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1. Kidney and Cardiovascular Effects of Canagliflozin According to Age and Sex: A Post Hoc Analysis of the CREDENCE Randomized Clinical Trial

Author: Yi, TW, Smyth, B ; https://orcid.org/0000-0003-1838-3348, Di Tanna, GL ; https://orcid.org/0000-0002-5470-3567, Arnott, C ; https://orcid.org/0000-0001-9370-9913, Cardoza, K, Kang, A ; https://orcid.org/0000-0002-0300-1282, Pollock, C, Agarwal, R, Bakris, G, Charytan, DM, de Zeeuw, D, Heerspink, HJL, Neal, B ; https://orcid.org/0000-0002-0490-7465, Wheeler, DC, Cannon, CP, Zhang, H, Zinman, B, Perkovic, V ; https://orcid.org/0000-0002-4257-7620, Levin, A, Mahaffey, KW, Jardine, M ; https://orcid.org/0000-0002-0160-2375, Brenner, BM, Greene, T, Jardine, MJ, 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 ; https://orcid.org/0000-0002-8015-9470, Lim, SK, Lim-Abrahan, MA, Santos, F, Chae, DW, Hwang, SJ, Vazelov, E, Rychlík, I, Hadjadj, S, Krane, V, Rosivall, L, De Nicola, L, Dreval, A, Nowicki, M, Schiller, A, Distiller, L, Górriz, JL, Kolesnyk, M, David, Wheeler, C, Guerrero, RAA, Albisu, JP, Alvarisqueta, A, Bartolacci, I, Berli, MA, Bordonava, A, Calella, P, Cantero, MC, Cartasegna, LR, Cercos, E, Coloma, GC, Colombo, H, Commendatore, V, Cuadrado, J, Cuneo, CA, Cusumano, AM, Douthat, WG, Dran, RD, Farias, E, Fernandez, MF, Finkelstein, H, Fragale, G, Fretes, JO, Garcia, NH, Gastaldi, A, Gelersztein, E, Glenny, JA, Gonzalez, JP, Colaso, PDCG, Goycoa, C, Greloni, GC, Guinsburg, A, Hermida, S, Juncos, LI, Klyver, MI, Kraft, F, Krynski, F, Lanchiotti, PV, Leon de la Fuente, RA, Marchetta, N, Mele, P, Nicolai, S, Novoa, PA, Orio, SI, Yi, TW, Smyth, B ; https://orcid.org/0000-0003-1838-3348, Di Tanna, GL ; https://orcid.org/0000-0002-5470-3567, Arnott, C ; https://orcid.org/0000-0001-9370-9913, Cardoza, K, Kang, A ; https://orcid.org/0000-0002-0300-1282, Pollock, C, Agarwal, R, Bakris, G, Charytan, DM, de Zeeuw, D, Heerspink, HJL, Neal, B ; https://orcid.org/0000-0002-0490-7465, Wheeler, DC, Cannon, CP, Zhang, H, Zinman, B, Perkovic, V ; https://orcid.org/0000-0002-4257-7620, Levin, A, Mahaffey, KW, Jardine, M ; https://orcid.org/0000-0002-0160-2375, Brenner, BM, Greene, T, Jardine, MJ, 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 ; https://orcid.org/0000-0002-8015-9470, Lim, SK, Lim-Abrahan, MA, Santos, F, Chae, DW, Hwang, SJ, Vazelov, E, Rychlík, I, Hadjadj, S, Krane, V, Rosivall, L, De Nicola, L, Dreval, A, Nowicki, M, Schiller, A, Distiller, L, Górriz, JL, Kolesnyk, M, David, Wheeler, C, Guerrero, RAA, Albisu, JP, Alvarisqueta, A, Bartolacci, I, Berli, MA, Bordonava, A, Calella, P, Cantero, MC, Cartasegna, LR, Cercos, E, Coloma, GC, Colombo, H, Commendatore, V, Cuadrado, J, Cuneo, CA, Cusumano, AM, Douthat, WG, Dran, RD, Farias, E, Fernandez, MF, Finkelstein, H, Fragale, G, Fretes, JO, Garcia, NH, Gastaldi, A, Gelersztein, E, Glenny, JA, Gonzalez, JP, Colaso, PDCG, Goycoa, C, Greloni, GC, Guinsburg, A, Hermida, S, Juncos, LI, Klyver, MI, Kraft, F, Krynski, F, Lanchiotti, PV, Leon de la Fuente, RA, Marchetta, N, Mele, P, Nicolai, S, Novoa, PA, and Orio, SI
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
Published: 2023

2. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy

Author: Perkovic, V., Jardine, M. J., Neal, B., Bompoint, S., Heerspink, H. J. L., Charytan, D. M., Edwards, R., Agarwal, R., Bakris, G., Bull, S., Cannon, C. P., Capuano, G., Chu, P. -L., De Zeeuw, D., Greene, T., Levin, A., Pollock, C., Wheeler, D. C., Yavin, Y., Zhang, H., Zinman, B., Meininger, G., Brenner, B. M., Mahaffey, K. W., Perkovic, V, Mahaffey, Kw, Agarwal, R, Bakris, G, Brenner, Bm, Cannon, Cp, Charytan, Dm, de Zeeuw, D, Greene, T, Jardine, Mj, Heerspink, Hjl, Levin, A, Meininger, G, Neal, B, Pollock, C, Wheeler, Dc, Zhang, H, Zinman, B, Mcguire, Dk, Holman, R, Home, P, Scharfstein, D, Parfrey, P, Shahinfar, S, August, P, Chang, T, Sinha, Ad, Januzzi, J, Kolansky, D, Amerena, J, Hillis, G, Gorelick, P, Kissela, B, Kasner, S, Lindley, R, Fulcher, G, Ounadjela, S, Hufert, K, von Ingersleben, G, Gaglia, J, Harris, R, Hudson, M, Turchin, A, Cheifetz, A, Sheth, S, Feuerstein, J, Cohen, S, Jardine, M, Li, N, Kolesnyk, I, Aizenberg, D, Pecoits-Filho, R, Cherney, D 3rd, Obrador, G, Chertow, G, Hawley, C, Ji, L, Wada, T, Jha, V, Lim, Sk, Lim-Abrahan, Ma, Santos, F, Chae, Dw, Hwang, Sj, Vazelov, E, Rychlík, I, Hadjadj, S, Krane, V, Rosivall, L, De Nicola, L, Dreval, A, Nowicki, M, Schiller, A, Distiller, L, Górriz, Jl, Kolesnyk, M, Morren, F, Goykhman, S, David, C, Yost, L, Wang, H, Hettiarachchi, M, Thimmaiah, R, Koppolu, D, George, S, Schmidt, M, Ignjatovic, J, Chapin, L, Travis, K, Destree, M, Sood, V, Coffee, L, De Brouwer, K, Zaviriukha, V, Starzec, A, Koizumi, M, Lin, G, Chen, E, Lin, P, Leia, C, Mascaro, D, Amigo, A, Limos, A, Abrahamsen, I, Jaffer, S, Ahuad Guerrero RA, Albisu, Jp, Alvarisqueta, A, Bartolacci, I, Berli, Ma, Bordonava, A, Calella, P, Cantero, Mc, Cartasegna, Lr, Cercos, E, Coloma, Gc, Colombo, H, Commendatore, V, Cuadrado, J, Cuneo, Ca, Cusumano, Am, Douthat, Wg, Dran, Rd, Farias, E, Fernandez, Mf, Finkelstein, H, Fragale, G, Fretes, Jo, Garcia, Nh, Gastaldi, A, Gelersztein, E, Glenny, Ja, Gonzalez, Jp, Gonzalez Colaso PDC, Goycoa, C, Greloni, Gc, Guinsburg, A, Hermida, S, Juncos, Li, Klyver, Mi, Kraft, F, Krynski, F, Lanchiotti, Pv, Leon de la Fuente RA, Marchetta, N, Mele, P, Nicolai, S, Novoa, Pa, Orio, Si, Otreras, F, Oviedo, A, Raffaele, P, Resk, Jh, Rista, L, Rodriguez Papini, N, Sala, J, Santos, Jc, Schiavi, Lb, Sessa, H, Smith Casabella, T, Ulla, Mr, Valdez, M, Vallejos, A, Villarino, A, Visco, Ve, Wassermann, A, Zaidman, Cj, 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 Vêncio SA, da Silva Franco RJ, D'Avila, D, de Souza Portes, E, de Souza, P, Deboni, Lm, Filho, Ff, Geloneze Neto, B, Gomes, M, Kohara, Sk, Keitel, E, Kerr Saraiva JF, Kurtz Lisboa HR, de Carvalho Contieri FL, Milagres, R, Montenegro Junior, R, Moreira de Brito, C, Nazzer Hissa, M, Nazario Sabbag ÂR, Noronha, I, Panarotto, D, Pecoits Filho, R, Pereira, Ma, Saporito, W, Scotton, As, Schuch, T, Simões de Almeida, R, Slompo Ramos, C, Soares Felício, J, Thomé, F, Tibes Hachmann JC, Yamada, S, Yoiti Hayashida, C, Zanata Petry TB, Zanella, Mt, 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, Dubé, 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, Fernández Montenegro MA, Godoy Jorquera JG, Medina Fariña, M, Saavedra Gajardo, V, 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, Accini Mendoza JL, Arcos, E, Avendano, J, Diaz Ruiz JEA, Garcia Ortiz LH, Gonzalez, A, Hernandez Triana, E, Higuera, Jd, Malaver, N, Molina de Salazar DI, Rosero, R, Terront Lozano MA, Valderrama Cometa, L, Valenzuela, A, Vargas Alonso RD, 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, Jp, Gourdy, P, Klein, A, Le Meur, Y, Penfornis, A, Roussel, R, Saulnier, Pj, 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 RA, Haase, Fp, Moreira Diaz JP, Ramirez Roca LA, Sánchez Arenales JA, Sanchez Polo JV, Turcios Juarez, E, 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, Rs, Deepak, D, Edwin, Fm, Gopalakrishnan, N, Gracious, N, Hansraj, A, Jain, D, Keshavamurthy, Cb, Khullar, D, Manisha, S, Peringat, J, Prasad, N, Satyanarayana, Rk, Sreedhar, R, Sreelatha, M, Sudhakar, B, Vyasam, Rc, Bonadonna, R, Castellino, P, Ceriello, A, Chiovato, L, De Cosmo, S, Derosa, G, Di Carlo, A, Di Cianni, G, Frascà, G, Fuiano, G, Gambaro, G, Garibotto, G, Giorda, C, Malberti, F, Mandreoli, M, Mannucci, E, Orsi, E, Piatti, P, Santoro, D, Sasso, Fc, Serviddio, G, Stella, A, Trevisan, R, Veronelli, Am, 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, Abdul Kadir, K, Ali, N, Che Yusof MD, Gan, Cl, Ismail, M, Kong, Wy, Lam, Sw, Lee, Ly, Loh, Cl, Manocha, Ab, Ng, Ks, Nik Ahmad NNF, Ratnasingam, V, Bin Shudim SS, Vengadasalam, P, Abraira Munoz LD, Salazar, Ma, Cruz, Jb, Soto, Mb, Ramos, Jc, Wong, Ac, Correa Rotter JR, Diaz Escalante, T, Enriquez Sosa FE, Flores Lozano, F, Flota Cervera LF, Frenk Baron, P, Garcia Ballesteros, C, Gomez Rangel JD, Herrera Jimenez LE, Irizar Santana SS, Jimenez Florez, F, Laviada Molina, H, Luna Ceballos RI, Martin Del Camp Blanco, B, Morales Franco, G, Moreno Loza OT, Mustieles Rocha, C, Obrador Vera, G, Orozco Castellanos, R, Peralta Calcaneo, J, Reyes Rosano MA, Rodriguez Pattzi, H, Rosas Guzman, J, Rucker Joerg IE, Saaveddra Sanchez SB, Sanchez Mijangos JH, Serrano Sanson, P, Tamayo, Y Orozco JA, Tellez Chavez, E, Valdes Depeda, A, Venegas Carrillo, L, Villagordoa Mesa, J, Zamarripa Escobedo, R, Baker, J, Noonan, P, Scott, R, Walker, R, Watson, E, Williams, M, Young, S, Abejuela, Z, Agra, J, Aquitania, G, Caringal, C, Comia, Rs, Delos Santos, L, Gomez, O, Jimeno, C, Tan, G, Tolentino, M, Yao, C, Yap, Ye, Ygpuara, Mdl, Bijata-Bronisz, R, Hotlos, L, Januszewicz, A, Kaczmarek, B, Kaminska, A, Lazuka, L, Madej, A, Mazur, S, Mlodawska-Choluj, D, Orlowska-Kowalik, G, Popenda, G, Rewerska, B, Sowinski, D, Angelescu, Lm, Anghel, V, Avram, Ri, Busegeanu, Mm, Cif, A, Cosma, D, Crisan, C, Demian, Ld, Ferariu, Ie, Halmagyi, I, Hancu, N, Munteanu, M, Negru, D, Onaca, Ag, Petrica, L, Popa, Ar, Ranetti, Ae, 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, 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, Ym, Jeong, Ik, Kim, Sg, Kim, Yh, Kwon, Hs, Kwon, Mj, Lee, Bw, Lee, J, Lee, Mk, Nam, Ms, Oh, Kh, Park, Cy, Park, Sh, Yoon, Kh, Alvarez Garcia, P, Asmarats Mercadal, L, Barrios, C, Cereto Castro, F, Cigarran Guldris, S, Dominquez Lopez, M, Egido de Los Rios, J, Fernandez Fresnedo, G, Galan Serrano, A, Garcia, I, Gonzalez Martinez FJ, Jodar Gimeno JE, Muñoz Lopez Mendoza, M, Malek Marin, T, Morales Portillo, C, Munar Vila MA, Muñoz Torres, M, Nieto Iglesias, J, Pantoja Perez, J, Perez Vera, M, Portoles Perez JM, Quesada Simón MA, Simo Canonge, R, Soto Gonzalez, A, Terns Riera, M, Tinahones Madueno FJ, Plaza, Mv, Chang, Ct, Chuang, Lm, Hsia, Tl, Hsieh, Ch, Lin, Cc, Lu, Yc, Sheu, Wh, Barna, O, Bilyk, Sd, 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, Dc, 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, Am, 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, 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, Mujica Trenche, S, Narayanan, M, Narvarte, J, Nassar, T, Newman, G, Nichol, B, Nicol, P, Nisnisan, J, Nossuli, Ak, 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, 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., Perkovic, Vlado, Jardine, Meg J, Neal, Bruce, Bompoint, Severine, Heerspink, Hiddo J L, Charytan, David M, Edwards, Robert, Agarwal, Rajiv, Bakris, George, Bull, Scott, Cannon, Christopher P, Capuano, George, Chu, Pei-Ling, de Zeeuw, Dick, Greene, Tom, Levin, Adeera, Pollock, Carol, Wheeler, David C, Yavin, Yshai, Zhang, Hong, Zinman, Bernard, Meininger, Gary, Brenner, Barry M, Mahaffey, Kenneth W, collaborator: Perkovic, V, Mahaffey, Kw, Agarwal, R, Bakris, G, Brenner, Bm, Cannon, Cp, Charytan, Dm, de Zeeuw, D, Greene, T, Jardine, Mj, Heerspink, Hjl, Levin, A, Meininger, G, Neal, B, Pollock, C, Wheeler, Dc, Zhang, H, Zinman, B, Mcguire, Dk, Holman, R, Home, P, Scharfstein, D, Parfrey, P, Shahinfar, S, August, P, Chang, T, Sinha, Ad, Januzzi, J, Kolansky, D, Amerena, J, Hillis, G, Gorelick, P, Kissela, B, Kasner, S, Lindley, R, Fulcher, G, Ounadjela, S, Hufert, K, von Ingersleben, G, Gaglia, J, Harris, R, Hudson, M, Turchin, A, Cheifetz, A, Sheth, S, Feuerstein, J, Cohen, S, Jardine, M, Li, N, Kolesnyk, I, Aizenberg, D, Pecoits-Filho, R, Cherney, D 3rd, Obrador, G, Chertow, G, Hawley, C, Ji, L, Wada, T, Jha, V, Lim, Sk, Lim-Abrahan, Ma, Santos, F, Chae, Dw, Hwang, Sj, Vazelov, E, Rychlík, I, Hadjadj, S, Krane, V, Rosivall, L, De Nicola, L, Dreval, A, Nowicki, M, Schiller, A, Distiller, L, Górriz, Jl, Kolesnyk, M, Morren, F, Goykhman, S, David, C, Yost, L, Wang, H, Hettiarachchi, M, Thimmaiah, R, Koppolu, D, George, S, Schmidt, M, Ignjatovic, J, Chapin, L, Travis, K, Destree, M, Sood, V, Coffee, L, De Brouwer, K, Zaviriukha, V, Starzec, A, Koizumi, M, Lin, G, Chen, E, Lin, P, Leia, C, Mascaro, D, Amigo, A, Limos, A, Abrahamsen, I, Jaffer, S, Ahuad Guerrero, Ra, Albisu, Jp, Alvarisqueta, A, Bartolacci, I, Berli, Ma, Bordonava, A, Calella, P, Cantero, Mc, Cartasegna, Lr, Cercos, E, Coloma, Gc, Colombo, H, Commendatore, V, Cuadrado, J, Cuneo, Ca, Cusumano, Am, Douthat, Wg, Dran, Rd, Farias, E, Fernandez, Mf, Finkelstein, H, Fragale, G, Fretes, Jo, Garcia, Nh, Gastaldi, A, Gelersztein, E, Glenny, Ja, Gonzalez, Jp, Gonzalez Colaso, Pdc, Goycoa, C, Greloni, Gc, Guinsburg, A, Hermida, S, Juncos, Li, Klyver, Mi, Kraft, F, Krynski, F, Lanchiotti, Pv, Leon de la Fuente, Ra, Marchetta, N, Mele, P, Nicolai, S, Novoa, Pa, Orio, Si, Otreras, F, Oviedo, A, Raffaele, P, Resk, Jh, Rista, L, Rodriguez Papini, N, Sala, J, Santos, Jc, Schiavi, Lb, Sessa, H, Smith Casabella, T, Ulla, Mr, Valdez, M, Vallejos, A, Villarino, A, Visco, Ve, Wassermann, A, Zaidman, Cj, 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 Vêncio, Sa, da Silva Franco, Rj, D'Avila, D, de Souza Portes, E, de Souza, P, Deboni, Lm, Filho, Ff, Geloneze Neto, B, Gomes, M, Kohara, Sk, Keitel, E, Kerr Saraiva, Jf, Kurtz Lisboa, Hr, de Carvalho Contieri, Fl, Milagres, R, Montenegro Junior, R, Moreira de Brito, C, Nazzer Hissa, M, Nazario Sabbag, Âr, Noronha, I, Panarotto, D, Pecoits Filho, R, Pereira, Ma, Saporito, W, Scotton, A, Schuch, T, Simões de Almeida, R, Slompo Ramos, C, Soares Felício, J, Thomé, F, Tibes Hachmann, Jc, Yamada, S, Yoiti Hayashida, C, Zanata Petry, Tb, Zanella, Mt, 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, Dubé, 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, Fernández Montenegro, Ma, Godoy Jorquera, Jg, Medina Fariña, M, Saavedra Gajardo, V, 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, Accini Mendoza, Jl, Arcos, E, Avendano, J, Diaz Ruiz, Jea, Garcia Ortiz, Lh, Gonzalez, A, Hernandez Triana, E, Higuera, Jd, Malaver, N, Molina de Salazar, Di, Rosero, R, Terront Lozano, Ma, Valderrama Cometa, L, Valenzuela, A, Vargas Alonso, Rd, 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, Jp, Gourdy, P, Klein, A, Le Meur, Y, Penfornis, A, Roussel, R, Saulnier, Pj, 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, Ra, Haase, Fp, Moreira Diaz, Jp, Ramirez Roca, La, Sánchez Arenales, Ja, Sanchez Polo, Jv, Turcios Juarez, E, 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, Deepak, D, Edwin, Fm, Gopalakrishnan, N, Gracious, N, Hansraj, A, Jain, D, Keshavamurthy, Cb, Khullar, D, Manisha, S, Peringat, J, Prasad, N, Satyanarayana, Rk, Sreedhar, R, Sreelatha, M, Sudhakar, B, Vyasam, Rc, Bonadonna, R, Castellino, P, Ceriello, A, Chiovato, L, De Cosmo, S, Derosa, G, Di Carlo, A, Di Cianni, G, Frascà, G, Fuiano, G, Gambaro, G, Garibotto, G, Giorda, C, Malberti, F, Mandreoli, M, Mannucci, E, Orsi, E, Piatti, P, Santoro, D, Sasso, Fc, Serviddio, G, Stella, A, Trevisan, R, Veronelli, Am, Zanoli, L, Akiyama, H, Aoki, H, Asano, A, Iitsuka, T et al, Groningen Kidney Center (GKC), and Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET)
Subjects: Aged, Canagliflozin, Cardiovascular Diseases, Creatinine, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Double-Blind Method, Female, Follow-Up Studies, Glomerular Filtration Rate, Humans, Kidney Failure, Chronic, Male, Middle Aged, Sodium-Glucose Transporter 2 Inhibitors, Type 2 diabetes, 030204 cardiovascular system & hematology, Diabetic nephropathy, Kidney Failure, chemistry.chemical_compound, 0302 clinical medicine, 030212 general & internal medicine, 03.02. Klinikai orvostan, Dapagliflozin, Chronic, 11 Medical and Health Sciences, EMPAGLIFLOZIN, General Medicine, Life Sciences & Biomedicine, Type 2, medicine.drug, medicine.medical_specialty, Nephropathy, 03 medical and health sciences, Medicine, General & Internal, Internal medicine, Diabetes mellitus, General & Internal Medicine, CREDENCE Trial Investigators, medicine, Diabetes Mellitus, Science & Technology, business.industry, urogenital system, diabetic nephropathy, Type 2 Diabetes Mellitus, KIDNEY-DISEASE, medicine.disease, chemistry, business, Kidney disease
Abstract: BACKGROUND: Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium-glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS: In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to 300 to 5000) and were treated with renin-angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of
Published: 2019

3. Effect of SGLT2 inhibitors on stroke and atrial fibrillation in diabetic kidney disease: Results from the CREDENCE trial and meta-analysis

Author: Zhou, Z ; https://orcid.org/0000-0001-6543-7113, Jardine, MJ ; https://orcid.org/0000-0002-0160-2375, Li, Q ; https://orcid.org/0000-0002-4384-8226, Neuen, BL ; https://orcid.org/0000-0001-9276-8380, Cannon, CP, De Zeeuw, D, Edwards, R, Levin, A, Mahaffey, KW, Perkovic, V ; https://orcid.org/0000-0002-4257-7620, Neal, B ; https://orcid.org/0000-0002-0490-7465, Lindley, RI, Guerrero, RAA, Aizenberg, D, Albisu, JP, Alvarisqueta, A, Bartolacci, I, Berli, MA, Bordonava, A, Calella, P, Cantero, MC, Cartasegna, LR, Cercos, E, Coloma, GC, Colombo, H, Commendatore, V, Cuadrado, J, Cuneo, CA, Cusumano, AM, Douthat, WG, Dran, RD, Farias, E, Fernandez, MF, Finkelstein, H, Fragale, G, Fretes, JO, Garcia, NH, Gastaldi, A, Gelersztein, E, Glenny, JA, Gonzalez, JP, Del Carmen Gonzalez Colaso, P, Goycoa, C, Greloni, GC, Guinsburg, A, Hermida, S, Juncos, LI, Klyver, MI, Kraft, F, Krynski, F, Lanchiotti, PV, De La Fuente, RAL, Marchetta, N, Mele, P, Nicolai, S, Novoa, PA, Orio, SI, Otreras, F, Oviedo, A, Raffaele, P, Resk, JH, Rista, L, Papini, NR, Sala, J, Santos, JC, Schiavi, LB, Sessa, H, Casabella, TS, Ulla, MR, Valdez, M, Vallejos, A, Villarino, A, Visco, VE, Wassermann, A, Zaidman, CJ, Cheung, NW, Droste, C, Fraser, I, Johnson, D, Mah, PM, Nicholls, K, Packham, D, Proietto, J, Roberts, A, Roger, S, Tsang, V, Raduan, RA, Da Costa, FAA, Amodeo, C, Turatti, LAA, Bregman, R, Sanches, FCC, Canani, LH, Chacra, AR, Borges, JLC, Vêncio, SAC, Da Silva Franco, RJ, D'Avila, D, De Souza Portes, E, De Souza, P, Phillips, Andrea, Zhou, Z ; https://orcid.org/0000-0001-6543-7113, Jardine, MJ ; https://orcid.org/0000-0002-0160-2375, Li, Q ; https://orcid.org/0000-0002-4384-8226, Neuen, BL ; https://orcid.org/0000-0001-9276-8380, Cannon, CP, De Zeeuw, D, Edwards, R, Levin, A, Mahaffey, KW, Perkovic, V ; https://orcid.org/0000-0002-4257-7620, Neal, B ; https://orcid.org/0000-0002-0490-7465, Lindley, RI, Guerrero, RAA, Aizenberg, D, Albisu, JP, Alvarisqueta, A, Bartolacci, I, Berli, MA, Bordonava, A, Calella, P, Cantero, MC, Cartasegna, LR, Cercos, E, Coloma, GC, Colombo, H, Commendatore, V, Cuadrado, J, Cuneo, CA, Cusumano, AM, Douthat, WG, Dran, RD, Farias, E, Fernandez, MF, Finkelstein, H, Fragale, G, Fretes, JO, Garcia, NH, Gastaldi, A, Gelersztein, E, Glenny, JA, Gonzalez, JP, Del Carmen Gonzalez Colaso, P, Goycoa, C, Greloni, GC, Guinsburg, A, Hermida, S, Juncos, LI, Klyver, MI, Kraft, F, Krynski, F, Lanchiotti, PV, De La Fuente, RAL, Marchetta, N, Mele, P, Nicolai, S, Novoa, PA, Orio, SI, Otreras, F, Oviedo, A, Raffaele, P, Resk, JH, Rista, L, Papini, NR, Sala, J, Santos, JC, Schiavi, LB, Sessa, H, Casabella, TS, Ulla, MR, Valdez, M, Vallejos, A, Villarino, A, Visco, VE, Wassermann, A, Zaidman, CJ, Cheung, NW, Droste, C, Fraser, I, Johnson, D, Mah, PM, Nicholls, K, Packham, D, Proietto, J, Roberts, A, Roger, S, Tsang, V, Raduan, RA, Da Costa, FAA, Amodeo, C, Turatti, LAA, Bregman, R, Sanches, FCC, Canani, LH, Chacra, AR, Borges, JLC, Vêncio, SAC, Da Silva Franco, RJ, D'Avila, D, De Souza Portes, E, De Souza, P, and Phillips, Andrea
Abstract: BACKGROUND AND PURPOSE: Chronic kidney disease with reduced estimated glomerular filtration rate or elevated albuminuria increases risk for ischemic and hemorrhagic stroke. This study assessed the effects of sodium glucose cotransporter 2 inhibitors (SGLT2i) on stroke and atrial fibrillation/flutter (AF/AFL) from CREDENCE (Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation) and a meta-Analysis of large cardiovascular outcome trials (CVOTs) of SGLT2i in type 2 diabetes mellitus. METHODS: CREDENCE randomized 4401 participants with type 2 diabetes mellitus and chronic kidney disease to canagliflozin or placebo. Post hoc, we estimated effects on fatal or nonfatal stroke, stroke subtypes, and intermediate markers of stroke risk including AF/AFL. Stroke and AF/AFL data from 3 other completed large CVOTs and CREDENCE were pooled using random-effects meta-Analysis. RESULTS: In CREDENCE, 142 participants experienced a stroke during follow-up (10.9/1000 patient-years with canagliflozin, 14.2/1000 patient-years with placebo; hazard ratio [HR], 0.77 [95% CI, 0.55-1.08]). Effects by stroke subtypes were: ischemic (HR, 0.88 [95% CI, 0.61-1.28]; n=111), hemorrhagic (HR, 0.50 [95% CI, 0.19-1.32]; n=18), and undetermined (HR, 0.54 [95% CI, 0.20-1.46]; n=17). There was no clear effect on AF/AFL (HR, 0.76 [95% CI, 0.53-1.10]; n=115). The overall effects in the 4 CVOTs combined were: Total stroke (HRpooled, 0.96 [95% CI, 0.82-1.12]), ischemic stroke (HRpooled, 1.01 [95% CI, 0.89-1.14]), hemorrhagic stroke (HRpooled, 0.50 [95% CI, 0.30-0.83]), undetermined stroke (HRpooled, 0.86 [95% CI, 0.49-1.51]), and AF/AFL (HRpooled, 0.81 [95% CI, 0.71-0.93]). There was evidence that SGLT2i effects on total stroke varied by baseline estimated glomerular filtration rate (P=0.01), with protection in the lowest estimated glomerular filtration rate (45 mL/min/1.73 m2]) subgroup (HRpooled, 0.50 [95% CI, 0.31-0.79]). CONCLUSIONS: Although we found no clear effect
Published: 2021

4. Canagliflozin and Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus and Chronic Kidney Disease in Primary and Secondary Cardiovascular Prevention Groups

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, Guerrero, Raa, Aizenberg, D, Albisu, Jp, Alvarisqueta, A, Bartolacci, I, Berli, Ma, Bordonava, A, Calella, P, Cantero, Mc, Cartasegna, Lr, Cercos, E, Coloma, Gc, Colombo, H, Commendatore, V, Cuadrado, J, Cuneo, Ca, Cusumano, Am, Douthat, Wg, Dran, Rd, Farias, E, Fernandez, Mf, Finkelstein, H, Fragale, G, Fretes, Jo, Garcia, Nh, Gastaldi, A, Gelersztein, E, Glenny, Ja, Gonzalez, Jp, Colaso, Pdg, Goycoa, C, Greloni, Gc, Guinsburg, A, Hermida, S, Juncos, Li, Klyver, Mi, Kraft, F, Krynski, F, Lanchiotti, Pv, de la Fuente, Ral, Marchetta, N, Mele, P, Nicolai, S., Novoa, Pa, Orio, Si, Otreras, F, Oviedo, A, Raffaele, P, Resk, Jh, Rista, L, Papini, Nr, Sala, J, Santos, Jc, Schiavi, Lb, Sessa, H, Casabella, Ts, Ulla, Mr, Valdez, M, Vallejos, A, Villarino, A, Visco, Ve, Wassermann, A, Zaidman, Cj, Cheung, Nw, Droste, C, Fraser, I, Johnson, D, Mah, Pm, Nicholls, K, Packham, D, Proietto, J, Roberts, A, Roger, S, Tsang, V, Raduan, Ra, da Costa, Faa, Amodeo, C, Turatti, Laa, Bregman, R, Sanches, Fcc, Canani, Lh, Chacra, Ar, Cunha Borges, Jl, Vencio, Sac, Franco, Rjd, D'Avila, D, Portes, Ed, de Souza, P, Deboni, Lm, Fraige, F, Neto, Bg, Gomes, M, Kohara, Sk, Keitel, E, Saraiva, Jfk, Lisboa, Hrk, Contieri, Fld, Milagres, R, Montenegro, R, de Brito, Cm, Hissa, Mn, Sabbag, Arn, Noronha, I, Panarotto, D, Pecoits, R, Pereira, Ma, Saporito, W, Scotton, As, Schuch, T, de Almeida, Rs, Ramos, Cs, Felicio, Js, Thome, F, Hachmann, Jct, Yamada, S, Hayashida, Cy, Petry, Tbz, Zanella, Mt, 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, Cherney, D, 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, Nadia, Fernandez Montenegro, Maria Alicia, Godoy Jorquera, Juan Gonzalo, Medina Farina, Marcelo, Saavedra Gajardo, Victor, Vejar, Margarita, Chen, Nan, Chen, Qinkai, Gan, Shenglian, Kong, Yaozhong, Detian, Li, Wenge, Li, Xuemei, Li, Lin, Hongli, Liu, Jian, Weiping, Lu, Mao, Hong, Ren, Yan, Song, Weihong, Sun, Jiao, Sun, Lin, Ping, Tu, Wang, Guixia, Yang, Jinkui, Yin, Aiping, Xueqing, Yu, Zhao, Minghui, Zheng, Hongguang, Accini Mendoza, Jose Luis, Arcos, Edgar, Avendano, Jorge, Diaz Ruiz, Jorge Ernesto Andres, Garcia Ortiz, Luis Hernando, Gonzalez, Alexander, Hernandez Triana, Eric, Diego Higuera, Juan, Malaver, Natalia, Ines Molina de Salazar, Dora, Rosero, Ricardo, Terront Lozano, Monica Alexandra, Valderrama Cometa, Luis, Valenzuela, Alex, Vargas Alonso, Ruben Dario, Villegas, Ivan, Yupanqui, Hernan, Bartaskova, Dagmar, Barton, Petr, Belobradkova, Jana, Dohnalova, Lenka, Drasnar, Tomas, Ferkl, Richard, Halciakova, Katarina, Klokocnikova, Vera, Kovar, Richard, Lastuvka, Jiri, Lukac, Martin, Pesickova, Satu, Peterka, Karel, Pumprla, Jiri, Rychlik, Ivan, Saudek, Frantisek, Tesar, Vladimir, Valis, Martin, Weiner, Pavel, Zemek, Stanislav, Alamartine, Eric, Borot, Sophie, Cariou, Bertrand, Dussol, Bertrand, Fauvel, Jean-Pierre, Gourdy, Pierre, Klein, Alexandre, Le Meur, Yannick, Penfornis, Alfred, Roussel, Ronan, Saulnier, Pierre-Jean, Thervet, Eric, Zaoui, Philippe, Burst, Volker, Faghih, Markus, Faulmann, Grit, Haller, Hermann, Jerwan-Keim, Reinhold, Maxeiner, Stephan, Paschen, Bjoern, Plassmann, Georg, Rose, Ludger, Gonzalez Orellana, Ronaldo Arturo, Paul Haase, Franklin, Moreira Diaz, Juan Pablo, Ramirez Roca, Luis Alberto, Sanchez Arenales, Jose Antonio, Sanchez Polo, Jose Vicente, Turcios Juarez, Erick, Csecsei, Gyongyi, Csiky, Botond, Danos, Peter, Deak, Laszlo, Dudas, Mihaly, Harcsa, Eleonora, Keltai, Katalin, Keresztesi, Sandor, Kiss, Konyves, Laszlo, Major, Lajos, Mileder, Margit, Molnar, Marta, Mucsi, Janos, Oroszlan, Tamas, Ory, Ivan, Paragh, Gyorgy, Peterfai, Eva, Petro, Gizella, Revesz, Katalin, Takacs, Robert, Vangel, Sandor, Vasas, Szilard, Zsom, Marianna, Abraham, Oomman, Bhushan, Raju Sree, Deepak, Dewan, Edwin, Fernando M., Gopalakrishnan, Natarajan, Gracious, Noble, Hansraj, Alva, Jain, Dinesh, Keshavamurthy, C. B., Khullar, Dinesh, Manisha, Sahay, Peringat, Jayameena, Prasad, Narayan, Satyanarayana, Rao K., Sreedhar, Reddy, Sreelatha, Melemadathil, Sudhakar, Bhimavarapu, Vyasam, Ramesh Chandra, Bonadonna, Riccardo, Castellino, Pietro, Ceriello, Antonio, Chiovato, Luca, De Cosmo, Salvatore, De Nicola, Luca, Derosa, Giuseppe, Di Carlo, Alberto, Di Cianni, Graziano, Frasca, Giovanni, Fuiano, Giorgio, Gambaro, Giovanni, Garibotto, Giacomo, Giorda, Carlo, Malberti, Fabio, Mandreoli, Marcora, Mannucci, Edoardo, Orsi, Emanuela, Piatti, Piermarco, Santoro, Domenico, Sasso, Ferdinando Carlo, Serviddio, Gaetano, Stella, Andrea, Trevisan, Roberto, Veronelli, Anna Maria, Zanoli, Luca, Akiyama, Hitoshi, Aoki, Hiromi, Asano, Akimichi, Iitsuka, Tadashi, Kajiyama, Shizuo, Kashine, Susumu, Kawada, Toshio, Kodera, Takamoto, Kono, Hiroshi, Koyama, Kazunori, Kumeda, Yasuro, Miyauchi, Shozo, Mizuyama, Kazuyuki, Niiya, Tetsuji, Oishi, Hiroko, Ota, Satoshi, Sakakibara, Terue, Takai, Masahiko, Tomonaga, Osamu, Tsujimoto, Mitsuru, Wada, Takashi, Wakasugi, Masakiyo, Wakida, Yasushi, Watanabe, Takayuki, Yamada, Masayo, Yanagida, Kazuhiro, Yanase, Toshihiko, and Yumita, Wataru
Subjects: Male, Risk, primary prevention, canagliflozin, clinical trial, diabetes mellitus, renal insufficiency, chronic, secondary prevention, renal insufficiency, Double-Blind Method, Original Research Articles, Humans, Sodium-Glucose Transporter 2 Inhibitors, Proportional Hazards Models, canagliflozin, clinical trial, diabetes mellitus, primary prevention, renal insufficiency, chronic, secondary prevention, Middle Aged, Placebo Effect, chronic, Treatment Outcome, Diabetes Mellitus, Type 2, Cardiovascular Diseases, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Kidney Failure, Chronic, Female
Abstract: Supplemental Digital Content is available in the text., 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

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

Author: 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. 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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

6. TREATMENT OF ALUMINUM INTOXICATION - A NEW SCHEME FOR DESFERRIOXAMINE ADMINISTRATION

Author: Douthat, Wg, Aguerre, Ga, Martin, Jlf, Mouzo, R., and Andia, Jbc

7. The incidence, risk factors and impact of acute kidney injury in hospitalized patients due to COVID-19.

Author: Fernández P, Saad EJ, Douthat Barrionuevo A, Marucco FA, Heredia MC, Tarditi Barra A, Rodriguez Bonazzi ST, Zlotogora M, Correa Barovero MA, Villada SM, Maldonado JP, Alaye ML, Caeiro JP, Albertini RA, De la Fuente J, and Douthat WG
Subjects: Child, Hospital Mortality, Humans, Incidence, Retrospective Studies, Risk Factors, SARS-CoV-2, Acute Kidney Injury epidemiology, Acute Kidney Injury etiology, COVID-19
Abstract: The incidence of acute kidney injury (AKI) in hospitalized patients with COVID-19 is variable, being associated with worse outcomes. The objectives of the study were to evaluate the incidence, risk factors (considering demographic characteristics, comorbidities, initial clinical presentation and associated complications) and impact of AKI in subjects hospitalized for COVID-19 in two third-level hospitals in Córdoba, Argentina. A retrospective cohort study was conducted. We included 448 adults who were consecutively hospitalized for COVID-19 between March 3 and October 31, 2020 and were followed throughout the hospitalization. The incidence of AKI was 19% (n = 85; stage I = 43, stage II = 17, and stage III = 25, 18 required renal replacement therapy). In the multivariate analysis, the variables that were independently associated with AKI were: age (for every 10 years, adjusted odd ratio [95%CI] = 1.30 [1.04-1.63], p = 0.022), history of chronic kidney disease -CKD- (9.92 [4.52-21.77], p < 0.001), blood neutrophil count at admission -BNCA- (for every increase of 1000 BNCA, 1.09 [1.01-1.18], p = 0.037) and requirement for mechanical ventilation -MV- (6.69 [2.24-19.90], p = 0.001). AKI was associated with longer hospitalization, higher admission (63.5 vs. 29.7%; p < 0.001) and longer stay in the intensive care unit, a positive association with respiratory bacterial superinfection, sepsis, respiratory distress syndrome, MV requirement and mortality (mortality without AK I = 12.4% vs with AKI = 47.1%; stage I = 26%, stage II = 41% and stage III = 88%; p < 0.001). AKI was independently associated with higher mortality (3.32 [1.6-6.9], p = 0.001). In conclusion, the incidence of AKI in adults hospitalized for COVID-19 was 19% and had a clear impact on morbidity and mortality. The independent risk factors for AKI were: Age, CKD, BNCA and MV.
Published: 2021

8. The authors reply.

Author: Pecoits-Filho R, Sola L, Correa-Rotter R, Claure-Del Granado R, Douthat WG, and Bellorin-Font E
Subjects: Humans, Latin America, Kidney Diseases, Nephrology
Published: 2019
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9. Kidney disease in Latin America: current status, challenges, and the role of the ISN in the development of nephrology in the region.

Author: Pecoits-Filho R, Sola L, Correa-Rotter R, Claure-Del Granado R, Douthat WG, and Bellorin-Font E
Subjects: Health Services Accessibility trends, Health Services Needs and Demand trends, Healthcare Disparities trends, Humans, Latin America epidemiology, Needs Assessment trends, Nephrologists education, Nephrologists statistics & numerical data, Nephrology education, Prognosis, Time Factors, Kidney Diseases diagnosis, Kidney Diseases epidemiology, Kidney Diseases therapy, Nephrologists trends, Nephrology trends, Societies, Medical trends
Published: 2018
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10. Complications of chronic kidney disease: current state, knowledge gaps, and strategy for action.

Author: Bello AK, Alrukhaimi M, Ashuntantang GE, Basnet S, Rotter RC, Douthat WG, Kazancioglu R, Köttgen A, Nangaku M, Powe NR, White SL, Wheeler DC, and Moe O
Abstract: The International Society of Nephrology has adopted a proactive approach to defining the current state of kidney care and unmet needs through a multifaceted Closing the Gaps initiative. As part of this initiative, the International Society of Nephrology convened a meeting of experts to develop an approach to tackle acute kidney injury and chronic kidney disease (CKD). This manuscript expands on the recently published International Society of Nephrology CKD Roadmap and reports on the discussions of the working group assigned to the task of reviewing the global impact of complication of CKD. The working group defined the following goals: Goal 1: Optimize the management of anemia and endocrine and metabolic abnormalities associated with CKD. The impact of these conditions at a global level is not well understood, particularly in regions where renal replacement therapy is not readily available. Some treatment regimens may be affordable in low- and middle-income countries and if implemented, could have an impact on the burden of suffering associated with CKD. Goal 2: Improve the prevention and management of cardiovascular complications linked to CKD. Most research on cardiovascular complications of CKD has focused on atherosclerotic diseases (myocardial infarction, ischemic stroke, and peripheral gangrene). There has been growing recognition that other forms of cardiovascular diseases, such as heart failure, valvular disease and arrhythmias, have a major impact on patient outcomes. Much less is known about the mechanisms and treatment of these non-atherosclerotic complications. Goal 3: Improve the diagnosis and management of symptoms associated with CKD. Symptom management is one of the greatest challenges in the management of CKD, with limited knowledge about the mechanisms associated with the development of these common problems and how best to characterize them into usable clinical phenotypes. Improved understanding of the complications of CKD may alleviate suffering and prolong life among millions of people worldwide both in developed countries and in regions where renal replacement therapy is not widely available.
Published: 2017
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11. [The role of kidney transplantation in reducing mortality in a chronic dialysis program].

Author: Douthat WG, Fernández P, Rechene J, Chiurchiu CR, De Arteaga J, Massari PU, and De La Fuente J
Subjects: Adult, Argentina epidemiology, Cadaver, Chronic Disease, Female, Follow-Up Studies, Graft Rejection, Hemodialysis Units, Hospital statistics & numerical data, Humans, Incidence, Kidney Transplantation statistics & numerical data, Male, Middle Aged, Peritoneal Dialysis mortality, Prevalence, Renal Dialysis statistics & numerical data, Tissue Donors, Waiting Lists, Kidney Transplantation mortality, Renal Dialysis mortality, Survival Rate
Abstract: For patients with chronic renal failure (CRF), kidney transplant (KT) is a better alternative to dialysis in terms of survival, life quality and costs. We studied the general characteristics, causes and survival rate of the dialysis population in 2010. We evaluated broader criteria for acceptance of transplants has affected the results of the procedure in that period. A total of 118 dialysis patients were included; mean age 56.9 ± 18.4 years, dialysis duration 45.5 ± 59.6 months, main cause of CRF was diabetes in 35 (30%), and 58 (49%) were included in waiting list for KT. Of the 34 patients who finished dialysis in 2010, 18 (53%) were KT, while 12 (35%) died (cardiovascular 50%, infectious 17%). Survival at 12 months was 85% for the total group, 98% on waiting list and 72% those who were not enrolled. During 2010 there were 88 KT, 62 with cadaveric donors (CD), 18 with living donors and 8 with double pancreas-kidney transplants. Recipients of CD were 50.7 years old, with 67 months on dialysis, 8 (13%) diabetics, and 12 (20%) with previous KT. Donors had a mean age of 45 years, 28 (45%) expanded criteria, and 27.7 hours of cold ischemia time. During an approximate follow-up of 11.4 months, 13 (21%) suffered acute graft rejection, survival was 88% for graft and 93% for patients. We emphasize KT as the main cause of success as regards dialysis. No differences in risk factors were found to significantly affect graft or patient survival.
Published: 2014

12. High prevalence of secondary hyperparathyroidism in chronic kidney disease patients on dialysis in Argentina.

Author: Douthat WG, Castellano M, Berenguer L, Guzmán MA, de Arteaga J, Chiurchiu CR, Massari PU, Garay G, Capra R, and de La Fuente JL
Subjects: Adolescent, Adult, Aged, Aged, 80 and over, Argentina epidemiology, Biomarkers, Bone and Bones metabolism, Calcitriol therapeutic use, Calcium blood, Child, Child, Preschool, Chronic Disease, Diabetic Nephropathies epidemiology, Diabetic Nephropathies therapy, Female, Humans, Hyperparathyroidism, Secondary blood, Hyperparathyroidism, Secondary drug therapy, Hyperparathyroidism, Secondary etiology, Kidney Diseases complications, Kidney Diseases therapy, Male, Middle Aged, Parathyroid Hormone blood, Peritoneal Dialysis, Phosphorus blood, Prevalence, Young Adult, Hyperparathyroidism, Secondary epidemiology, Kidney Diseases epidemiology, Renal Dialysis
Abstract: Background: There are few data in Argentina on the prevalence and management of bone and mineral metabolism (BMM) in patients with chronic kidney disease (CKD)., Objectives and Methods: A survey was carried out in dialysis units in 2010 to measure the prevalence of and types of treatments for BMM disorders in Argentina. The data obtained was then compared to the published results from other large population studies. We recorded characteristics of dialysis centres and participating patients, the frequency of measurements and individual results for BMM biochemical markers, as well as the type of management used to control hyperphosphataemia and secondary hyperparathyroidism., Results: 1210 patients from 25 dialysis centres in Argentina participated in the study (representing 4.7% of the country’s prevalent dialysis population in 2010). The mean patient age was 55.3±17.6 years, 60.8% were male, 3.3% were on peritoneal dialysis and 29.1% suffered diabetes. In all centres, phosphataemia and calcaemia were measured on a monthly basis, 60% of centres measured intact parathyroid hormone (iPTH) every 6 months, 36% every 3 to 4 months, and 4% annually. As recommended by K/DOQI, 51.6% of patients had adequate levels of calcium (8.4-9.5 mg/dl), 51.6% had adequate phosphorus (3.5-5.5 mg/dl) and 21.1% displayed acceptable iPTH levels (150-300 pg/ml). 24% had iPTH <150 pg/ml and 54.5% >300 pg/ml. iPTH ≥600 pg/ml was present in 28.3%, and 13.3% had values ≥1000 pg/ml. These figures differed from those published by the DOPPS II study, in which 51.1% of patients had iPTH <150 pg/ml, and only 26.7% had iPTH ≥300 pg/ml. Calcium-based phosphate binders were used in 83.6% of the patients, 5.6% used sevelamer and 4.0% used aluminium-containing compounds. To achieve control of hyperparathyroidism, oral or intravenous calcitriol was predominantly used (50.5%) with a small percentage of patients receiving paricalcitol or doxercalciferol., Conclusions: The present study shows a high prevalence of secondary hyperparathyroidism, which differs from that published by other large population studies. There was a high proportion of patients with BMM markers outside the ranges suggested by K/DOQI. Mainly phosphate binders based on calcium and calcitriol continue to be used for the management of hyperphosphatemia and hyperparathyroidism respectively.
Published: 2013
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13. New options for the management of hyperparathyroidism after renal transplantation.

Author: Douthat WG, Chiurchiu CR, and Massari PU
Abstract: The persistence and severity of hyperparathyroidism (HPT) post-renal transplantation is relatively frequent and primarily associated with the timing and its magnitude in the pre-transplant period and with the presence of parathyroid adenomas. HPT after renal transplantation is clinically manifested with hypercalcemia, hypophosphatemia, bone pain, fractures, and in more serious cases with cardiovascular calcifications that affect the survival. The primary clinical objective for patients with secondary HPT after renal transplantation is to obtain a level of parathyroid hormone (PTH) adequate to the renal transplanted function and to normalize levels of calcium, phosphorus and vitamin D. In many cases during this period, the development of hypercalcemia and/or hypophosphatemia makes it necessary to take different therapeutic measures. The use of vitamin D or its analogues has been extrapolated from the management of pre-transplant HPT obtaining variable outcomes, although its use is limited by its capacity to produce hypercalcemia. Calcimimetics are drugs that have proven be effective in reducing PTH levels in patients with HPT on dialysis and has been effective in reducing up to 50% PTH levels in moderate to severe HPT in post-renal transplantation.When HPT persists after renal transplantation and does not respond to medical treatment, invasive management by percutaneous ethanol injection therapy of parathyroid glands or parathyroidectomy should be considered. The emergence of new methods for the management of HPT expands the availability of therapeutic tools for transplant patients.
Published: 2012
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14. Use of percutaneous ethanol injection therapy for recurrent secondary hyperparathyroidism after subtotal parathyroidectomy.

Author: Douthat WG, Cardozo G, Garay G, Orozco S, Chiurchiu C, de la Fuente J, de Arteaga J, and Massari PU
Abstract: We evaluated the efficacy of percutaneous ethanol injection therapy (PEIT) as a therapeutic option for recurrence of secondary hyperparathyroidism after subtotal parathyroidectomy in ESRD patients. Six patients underwent PEIT. A mean of 1.3 ± 0.8 ethanol injections was performed. Nodular volume was 1.5 ± 1.7 cm(3), and 2.8 ± 2.8 cm(3) of ethanol was injected per patient. After ethanol injection PTH decreased significantly (1897 ± 754 to 549 ± 863 pg/mL (P < .01)). There was also a reduction in serum calcium, phosphorus and calcium-phosphorus product. A positive and significant correlation was found between nodular volume with ethanol injected and time from parathyroidectomy. Only one patient required hospitalization due to severe hypocalcaemia. In other two cases, local discomfort and temporary mild dysphonia were registered. PEIT is an effective treatment to control recurrences of secondary hyperparathyroidism postsubtotal parathyroidectomy.
Published: 2011
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15. Percutaneous ethanol injection therapy in post-transplant patients with secondary hyperparathyroidism.

Author: Douthat WG, Orozco SE, Maino P, Cardozo G, de Arteaga J, de la Fuente J, Chiurchiu CR, and Massari PU
Subjects: Adult, Female, Humans, Injections, Intralesional, Male, Middle Aged, Ethanol administration & dosage, Hyperparathyroidism, Secondary drug therapy, Kidney Transplantation, Postoperative Complications drug therapy
Abstract: Persistent hyperparathyroidism is frequent in postrenal transplant patients. Percutaneous ethanol injection therapy (PEIT) is an alternative for treatment of patients with secondary hyperparathyroidism but it was not described in postrenal transplant patients. We report our experience with PEIT to control hyperparathyroidism in the post-transplant period. We performed PEIT under ultrasonographic guidance and local anesthesia in eight patients because of persistent secondary hyperparathyroidism after renal transplantation. Indications for PEIT were: high intact parathyroid hormone (iPTH) levels with hypercalcemia, hypophosphatemia, osteopenia and/or bone pain. All patients had at least one visible parathyroid nodule by ultrasonography. Biochemical assays were performed immediately before PEIT, between 1 and 7 days after last PEIT, and a mean of 8.0 +/- 2.8 months after PEIT. Serum iPTH and calcium levels decreased significantly after treatment and remained unchanged until final control. Serum iPTH decreased from 286.9 +/- 107.2 to 154.6 +/- 42.2 pg/ml (P < 0.01) after PEIT (percentual reduction 36.5 +/- 9.5%). This response was significantly correlated to total ethanol volume used (r: 0.94, P < 0.0001). Hypercalcemia disappeared in six of eight patients treated. Only minor complications were registered. There were no changes in renal function related to the treatment. Our findings show that PEIT is a useful and safe alternative for patients with persistent post-transplant secondary hyperparathyroidism.
Published: 2007
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16. [Early urinary tract infection in kidney transplantation. Risk factors and impact on graft survival].

Author: Cepeda PA, Balderramo DC, De Arteaga J, Douthat WG, and Massari PU
Subjects: Adult, Epidemiologic Methods, Female, Graft Rejection etiology, Humans, Klebsiella pneumoniae isolation & purification, Male, Postoperative Complications microbiology, Pseudomonas aeruginosa isolation & purification, Urinary Tract Infections epidemiology, Urinary Tract Infections microbiology, Graft Survival, Kidney Transplantation, Postoperative Complications etiology, Urinary Tract Infections etiology
Abstract: The early urinary tract infection (EUTI) in kidney transplant recipients is an infection develop during the first 3 months post transplant surgery. The effect of EUTI on graft survival and risk factors have been scarcely studied. Our objetives were the evaluation of risk factors to EUTI, the assessment of the causal agent and graft survival impact. A retrospective analysis of kidney transplantation, period 1997-2000 in Hospital Privado-Centro Médico de Córdoba was carried out. There were two groups of patients with (EUTI group) and without EUTI (control group). Cox model was used to analyze risk factors and Kaplan-Meier method for graft survival. A total of 226 consecutive patients received kidney transplantation. In 55 patients (24.3%) EUTI was detected. Risk factors for EUTI were: invasive urological maneuvers (RR = 4.34, CI 95% 1.42-13.21), diabetes mellitus (RR = 3.79, CI 95% 1.42-10.14), cytomegalovirus infection (RR = 2.9, CI 95% 1.02-8.24) and previous transplants (RR = 2.83, CI 95% 1.08-7.45). Delayed graft function was associated with lower incidence of EUTI (RR = 0.38, CI 95% 0.15-0.94). The causal agents were: Klebsiella pneumoniae (36%), Pseudomonas aeruginosa (24%) and Escherichia coli (9%). Graft survival at 2 years was similar in EUTI (87.2%) and control group (81.2%, p = 0.32). This series shows that invasive urological maneuvers were the main risk factors for EUTI. Graft survival was similar. High prevalence of non coli bacteria need further evaluation.
Published: 2005

17. [Primary osteoporosis risk factors in women from Córdoba, Argentina].

Author: Balderramo DC, Ramacciotti CF, and Douthat WG
Subjects: Adult, Aged, Argentina epidemiology, Body Mass Index, Bone Density, Case-Control Studies, Female, Fractures, Bone epidemiology, Fractures, Bone etiology, Humans, Logistic Models, Middle Aged, Osteoporosis epidemiology, Postmenopause, Premenopause, Risk Factors, Osteoporosis etiology
Abstract: Unlabelled: Risk factors for osteoporosis were evaluated in women from Cordoba, Argentina. Female patients that consulted about diagnosis or treatment of osteoporosis from January 2000 to June 2002 were included. Secondary osteoporosis patients were excluded. Participants were studied using standardized questionnaire, clinical examination, biochemical analysis, and dual-energy X-ray absorptiometry (DXA). According to lumbar spine DXA results and WHO criterion, we considered 2 groups: Osteoporosis (T score < -2.5 standard deviation, SD) and Control (T score > or = -2.5 SD). One hundred and fifty five women (Osteoporosis Group: 47;, Control Group: 108) were studied. In univariate analysis age, years from menopause, weight, smoking duration, estrogen replacement therapy duration, bilateral oophorectomy with hysterectomy, alkaline phosphatase levels, and Pouteau-Colles fractures were different between both groups. After multivariate analysis, including variables that were statistical different in univariate analysis, and considering osteoporosis as dependent variable, body weight (Odds Ratio, OR=0.92; CI 95% 0.87-0.98), alkaline phosphatase (OR=1.01; CI 95% 1.00-1.02), years from menopause (OR=1.12; CI 95% 1.05-1.21), and Pouteau-Colles fractures (OR=15.15; CI 95% 1.68-135.7) were independent risk factors for osteoporosis.
Published: 2004

18. Treatment of refractory secondary hyperparathyroidism with ethanol injection: the importance of glandular volume.

Author: Douthat WG, Orozco SE, de Arteaga J, and Massari PU
Subjects: Alkaline Phosphatase blood, Biomarkers, Calcium blood, Chronic Kidney Disease-Mineral and Bone Disorder pathology, Humans, Hyperparathyroidism, Secondary diagnostic imaging, Kidney Failure, Chronic complications, Parathyroid Hormone blood, Parathyroidectomy, Phosphorus blood, Radionuclide Imaging, Radiopharmaceuticals, Recurrence, Technetium Tc 99m Sestamibi, Ethanol administration & dosage, Hyperparathyroidism, Secondary therapy, Parathyroid Glands physiology
Abstract: Background: Percutaneous ethanol injection treatment (PEIT) has been proposed as an alternative to surgery for patients with secondary hyperparathyroidism. The present study was undertaken to determine factors that may predict results., Methods: We performed PEIT in 19 patients with secondary hyperparathyroidism refractory to medical therapy under ultrasonographic guidance in an ambulatory facility with local anesthesia. Biochemical assays were performed immediately before the last dialysis session (basal) and between 1 to 7 days after PEIT (post-PEIT)., Results: Serum PTH, calcium, and phosphorus levels decreased significantly after treatment. The percent of change in serum PTH was significantly correlated to total nodular volume (r = 0.73, P = 0.0004), and basal PTH levels (r = 0.48, P = 0.03). Post-PEIT serum phosphate and calcium x phosphate product disclosed negative correlations that were statistically significant with the decrease of PTH levels (r = -0.60, P = 0.009, and r = -0.60, P = 0.01, respectively). The total nodular volume was significantly correlated to the percent change in serum calcium levels (r = 0.60, P = 0.01), in phosphate levels (r = 0.64, P = 0.009), and calcium x phosphate product (r = 0.66, P = 0.01)., Conclusion: Our findings suggest that patients with uncontrolled secondary hyperparathyroidism may benefit from PEIT if they present with very high basal PTH levels and/or big nodule size.
Published: 2003
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19. [Biochemical and histological spectrum of renal osteodystrophy in Argentina].

Author: Douthat WG, Garay G, de Arteaga J, Fernández Martín JL, Cannata Andía JB, and Massari PU
Subjects: Adolescent, Adult, Aged, Alkaline Phosphatase blood, Aluminum analysis, Argentina epidemiology, Biomarkers, Biopsy, Bone Remodeling, Bone and Bones chemistry, Calcium blood, Chronic Kidney Disease-Mineral and Bone Disorder blood, Chronic Kidney Disease-Mineral and Bone Disorder etiology, Chronic Kidney Disease-Mineral and Bone Disorder pathology, Female, Humans, Kidney Failure, Chronic blood, Kidney Failure, Chronic complications, Kidney Failure, Chronic pathology, Male, Middle Aged, Parathyroid Hormone blood, Phosphorus blood, Bone and Bones pathology, Chronic Kidney Disease-Mineral and Bone Disorder epidemiology
Abstract: Between 1994-2001 we have performed 57 bone biopsies for diagnostic purposes in symptomatic CRF patients. We analyzed here 52 samples where the material was optimal for study, and divided them into 2 periods according to when the biopsy was performed: 1994-1996 and 1997-2001, to verify changes in the spectrum of renal osteodystrophy. Mean serum values were: serum calcium 9.9 +/- 1.8 mg/dl, phosphate 5.8 +/- 3.2 mg/dl, alkaline phosphatase 693.9 +/- 968.9 Ul/L, iPTH 562.0 +/- 598.5 pg/ml, serum aluminum 65.7 +/- 79.3 ug/L and bone aluminum 22.8 +/- 22.4 ug/g. Hyperparathyroidism was the most common histological diagnosis as severe in 13 patients (25%), or as mild in 14 (27%). Ten patients had osteomalacia (19%), adynamic bone disease was diagnosed in 5 (9.6%) and mixed renal osteodystrophy in 10 (19.2%). Low bone turnover patients showed higher bone and serum aluminum than high bone turnover patients. We observed a relative increment in high turnover bone disease in the later period (1997-2001) without changes in low turnover bone disease. These data showed a high prevalence of hyperparathyroidism and aluminum-related low turnover bone disease, with no significant changes between the two time-periods analyzed here.
Published: 2003

20. [Importance of the "adequate blood phosphorus" concept as a risk factor for hyperphosphatemia].

Author: Douthat WG, Alles A, Marinovich S, Tirado S, Peñalba A, and Prudkin S
Subjects: Argentina, Blood Chemical Analysis statistics & numerical data, Calcinosis blood, Calcinosis etiology, Calcium blood, Chelation Therapy statistics & numerical data, Chronic Kidney Disease-Mineral and Bone Disorder blood, Chronic Kidney Disease-Mineral and Bone Disorder etiology, Culture, Diagnostic Tests, Routine statistics & numerical data, Health Surveys, Hemodialysis Units, Hospital statistics & numerical data, Humans, Hyperparathyroidism, Secondary blood, Hyperparathyroidism, Secondary drug therapy, Hyperparathyroidism, Secondary etiology, Kidney Failure, Chronic blood, Kidney Failure, Chronic complications, Kidney Failure, Chronic therapy, Phosphorus blood, Practice Patterns, Physicians' statistics & numerical data, Reference Values, Renal Dialysis adverse effects, Risk Factors, Vitamin D therapeutic use, Attitude of Health Personnel, Chronic Kidney Disease-Mineral and Bone Disorder prevention & control, Phosphates blood, Physicians psychology
Abstract: Hyperphosphatemia is an important risk factor of secondary hyperparathyroidism and extraosseous calcifications in chronic renal failure patients. In this study our hypothesis is that physicians misconception of adequate phosphatemia is a risk factor for hyperphosphatemia. In 1999 GEMOR sent a renal osteodystrophy inquiry to different hemodialysis centers in Argentina. It included 80 dialysis centers in 17 Argentinian provinces. The enquire had 33 questions about renal osteodystrophy. Here we report the section related to phosphorous metabolism. We obtained responses from 80 dialysis centers (4,512 dialysis patients), which represents about 24% of Argentinian dialysis centers. Physicians considered phosphorous levels between 4.5 to 5.5 mg/dl in 83.5% of centers as adequate, and between 5.5 to 6.5 mg/dl in 10.1%. Five out of 77 centers reported that they had no patients with hyperphosphatemia. The percentage of hemodialysis patients that had more than 6 mg/dl in each center was 28.8 +/- 15.9%. Those centers that aimed for phosphatemia between 5.5 and 6.5 mg/dl, had a higher percentage of patients with phosphatemia above 6 mg/dl than those aiming for between 4.5 and 5.5 mg/dl (42.8 +/- 16.7 vs 27.1 +/- 15.2% respectively, p = 0.007), and had higher mean of phosphatemia (6.4 +/- 0.7 vs 5.3 +/- 0.7 mg/dl respectively, p = 0.0001), than the last group. In conclusion, a higher mean phosphate level was obtained in hemodialysis centers where physicians considered higher pre-dialysis target levels. Some centers had no patients with hyperphosphatemia (neglect or good control?).
Published: 2003

21. Treatment of aluminium intoxication: a new scheme for desferrioxamine administration.

Author: Douthat WG, Acuña Aguerre G, Fernández Martín JL, Mouzo R, and Cannata Andía JB
Subjects: Drug Administration Schedule, Humans, Aluminum blood, Aluminum poisoning, Deferoxamine administration & dosage, Renal Dialysis adverse effects
Abstract: In order to control aluminium toxicity in dialysis patients it is preferable to prevent or limit exposure to it. However, it is sometimes necessary to remove the aluminium by the use of appropriate techniques. The collateral effects of desferrioxamine have led us to test new forms of administering desferrioxamine and attempt to reduce the dose. The aim of this study was to compare the removal of aluminium by administration of 15 mg/kg of desferrioxamine under two different schemes, that is, 44 h before the dialysis (classic scheme) and 1 h before dialysis (new scheme). The study was carried out in 10 patients over a period of 4 weeks. Aluminium removal was quantified in the dialysate throughout the dialysis. Measurement was also performed of the serum aluminium changes that occurred during the study. The total removal of aluminium was determined over three consecutive dialysis sessions following the administration of desferrioxamine. A similar amount of aluminium was found under both schemes. However, in the case of those patients given desferrioxamine 1 h prior to dialysis, removal of aluminium induced significantly lower serum aluminium peaks: (P < 0.02). These results suggest that the administration of desferrioxamine 1 h before dialysis is a valid alternative to the classic scheme (44 h before). The removal of aluminium at lower increments in the serum aluminium entails less risk for patients.
Published: 1994

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21 results on '"Douthat WG"'

1. Kidney and Cardiovascular Effects of Canagliflozin According to Age and Sex: A Post Hoc Analysis of the CREDENCE Randomized Clinical Trial

2. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy

3. Effect of SGLT2 inhibitors on stroke and atrial fibrillation in diabetic kidney disease: Results from the CREDENCE trial and meta-analysis

4. Canagliflozin and Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus and Chronic Kidney Disease in Primary and Secondary Cardiovascular Prevention Groups

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

6. TREATMENT OF ALUMINUM INTOXICATION - A NEW SCHEME FOR DESFERRIOXAMINE ADMINISTRATION

7. The incidence, risk factors and impact of acute kidney injury in hospitalized patients due to COVID-19.

8. The authors reply.

9. Kidney disease in Latin America: current status, challenges, and the role of the ISN in the development of nephrology in the region.

10. Complications of chronic kidney disease: current state, knowledge gaps, and strategy for action.

11. [The role of kidney transplantation in reducing mortality in a chronic dialysis program].

12. High prevalence of secondary hyperparathyroidism in chronic kidney disease patients on dialysis in Argentina.

13. New options for the management of hyperparathyroidism after renal transplantation.

14. Use of percutaneous ethanol injection therapy for recurrent secondary hyperparathyroidism after subtotal parathyroidectomy.

15. Percutaneous ethanol injection therapy in post-transplant patients with secondary hyperparathyroidism.

16. [Early urinary tract infection in kidney transplantation. Risk factors and impact on graft survival].

17. [Primary osteoporosis risk factors in women from Córdoba, Argentina].

18. Treatment of refractory secondary hyperparathyroidism with ethanol injection: the importance of glandular volume.

19. [Biochemical and histological spectrum of renal osteodystrophy in Argentina].

20. [Importance of the "adequate blood phosphorus" concept as a risk factor for hyperphosphatemia].

21. Treatment of aluminium intoxication: a new scheme for desferrioxamine administration.

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