SGLT1/2 inhibitor Zynquista (sotagliflozin): Qhia txog kev mob plawv&cov txiaj ntsig hypoglycemic!--2/2

Nws tsim nyog hais tias Sanofi tau mus txog US $ 1.7 billion daim ntawv tso cai pom zoo nrog Lexicon thaum Lub Kaum Ib Hlis 2015, tau txais cov cai thoob ntiaj teb tshwj xeeb ntawmtshuaj sotagliflozinsab nraud ntawm Nyiv. Txawm li cas los xij, thaum Lub Xya Hli 2019, Sanofi tshaj tawm qhov kev txiav tawm ntawm sotagliflozin project nrog Lexicon. Sanofi lub laj thawj yog tias ob theem III kev tshawb fawb (SOTA-CKD3, SOTA) tau ua nyob rau hauv kev kho mob ntawm hom 2 mob ntshav qab zib mellitus cov neeg mob uas muaj nruab nrab (theem 3) thiab mob hnyav (theem 4) mob raum mob (CKD). -CKD4), cov ntaub ntawv tsis tau raws li Sanofi' lub hom phiaj xav tau.

Hais txog kev cai,tshuaj sotagliflozintau pom zoo nyob rau hauv European Union thaum lub Plaub Hlis 2019 (lub npe lag luam: Zynquista): ua cov tshuaj pab rau insulin, nws yog siv rau hom 1 mob ntshav qab zib mellitus nrog lub cev qhov hnyav ≥27kg / m2 thiab tau txais kev kho tshuaj insulin zoo thiab tseem tsis tuaj yeem ua tiav cov ntshav txaus. tswj suab thaj. (T1D) Cov neeg laus. Tam sim no, Zynquista tseem tsis tau nyob hauv khw. Hauv Tebchaws Meskas, sotagliflozin tsis pom zoo rau kev kho mob ntshav qab zib hom 1 hauv lub Peb Hlis 2019.

Clinical kawm ntawmtshuaj sotagliflozinhauv kev kho mob plawv tsis ua hauj lwm:

SOLOIST yog ntau lub chaw, randomized, ob-dig muag, placebo-tswj theem 3 txoj kev tshawb fawb hauv 1,222 cov neeg mob ntshav qab zib hom 2 uas nyuam qhuav mus pw hauv tsev kho mob rau lub plawv tsis ua hauj lwm. Nws ntsuas qhov sib ntxiv ntawmtshuaj sotagliflozinlos yog cov placebo rau cov hlab plawv system nyob rau hauv cov qauv kev kho mob Curative nyhuv. Lub ntsiab lus kawg yog tag nrho cov neeg tuag los ntawm cov kab mob plawv, mus pw hauv tsev kho mob rau lub plawv tsis ua haujlwm, thiab mus ntsib kws kho mob xwm txheej ceev rau lub plawv tsis ua hauj lwm hauv pab pawg kho mob sotagliflozin piv nrog cov placebo pawg.

SCORED yog ntau qhov chaw, randomized, ob-dig muag, placebo-tswj theem 3 txoj kev tshawb fawb, hauv 10584 cov neeg mob uas muaj ntshav qab zib hom 2, kab mob raum ntev (eGFR: 25-60 ml / 1.73 square metres ib feeb), thiab kab mob plawv tau nqa. tawm hauv cov neeg mob uas muaj kev pheej hmoo, thiab kev ua tau zoo ntawm cov hlab plawv ntawm kev ntxiv sotagliflozin lossis placebo rau kev saib xyuas tus qauv raug soj ntsuam. Thawj qhov kawg yog tag nrho cov neeg tuag los ntawm kev mob plawv, mus pw hauv tsev kho mob rau lub plawv tsis ua haujlwm, thiab mus ntsib kws kho mob xwm txheej ceev rau lub plawv tsis ua haujlwmtshuaj sotagliflozinpab pawg kho mob piv nrog cov pab pawg placebo.

Ob txoj kev kawm SOLOIST thiab SCORED txoj kev kawm tau mus txog lawv qhov kawg ntawm qhov kawg. Cov txiaj ntsig ntawm ob txoj kev tshawb fawb no tau luam tawm nyob rau hauv lub rooj sib tham zaum kawg ntawm American Heart Association (AHA) 2020 Kev Sib Tham Txog Kev Tshawb Fawb, thiab tib lub sijhawm tau tshaj tawm hauv ob tsab xov xwm hauv New England Journal of Medicine (NEJM) nrog cov npe: Sotagliflozin hauv Cov neeg mob uas muaj ntshav qab zib thiab tsis ntev los no mob plawv tsis ua haujlwm thiab Sotagliflozin hauv cov neeg mob ntshav qab zib thiab mob raum mob.