringer Ingelheim Diabetes Alliance tsis ntev los no tau tshaj tawm tias Tsoomfwv Meskas Khoom Noj thiab Tshuaj (FDA) tau tso cai SGLT2 inhibitor chav kawm ntawm cov tshuaj hypoglycemic Jardiance (empagliflozin) Kev nrawm nrawm los tsim (FTD) rau kev siv ib zaug Cov neeg mob uas mob myocardial infarction (feem ntau hu ua mob plawv) (nrog thiab tsis mob ntshav qab zib) tuaj yeem tiv thaiv tsev kho mob rau lub plawv tsis ua hauj lwm thiab txo kev tuag.

Hauv Tebchaws Meskas, muaj ntau dua 1.5 lab lub plawv nres txhua xyoo, uas yog qhov ua rau lub plawv tsis ua thiab cuam tshuam nrog kev pheej hmoo siab tuag. Ib lub plawv nres tshwm sim vim qhov txo qis hauv cov ntshav ntws mus rau ib feem ntawm cov leeg plawv.

Yav dhau los, FDA tau tso cai Jardiance 2 FTDs: (1) Lub Rau Hli 2019, kom txo cov kev pheej hmoo ntawm cov hlab plawv tuag thiab mob plawv tsis tuaj yeem pw hauv tsev kho mob hauv cov neeg mob uas muaj lub plawv tsis ua haujlwm ntev (CHF). (2) Lub Peb Hlis 2020, txo cov kev pheej hmoo mob raum thiab mob plawv tuag rau cov neeg laus uas muaj mob raum (CKD).

Kev khiav ceev ceev (FTD) lub hom phiaj ua kom nrawm nrawm txhim kho thiab tshuaj xyuas sai sai ntawm cov tshuaj rau cov kab mob loj los daws cov kev kho mob tsis txaus ntseeg nyob hauv thaj chaw tseem ceeb. Tau txais cov peev txheej nrawm nrawm rau cov tshuaj sim txhais tau tias cov tuam txhab kws kho mob tuaj yeem cuam tshuam nrog FDA ntau dua thaum lub sijhawm tshawb fawb thiab kev txhim kho. Tom qab xa tawm daim ntawv thov kev lag luam, lawv tsim nyog rau kev pom zoo nrawm thiab kev tshuaj xyuas ua ntej yog tias lawv ua tau raws cov qauv tsim nyog. Ib qho ntxiv, lawv kuj tsim nyog rau cov nqi tshuaj xyuas.

Kev kawm EMPACT-MI yog ntsuas kev cuam tshuam ntawm Jardiance rau txhua yam ua rau kev tuag thiab lub plawv pw hauv tsev kho mob hauv cov neeg mob neeg laus (nrog thiab tsis muaj ntshav qab zib hom 2) uas tau muaj tus mob myocardial infarction thiab tsis muaj keeb kwm ntawm lub plawv tsis ua haujlwm ntev. Qhov kev soj ntsuam sim zaum 3 no raug sim, ntsuas thiab tshaj tawm nrog kev sib koom tes nrog Duke Chaw Tshawb Xyuas Kev Tshawb Fawb (DCRI), thiab tau nyiaj los ntawm Boehringer Ingelheim thiab Eli Lilly. EMPACT-MI yog ib feem ntawm EMPOWER' s cov chaw pabcuam, uas yog cov kev pabcuam dav dav thiab dav tshaj plaws rau SGLT2 inhibitors. EMPOWER tsom lub luag haujlwm ntawm Jardiance rau cov kab mob metabolic ntawm lub plawv thiab raum.

Mohamed Eid, tus lwm thawj kws saib xyuas kev kho mob thiab kev noj qab haus huv rau Boehringer Ingelheim Cardiometabolic thiab Chaw Kho Mob Hlawv, tau hais tias:" Ischemia mob plawv (IHD) yog qhov ua rau tuag thiab xiam oob khab hauv tebchaws Asmeskas. Myocardial infarction lossis lub plawv nres yog qhov ua rau muaj tus kab mob ntau tshaj ntawm IHD. Cov kev mob tshwm sim, cov kev kho mob yog qhov xav tau nrawm txhawm rau txhawm rau txhim kho qhov kev kwv yees. Peb cia siab tias yuav koom tes nrog FDA txhawm rau tshawb nrhiav qhov tseeb ntawm Jardiance kev txhim kho kom muaj sia nyob ntawm cov neeg laus uas muaj mob plawv nres thiab tiv thaiv tsev kho mob vim tias lub plawv tsis ua haujlwm los ntawm peb qhov kev sim EMPACT-MI"

Jeff Emmick, MD, Tus Lwm Thawj Coj ntawm Kev Txhim Kho Khoom ntawm Eli Lilly, tau hais tias:" FDA' s kev taug qab cov ntawv pov thawj ceev ntawm Jardiance yog lub sijhawm tseem ceeb hauv kev daws cov kev xav tau tsis txaus ntseeg ntawm cov neeg mob plawv. Peb tau cog lus tias yuav nrhiav kev los ua kom tiav rau cov neeg mob thiab tsis muaj ntshav qab zib hom 2. Kev sib deev tshwm sim, suav nrog kev tiv thaiv thiab kho lub plawv tsis ua haujlwm. Peb cia siab tias kom nkag siab txog kev soj ntsuam EMPACT-MI, uas xav tias yuav ua tiav xyoo 2023."

Kev Sib Tham (Enpagliflozin) belongs rau sodium-glucose cotransporter-2 (SGLT-2) inhibitor chav kawm ntawm cov tshuaj. Cov tshuaj SGLT-2 cov tshuaj inhibitor tau muab pov thawj los txhawm rau txhawm rau txhawm rau txhawm rau cov kua nplaum hauv lub raum, tshem tawm cov piam thaj ntau dhau mus rau lub cev, yog li ua tiav cov nyhuv ntawm cov ntshav qab zib kom tsawg, thiab cov nyhuv hypoglycemic tsis vam khom β Cell ua haujlwm thiab insulin tsis kam. Cov.

Ntxiv nrog rau qhov pom tseeb hypoglycemic effect, cov tshuaj kuj tseem tuaj yeem nqa cov txiaj ntsig ntxiv ntawm kev poob phaus, txo ntshav siab, thiab qis dua uric acid. Jardiance muaj kev nyab xeeb thiab tuaj yeem txo qhov kev pheej hmoo ntawm cov hlab plawv tshwm sim hauv cov neeg mob ntshav qab zib. Nws yog lub ntiaj teb' s thawj hom 2 mob ntshav qab zib tshuaj uas tau tshawb fawb kom txo cov kev pheej hmoo ntawm kev mob plawv tuag.

Jardiance tau pom zoo rau kev lag luam thaum Lub Yim Hli 2014 rau kev kho mob ntawm cov neeg mob ntshav qab zib hom 2. Thaum kawg ntawm 2016, Jardiance tau txais kev pom zoo dua txhawm rau txo qis kev mob plawv hauv cov neeg mob ntshav qab zib hom 2 nyuaj los ntawm kab mob plawv. Qhov kev pom zoo no ua rau Jardiance thawj cov tshuaj tiv thaiv kab mob ntshav siab tau pom zoo thoob ntiaj teb los txo qis kev mob plawv hauv cov neeg mob ntshav qab zib hom 2.

Jardiance yog qhov hnyav hnyav SGLT2 inhibitor chav kawm ntawm cov tshuaj hypoglycemic, uas tam sim no suav rau ntau dua 50% ntawm cov lag luam feem ntawm SGLT2 inhibitors. Xyoo tsis ntev los no, Eli Lilly-Boehringer Ingelheim Alliance tau cog lus los tsim cov tshuaj no rau kev kho mob lub plawv tsis ua haujlwm thiab mob raum.

Hauv Suav Teb, Jardiance tau pom zoo rau kev lag luam thaum lub Cuaj Hlis 2017. Nws tuaj yeem siv los ua ib qho yeeb tshuaj, ua ke nrog metformin lossis ua ke nrog metformin thiab sulfonylureas txhawm rau txhim kho ntshav qab zib kom tswj tau hauv cov neeg mob ntshav qab zib hom 2. Thaum Lub Kaum Ib Hlis 2019, Jardiance (Ou Tang Jing?) Tau raug suav nrog nyob rau hauv phau ntawv tuav pov hwm mob nkeeg hauv tebchaws. Phau ntawv teev cov ntawv kho mob tau ua tiav thoob tebchaws thaum Lub Ib Hlis 1, 2020. Kuv ntseeg tias nrog kev nce qib ntawm cov ntawv pov hwm kev kho mob thoob tebchaws, ntau tus neeg mob ntshav qab zib Suav yuav tau txais txiaj ntsig zoo los ntawm cov tshuaj zoo tshaj no!