Bayer Thawj Cov Tshuaj, Kerendia (finerenone), Tau Pom Zoo Los Ntawm Asmeskas FDA Thiab Tau Tshawb Xyuas Hauv Suav Teb!

Bayer tsis ntev los no tshaj tawm tias Asmeskas Cov Khoom Noj thiab Tshuaj Yeeb Tshuaj (FDA) tau pom zoo Kerendia (finerenone) rau kev kho mob rau cov neeg laus uas muaj mob raum mob raum (CKD) thiab hom 2 mob ntshav qab zib (T2D), txo qhov kwv yees tas li glomerulus Kev pheej hmoo ntawm txo qis pom tus nqi (eGFR), kab mob raum kawg (ESKD), mob plawv tuag, tsis tuag myocardial infarction, thiab mus pw hauv tsev kho mob rau lub plawv tsis ua haujlwm. Kerendia tau pom zoo los ntawm txheej txheem tshuaj xyuas ua ntej. Tam sim no, cov tshuaj no tseem tab tom tshuaj xyuas los ntawm European Union, Tuam Tshoj thiab qee lub tebchaws.

Kerendia yog tus thawj coj, tsis yog tshuaj steroidal, xaiv mineralocorticoid receptor antagonist (MRA), uas tuaj yeem txo qis kev phom sij ntawm kev ua kom ntau mineralocorticoid receptor (MR). Kev ua kom ntau dhau ntawm MR tuaj yeem ua rau mob thiab mob fibrosis, uas yog tus tsav tseem ceeb ntawm CKD kev nce qib thiab ua rau lub plawv puas tsuaj.

Nws yog qhov tsim nyog hais tias Kerendia yog thawj qhov tsis-steroidal selective MRA los qhia pom lub raum thiab hlab plawv tau zoo hauv cov neeg mob CKD thiab T2D. Txawm hais tias muaj cov txheej txheem txheej txheem kev kho mob, ntau tus neeg mob CKD thiab T2D tseem yuav txhim kho kev ua haujlwm tsis zoo ntawm lub raum thiab muaj kev pheej hmoo siab mob plawv. Kerendia' cov txheej txheem ntawm kev ua yog txawv ntawm kev kho mob uas twb muaj lawm. Los ntawm kev thaiv qhov ua kom ntau dhau ntawm MR, cov tshuaj tuaj yeem ncaj qha rau qhov mob thiab mob fibrosis txhawm rau ncua kev kis tus kab mob.

Kev pom zoo los ntawm FDA ntawm Kerendia yog ua raws qhov txiaj ntsig zoo ntawm qhov tseem ceeb Phase 3 FIDELIO-DKD txoj kev tshawb fawb. Cov ntaub ntawv cuam tshuam tau tshaj tawm ntawm American Society of Nephrology (ASN) Lub Limtiam Lub Limtiam 2020 thiab luam tawm nyob rau hauv New England Journal of Medicine (NEJM) thaum Lub Kaum Hli 2020. Yog xav paub ntxiv, saib: Cov txiaj ntsig ntawm Finerenone rau Kev Mob Raum Mob Raum Hauv Hom 2 Ntshav Qab Zib.

Tus thawj coj tshawb fawb ntawm FIDELIO-DKD txoj kev tshawb fawb, xibfwb George L. Bakris ntawm University of Chicago Tsev Kawm Ntawv ntawm Tshuaj, hais tias: "Muaj ntau dua 160 lab tus neeg mob CKD nrog T2D hauv ntiaj teb. Txawm hais tias cov ntshav qab zib thiab ntshav siab tau tswj tau zoo, cov neeg mob tseem muaj kev txhim kho CKD. Risk. Qhov no txhais tau tias kev kho mob xav tau kev pab cuam thaum ntxov yog siab heev, thiab nws yog qhov tsim nyog los tiv thaiv kev puas tsuaj ntawm lub cev txuas ntxiv thiab kev tuag ntxov ntxov los ntawm kev ua kom qeeb ntawm kev ua haujlwm ntawm lub raum poob qis hauv cov neeg mob thiab txo qis kev pheej hmoo plawv. Kev pom zoo ntawm finenone muab txoj hauv kev tshiab. Txhawm rau tiv thaiv cov neeg mob los ntawm kev puas tsuaj rau lub raum ntxiv los ntawm kev hais txog MR kev ua haujlwm ntau (tus tsav tseem ceeb ntawm kev txhim kho CKD), tam sim no muaj kev kho mob tseem tsis tau hais txog qhov teeb meem no."

nplua nuj tshuaj lom neeg qauv

Txoj kev tshawb fawb FIDELIO-DKD tau ua tiav hauv cov neeg mob CKD thiab T2D los tshuaj xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm cov nplua nuj thiab cov placebo. Ob pawg tau txais kev saib xyuas tus qauv, suav nrog kev kho mob hypoglycemic thiab qhov siab tshaj qhov tau txais tshuaj renin-angiotensin system (RAS) thaiv kev kho, xws li angiotensin-hloov pauv enzyme (ACE) inhibitors lossis angiotensin II receptors Blocker (ARB).

Cov txiaj ntsig tau pom tias txoj kev tshawb fawb mus txog qhov kawg qhov kawg: thaum ua ke nrog kev saib xyuas tus qauv, nplua nuj tau txo qis qhov kev pheej hmoo ntawm kev sib xyaw ua ke thawj qhov kawg ntawm CKD kev nce qib, lub raum tsis ua haujlwm, thiab lub raum tuag piv nrog cov placebo. Tshwj xeeb, nrog kev rov qab saib xyuas nruab nrab ntawm 2.6 xyoo, piv nrog cov placebo, finerenone yuav ua rau lub raum tsis ua haujlwm thawj zaug, kwv yees kwv yees tus lej pom (eGFR) yuav txuas ntxiv txo qis los ntawm ≥40% tsawg kawg 4 lub lis piam, thiab lub raum Kev pheej hmoo ntawm kev tuag tau txo qis 18% (HR=0.82; 95% CI: 0.73-0.93; p=0.0014). Hauv pawg ua ntej tau teev tseg, cov txiaj ntsig ntawm finerenone ntawm qhov txiaj ntsig tseem ceeb feem ntau zoo ib yam, thiab cov txiaj ntsig kev kho mob tau txhawb nqa thoob plaws lub sijhawm kawm.

Ib qho ntxiv, nrog kev rov qab saib xyuas nruab nrab ntawm 2.6 xyoo, piv nrog cov placebo, finerenone kuj tseem txo qhov kev pheej hmoo ntawm cov ntsiab lus tseem ceeb thib ob: txo kev pheej hmoo ua ke ntawm kev mob plawv tuag, tsis tuag myocardial infarction, tsis tuag taus lossis lub plawv tsis ua haujlwm hauv tsev kho mob nyob 14% (txo kev pheej hmoo txheeb ze, HR=0. 86 [95% CI: 0.75-0.99; p=0.0339]).

Hauv txoj kev tshawb fawb no, finerenone tau ua tib zoo, zoo ib yam nrog kev nyab xeeb pom hauv kev tshawb fawb dhau los. Cov xwm txheej tsis zoo tag nrho thiab cov xwm txheej tsis zoo tshwm sim los ntawm kev kho mob zoo ib yam ntawm ob pab pawg. Cov xwm txheej tsis zoo feem ntau yog me me lossis nruab nrab. Piv nrog rau cov pab pawg placebo, qhov xwm txheej ntawm cov xwm txheej tsis zoo tau qis dua hauv pawg neeg nplua nuj (31.9% vs 34.3%) thiab qhov tshwm sim ntawm hyperkalemia cuam tshuam txog cov xwm txheej tsis zoo tau siab dua (18.3% vs 9%), thiab ob pab pawg tau hnyav heev cuam ​​tshuam nrog hyperkalemia Qhov tshwm sim ntawm cov xwm txheej tsis zoo tau qis (1.6% vs 0.4%), thiab tsis muaj kev phom sij ntsig txog ntshav ntau hauv ob pawg. Qhov kev faib ua feem ntawm cov neeg mob uas ncua kev kho mob vim hyperkalemia hauv pawg finerenone yog 2.0%, piv nrog 0.9% hauv pawg placebo.