Empagliflozin Benefits CKD Cov Neeg Mob
Jan 09, 2023
Cov kab mob raum ntev (CKD) yog ib yam kab mob uas ua rau lub raum tsis ua haujlwm qeeb thiab tsis txhob kis mus rau qhov kawg ntawm tus kab mob vim kev mob CKD ntau dhau thiab kev tuag, cuam tshuam rau tus neeg mob lub neej zoo, thiab tus nqi siab ntawm kev kho lub raum hloov. Kab mob raum (ESKD) yog qhov tseem ceeb.
Nyem rau cistanche tshuaj xyuas kab mob raum
Lub plawv muaj feem xyuam nrog rau lub raum, thiab kev pheej hmoo ntawm cov kab mob plawv hauv cov neeg mob CKD tau nce ntau, thiab cov kab mob plawv yog ib qho tseem ceeb ntawm kev tuag ntawm cov neeg mob CKD.
Renin-angiotensin system inhibitors (RASi) tuaj yeem txo cov proteinuria thiab ncua kev loj hlob ntawm proteinuric raum kab mob; txo cov ntshav siab thiab qis qis lipoprotein cov roj cholesterol tuaj yeem txo qhov kev pheej hmoo ntawm cov kab mob plawv hauv cov neeg mob CKD.
Txawm li cas los xij, txawm tias cov kev cuam tshuam no, cov neeg mob CKD tseem muaj qhov pheej hmoo loj, thiab cov kev kho tshiab yuav tsum tau ua raws li cov qauv kev kho mob uas twb muaj lawm los txuas ntxiv ncua kev loj hlob ntawm cov neeg mob CKD mus rau ESKD thiab txo lawv txoj kev pheej hmoo ntawm cov hlab plawv.
Txij lub Kaum Ib Hlis 3 txog 6, 2022, American Society of Nephrology (ASN) Lub Limtiam Lub Limtiam yuav tshaj tawm cov txiaj ntsig ntawm EMPA-KIDNEY txoj kev kawm thiab tshaj tawm lawv hauv New England Journal of Medicine. Txoj kev tshawb no tsom los soj ntsuam cov txiaj ntsig ntawm empagliflozin ntawm kev pheej hmoo ntawm kab mob hauv lub raum kev loj hlob lossis mob plawv tuag nyob rau ntau yam ntawm cov neeg mob CKD uas muaj kev pheej hmoo ntawm ESKD.
Txoj kev tshawb no yog tsim los ntawm tus kheej, ua, tshuaj xyuas, thiab qhia los ntawm Oxford University Medical Research Council Population Health Research Unit. Coj los ntawm General Tsev Kho Mob ntawm Eastern Theatre Command thiab National Clinical Research Center for Kidney Diseases, 17 lub chaw tshawb fawb hauv Suav teb tau sib koom ua ke hauv lub ntiaj teb no, ntau qhov chaw, loj theem III kev tshawb fawb soj ntsuam.
Txij li thaum txoj kev tshawb fawb tau tsim nyob rau xyoo 2019, nws tau ntsib qhov kev sib tw ntawm lub ntiaj teb tshiab tus kabmob kis tau peb xyoos, thiab thaum kawg tau ua tiav tiav rau ze li ib txhiab tus neeg mob Suav. kev pab zoo heev.
Ntiaj teb no multi-center loj-scale theem III EMPA-KIDNEY kev soj ntsuam soj ntsuam
Tag nrho ntawm 6,609 CKD cov neeg mob tau tso npe rau hauv EMPA-KIDNEY txoj kev tshawb fawb thiab random muab rau empagliflozin (10 mg / hnub) lossis cov placebo.
Cov txheej txheem suav nrog
✔ Cov neeg laus laus dua lossis sib npaug li 18 xyoo;
✔ Cov ntaub ntawv pov thawj ntawm tus kab mob raum loj yog txhais raws li kev soj ntsuam hauv zos tau sau tseg tsawg kawg 3 lub hlis ua ntej thiab ntawm Kev Mus Saib Xyuas thiab xav tau:
(a) eGFR Ntau dua lossis sib npaug rau 20-<45 mL/min/1.73㎡;
los yog
(b) eGFR Ntau dua lossis sib npaug rau 45-<90 mL/min/1.73 m² and uACR ≥ 200 mg/g.
kawm endpoint
✔ Cov ntsiab lus tseem ceeb ntawm txoj kev tshawb fawb: cov ntsiab lus kawg ntawm thawj qhov tshwm sim ntawm cov kab mob hauv lub raum kev loj hlob lossis kev tuag ntawm cov hlab plawv
① Progressive raum kab mob txhais tau tias:
a. End-stage mob raum
b. eGFR tseem poob rau<10 mL/min/1.73 ㎡
c. Kev tuag los ntawm lub raum ua rau
d. Kev poob qis hauv eGFR Ntau dua lossis sib npaug li 40 feem pua tom qab randomization.
✔ Cov ntsiab lus tseem ceeb Secondary Endpoints:
① Thawj qhov tshwm sim ntawm lub plawv tsis ua hauj lwm mus pw hauv tsev kho mob lossis mob plawv
② Txhua-ua rau tsev kho mob (thawj zaug thiab rov tshwm sim)
③ Txhua yam ua rau tuag
Cov yam ntxwv ntawm lub hauv paus
Tag nrho ntawm 6,609 tus neeg mob CKD los ntawm 8 lub tebchaws suav nrog Europe, North America, thiab East Asia tau suav nrog hauv txoj kev tshawb no. Kev faib tawm ntawm cov yam ntxwv hauv paus tau sib npaug ntawm pawg empagliflozin thiab pawg placebo. Lub sijhawm nruab nrab ntawm kev soj ntsuam yog 2 xyoos.
✔ Qhov nruab nrab eGFR yog 37.3 mL / min / 1.73 ㎡, thiab 35 feem pua ntawm cov neeg mob muaj eGFR < 30 mL / min / 1.73 ㎡.
✔ Median uACR yog 329 mg / g, nrog 48 feem pua ntawm cov neeg mob muaj uACR <300 mg / g.
✔ Hauv CKD etiology kev faib tawm
31 feem pua tau mob ntshav qab zib raum (DKD)
22% hypertensive nephropathy / kab mob renovascular 25% glomerular nephropathy
12 feem pua tau muaj IgA nephropathy
Kev tshawb fawb tshwm sim
✔ Cov ntsiab lus tseem ceeb ntawm qhov kawg: Cov kab mob hauv lub raum lossis cov hlab plawv tuag tshwm sim hauv 432 tus neeg mob (13.1 feem pua) hauv pawg empagliflozin thiab 558 tus neeg mob (16.9 feem pua) hauv cov placebo pawg.
Piv nrog rau cov placebo pab pawg, qhov kev pheej hmoo ntawm cov kab mob hauv lub raum lossis cov hlab plawv tuag tau txo qis hauv pawg empagliflozin los ntawm 28 feem pua (HR 0.72, 95 feem pua CI 0.64-0. 82, p < 0.000001).
✔ Piv nrog cov placebo pab pawg, kev pheej hmoo ntawm kev mob raum, ESKD, lossis cov hlab plawv tuag hauv pawg empagliflozin tau txo qis los ntawm 29 feem pua (HR 0.71, 95 feem pua CI 0). 5}}.81), 27 feem pua (HR 0.73, 95 feem pua CI 0.59-0.89).
✔ Cov ntsiab lus tseem ceeb thib ob: Piv nrog cov placebo pab pawg, qhov kev pheej hmoo ntawm kev mus pw hauv tsev kho mob tau txo qis hauv pawg empagliflozin los ntawm 14 feem pua (HR 0.86, 95 feem pua CI 0 .78-0.95, p=0.003).
Txawm hais tias tsis muaj qhov tseem ceeb ntawm kev pheej hmoo txo qis rau txhua qhov ua rau tuag, lub plawv tsis ua haujlwm hauv tsev kho mob, lossis kev tuag ntawm lub plawv, cov ntaub ntawv tau zoo ib yam nrog cov kev tshawb fawb yav dhau los.
✔ Cov txiaj ntsig kev nyab xeeb: Cov txiaj ntsig ntawm txoj kev tshawb fawb no tau pom tias tag nrho kev nyab xeeb ntawm Empagliflozin hauv kev kho mob ntawm CKD cov neeg mob tau zoo, ua raws li cov yam ntxwv ntawm kev nyab xeeb uas tau pom hauv kev tshawb fawb soj ntsuam yav dhau los, thiab tsis pom muaj cov cim kev nyab xeeb tshiab.
Cov ntsiab lus
Rau cov neeg mob CKD, tseem muaj qhov xav tau kev kho mob loj heev hauv kev ncua kev loj hlob ntawm cov kab mob raum thiab txo qhov kev pheej hmoo ntawm cov hlab plawv.
Piv nrog cov kev tshawb fawb soj ntsuam yav dhau los ntawm SGLT-2i hauv cov neeg mob uas muaj kab mob raum, txoj kev tshawb fawb EMPA-KIDNEY suav nrog ntau yam ntawm cov neeg mob CKD, tsuas yog 31 feem pua yog cov neeg mob DKD, thiab qhov suav nrog ntau ntawm eGFR poob rau 20 mL / min / 1.73 m2, thiab ntau tus neeg mob nrog normoalbuminuria / microalbuminuria tau suav nrog.
Cov txiaj ntsig ntawm EMPA-KIDNEY txoj kev tshawb fawb pom tau tias piv nrog cov placebo pab pawg, kev pheej hmoo ntawm kev mob raum, ESKD lossis cov hlab plawv tuag hauv pawg empagliflozin tau txo qis los ntawm 29 feem pua thiab 27 feem pua; tag nrho-ua rau pw hauv tsev kho mob tshwm sim hauv pawg empagliflozin Qhov kev pheej hmoo tau txo qis los ntawm 14 feem pua, thiab tag nrho kev nyab xeeb profile tau zoo.
Kev tshaj tawm cov txiaj ntsig ntawm EMPA-KIDNEY txoj kev tshawb fawb tau lees paub cov txiaj ntsig kev kho mob ntawm empagliflozin nyob rau hauv ntau yam ntawm CKD cov neeg, thiab yog ib qho tseem ceeb hauv kev txhim kho ntawm kev kawm txog kab mob raum thiab kev kuaj mob thiab kev kho mob, thiab yuav muaj txiaj ntsig ntau rau cov neeg mob. nrog mob raum mob.
Yog xav paub ntxiv: Ali.ma@wecistanche.com
