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IRIS
Rationale & Objective: It is unclear whether the effect of canagliflozin on adverse kidney and cardiovascular events in those with diabetic kidney disease varies by age and sex. We assessed the effects of canagliflozin among age group categories and between sexes in the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) study. Study Design: Secondary analysis of a randomized controlled trial. Setting & Participants: Participants in the CREDENCE trial. Intervention: Participants were randomly assigned to receive canagliflozin 100 mg/d or placebo. Outcomes: Primary composite outcome of kidney failure, doubling of serum creatinine concentration, or death due to kidney or cardiovascular disease. Prespecified secondary and safety outcomes were also analyzed. Outcomes were evaluated by age at baseline (<60, 60-69, and ≥70 years) and sex in the intention-to-treat population using Cox regression models. Results: The mean age of the cohort was 63.0 ± 9.2 years, and 34% were female. Older age and female sex were independently associated with a lower risk of the composite of adverse kidney outcomes. There was no evidence that the effect of canagliflozin on the primary outcome (a composite of kidney failure, a doubling of serum creatinine concentration, or death from kidney or cardiovascular causes) differed between age groups (HRs, 0.67 [95% CI, 0.52-0.87], 0.63 [0.48-0.82], and 0.89 [0.61-1.29] for ages <60, 60-69, and ≥70 years, respectively; P = 0.3 for interaction) or sexes (HRs, 0.71 [95% CI, 0.54-0.95] and 0.69 [0.56-0.84] in women and men, respectively; P = 0.8 for interaction). No differences in safety outcomes by age group or sex were observed. Limitations: This was a post hoc analysis with multiple comparisons. Conclusions: Canagliflozin consistently reduced the relative risk of kidney events in people with diabetic kidney disease in both sexes and across age subgroups. As a result of greater background risk, the absolute reduction in adverse kidney outcomes was greater in younger participants. Funding: This post hoc analysis of the CREDENCE trial was not funded. The CREDENCE study was sponsored by Janssen Research and Development and was conducted collaboratively by the sponsor, an academic-led steering committee, and an academic research organization, George Clinical. Trial Registration: The original CREDENCE trial was registered at ClinicalTrials.gov with study number NCT02065791.
Kidney and Cardiovascular Effects of Canagliflozin According to Age and Sex: A Post Hoc Analysis of the CREDENCE Randomized Clinical Trial
Yi T. W.;Smyth B.;Di Tanna G. L.;Arnott C.;Cardoza K.;Kang A.;Pollock C.;Agarwal R.;Bakris G.;Charytan D. M.;de Zeeuw D.;Heerspink H. J. L.;Neal B.;Wheeler D. C.;Cannon C. P.;Zhang H.;Zinman B.;Perkovic V.;Levin A.;Mahaffey K. W.;Jardine M.;Brenner B. M.;Greene T.;Meininger G.;Li N.;Kolesnyk I.;Aizenberg D.;Pecoits-Filho R.;Cherney D.;Obrador G.;Chertow G.;Chang T.;Hawley C.;Ji L.;Wada T.;Jha V.;Lim S. K.;Lim-Abrahan M. A.;Santos F.;Chae D. -W.;Hwang S. -J.;Vazelov E.;Rychlik I.;Hadjadj S.;Krane V.;Rosivall L.;De Nicola L.;Dreval A.;Nowicki M.;Schiller A.;Distiller L.;Gorriz J. L.;Kolesnyk M.;David;Wheeler C.;Guerrero R. A. A.;Albisu J. P.;Alvarisqueta A.;Bartolacci I.;Berli M. A.;Bordonava A.;Calella P.;Cantero M. C.;Cartasegna L. R.;Cercos E.;Coloma G. C.;Colombo H.;Commendatore V.;Cuadrado J.;Cuneo C. A.;Cusumano A. M.;Douthat W. G.;Dran R. D.;Farias E.;Fernandez M. F.;Finkelstein H.;Fragale G.;Fretes J. O.;Garcia N. H.;Gastaldi A.;Gelersztein E.;Glenny J. A.;Gonzalez J. P.;Colaso P. D. C. G.;Goycoa C.;Greloni G. C.;Guinsburg A.;Hermida S.;Juncos L. I.;Klyver M. I.;Kraft F.;Krynski F.;Lanchiotti P. V.;Leon de la Fuente R. A.;Marchetta N.;Mele P.;Nicolai S.;Novoa P. A.;Orio S. I.;Otreras F.;Oviedo A.;Raffaele P.;Resk J. H.;Rista L.;Papini N. R.;Sala J.;Santos J. C.;Schiavi L. B.;Sessa H.;Casabella T. S.;Ulla M. R.;Valdez M.;Vallejos A.;Villarino A.;Visco V. E.;Wassermann A.;Zaidman C. J.;Cheung N. W.;Droste C.;Fraser I.;Johnson D.;Mah P. M.;Nicholls K.;Packham D.;Proietto J.;Roberts A.;Roger S.;Tsang V.;Raduan R. A.;Costa F. A. A. D.;Amodeo C.;Turatti L. A. A.;Bregman R.;Sanches F. C. C.;Canani L. H.;Chacra A. R.;Borges J. L. C.;Vencio S. A. C.;Franco R. J. D. S.;d'Avila D.;Portes E. D. S.;de Souza P.;Deboni L. M.;Fraige Filho F.;Neto B. G.;Gomes M.;Kohara S. K.;Keitel E.;Saraiva J. F. K.;Lisboa H. R. K.;Contieri F. L. D. C.;Milagres R.;Junior R. M.;de Brito C. M.;Hissa M. N.;Sabbag A. R. N.;Noronha I.;Panarotto D.;Filho R. P.;Pereira M. A.;Saporito W.;Scotton A. S.;Schuch T.;de Almeida R. S.;Ramos C. S.;Felicio J. S.;Thome F.;Hachmann J. C. T.;Yamada S.;Hayashida C. Y.;Petry T. B. Z.;Zanella M. T.;Andreeva V.;Angelova A.;Dimitrov S.;Genadieva V.;Genova-Hristova G.;Hristozov K.;Kamenov Z.;Koundurdjiev A.;Lozanov L.;Margaritov V.;Nonchev B.;Rangelov R.;Shinkov A.;Temelkova M.;Velichkova E.;Yakov A.;Aggarwal N.;Aronson R.;Bajaj H.;Chouinard G.;Conway J.;Cournoyer S.;DaRoza G.;De Serres S.;Dube F.;Goldenberg R.;Gupta A.;Gupta M.;Henein S.;Khandwala H.;Leiter L.;Madore F.;McMahon A.;Muirhead N.;Pichette V.;Rabasa-Lhoret R.;Steele A.;Tangri N.;Torshizi A.;Woo V.;Zalunardo N.;Montenegro M. A. F.;Gonzalo Godoy Jorquera J.;Farina M. M.;Gajardo V. S.;Vejar M.;Chen N.;Chen Q.;Gan S.;Kong Y.;Li D.;Li W.;Li X.;Lin H.;Liu J.;Lu W.;Mao H.;Ren Y.;Song W.;Sun J.;Sun L.;Tu P.;Wang G.;Yang J.;Yin A.;Yu X.;Zhao M.;Zheng H.;Mendoza J. L. A.;Arcos E.;Avendano J.;Diaz Ruiz J. E. A.;Ortiz L. H. G.;Gonzalez A.;Triana E. H.;Higuera J. D.;Malaver N.;de Salazar D. I. M.;Rosero R.;Alexandra Terront Lozano M.;Cometa L. V.;Valenzuela A.;Vargas Alonso R. D.;Villegas I.;Yupanqui H.;Bartaskova D.;Barton P.;Belobradkova J.;Dohnalova L.;Drasnar T.;Ferkl R.;Halciakova K.;Klokocnikova V.;Kovar R.;Lastuvka J.;Lukac M.;Pesickova S.;Peterka K.;Pumprla J.;Rychlik I.;Saudek F.;Tesar V.;Valis M.;Weiner P.;Zemek S.;Alamartine E.;Borot S.;Cariou B.;Dussol B.;Fauvel J. -P.;Gourdy P.;Klein A.;Le Meur Y.;Penfornis A.;Roussel R.;Saulnier P. -J.;Thervet E.;Zaoui P.;Burst V.;Faghih M.;Faulmann G.;Haller H.;Jerwan-Keim R.;Maxeiner S.;Paschen B.;Plassmann G.;Rose L.;Gonzalez Orellana R. A.;Haase F. P.;Moreira Diaz J. P.;Ramirez Roca L. A.;Sanchez Arenales J. A.;Sanchez Polo J. V.;Juarez E. T.;Csecsei G.;Csiky B.;Danos P.;Deak L.;Dudas M.;Harcsa E.;Keltai K.;Keresztesi S.;Kiss K.;Konyves L.;Major L.;Mileder M.;Molnar M.;Mucsi J.;Oroszlan T.;Ory I.;Paragh G.;Peterfai E.;Petro G.;Revesz K.;Takacs R.;Vangel S.;Vasas S.;Zsom M.;Abraham O.;Bhushan R. S.;Deepak D.;Edwin F. M.;Gopalakrishnan N.;Gracious N.;Hansraj A.;Jain D.;Keshavamurthy C. B.;Khullar D.;Manisha S.;Peringat J.;Prasad N.;Satyanarayana R. K.;Sreedhar R.;Sreelatha M.;Sudhakar B.;Chandra Vyasam R.;Bonadonna R.;Castellino P.;Ceriello A.;Chiovato L.;De Cosmo S.;Derosa G.;Di Carlo A.;Di Cianni G.;Frasca G.;Fuiano G.;Gambaro G.;Garibotto G.;Giorda C.;Malberti F.;Mandreoli M.;Mannucci E.;Orsi E.;Piatti P.;Santoro D.;Sasso F. C.;Serviddio G.;Stella A.;Trevisan R.;Veronelli A. M.;Zanoli L.;Akiyama H.;Aoki H.;Asano A.;Iitsuka T.;Kajiyama S.;Kashine S.;Kawada T.;Kodera T.;Kono H.;Koyama K.;Kumeda Y.;Miyauchi S.;Mizuyama K.;Niiya T.;Oishi H.;Ota S.;Sakakibara T.;Takai M.;Tomonaga O.;Tsujimoto M.;Wakasugi M.;Wakida Y.;Watanabe T.;Yamada M.;Yanagida K.;Yanase T.;Yumita W.;Gaupsiene E.;Kozloviene D.;Navickas A.;Urbanaviciene E.;Abdul Ghani R.;Kadir K. A.;Ali N.;Che Yusof M. D.;Gan C. L.;Ismail M.;Kong W. Y.;Lam S. W.;Lee L. Y.;Loh C. L.;Manocha A. B.;Ng K. S.;Ahmad N. N. F. N.;Ratnasingam V.;Shudim S. S. B.;Vengadasalam P.;Abraira Munoz L. D.;Salazar M. A.;Cruz J. B.;Soto M. B.;Ramos J. C.;Wong A. C.;Correa Rotter J. R.;Escalante T. D.;Enriquez Sosa F. E.;Lozano F. F.;Flota Cervera L. F.;Baron P. F.;Ballesteros C. G.;Gomez Rangel J. D.;Herrera Jimenez L. E.;Irizar Santana S. S.;Flores F. J.;Molina H. L.;Luna Ceballos R. I.;del Campo Blanco B. M.;Franco G. M.;Moreno Loza O. T.;Rocha C. M.;Vera G. O.;Castellanos R. O.;Calcaneo J. P.;Reyes Rosano M. A.;Pattzi H. R.;Guzman J. R.;Rucker Joerg I. E.;Saavedra Sanchez S. B.;Sanchez Mijangos J. H.;Sanson P. S.;Tamayo y Orozco J. A.;Chavez E. T.;Cepeda A. V.;Carrillo L. V.;Mesa J. V.;Escobedo R. Z.;Baker J.;Noonan P.;Scott R.;Walker R.;Watson E.;Williams M.;Young S.;Abejuela Z.;Agra J.;Aquitania G.;Caringal C.;Comia R. S.;Santos L. D.;Gomez O.;Jimeno C.;Tan G.;Tolentino M.;Yao C.;Yap Y. E.;Lallaine Ygpuara M. D.;Bijata-Bronisz R.;Hotlos L.;Januszewicz A.;Kaczmarek B.;Kaminska A.;Lazuka L.;Madej A.;Mazur S.;Mlodawska-Choluj D.;Nowicki M.;Orlowska-Kowalik G.;Popenda G.;Rewerska B.;Sowinski D.;Angelescu L. M.;Anghel V.;Avram R. -I.;Busegeanu M. -M.;Cif A.;Cosma D.;Crisan C.;Demian L. D.;Ferariu I. E.;Halmagyi I.;Hancu N.;Munteanu M.;Negru D.;Onaca A. G.;Petrica L.;Popa A. R.;Ranetti A. -E.;Serafinceanu C.;Toarba C.;Agafyina A.;Barbarash O.;Barysheva O.;Chizhov D.;Dobronravov V.;Glinkina I.;Grineva E.;Khirmanov V.;Kolmakova E.;Koroleva T.;Kvitkova L.;Marasaev V.;Mkrtumyan A.;Morugova T.;Nagibovich G.;Nagibovich O.;Nedogoda S.;Osipova I.;Raskina T.;Samoylova Y.;Sazonova O.;Shamkhalova M.;Shutemova E.;Shwartz Y.;Uriasyev O.;Vorobyev S.;Zateyshchikova A.;Zateyshshikov D.;Zykova T.;Antic S.;Djordjevic M.;Kendereski A.;Lalic K.;Lalic N.;Popovic-Radinovic V.;Babikova J.;Benusova O.;Buganova I.;Culak J.;Dzupina A.;Dzuponova J.;Fulop P.;Ilavska A.;Martinka E.;Ochodnicka Z.;Pella D.;Smatanova I.;Ahmed F.;Badat A.;Breedt J.;Distiller L.;Govender V.;Govender R.;Joshi M.;Jurgens J.;Latiff G.;Lombard L.;Mookadam M.;Ngcakani N.;Nortje H.;Oosthuizen H.;Pillay-Ramaya L.;Prozesky H.;Reddy J.;Rheeder P.;Seeber M.;Cho Y. M.;Jeong I. -K.;Kim S. G.;Kim Y. H.;Kwon H. -S.;Kwon M. J.;Lee B. -W.;Lee J.;Lee M. -K.;Nam M. -S.;Oh K. -H.;Park C. -Y.;Park S. -H.;Yoon K. H.;Garcia P. A.;Mercadal L. A.;Barrios C.;Castro F. C.;Guldris S. C.;Lopez M. D.;Egido de los Rios J.;Fresnedo G. F.;Serrano A. G.;Garcia I.;Gonzalez Martinez F. J.;Jodar Gimeno J. E.;Mendoza M. L.;Marin T. M.;Portillo C. M.;Munar Vila M. A.;Torres M. M.;Iglesias J. N.;Perez J. P.;Vera M. P.;Portoles Perez J. M.;Quesada Simon M. A.;Canonge R. S.;Gonzalez A. S.;Riera M. T.;Tinahones Madueno F. J.;Plaza M. V.;Chang C. -T.;Chuang L. -M.;Hsia T. -L.;Hsieh C. -H.;Lin C. -C.;Lu Y. -C.;Sheu W. H. -H.;Barna O.;Bilyk S. D.;Botsyurko V.;Dudar I.;Fushtey I.;Godlevska O.;Golovchenko O.;Gyrina O.;Kazmirchuk A.;Komisarenko I.;Korzh O.;Kravchun N.;Legun O.;Mankovskyy B.;Martynyuk L.;Mostovoy Y.;Pashkovska N.;Pererva L.;Pertseva T.;Samoylov O.;Smirnov I.;Svyshchenko Y.;Tomashkevych H.;Topchii I.;Tryshchuk N.;Tseluyko V.;Vizir V.;Vlasenko M.;Zlova T.;Zub L.;Abusnana S.;Railey M.;Abouglila K.;Ainsworth P.;Ali Z.;Arutchelvam V.;Barnard M.;Bellary S.;Davies E.;Davies M.;Davies S.;Dawson A.;El Kossi M.;English P.;Fraser D.;Gnudi L.;Gunstone A.;Hall T.;Hanif W.;Jackson A.;Johnson A.;Joseph F.;Krishnan S.;Kumwenda M.;MacDougall I.;Nixon P.;O'Hare J.;Philip S.;Ramtoola S.;Saxena M.;Sennik D.;Simon G.;Singh B.;Stephens J.;Strzelecka A.;Symonds R.;Turner W.;Wahba M.;Wakeling J.;Wheeler D.;Winocour P.;Abdallah J.;Abdullah R.;Abramowitz M.;Acosta I.;Aiello J.;Akright L.;Akyea-Djamson A.;Alappan R.;Alicic R.;Al-Karadsheh A.;Allison D. C.;Arauz-Pacheco C.;Arfeen S.;Arif A.;Arvind M.;Atray N.;Awad A.;Barnhill P.;Barranco E.;Barrera C.;Beacom M.;Behara V.;Belo D.;Bentley-Lewis R.;Berenguer R.;Bermudez L.;Bernardo M.;Biscoveanu M.;Bowman-Stroud C.;Brandon D.;Brusco O.;Busch R.;Canaan Y.;Chilito A.;Christensen T.;Christiano C.;Christofides E.;Chuateco C.;Cohen K.;Cohen R.;Cohen-Stein D.;Cook C.;Coyne D.;Daboul N.;Darwish R.;Daswani A.;Deck K.;Desouza C.;Dev D.;Dhillon M.;Dua S.;Eder F.;Elosegui A. M.;El-Shahawy M.;Ervin J.;Esquenazi A.;Evans J.;Fishbane S.;Frias J.;Galindo-Ramos E.;Galphin C.;Ghazi A.;Gonzalez E.;Gorson D.;Gowda A.;Greco B.;Grubb S.;Gulati R.;Hammoud J.;Handelsman S.;Hartman I.;Hershon K.;Hiser D.;Hon G.;Jacob R.;Jaime M.;Jamal A.;Kaupke C.;Keightley G.;Kern E.;Khanna R.;Khitan Z.;Kim S.;Kopyt N.;Kovesdy C.;Krishna G.;Kropp J. J.;Kumar A.;Kumar J.;Kumar N.;Kusnir J.;Lane W.;Lawrence M.;Lehrner L.;Lentz J.;Levinson D.;Lewis D.;Liss K.;Maddux A.;Maheshwari H.;Mandayam S.;Marar I.;Mehta B.;Middleton J.;Mordujovich J.;Moreda R.;Moustafa M.;Trenche S. M.;Narayanan M.;Narvarte J.;Nassar T.;Newman G.;Nichol B.;Nicol P.;Nisnisan J.;Nossuli A. K.;Obialo C.;Olelewe S.;Oliver M.;O'Shaughnessy A.;Padron J.;Pankhaniya R.;Parker R.;Patel D.;Patel G.;Patel N.;Pavon H.;Perez A.;Perez C.;Perlman A.;Pettis K.;Pharr W.;Phillips A.;Purighalla R.;Quesada-Suarez L.;Ranjan R.;Rastogi S.;Reddy J.;Rendell M.;Rich L.;Robinson M.;Rodriguez H.;Rosas S.;Saba F.;Sankaram R.;Sarin R.;Schreiman R.;Scott D.;Sekkarie M.;Sensenbrenner J.;Shakeel M.;Shanik M.;Shaw S.;Smith S.;Solomon R.;Sprague A.;Spry L.;Suchinda P.;Sultan S.;Surampudi P.;Sussman S.;Tan A.;Terrelonge A.;Thompson M.;Trespalacios F.;Trippe B.;Trueba P.;Twahirwa M.;Updegrove J.;Van Buren P.;Vannorsdall M.;Varghese F.;Velasquez-Mieyer P.;Ventrapragada S.;Vukotic G.;Wadud K.;Warren M.;Watson H.;Watts R.;Weiner D.;Welker J.;Welsh J.;Williams S.;Zaniewski-Singh M.
2023
Abstract
Rationale & Objective: It is unclear whether the effect of canagliflozin on adverse kidney and cardiovascular events in those with diabetic kidney disease varies by age and sex. We assessed the effects of canagliflozin among age group categories and between sexes in the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) study. Study Design: Secondary analysis of a randomized controlled trial. Setting & Participants: Participants in the CREDENCE trial. Intervention: Participants were randomly assigned to receive canagliflozin 100 mg/d or placebo. Outcomes: Primary composite outcome of kidney failure, doubling of serum creatinine concentration, or death due to kidney or cardiovascular disease. Prespecified secondary and safety outcomes were also analyzed. Outcomes were evaluated by age at baseline (<60, 60-69, and ≥70 years) and sex in the intention-to-treat population using Cox regression models. Results: The mean age of the cohort was 63.0 ± 9.2 years, and 34% were female. Older age and female sex were independently associated with a lower risk of the composite of adverse kidney outcomes. There was no evidence that the effect of canagliflozin on the primary outcome (a composite of kidney failure, a doubling of serum creatinine concentration, or death from kidney or cardiovascular causes) differed between age groups (HRs, 0.67 [95% CI, 0.52-0.87], 0.63 [0.48-0.82], and 0.89 [0.61-1.29] for ages <60, 60-69, and ≥70 years, respectively; P = 0.3 for interaction) or sexes (HRs, 0.71 [95% CI, 0.54-0.95] and 0.69 [0.56-0.84] in women and men, respectively; P = 0.8 for interaction). No differences in safety outcomes by age group or sex were observed. Limitations: This was a post hoc analysis with multiple comparisons. Conclusions: Canagliflozin consistently reduced the relative risk of kidney events in people with diabetic kidney disease in both sexes and across age subgroups. As a result of greater background risk, the absolute reduction in adverse kidney outcomes was greater in younger participants. Funding: This post hoc analysis of the CREDENCE trial was not funded. The CREDENCE study was sponsored by Janssen Research and Development and was conducted collaboratively by the sponsor, an academic-led steering committee, and an academic research organization, George Clinical. Trial Registration: The original CREDENCE trial was registered at ClinicalTrials.gov with study number NCT02065791.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11591/545105
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simulazione ASN
Il report seguente simula gli indicatori relativi alla propria produzione scientifica in relazione alle soglie ASN 2023-2025 del proprio SC/SSD. Si ricorda che il superamento dei valori soglia (almeno 2 su 3) è requisito necessario ma non sufficiente al conseguimento dell'abilitazione. La simulazione si basa sui dati IRIS e sugli indicatori bibliometrici alla data indicata e non tiene conto di eventuali periodi di congedo obbligatorio, che in sede di domanda ASN danno diritto a incrementi percentuali dei valori. La simulazione può differire dall'esito di un’eventuale domanda ASN sia per errori di catalogazione e/o dati mancanti in IRIS, sia per la variabilità dei dati bibliometrici nel tempo. Si consideri che Anvur calcola i valori degli indicatori all'ultima data utile per la presentazione delle domande.
La presente simulazione è stata realizzata sulla base delle specifiche raccolte sul tavolo ER del Focus Group IRIS coordinato dall’Università di Modena e Reggio Emilia e delle regole riportate nel DM 589/2018 e allegata Tabella A. Cineca, l’Università di Modena e Reggio Emilia e il Focus Group IRIS non si assumono alcuna responsabilità in merito all’uso che il diretto interessato o terzi faranno della simulazione. Si specifica inoltre che la simulazione contiene calcoli effettuati con dati e algoritmi di pubblico dominio e deve quindi essere considerata come un mero ausilio al calcolo svolgibile manualmente o con strumenti equivalenti.
