Ntu 2 Kev Tshawb Fawb Txog Kev Kho Mob Tshiab Rau Cov Neeg Mob Mob Raum Kab Mob Hauv Hom 2 Mob Ntshav Qab Zib: Lub luag haujlwm ntawm Finerenone
May 30, 2023
Finerenone Phase III project
FIDELIO-DKD thiab FIGARO-DKD yog cov loj-teev (n ¼ 5674 thiab n ¼ 7354, ntsig txog) thoob ntiaj teb, randomized, ob qhov muag tsis pom kev, cov tshuaj placebo-tswj tshuaj ntsuam xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm finer enone hauv kev txo qis CKD kev nce qib thiab CV kev tuag thiab morbidity hauv cov neeg mob nrog CKD thiab T2D [43, 44]. Cov kev tshawb fawb tau tso npe cov neeg mob los ntawm 48 lub teb chaws thiab thaj chaw thoob plaws 6 lub teb chaws (Daim duab 3 thiab cov ntaub ntawv ntxiv, Daim duab 1) [43, 44].
FIDELIO-DKD thiab FIGARO-DKD yog ib qho kev ywj pheej-tsav kev sim uas ib tus zuj zus, nrog rau tag nrho cov ntsiab lus tseem ceeb tau txais, muab qhov tsawg kawg nkaus ntawm 90 feem pua lub zog txhawm rau txheeb xyuas 20 feem pua ntawm cov kev pheej hmoo txo qis hauv lawv cov ntsiab lus tseem ceeb kawg nrog finer enone piv nrog cov tshuaj placebo. Cov kev sim no tau tsim los suav nrog cov ntsiab lus tseem ceeb thiab sib luag thiab cov ntsiab lus tseem ceeb thib ob uas muaj qhov tseem ceeb thiab cuam tshuam rau lub raum thiab CV cov txiaj ntsig (Daim duab 3). FIDELIO-DKD thawj qhov kawg yog qhov sib xyaw ntawm lub sijhawm rau thawj qhov tshwm sim ntawm lub raum tsis ua haujlwm, txhais tau tias yog qhov pib ntawm kev lim ntshav ntev tshaj 90 hnub lossis hloov lub raum (ESKD) lossis kev txhawb nqa eGFR<15 mL/min/1.73 m2 over at least 4 weeks, a sustained decrease in eGFR of 40% from baseline over at least 4 weeks or renal death, whereas the key prespecified secondary endpoint is a composite of CV death, nonfatal myocardial infarction, nonfatal stroke or hospitalization for heart failure [43]. The FIGARO-DKD primary endpoint is the composite of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure, with the key prespecified secondary endpoint replicating the primary composite endpoint of FIDELIO-DKD (Figure 3) [43, 44]
Lwm qhov kawg qhov kawg suav nrog kev tuag thiab pw hauv tsev kho mob los ntawm ib qho laj thawj. Kev tshawb nrhiav cov ntsiab lus kawg xws li eGFR nqes hav txhua xyoo yuav raug kawm. Tsis tas li ntawd, qhov kev sim siab yuav soj ntsuam qhov kev hloov pauv ntawm kev noj qab haus huv ntawm lub neej, uas yuav raug soj ntsuam hauv txhua tus neeg mob uas siv cov khoom 36-Kidney Disease Quality of Life thiab 5-level European Quality of Life { {3}} Dimensions questionnaires. Tsis tas li ntawd, cov kev sim no yuav suav nrog echocardiography thiab biomarker substudies, yog li ua rau muaj kev nkag siab tob tob uas txiav txim siab txog pathophysiology nrog rau cov txiaj ntsig ntawm tus neeg mob, yam uas tsis tau hais txog yav dhau los rau qhov no hauv cov neeg mob no.
Nyem qhov no kom tau txaiscov txiaj ntsig Cistanche
Sib piv FIGARO-DKD thiab FIDELIO-DKD cov pej xeem nrog rau lwm qhov kev sim hauv CKD nrog T2D
Cov neeg mob uas tau khaws cia eGFR feem ntau tsis suav nrog CKD nrog kev sim T2D. Yav dhau los understudied pab pawg neeg mob hais txog lub raum thiab CV cov txiaj ntsig, xws li cov neeg muaj albuminuria siab (UACR 30–<300 mg/g) or very high albuminuria (UACR >300 mg/g) and eGFR >60 mL / min / 1.73 m2 (Daim duab 4A thiab Table 1) tam sim no zoo sawv cev. Nyob rau hauv tag nrho, 39.9 feem pua (5196/ 13 028) ntawm cov neeg mob nyob rau hauv ob qho tib si kev sim sib raug rau cov pejxeem no nrog khaws cia eGFR.
Txhawm rau kom muaj txiaj ntsig zoo dua cardiorenal hauv FIDELIO-DKD thiab FIGARO-DKD cov neeg mob peb siv cov cuab yeej siv tau. KDIGO CKD pawg ua haujlwm siv kev sib xyaw ua ke ntawm eGFR thiab UACR pawg hauv nws qhov kev pheej hmoo stratification cuab yeej rau kwv yees CKD thiab CV cov txiaj ntsig [12]. Cov txiaj ntsig tau pom hauv daim duab 4B. Thoob plaws ob qhov kev sim siab, nruab nrab, siab, thiab siab heev KDIGO cov qhab nia muaj kev pheej hmoo tau sau tseg hauv 10, 41.1, thiab 48.3 feem pua ntawm cov neeg mob, feem; ~ 90 feem pua tseem muaj tsawg kawg yog qhov kev pheej hmoo siab ntawm qhov kev kuaj mob loj.
Cistanche extract thiab Cistanche hmoov
Txhawm rau sib piv FIDELIO-DKD thiab FIGARO-DKD cov neeg mob ntxiv nrog rau lwm qhov kev sim peb tau npaj cov ntsiab lus kwv yees ntawm cov ntaub ntawv hauv paus UACR thiab eGFR tau tso npe hauv CKD tsis ntev los no hauv T2D kev sim tshuaj xyuas CV thiab / lossis lub raum cov txiaj ntsig (Daim duab 5; Cov ntaub ntawv ntxiv, Daim duab 2 thiab cov ntaub ntawv ntxiv, Table 2). Cov neeg mob albuminuria siab tsis muaj npe nyob rau hauv lwm qhov kev sim tab sis tau sawv cev zoo hauv FIDELIODKD thiab FIGARO-DKD qhov kev pab cuam, qhov twg 4070 (31.2 feem pua) cov neeg mob muaj albuminuria siab ntawm lub hauv paus (Daim duab 5; Cov ntaub ntawv ntxiv, Daim duab 2 thiab cov ntaub ntawv ntxiv, Table 2) . Albuminuria yog ib qho kev pheej hmoo ntawm kev ywj pheej rau CV thiab tag nrho-ua rau kev tuag, txawm tias nyob rau theem nyob rau hauv ib txwm muaj [8, 9]. Raws li qhov no, cov neeg muaj kev pheej hmoo siab CV no yuav tsum tso cai rau kev nkag siab ntau dua rau cov txiaj ntsig tau zoo ntawm cov txiaj ntsig zoo rau kev txo cov txiaj ntsig CV hauv pab pawg neeg mob nrog cov theem ua ntej ntawm CKD.
Txawm hais tias cov pej xeem sib sau ua ke tau muaj kev pheej hmoo siab ntawm CV cov xwm txheej thiab muaj qhov qis dua eGFR ntawm lub hauv paus piv nrog CREDENCE (Canagliflozin thiab Renal Events in Diabetes and Nephropathy Clinical Evaluation) sim ntawm canagliflozin hauv cov neeg mob T2D thiab CKD (Table 1; Supplementary. cov ntaub ntawv, Table 2 thiab cov ntaub ntawv ntxiv, Daim duab 2), cov pej xeem FIDELIODKD thiab FIGARO-DKD tau tswj tau zoo txheeb ze rau CREDENCE mus sib hais txog qhov qis qis HbA1c thiab systolic ntshav siab (Table 1; Cov ntaub ntawv ntxiv, Table 2). Kev ntsuam xyuas cov neeg mob tswj tau zoo txo qis qhov kev hloov pauv thiab tsis meej pem hauv cov txiaj ntsig sim. Tsis tas li ntawd, nws tso cai rau kev lees paub ntawm cov txiaj ntsig cardiorenal ntawm finer enone ntxiv rau tus qauv zoo tshaj plaws ntawm kev saib xyuas glycemic tswj thiab CV kev pheej hmoo.
FIDELIO-DKD thiab FIGARO-DKD kev sim yog tsim los tshawb xyuas cov txiaj ntsig zoo ntawm kev txo qis kev pheej hmoo ntawm CV kab mob hauv FIGARO-DKD nrog rau CKD kev nce qib hauv FIDELIO-DKD, tab sis hla kev tshawb pom hauv ib qho kev sim. Tsis muaj qhov kev sim ua dhau los tau raug tsim los li no. Raws li nrog rau lwm qhov kev sim, FIDELIO-DKD thiab FIGARO-DKD tau tshawb xyuas cov neeg mob tau txais cov qauv kev pom zoo ntawm kev saib xyuas nrog qhov siab tshaj plaws uas tau sau npe koob tshuaj ACEi lossis ARB (Table 1). Tsis tas li ntawd, ~ 7 feem pua ntawm cov neeg mob suav nrog kuj tau txais SGLT2is thiab glucagon-zoo li peptide -1 receptor agonists ntawm lub hauv paus (Table 1). Txawm hais tias cov pej xeem tau txais SGLT2is nyob rau hauv FIDELIO-DKD thiab FIGARO-DKD kev sim yog qhov sib piv me me, pawg pab pawg no tuaj yeem muab kev nkag siab txog qhov cuam tshuam ntawm kev tau txais ob qho tib si finer enone thiab SGLT2i.
Herba Cistanche
Cov lus xaus
Cov kev tshawb fawb FIDELIO-DKD thiab FIGARO-DKD suav nrog cov txiaj ntsig ntawm CKD loj tshaj plaws rau hnub tim thiab yuav txiav txim siab qhov cuam tshuam ntawm txoj hauv kev tshiab rau kev kho CKD hauv T2D uas yog lub hom phiaj ntawm cov txheej txheem kab mob. Txoj hauv kev no txuas ntxiv cov neeg mob CKD mus txog los ntawm suav nrog cov neeg tsis tau kawm yav dhau los thiab muaj kev pheej hmoo siab cardiorenal subgroups. Yog li ntawd, cov kev sim no txhob txwm tshaj tawm nrog cov neeg mob siab thiab siab heev albuminuria ntawm kev pheej hmoo siab cardiorenal txawm tias tus qauv zoo tshaj plaws ntawm kev saib xyuas glycemic tswj thiab tswj ntawm CV kev pheej hmoo (Table 1). Tsis tas li, cov kev sim no tau siv los ua kom pom kev ua tau zoo thiab kev nyab xeeb ntawm lub raum loj thiab CV cov txiaj ntsig hauv cov neeg muaj kev pheej hmoo siab. Thaum kawg, qhov kev sim FIDELIO-DKD thiab FIGARO-DKD yog cov kev tshawb fawb zoo tshaj plaws uas tsis yog kev sim kev nyab xeeb thiab ntsuas qhov kev kho mob uas tsis muaj cov piam thaj txo qis. Cov kev sim no muaj peev xwm txo qis CKD kev nce qib thiab them taus kev tiv thaiv cardiorenal hauv cov neeg mob T2D hla CKD txuas ntxiv. Cov kev sim siab xav tias yuav ua tiav hauv 2020 thiab 2021, raws li
Cistanche ntsiav tshuaj
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Rajiv Agarwal 1, Stefan D. Anker2, George Bakris3, Gerasimos Filippatos4, Bertram Pitt5, Peter Rossing6,7, Luis Ruilope8,9,10, Martin Gebel11, Peter Kolkhof12, Christina Nowack13 thiab Amer Joseph14; sawv cev ntawm FIDELIO-DKD thiab FIGARO-DKD Cov Neeg Tshawb Fawb
1 Richard L. Roudebush VA Medical Center thiab Indiana University, Indianapolis, IN, USA,
2 Department of Cardiology (CVK) thiab Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charite' Universita¨tsmedizin, Berlin, Lub teb chaws Yelemees,
3 Department of Medicine, University of Chicago Medicine, Chicago, IL, USA,
4 National thiab Kapodistrian University of Athens, Tsev Kawm Ntawv Tshuaj, Department of Cardiology, Attikon University Tsev Kho Mob, Athens, Greece,
5 Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI, Tebchaws USA,
6 Steno Diabetes Center Copenhagen, Gentofte, Denmark,
7 Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark,
8 Cardiorenal Translational Laboratory thiab Hypertension Unit, Lub Tsev Kawm Ntawv ntawm Kev Tshawb Fawb imas12, Madrid, Spain,
9 IBER-CV, Tsev Kho Mob Universitario, 12 de Octubre, Madrid, Spain,
10 Kws qhia ntawv ntawm Kev Ua Si Ncaws Pob, European University of Madrid, Madrid, Spain,
11 Kev Tshawb Fawb thiab Kev Txhim Kho, Kev Txheeb Xyuas thiab Cov Ntaub Ntawv Kev Pom Zoo, Bayer AG, Berlin, Lub Tebchaws Yelemees,
12 Kev Tshawb Fawb thiab Kev Txhim Kho, Kev Tshawb Fawb Txog Kev Tshawb Fawb Txog Kev Kho Mob, Bayer AG, Wuppertal, Lub Tebchaws Yelemees,
13 Kev Tshawb Fawb thiab Kev Txhim Kho, Kev Txhim Kho Kev Txhim Kho Kev Ua Haujlwm, Bayer AG, Wuppertal, Lub Tebchaws Yelemees
14 Cardiology thiab Nephrology Clinical Development, Bayer AG, Berlin, Lub teb chaws Yelemees
