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1. The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study Rationale, Design, and Baseline Characteristics

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Abdallah J, Abdul Ghani R, Abdul Kadir K, Abdullah R, Abejuela Z, Abraham O, Abramowitz M, Abusnana S, Accini Mendoza JL, Acosta I, Agafyina A, Aggarwal N, Ahmed F, Ahuad Guerrero RA, Aiello J, Ainsworth P, Aizenberg D, Akiyama H, Akright L, Akyea-Djamson A, Alamartine E, Alappan R, Ali N, Ali Z, Alicic R, Al-Karadsheh A, Alpizar Salazar M, Alvarez Garcia P, Alvarisqueta A, Amodeo C, Andreeva V, Andreotti Turatti LA, Angelescu LM, Angelova A, Anghel V, Antic S, Aoki H, Aquitania G, Arauz-Pacheco C, Arce-Nunez E, Arcos Palma EG, Arfeen S, Arif A, Aronson R, Arutchelvam V, Asano A, Atray N, Avram RI, Awad A, Baas Cruz J, Babikova J, Badat A, Bajaj H, Baker J, Bakris G, Barbarash O, Barna O, Barnard M, Barranco E, Barrera C, Bartaskova D, Bartolacci I, Barysheva O, Behara V, Bellary S, Belo D, Bentley-Lewis R, Benusova O, Berenguer R, Berli MA, Bernardo M, Biscoveanu M, Bordonava AP, Borot S, Botsyurko V, Bowman-Stroud C, Brandon D, Bregman R, Brusco O, Buganova I, Burgos Soto M, Busch R, Busegeanu MM, Calella P, Camelo Sanches FC, Canaan Y, Canani LH, Cantero MC, Cariou B, Cartasegna LR, Castellino P, Cereto Castro F, Certow G, Chacra AR, Chae DW, Chang CT, Chang T, Che Yusof MD, Chen N, Chen Q, Cherney D, Cheung NW, Chevaile Ramos J, Chew Wong A, Chiovato L, Chizhov D, Cho YM, Christiano C, Christofides E, Chuang LM, Chuateco C, Cif A, Cigarran Guldris S, Cohen K, Cohen R, Coloma GC, Comia RS, Commendatore V, Conway J, Cook C, Cosma D, Cournoyer S, Coyne D, Crisan C, Csecsei G, Csiky B, Cuadrado J, Cuneo CA, Cunha Borges JL, Cunha Vêncio SA, Cusumano AM, da Silva Franco RJ, Daboul N, Danos P, DaRoza G, Davies E, Davies M, Davies S, Dawson A, De Cosmo S, De Nicola L, De Serres S, de Souza Portes E, Deak L, Deck K, Deepak D, Derosa G, Desouza C, Dev D, Dhillon M, DI CARLO, Alfonso, Di Cianni G, Diaz Escalante T, Dimitrov S, Distiller L, Djordjevic M, Dobronravov V, Dohnalova L, Dominguez Lopez M, Douthat WG, Dran RD, Drasnar T, Dreval A, Droste C, Dua S, Dube F, Dudar I, Dudas M, Dussol B, Dzupina A, Eder F, Egido de Los Rios J, El Kossi M, El-Shahawy M, English P, Enriquez Sosa FE, Ervin J, Esquenazi A, Evans J, Faghih M, Farias E, Faulmann G, Fauvel JP, Ferariu IE, Fernandez MF, Fernandez Fresnedo G, Fernandez Montenegro MA, Finkelstein H, Flores Lozano F, Flota Cervera L, Fraige Filho F, Fraser D, Frenk Baron P, Fretes JO, Frias J, Fuiano G, Fulop P, Fushtey I, Galan Serrano A, Galphin C, Gan S, Gan CL, Garcia NH, Garcia I, Garcia Ballesteros C, Garcia Ortiz LH, Garrido N, Gastaldi A, Gelersztein E, Geloneze Neto B, Genadieva V, Genova-Hristova G, Genovese S, Ghazi A, Giorda C, Glenny JA, Glinkina I, Godlevska O, Godoy Jorquera JG, Goldenberg R, Golovchenko O, Gomes Bastos M, Gomez O, Gomez Rangel JD, Gonzalez E, Gonzalez Dorado A, Gonzalez Martinez FJ, Gonzalez Orellana RA, Gopalakrishnan N, Gorriz JL, Gorson D, Govender V, Gracious N, Greco B, Gregar R, Greloni GC, Grineva E, Guinsburg A, Gulati R, Gunstone A, Gupta A, Gupta M, Gyrina O, Hadjadj S, Halciakova K, Hall T, Haller H, Halmagyi I, Hammoud J, Hancu N, Hanif W, Hansraj A, Hawley C, Henein S, Hermida S, Hernandez Triana E, Herrera Jimenez LE, Hershon K, Higuera Cobos JD, Hiser D, Hocking S, Hon G, Hristozov K, Hsieh CH, Hura C, Hwang SJ, Ilavska A, Irizar Santana SS, Ismail M, Jackson A, Jain D, Jamal A, Januszewicz A, Jeong IK, Jha V, Jimenez Flores F, Jodar Gimeno JE, Johnson A, Joseph F, Joshi M, Juncos LI, Jurgens J, Kajiyama S, Kaminska A, Kashine S, Kaupke C, Kawada T, Keiko Kohara S, Keitel E, Keltai K, Kendereski A, Keresztesi S, Kern E, Kerr Saraiva JF, Keshavamurthy CB, Khandwala H, Khanna R, Khitan Z, Khullar D, Kim SG, Kim YH, Kim S, Kiss K, Klein A, Klyver MI, Kodera T, Kolesnyk M, Kolmakova E, Komisarenko I, Kong Y, Kong WY, Kono H, Konyves L, Kopyt N, Korzh O, Kovar R, Kovesdy C, Koyama K, Kozloviene D, Kraft F, Krane V, Kravchun N, Krishna G, Krishnan S, Kropp JJ, Kumar A, Kumar J, Kumeda Y, Kumwenda M, Kurtz Lisboa HR, Kvitkova L, Kwon HS, Kwon MJ, Lalic K, Lalic N, Lanchiotti PV, Lastuvka J, Laviada Molina H, Lawrence M, Le Meur Y, Lee LY, Lee BW, Lee J, Lee MK, Legun O, Leiter L, Lentz J, Leon de la Fuente RA, Levin A, Lewis D, Li D, Li W, Li X, Lim SK, Lin H, Lin CC, Liss K, Liu J, Loh CL, Lombard L, Lopez Mendoza M, Lopez Tarabay C, Lorenzoni d'avila DO, Loss de Carvalho Contieri F, Lu W, Lu YC, Luna Ceballos R, M. Edwin F, MacDougall I, Macedo de Souza PA, Madej A, Madore F, Magalhaes Montenegro Junior R, Mah PM, Maheshwari H, Major L, Malberti F, Malek Marin T, Mandayam S, Mandreoli M, Manisha S, Mankovskyy B, Mannucci E, Manocha AB, Mao H, Marar I, Marasaev V, Marchetta N, Martin Del Campo Blanco B, Martinka E, Martynyuk L, Maxeiner S, Mazur S, McMahon A, Medina Farina M, Mehta B, Middleton J, Mileder M, Miyauchi S, Mizuyama K, Mkrtumyan A, Mlodawska-Choluj D, Molina de Salazar DI, Molnar M, Mookadam M, Morales Franco G, Morales Portillo C, Mordujovich J, Moreira de Brito C, Moreira Diaz JP, Moreno Loza OT, Mostovoy Y, Moustafa M, Muirhead N, Mujica Trenche S, Munar Vila MA, Munoz Torres M, Munteanu M, Mustieles Rocha C, Nagibovich G, Nam MS, Narvarte J, Nasser Hissa M, Navickas A, Nazario Sabbag ÂR, Nedogoda S, Negru D, Newman G, Ng KS, Ngcakani N, Nicholls K, Nicol P, Nieto Iglesias J, Niiya T, Nik Ahmad NNF, Nisnisan J, Nonchev B, Noronha IL, Nortje H, Nossuli AK, Nowicki M, Obialo C, Obrador Vera G, Ochodnicka Z, Oh KH, Oishi H, Olelewe S, Oliver M, Oosthuizen H, Orio SI, Orlowska-Kowalik G, Oroszlan T, Orozco Castellanos R, Orsi E, Ory I, O'Shaughnessy A, Ota S, Otreras F, Oviedo A, Packham D, Padron J, Panarotto D, Pankhaniya R, Pantoja Perez J, Paragh G, Park CY, Park SH, Pashkovska N, Patel D, Patel G, Pavon H, Pei D, Pella D, Penfornis A, Peralta Calcaneo J, Pereira MA, Pererva L, Perez Vera M, Peringat J, Pertseva T, Pesickova S, Peterfai E, Peterka K, Petrica L, Petro G, Pettis K, Pharr W, Philip S, Phillips A, Piatti P, Pichette V, Pontiroli A, Popa AR, Popenda G, Popovic-Radinovic V, Portoles Perez JM, Prasad N, Proietto J, Prozesky H, Pumprla J, Purighalla R, Quesada Simon MA, Quesada-Suarez L, Rabasa-Lhoret R, Ramirez Roca LA, Ramtoola S, Ranetti AE, Rangelov R, Ranjan R, Raskina T, Rastogi S, Ratnasingam V, Reddy J, Ren Y, Resk JH, Rewerska B, Reyes Rosano MA, Rich L, Rista L, Roberts A, Robinson M, Rodelo J, Rodriguez H, Rodriguez Papini N, Roger S, Rosas S, Rosas Guzman J, Rosivall L, Roussel R, Rucker Joerg IE, Rychlik I, Saavedra Gajardo V, Saavedra Sanchez SB, Sala J, Samoylov O, Samoylova Y, Sanchez Arenales JA, Sanchez Mijangos JH, Sanchez Polo JV, Sankaram R, Santoro D, Santos JC, Santos F, Sarin R, Saudek F, Saumell F, Saxena M, Sazonova O, Schiavi LB, Schiller A, Schuch T, Scott R, Scott D, Seeber M, Seiji Yamada S, Sekkarie M, Sensenbrenner J, Serafinceanu C, Serrano Sanson P, Sessa H, Shakeel M, Shamkhalova M, Shanik M, Shaw S, Sheu WH, Shinkov A, Shutemova E, Silva Pecoits Filho RF, Simo Canonge R, Simoes de Almeida R, Simon G, Singh B, Slompo Ramos C, Smatanova I, Smirnov I, Smith S, Smith Casabella T, Soares Felicio J, Soler Romeo MJ, Solomon R, Song W, Soto Gonzalez A, Sowinski D, Sprague A, Sree Bhushan R, Sreedhar R, Sreelatha M, Steele A, SPEDDING, Stephen John, Strzelecka A, Suchinda P, Sudhakar B, Sun J, Sun L, Surampudi P, Sussman S, Svyshchenko Y, Symonds R, Szlachcic Y, Takacs R, Takai M, Tamayo Y. Orozco J, Tan G, Tellez Chavez E, Temelkova M, Terns Riera M, Terront Lozano MA, Tesar V, Thompson M, Tibes Hachmann JC, Tinahones Madueno FJ, Tolentino M, Tomashkevych H, Tomonaga O, Topchii I, Torshizi A, Trespalacios F, Trevisan R, Trueba P, Tryshchuk N, Tseluyko V, Tsujimoto M, Tu P, Turcios Juarez E, Turner W, Twahirwa M, Ulla MR, Updegrove J, Urbanaviciene E, Valderrama Cometa L, Valdes Cepeda A, Valenzuela A, Valis M, Vallejos A, Vangel S, Vannorsdall M, Vargas Alonso RD, Varghese F, Vasas S, Vazelov E, Vejar M, Velasquez-Mieyer P, Velichkova E, Velo M, Venegas Carrillo L, Vengadasalam P, Ventrapragada S, Villagordoa Mesa J, Villarino AA, Villegas I, Visco VE, Vizir V, Vlasenko M, Vyasam RC, Wada T, Wadud K, Wahba M, Wakasugi M, Wakeling J, Wakida Y, WALKER, JOHN RICHARD, Wang G, Warren M, Wassermann A, Watanabe T, Watson E, Watts R, Weiner P, Weiner D, Welsh J, Wheeler D, Williams M, Winocour P, Woo V, Yamada M, Yanagida K, Yanase T, Yang J, Yao C, Yap YE, Ygpuara MDL, Yin A, Yoiti Hayashida C, Yoon KH, Young S, Yu X, Yumita W, Yupanqui H, Zaidman CJ, Zamarripa Escobedo R, Zanata Petry TB, Zanella MT, Zaoui P, Zavaroni I, Zemek S, Zhang H, Zhao M, Zheng H, Zlova T, Zsom M, Zykova T., Groningen Kidney Center (GKC), Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), Abdallah, J, Abdul Ghani, R, Abdul Kadir, K, Abdullah, R, Abejuela, Z, Abraham, O, Abramowitz, M, Abusnana, S, Accini Mendoza, Jl, Acosta, I, Agafyina, A, Aggarwal, N, Ahmed, F, Ahuad Guerrero, Ra, Aiello, J, Ainsworth, P, Aizenberg, D, Akiyama, H, Akright, L, Akyea-Djamson, A, Alamartine, E, Alappan, R, Ali, N, Ali, Z, Alicic, R, Al-Karadsheh, A, Alpizar Salazar, M, Alvarez Garcia, P, Alvarisqueta, A, Amodeo, C, Andreeva, V, Andreotti Turatti, La, Angelescu, Lm, Angelova, A, Anghel, V, Antic, S, Aoki, H, Aquitania, G, Arauz-Pacheco, C, Arce-Nunez, E, Arcos Palma, Eg, Arfeen, S, Arif, A, Aronson, R, Arutchelvam, V, Asano, A, Atray, N, Avram, Ri, Awad, A, Baas Cruz, J, Babikova, J, Badat, A, Bajaj, H, Baker, J, Bakris, G, Barbarash, O, Barna, O, Barnard, M, Barranco, E, Barrera, C, Bartaskova, D, Bartolacci, I, Barysheva, O, Behara, V, Bellary, S, Belo, D, Bentley-Lewis, R, Benusova, O, Berenguer, R, Berli, Ma, Bernardo, M, Biscoveanu, M, Bordonava, Ap, Borot, S, Botsyurko, V, Bowman-Stroud, C, Brandon, D, Bregman, R, Brusco, O, Buganova, I, Burgos Soto, M, Busch, R, Busegeanu, Mm, Calella, P, Camelo Sanches, Fc, Canaan, Y, Canani, Lh, Cantero, Mc, Cariou, B, Cartasegna, Lr, Castellino, P, Cereto Castro, F, Certow, G, Chacra, Ar, Chae, Dw, Chang, Ct, Chang, T, Che Yusof, Md, Chen, N, Chen, Q, Cherney, D, Cheung, Nw, Chevaile Ramos, J, Chew Wong, A, Chiovato, L, Chizhov, D, Cho, Ym, Christiano, C, Christofides, E, Chuang, Lm, Chuateco, C, Cif, A, Cigarran Guldris, S, Cohen, K, Cohen, R, Coloma, Gc, Comia, R, Commendatore, V, Conway, J, Cook, C, Cosma, D, Cournoyer, S, Coyne, D, Crisan, C, Csecsei, G, Csiky, B, Cuadrado, J, Cuneo, Ca, Cunha Borges, Jl, Cunha Vêncio, Sa, Cusumano, Am, da Silva Franco, Rj, Daboul, N, Danos, P, Daroza, G, Davies, E, Davies, M, Davies, S, Dawson, A, De Cosmo, S, De Nicola, L, De Serres, S, de Souza Portes, E, Deak, L, Deck, K, Deepak, D, Derosa, G, Desouza, C, Dev, D, Dhillon, M, DI CARLO, Alfonso, Di Cianni, G, Diaz Escalante, T, Dimitrov, S, Distiller, L, Djordjevic, M, Dobronravov, V, Dohnalova, L, Dominguez Lopez, M, Douthat, Wg, Dran, Rd, Drasnar, T, Dreval, A, Droste, C, Dua, S, Dube, F, Dudar, I, Dudas, M, Dussol, B, Dzupina, A, Eder, F, Egido de Los Rios, J, El Kossi, M, El-Shahawy, M, English, P, Enriquez Sosa, Fe, Ervin, J, Esquenazi, A, Evans, J, Faghih, M, Farias, E, Faulmann, G, Fauvel, Jp, Ferariu, Ie, Fernandez, Mf, Fernandez Fresnedo, G, Fernandez Montenegro, Ma, Finkelstein, H, Flores Lozano, F, Flota Cervera, L, Fraige Filho, F, Fraser, D, Frenk Baron, P, Fretes, Jo, Frias, J, Fuiano, G, Fulop, P, Fushtey, I, Galan Serrano, A, Galphin, C, Gan, S, Gan, Cl, Garcia, Nh, Garcia, I, Garcia Ballesteros, C, Garcia Ortiz, Lh, Garrido, N, Gastaldi, A, Gelersztein, E, Geloneze Neto, B, Genadieva, V, Genova-Hristova, G, Genovese, S, Ghazi, A, Giorda, C, Glenny, Ja, Glinkina, I, Godlevska, O, Godoy Jorquera, Jg, Goldenberg, R, Golovchenko, O, Gomes Bastos, M, Gomez, O, Gomez Rangel, Jd, Gonzalez, E, Gonzalez Dorado, A, Gonzalez Martinez, Fj, Gonzalez Orellana, Ra, Gopalakrishnan, N, Gorriz, Jl, Gorson, D, Govender, V, Gracious, N, Greco, B, Gregar, R, Greloni, Gc, Grineva, E, Guinsburg, A, Gulati, R, Gunstone, A, Gupta, A, Gupta, M, Gyrina, O, Hadjadj, S, Halciakova, K, Hall, T, Haller, H, Halmagyi, I, Hammoud, J, Hancu, N, Hanif, W, Hansraj, A, Hawley, C, Henein, S, Hermida, S, Hernandez Triana, E, Herrera Jimenez, Le, Hershon, K, Higuera Cobos, Jd, Hiser, D, Hocking, S, Hon, G, Hristozov, K, Hsieh, Ch, Hura, C, Hwang, Sj, Ilavska, A, Irizar Santana, S, Ismail, M, Jackson, A, Jain, D, Jamal, A, Januszewicz, A, Jeong, Ik, Jha, V, Jimenez Flores, F, Jodar Gimeno, Je, Johnson, A, Joseph, F, Joshi, M, Juncos, Li, Jurgens, J, Kajiyama, S, Kaminska, A, Kashine, S, Kaupke, C, Kawada, T, Keiko Kohara, S, Keitel, E, Keltai, K, Kendereski, A, Keresztesi, S, Kern, E, Kerr Saraiva, Jf, Keshavamurthy, Cb, Khandwala, H, Khanna, R, Khitan, Z, Khullar, D, Kim, Sg, Kim, Yh, Kim, S, Kiss, K, Klein, A, Klyver, Mi, Kodera, T, Kolesnyk, M, Kolmakova, E, Komisarenko, I, Kong, Y, Kong, Wy, Kono, H, Konyves, L, Kopyt, N, Korzh, O, Kovar, R, Kovesdy, C, Koyama, K, Kozloviene, D, Kraft, F, Krane, V, Kravchun, N, Krishna, G, Krishnan, S, Kropp, Jj, Kumar, A, Kumar, J, Kumeda, Y, Kumwenda, M, Kurtz Lisboa, Hr, Kvitkova, L, Kwon, H, Kwon, Mj, Lalic, K, Lalic, N, Lanchiotti, Pv, Lastuvka, J, Laviada Molina, H, Lawrence, M, Le Meur, Y, Lee, Ly, Lee, Bw, Lee, J, Lee, Mk, Legun, O, Leiter, L, Lentz, J, Leon de la Fuente, Ra, Levin, A, Lewis, D, Li, D, Li, W, Li, X, Lim, Sk, Lin, H, Lin, Cc, Liss, K, Liu, J, Loh, Cl, Lombard, L, Lopez Mendoza, M, Lopez Tarabay, C, Lorenzoni d'avila, Do, Loss de Carvalho Contieri, F, Lu, W, Lu, Yc, Luna Ceballos, R, M., Edwin F, Macdougall, I, Macedo de Souza, Pa, Madej, A, Madore, F, Magalhaes Montenegro Junior, R, Mah, Pm, Maheshwari, H, Major, L, Malberti, F, Malek Marin, T, Mandayam, S, Mandreoli, M, Manisha, S, Mankovskyy, B, Mannucci, E, Manocha, Ab, Mao, H, Marar, I, Marasaev, V, Marchetta, N, Martin Del Campo Blanco, B, Martinka, E, Martynyuk, L, Maxeiner, S, Mazur, S, Mcmahon, A, Medina Farina, M, Mehta, B, Middleton, J, Mileder, M, Miyauchi, S, Mizuyama, K, Mkrtumyan, A, Mlodawska-Choluj, D, Molina de Salazar, Di, Molnar, M, Mookadam, M, Morales Franco, G, Morales Portillo, C, Mordujovich, J, Moreira de Brito, C, Moreira Diaz, Jp, Moreno Loza, Ot, Mostovoy, Y, Moustafa, M, Muirhead, N, Mujica Trenche, S, Munar Vila, Ma, Munoz Torres, M, Munteanu, M, Mustieles Rocha, C, Nagibovich, G, Nam, M, Narvarte, J, Nasser Hissa, M, Navickas, A, Nazario Sabbag, Âr, Nedogoda, S, Negru, D, Newman, G, Ng, K, Ngcakani, N, Nicholls, K, Nicol, P, Nieto Iglesias, J, Niiya, T, Nik Ahmad, Nnf, Nisnisan, J, Nonchev, B, Noronha, Il, Nortje, H, Nossuli, Ak, Nowicki, M, Obialo, C, Obrador Vera, G, Ochodnicka, Z, Oh, Kh, Oishi, H, Olelewe, S, Oliver, M, Oosthuizen, H, Orio, Si, Orlowska-Kowalik, G, Oroszlan, T, Orozco Castellanos, R, Orsi, E, Ory, I, O'Shaughnessy, A, Ota, S, Otreras, F, Oviedo, A, Packham, D, Padron, J, Panarotto, D, Pankhaniya, R, Pantoja Perez, J, Paragh, G, Park, Cy, Park, Sh, Pashkovska, N, Patel, D, Patel, G, Pavon, H, Pei, D, Pella, D, Penfornis, A, Peralta Calcaneo, J, Pereira, Ma, Pererva, L, Perez Vera, M, Peringat, J, Pertseva, T, Pesickova, S, Peterfai, E, Peterka, K, Petrica, L, Petro, G, Pettis, K, Pharr, W, Philip, S, Phillips, A, Piatti, P, Pichette, V, Pontiroli, A, Popa, Ar, Popenda, G, Popovic-Radinovic, V, Portoles Perez, Jm, Prasad, N, Proietto, J, Prozesky, H, Pumprla, J, Purighalla, R, Quesada Simon, Ma, Quesada-Suarez, L, Rabasa-Lhoret, R, Ramirez Roca, La, Ramtoola, S, Ranetti, Ae, Rangelov, R, Ranjan, R, Raskina, T, Rastogi, S, Ratnasingam, V, Reddy, J, Ren, Y, Resk, Jh, Rewerska, B, Reyes Rosano, Ma, Rich, L, Rista, L, Roberts, A, Robinson, M, Rodelo, J, Rodriguez, H, Rodriguez Papini, N, Roger, S, Rosas, S, Rosas Guzman, J, Rosivall, L, Roussel, R, Rucker Joerg, Ie, Rychlik, I, Saavedra Gajardo, V, Saavedra Sanchez, Sb, Sala, J, Samoylov, O, Samoylova, Y, Sanchez Arenales, Ja, Sanchez Mijangos, Jh, Sanchez Polo, Jv, Sankaram, R, Santoro, D, Santos, Jc, Santos, F, Sarin, R, Saudek, F, Saumell, F, Saxena, M, Sazonova, O, Schiavi, Lb, Schiller, A, Schuch, T, Scott, R, Scott, D, Seeber, M, Seiji Yamada, S, Sekkarie, M, Sensenbrenner, J, Serafinceanu, C, Serrano Sanson, P, Sessa, H, Shakeel, M, Shamkhalova, M, Shanik, M, Shaw, S, Sheu, Wh, Shinkov, A, Shutemova, E, Silva Pecoits Filho, Rf, Simo Canonge, R, Simoes de Almeida, R, Simon, G, Singh, B, Slompo Ramos, C, Smatanova, I, Smirnov, I, Smith, S, Smith Casabella, T, Soares Felicio, J, Soler Romeo, Mj, Solomon, R, Song, W, Soto Gonzalez, A, Sowinski, D, Sprague, A, Sree Bhushan, R, Sreedhar, R, Sreelatha, M, Steele, A, Spedding, Stephen John, Strzelecka, A, Suchinda, P, Sudhakar, B, Sun, J, Sun, L, Surampudi, P, Sussman, S, Svyshchenko, Y, Symonds, R, Szlachcic, Y, Takacs, R, Takai, M, Tamayo Y., Orozco J, Tan, G, Tellez Chavez, E, Temelkova, M, Terns Riera, M, Terront Lozano, Ma, Tesar, V, Thompson, M, Tibes Hachmann, Jc, Tinahones Madueno, Fj, Tolentino, M, Tomashkevych, H, Tomonaga, O, Topchii, I, Torshizi, A, Trespalacios, F, Trevisan, R, Trueba, P, Tryshchuk, N, Tseluyko, V, Tsujimoto, M, Tu, P, Turcios Juarez, E, Turner, W, Twahirwa, M, Ulla, Mr, Updegrove, J, Urbanaviciene, E, Valderrama Cometa, L, Valdes Cepeda, A, Valenzuela, A, Valis, M, Vallejos, A, Vangel, S, Vannorsdall, M, Vargas Alonso, Rd, Varghese, F, Vasas, S, Vazelov, E, Vejar, M, Velasquez-Mieyer, P, Velichkova, E, Velo, M, Venegas Carrillo, L, Vengadasalam, P, Ventrapragada, S, Villagordoa Mesa, J, Villarino, Aa, Villegas, I, Visco, Ve, Vizir, V, Vlasenko, M, Vyasam, Rc, Wada, T, Wadud, K, Wahba, M, Wakasugi, M, Wakeling, J, Wakida, Y, Walker, JOHN RICHARD, Wang, G, Warren, M, Wassermann, A, Watanabe, T, Watson, E, Watts, R, Weiner, P, Weiner, D, Welsh, J, Wheeler, D, Williams, M, Winocour, P, Woo, V, Yamada, M, Yanagida, K, Yanase, T, Yang, J, Yao, C, Yap, Ye, Ygpuara, Mdl, Yin, A, Yoiti Hayashida, C, Yoon, Kh, Young, S, Yu, X, Yumita, W, Yupanqui, H, Zaidman, Cj, Zamarripa Escobedo, R, Zanata Petry, Tb, Zanella, Mt, Zaoui, P, Zavaroni, I, Zemek, S, Zhang, H, Zhao, M, Zheng, H, Zlova, T, Zsom, M, and Zykova, T.

Subjects
medicine.medical_specialty, ALBUMINURIA, Urology, Renal function, 030209 endocrinology & metabolism, PROGRESSION, Type 2 diabetes, Diabetic nephropathy, 030204 cardiovascular system & hematology, GLOMERULAR-FILTRATION-RATE, CARDIOVASCULAR OUTCOMES, Nephropathy, 03 medical and health sciences, 0302 clinical medicine, Diabetes mellitus, Chronic kidney disease, medicine, 03.02. Klinikai orvostan, Renal outcome, Canagliflozin, Science & Technology, ATRIAL-NATRIURETIC-PEPTIDE, IRBESARTAN, GFR DECLINE, business.industry, 1103 Clinical Sciences, KIDNEY-DISEASE, Urology & Nephrology, medicine.disease, Renal outcomes, Nephrology, COLLABORATIVE METAANALYSIS, Albuminuria, Original Report: Patient-Oriented, Translational Research, LOSARTAN, medicine.symptom, business, Life Sciences & Biomedicine, CREDENCE study investigators, medicine.drug, Kidney disease
Abstract

Background: People with diabetes and kidney disease have a high risk of cardiovascular events and progression of kidney disease. Sodium glucose co-transporter 2 inhibitors lower plasma glucose by reducing the uptake of filtered glucose in the kidney tubule, leading to increased urinary glucose excretion. They have been repeatedly shown to induce modest natriuresis and reduce HbA1c, blood pressure, weight, and albuminuria in patients with type 2 diabetes. However, the effects of these agents on kidney and cardiovascular events have not been extensively studied in patients with type 2 diabetes and established kidney disease. Methods: The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial aims to compare the efficacy and safety of canagliflozin ­versus placebo at preventing clinically important kidney and cardiovascular outcomes in patients with diabetes and established kidney disease. CREDENCE is a randomized, double-blind, event-driven, placebo-controlled trial set in in 34 countries with a projected duration of ∼5.5 years and enrolling 4,401 adults with type 2 diabetes, estimated glomerular filtration rate ≥30 to 2, and albuminuria (urinary albumin:creatinine ratio >300 to ≤5,000 mg/g). The study has 90% power to detect a 20% reduction in the risk of the primary outcome (α = 0.05), the composite of end-stage kidney disease, doubling of serum creatinine, and renal or cardiovascular death. Conclusion: CREDENCE will provide definitive evidence about the effects of canagliflozin on renal (and cardiovascular) outcomes in patients with type 2 diabetes and established kidney disease. Trial Registration: EudraCT number: 2013-004494-28; ClinicalTrials.gov identifier: NCT02065791.

Published
2017

2. Canagliflozin and Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus and Chronic Kidney Disease in Primary and Secondary Cardiovascular Prevention Groups Results From the Randomized CREDENCE Trial

Author

Mahaffey, KW, Jardine, MJ, Bompoint, S, Cannon, CP, Neal, B, Heerspink, HJL, Charytan, DM, Edwards, R, Agarwal, R, Bakris, G, Bull, S, Capuano, G, de Zeeuw, D, Greene, T, Levin, A, Pollock, C, Sun, T, Wheeler, DC, Yavin, Y, Zhang, H, Zinman, B, Rosenthal, N, Brenner, BM, Perkovic, V, Ahuad Guerrero, RA, Aizenberg, D, Pablo Albisu, J, Alvarisqueta, A, Bartolacci, I, Alberto Berli, M, Bordonava, A, Calella, P, Cecilia Cantero, M, Rodolfo Cartasegna, L, Cercos, E, Cecilia Coloma, G, Colombo, H, Commendatore, V, Cuadrado, J, Alberto Cuneo, C, Maria Cusumano, A, Guillermo Douthat, W, Dario Dran, R, Farias, E, Florencia Fernandez, M, Finkelstein, H, Fragale, G, Osvaldo Fretes, J, Horacio Garcia, N, Gastaldi, A, Gelersztein, E, Archibaldo Glenny, J, Pablo Gonzalez, J, Gonzalez Colaso, PDC, Goycoa, C, Cristian Greloni, G, Guinsburg, A, Hermida, S, Isaias Juncos, L, Isabel Klyver, M, Kraft, F, Krynski, F, Virginia Lanchiotti, P, Alfonso Leon de la Fuente, R, Marchetta, N, Mele, P, Nicolai, S, Antonio Novoa, P, Ines Orio, S, Otreras, F, Oviedo, A, Raffaele, P, Hector Resk, J, Rista, L, Rodriguez Papini, N, Sala, J, Santos, JC, Beatriz Schiavi, L, Sessa, H, Smith Casabella, T, Rosa Ulla, M, Valdez, M, Vallejos, A, Villarino, A, Esther Visco, V, Wassermann, A, Javier Zaidman, C, Cheung, NW, Droste, C, Fraser, I, Johnson, D, Mah, PM, Nicholls, K, Packham, D, Proietto, J, Roberts, A, Roger, S, Tsang, V, Raduan, RA, Alves da Costa, FA, Amodeo, C, Andreotti Turatti, LA, Bregman, R, Camelo Sanches, FC, Canani, LH, Chacra, AR, Cunha Borges, JL, Cunha Vencio, SA, da Silva Franco, RJ, d'Avila, D, Portes, EDS, de Souza, P, Deboni, LM, Fraige Filho, F, Geloneze Neto, B, Gomes, M, Kohara, SK, Keitel, E, Kerr Saraiva, JF, Kurtz Lisboa, HR, de Carvalho Contieri, FL, Milagres, R, Montenegro Junior, R, de Brito, CM, Hissa, MN, Nazario Sabbag, AR, Noronha, I, Panarotto, D, Pecoits Filho, R, Pereira, MA, Saporito, W, Scotton, AS, Schuch, T, de Almeida, RS, Ramos, CS, Felicio, JS, Thome, F, 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Abstract

BACKGROUND: Canagliflozin reduces the risk of kidney failure in patients with type 2 diabetes mellitus and chronic kidney disease, but effects on specific cardiovascular outcomes are uncertain, as are effects in people without previous cardiovascular disease (primary prevention). METHODS: In CREDENCE (Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation), 4401 participants with type 2 diabetes mellitus and chronic kidney disease were randomly assigned to canagliflozin or placebo on a background of optimized standard of care. RESULTS: Primary prevention participants (n=2181, 49.6%) were younger (61 versus 65 years), were more often female (37% versus 31%), and had shorter duration of diabetes mellitus (15 years versus 16 years) compared with secondary prevention participants (n=2220, 50.4%). Canagliflozin reduced the risk of major cardiovascular events overall (hazard ratio [HR], 0.80 [95% CI, 0.67-0.95]; P=0.01), with consistent reductions in both the primary (HR, 0.68 [95% CI, 0.49-0.94]) and secondary (HR, 0.85 [95% CI, 0.69-1.06]) prevention groups (P for interaction=0.25). Effects were also similar for the components of the composite including cardiovascular death (HR, 0.78 [95% CI, 0.61-1.00]), nonfatal myocardial infarction (HR, 0.81 [95% CI, 0.59-1.10]), and nonfatal stroke (HR, 0.80 [95% CI, 0.56-1.15]). The risk of the primary composite renal outcome and the composite of cardiovascular death or hospitalization for heart failure were also consistently reduced in both the primary and secondary prevention groups (P for interaction >0.5 for each outcome). CONCLUSIONS: Canagliflozin significantly reduced major cardiovascular events and kidney failure in patients with type 2 diabetes mellitus and chronic kidney disease, including in participants who did not have previous cardiovascular disease. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02065791.

Published
2019

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