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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, 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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, 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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

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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

6. Thrombotic thrombocytopenic purpura and hemolytic uremic syndrome are distinct pathologic entities.

Author

Hosler GA, Cusumano AM, and Hutchins GM

Abstract

Context.--Thrombotic thrombocytopenic purpura (TTP) and the hemolytic uremic syndrome (HUS) share many clinical features and have been difficult to separate into distinct entities. Histologic examination of organs from autopsied patients suggested that TTP and HUS have dissimilar lesions of different severity and distribution. Objective.--To perform a retrospective observational review of autopsied patients with TTP or HUS to compare the nature and severity of the lesions found. Design.--To examine the pathologic features of these conditions, we reviewed all cases among 51 350 indexed autopsies at The Johns Hopkins Hospital (Baltimore, Md) diagnosed with TTP or HUS, and included those showing multiple arteriolar thrombi or their sequela. Results.--The 56 cases that met the inclusion criteria fell into 2 distinct groups, based on distribution and severity of arteriolar lesions. In 25 patients classified as having TTP, platelet-rich thrombi were present--in decreasing severity--in heart, pancreas, kidney, adrenal gland, and brain. In 31 patients with HUS, fibrin/red cell--rich thrombi were present, largely confined to the kidney and often severe, and only 6 cases showed pancreas involvement, 4 adrenal gland involvement, 2 brain involvement, and 1 heart involvement. Conclusion.--Despite similar clinical features and therapeutic approaches, TTP and HUS each have a characteristic constellation of histopathologic findings. This observation suggests that TTP and HUS are 2 distinct disease entities with different pathophysiologies, and that they do not represent a spectrum of the same disease process. (Arch Pathol Lab Med. 2003;127:834-839). [ABSTRACT FROM AUTHOR]

Published
2003
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7. Unmet Needs of CKD in Latin America: A Review from Expert Virtual Working Group.

Author

Correa-Rotter R, Méndez Durán A, Vallejos A, Rico-Fontalvo J, Cusumano AM, Rosa-Diez GJ, Sánchez Polo V, Goecke H, Arango JJ, Cerón VV, Diná E, Fonseca FH, Valdés RA, and Vanoni M

Abstract

Chronic kidney disease (CKD) represents a major challenge for Latin American (LatAm) because of its epidemic proportions. Therefore, the current status and knowledge of CKD in Latin America is not clearly understood. Moreover, there is a paucity of epidemiologic studies that makes the comparison across the countries even more difficult. To address these gaps, a virtual kidney expert opinion meeting of 14 key opinion leaders from Argentina, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Mexico, and Panama was held in January 2022 to review and discuss the status of CKD in various LatAm regions. The meeting discussed the following: (i) epidemiology, diagnosis, and treatment of CKD, (ii) detection and prevention programs, (iii) clinical guidelines, (iv) state of public policies about diagnosis and management of chronic kidney disease, and (v) role of innovative therapies in the management of CKD. The expert panel emphasized that efforts should be made to implement timely detection programs and early evaluation of kidney function parameters to prevent the development or progression of CKD. Furthermore, the panel discussed the importance of raising awareness among health care professionals; disseminating knowledge to the authorities, the medical community, and the general population about the kidney and cardiovascular benefits of novel therapies; and the need for timely updating of clinical practice guidelines, regulatory policies, and protocols across the region., (© 2023 Published by Elsevier Inc. on behalf of the International Society of Nephrology.)

Published
2023
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9. The Glomerular Filtration Rate: From the Diagnosis of Kidney Function to a Public Health Tool.

Author

Cusumano AM, Tzanno-Martins C, and Rosa-Diez GJ

Abstract

The prevalence of chronic kidney disease (CKD) continues to increase worldwide, as well as the associated morbidity and mortality and the consequences on the patients' quality of life and countries' economies. CKD often evolves without being recognized by patients and physicians, although the diagnosis is based on two simple laboratory data: the estimated glomerular filtration rate (eGFR) and urine analysis. To measure GFR, the knowledge about the physiologic processes at the nephron level, the concept of clearance, and the identification of creatinine as a suitable endogenous marker for measuring the creatinine clearance (CrCl) had to be previously developed. On those bases, different equations to calculate CrCl (Cockcroft and Gault, 1976), or estimated GFR (four variables MDRD, 1999; CKD-Epi, 2009, among others) were generated. They all include creatinine and some demographic data, such as sex and age. However, to compare results throughout life or among laboratories, the creatinine determination must be standardized. In addition, the accuracy of these equations remains controversial in certain subgroups of patients. For these reasons, other mathematical models to improve CrCl estimation have been developed, such as when urine cannot be collected, in debilitated elderly patients and patients with trauma, diabetes, or obesity. Currently, eGFR in adults can be measured and reported immediately, using isotope dilution mass spectrometry traceable creatinine-based equations. In conclusion, based on knowledge obtained from renal physiology, eGFR can be used in the clinic for the diagnosis and early treatment of CKD, as well as a public instrument to estimate the prevalence., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Cusumano, Tzanno-Martins and Rosa-Diez.)

Published
2021
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10. Renal length and volume prediction in healthy children.

Author

Bianchi ME, Forlino D, Velasco GA, Rodriguez PO, López G, and Cusumano AM

Subjects
Adolescent, Child, Child, Preschool, Cross-Sectional Studies, Female, Humans, Infant, Infant, Newborn, Kidney diagnostic imaging, Linear Models, Male, Organ Size, Ultrasonography, Kidney anatomy & histology
Abstract

Introduction: Little information is available regarding the evaluation of renal volume in healthy Latin-American children of different ages. The objective of this work was to establish a predictive model of renal size (volume and length) and develop a web-based calculator., Materials and Methods: A selective and representative sample was obtained randomly from the database of healthy children living in Resistencia city, Chaco, Argentina: a) the National Health Program for children under 6 years old; b) school children until 18 years old (primary and middle education). Renal dimensions were obtained by ultrasonography via a single experienced operator at the indicated site (schools or primary health care centers). Renal volume was calculated using Dinkel's formula. A multiple linear regression model was applied using potential predictors. The final model was implemented in a free web-based application., Results: Random selection was made from the database to include 882 subjects with ages between 0.03 and 230.63 months. The data was divided into two sets (one for training and the other for model testing). The training set (423) included 212 (50%) females. Significant predictors included age, height, current weight and birth weight, and the interaction between age and present weight. Using the test dataset, both renal volume and length root mean square errors were 5.06 cm 3 and 0.59 cm., Conclusion: The prediction model was accurate and allowed for the development a freely-available web app: Renal size prediction (https://porbm28.shinyapps.io/RenalVolume/). Once the models are validated by additional studies, the app could be a useful tool to predict renal volume and length in pediatric clinical practice.

Published
2020
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11. [Prevalence of obesity and arterial hypertension and their relationship with age and gender in the city of Resistencia, Argentina, in the years 2008-2014].

Author

Bianchi MEV, Cusumano AM, Torres C, Rojas NG, and Velasco GA

Subjects
Adult, Age Factors, Aged, Argentina epidemiology, Cross-Sectional Studies, Female, Humans, Male, Middle Aged, Prevalence, Risk Factors, Sex Factors, Young Adult, Hypertension epidemiology, Obesity epidemiology
Abstract

Introduction: Obesity (OB) is a global pandemic, which is associated with arterial hypertension (AH). The differences in this relationship according to gender and age remain unclear. The objectives of this study were to establish the prevalence of OB and AH in an adult population, and to determine the risk of AH associated with OB in relationship to gender and age., Material and Methods: A cross-sectional study was performed using the database of successive cross-sectional studies carried out in 5 city squares in Resistencia (Argentina) during the years 2008-2014. The sample was randomised according to gender and age, according to the distribution of the last National Argentine Census., Results: A total of 7,898 passers-by (46.8% males) with a mean age 42.74 ± 16.70 years were included. OB in men increased from 21.3% to 26.9%, and in women from 15.2% to 23%, the former having the highest prevalence between 40-49 years, and the latter between 50-59 years, and thereafter it was always higher in women. AH increased in men from 39.9% to 42.7%, and in women from 25.8% to 29.2%, the former having the highest prevalence between 60-69 years, the latter between 70-79 years., Conclusion: In the 7 years of the study, OB and AH prevalence increased. It was higher in men, although the risk of developing AH associated with OB was greater in older women. The highest prevalence of OB and AH appears a decade earlier in men., (Copyright © 2018 SEH-LELHA. Publicado por Elsevier España, S.L.U. All rights reserved.)

Published
2019
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13. Latin American Dialysis and Transplant Registry: Experience and contributions to end-stage renal disease epidemiology.

Author

Cusumano AM, Rosa-Diez GJ, and Gonzalez-Bedat MC

Abstract

In 2015, 634387 million people (9% of the world's population) resided in Latin America (LA), with half of those populating Brazil and Mexico. The LA Dialysis and Transplant Registry was initiated in 1991, with the aim of collecting data on renal replacement therapy (RRT) from the 20 LA-affiliated countries. Since then, the Registry has revealed a trend of increasing prevalence and incidence of end-stage kidney disease on RRT, which is ongoing and is correlated with gross national income, life expectancy at birth, and percentage of population that is older than 65 years. In addition, the rate of kidney transplantation has increased yearly, with > 70% being performed from deceased donors. According to the numbers reported for 2013, the rates of prevalence, incidence and transplantation were (in patients per million population) 669, 149 and 19.4, respectively. Hemodialysis was the treatment of choice (90%), and 43% of the patients undergoing this treatment was located in Brazil; in contrast, peritoneal dialysis prevailed in Costa Rica, El Salvador and Guatemala. To date, the Registry remains the only source of RRT data available to healthcare authorities in many LA countries. It not only serves to promote knowledge regarding epidemiology of end-stage renal disease and the related RRT but also for training of nephrologists and renal researchers, to improve understanding and clinical application of dialysis and transplantation services. In LA, accessibility to RRT is still limited and it remains necessary to develop effective programs that will reduce risk factors, promote early diagnosis and treatment of chronic kidney disease, and strengthen transplantation programs.

Published
2016
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14. Latin American Dialysis and Transplant Registry: 2008 prevalence and incidence of end-stage renal disease and correlation with socioeconomic indexes.

Author

Cusumano AM, Garcia-Garcia G, Gonzalez-Bedat MC, Marinovich S, Lugon J, Poblete-Badal H, Elgueta S, Gomez R, Hernandez-Fonseca F, Almaguer M, Rodriguez-Manzano S, Freire N, Luna-Guerra J, Rodriguez G, Bochicchio T, Cuero C, Cuevas D, Pereda C, and Carlini R

Abstract

In 2008, 563,294,000 people were living in Latin America (LA), of which 6.6% were older than 65. The region is going through a fast demographic and epidemiologic transition process, in the context of an improvement in socio-economic indices. The Latin American Dialysis and Renal Transplant Registry has collected data since 1991, through an annual survey completed by 20 affiliated National Societies. Renal replacement treatment (RRT) prevalence and incidence showed an increase year by year. The prevalence rate (in all modalities) correlated with the World Bank country classification by income and the epidemiologic transition stage the countries were experiencing. RRT prevalence and kidney transplantation rates correlated significantly with gross national income (GNI), health expenditure in constant dollars (HeExp), % older than 65, life expectancy at birth, and % of the population living in urban settings. Kidney transplantation increased also, year by year, with more than 50% of transplants performed using kidneys from deceased donors. Double transplants were performed in six countries. RRT prevalence and incidence increased in LA, and are associated with indexes reflecting higher and more evenly distributed national wealth (GNI and HeExp), and the stage of demographic and epidemiological transition.

Published
2013
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15. The health system in Chile: the nephrologist perspective.

Author

Ardiles LG, Poblete H, Ortiz M, Elgueta S, Cusumano AM, Vukusich A, and Mezzano S

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Chile epidemiology, Chronic Disease, Delivery of Health Care economics, Female, Health Care Costs statistics & numerical data, Health Surveys, Humans, Kidney Diseases economics, Kidney Transplantation economics, Kidney Transplantation statistics & numerical data, Male, Middle Aged, Peritoneal Dialysis economics, Peritoneal Dialysis statistics & numerical data, Prevalence, Registries, Renal Dialysis economics, Renal Dialysis statistics & numerical data, Renal Replacement Therapy economics, Renal Replacement Therapy statistics & numerical data, Retrospective Studies, Young Adult, Delivery of Health Care statistics & numerical data, Kidney Diseases epidemiology, Kidney Diseases therapy, Renal Replacement Therapy methods
Abstract

Chile is a country with 17 million inhabitants, 13% of them living in rural areas, and with a per capita income of approximately US $14,500. Three percent of national income is assigned to the health budget, with a mixed public and private system, with guaranteed medical benefits from the state to cover chronic kidney disease (CKD) and renal replacement therapy (RRT). Hemodialysis has reached in 2009 a prevalence of 857 patients per million population (pmp). Peritoneal dialysis is less developed, with a prevalence of 40 patients pmp. Both therapies show good quality indexes with a patient mortality rate close to 12% per year. A centralized national renal transplantation program registered 5,949 renal transplants performed up to 2009. Renal survival at 5 years is 86% for living and 76% for cadaveric donor transplants. Organ donation is relatively low with 7.1 cadaveric donors pmp in 2009, despite legal and educational strategies to increase it. Although the country demonstrates one of the highest standards for RRT indexes in Latin America, the proportion of resources invested makes it necessary to improve early diagnosis and renal prevention policies to avoid having the growing incidence of CKD constrain the national health budget.

Published
2011
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16. Latin American Dialysis and Renal Transplant Registry: 2008 report (data 2006).

Author

Cusumano AM, Gonzalez Bedat MC, García-García G, Maury Fernandez S, Lugon JR, Poblete Badal H, Elgueta Miranda S, Gómez R, Cerdas Calderón M, Almaguer López M, Moscoso Tobar J, Leiva Merino R, Sánchez Polo J, Lou Meda R, Franco Acosta B, Ayala Ferrari R, Escudero E, Saavedra López A, Mena Castro E, Milanés C, Carlini R, and Duro Garcia V

Subjects
Humans, Kidney Transplantation trends, Latin America, Registries, Renal Dialysis trends, Kidney Transplantation statistics & numerical data, Renal Dialysis statistics & numerical data
Abstract

Introduction: Between 1991 and 2006, the Latin American Dialysis and Renal Transplantation Registry collected data from 20 countries (Argentina, Brazil, Bolivia, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Puerto Rico, Dominican Republic, Venezuela and Uruguay). Access to RRT was universal in Argentina, Brazil, Chile, Cuba, Puerto Rico, Venezuela and Uruguay, all countries belonging to the medium-high or high income group., Methods: Data about patients on renal replacement therapy (RRT) were supplied by national affiliates or the Registry's Coordination Committee. Transplant data were gathered and shared with the Latin American and Caribbean Society of Transplantation., Results: RRT prevalence increased from 162 patients per million population (pmp) in 1991 to 478 pmp in 2005 and 473 pmp in 2006 (59.2% hemodialysis, 20.4% peritoneal dialysis and 20.4% with a functioning kidney allograft). Countries with the highest prevalence were Puerto Rico (1,148.9 pmp), Uruguay (924.5 pmp) and Chile (907.6 pmp). Latin America's (LA) incidence increased from 27.8 pmp in 1992 to 188 pmp in 2006. The LA Kidney transplant rate increased from 3.7 pmp in 1987 to 15,4 pmp in 2006, and 166 combined transplants - kidney and another organ, mainly pancreas - were performed. In the medium-high income group 2006, (Argentina, Brazil, Chile, Costa Rica, Cuba, Mexico, Panama, Uruguay, Venezuela) the prevalence rate was 534.8 pmp vs. 289.5 pmp in the middle-low income group. The transplant rate was 18.4 pmp in the medium-high income group vs. 7 pmp in the middle-low group (p < 0.01)., Conclusions: RRT incidence and prevalence continue to grow steadily. Access to RRT is universal only in some countries included in the medium-high or high income group. It is imperative to accomplish the goal of making RRT available to all who need it.

Published
2010

17. [Latin-American Dialysis and Kidney Transplantation Registry: data on the treatment of end-stage renal disease in Latin America].

Author

Cusumano AM, Romao JE, Poblete Badal H, Elgueta Miranda S, Gomez R, Cerdas Calderon M, Almaguer Lopez M, Moscoso J, Leiva Merino R, Sánchez Polo JV, Garcia GG, Franco Acosta BV, Saavedra Lopez A, Mena E, Gonzalez C, and Milanes CL

Subjects
Humans, Latin America, Kidney Failure, Chronic therapy, Kidney Transplantation statistics & numerical data, Registries, Renal Dialysis statistics & numerical data
Abstract

Latin America, a region composed of a series of neighboring countries that share their history, Latin ancestry and language (Spanish or Portuguese), includes Mexico, Central America, the Spanish Caribbean islands, and South America. The Latin-American Dialysis and Kidney Transplantation Registry, which has been operative since 1991, collects data from 20 countries (Argentina, Brazil, Bolivia, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Puerto Rico, Dominican Republic, Venezuela and Uruguay), where 97% of Latin Americans live. The prevalence of renal replacement therapy (RRT) has increased from 119 patients per million (pmp) in 1991 to 478.2 in 2005 (147,158 patients [57%] on chronic hemodialysis, 58,251 [23%] on peritoneal dialysis and 52,565 [20%] living with a functioning kidney graft). The incidence rate also increased from 27.8 pmp in 1992 to 167 in 2005. The increment in prevalence and incidence occurred in all Latin- American countries. The transplantation rate increased from 3,7 pmp in 1987 to 15 pmp in 2005 (7,968 kidney transplants performed this year, the cumulative number being 98,415). Access to RRT was available for every patient diagnosed with end-stage renal disease only in Argentina, Brazil, Chile, Cuba, Puerto Rico, Venezuela and Uruguay. In Latin America, the incidence and prevalence of RRT increased year by year. Only in some countries is access to RRT available to 100% of diagnosed patients. Detection and prevention programs for chronic kidney disease are needed in the region. Meanwhile, access to RRT has to be improved for everybody who needs it.

Published
2008

18. Chronic kidney disease in Latin America: time to improve screening and detection.

Author

Cusumano AM and González Bedat MC

Subjects
Chronic Disease, Disease Progression, Humans, Kidney Diseases diagnosis, Kidney Diseases epidemiology, Kidney Failure, Chronic therapy, Latin America, Prevalence, Risk Factors, Kidney Failure, Chronic diagnosis, Mass Screening
Abstract

Latin America is a conglomerate of adjacent countries that share a Latin extraction and language (Spanish or Portuguese) and exhibit extreme variations in socioeconomic status. End-stage renal disease prevalence and incidence rates have been growing steadily, probably as a result of the increase in life expectancy, aging of the population, a growing epidemic of type 2 diabetes, and a fast epidemiologic transition across the region. Chronic noncommunicable diseases impose an enormous cost, barely supported at present and unlikely afforded by Latin America in the future. National health surveys in Chile, Mexico, and Argentina showed a high prevalence of cardiovascular risk factors. A total of 21% of the Chilean population had a creatinine clearance <80 ml/min. Among the surveyed people, 8.6% of Argentines, 14.2% of Chileans, and 9.2% of Mexicans had proteinuria. There are ongoing national chronic kidney disease detection programs in Brazil, Cuba, Peru, Uruguay, and Venezuela; Argentina, Colombia, Bolivia, Dominican Republic, Guatemala, and Paraguay are still developing them. The prevalence of cardiovascular and renal risk factors is high in Latin America. Data about chronic kidney disease are scarce, but public health awareness is high, evidenced by ongoing or developing chronic kidney disease detection programs. High-risk patients (e.g., those with hypertension or diabetes, elderly) must be studied, using simple determinations such as creatinine and proteinuria. For these programs to succeed, lifestyle changes must be encouraged, and public awareness must be increased through teaching and media-oriented activities.

Published
2008
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19. Present, prevention, and management of chronic kidney disease in Latin America.

Author

Correa-Rotter R and Cusumano AM

Subjects
Diabetes Complications prevention & control, Health Services Accessibility, Humans, Incidence, Kidney Failure, Chronic epidemiology, Kidney Failure, Chronic ethnology, Latin America epidemiology, Prevalence, Kidney Failure, Chronic prevention & control, Kidney Failure, Chronic therapy, Renal Replacement Therapy statistics & numerical data
Abstract

In recent decades, Latin America (LA) has experienced profound demographic and epidemiologic changes conditioning an enormous increase in prevalence and incidence of chronic non-communicable diseases. End-stage renal disease has steadily increased in prevalence and incidence (478.2 and 168.7 pmp, respectively) and is emerging as a devastating medical, social, and economic problem for patients, families, and national health systems. The development of successful renal replacement treatment modalities has emphasized the wide breach in healthcare between developed and emerging nations. LA is composed of many nations that have a common social and cultural background yet exhibit significant variations in socioeconomic status, ethnicities, and human development. In addition, the region is experiencing a type 2 diabetes mellitus epidemic and a constant growth of related end-stage renal disease which at present is not sustainable and will be unaffordable in most countries, unless changes in public health policy and a new focus on the problem is generated. Renal transplantation, though increasing, cannot revert the growing prevalence. The development of public health policies and prevention programs is mandatory in LA and requires a better knowledge of prevalence and distribution of risk factors in the different nations of the region., ((c) 2008 S. Karger AG, Basel.)

Published
2008
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20. [Nephrology of the future: the law of supply and demand].

Author

Cusumano AM

Subjects
Humans, Acute Kidney Injury epidemiology, Ambulatory Care Facilities statistics & numerical data, Hemodialysis Units, Hospital statistics & numerical data, Kidney Failure, Chronic epidemiology, Renal Dialysis statistics & numerical data
Published
2007

21. Growth hormone promotes glomerular lipid accumulation in bGH mice.

Author

Machado MO, Hirata RD, Sellitti DF, Iotti R, Iotti A, Cusumano AM, Riordan GP, Coschigano KT, Kopchick JJ, Zuhl I, Nguyen N, Hirata MH, and Doi SQ

Subjects
Animals, Cattle, Genotype, Growth Hormone metabolism, Mice, Mice, Transgenic, RNA, Messenger analysis, Receptors, LDL genetics, Receptors, LDL metabolism, Receptors, Scavenger genetics, Receptors, Scavenger metabolism, Glomerulosclerosis, Focal Segmental genetics, Glomerulosclerosis, Focal Segmental metabolism, Growth Hormone genetics, Kidney Glomerulus metabolism, Lipid Metabolism genetics
Abstract

Background: Bovine growth hormone (bGH) transgenic mice develop progressive glomerulosclerosis and exhibit abnormalities in hepatic lipid metabolism. We have previously shown that growth hormone up-regulates the low-density lipoprotein (LDL) receptor and 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMGR) in mouse mesangial cells. However, a role of lipid abnormalities in bGH kidney disease has not yet been demonstrated., Methods: Groups of bGH mice (5 and 11 months old) presenting with, respectively, moderate and severe degrees of glomerulosclerosis were compared to age-matched controls. Neutral lipid content in kidney cortex was determined by oil red-O staining, serum cholesterol, and triglycerides by enzymatic assays, relative mRNA expression of LDL receptors, HMGR, and scavenger receptor by real-time reverse transcription-polymerase chain reaction (RT-PCR), and HMGR protein expression by immunoblotting. Two younger (5 and 12 weeks old) groups of mice were used to study scavenger receptor expression at earlier time points., Results: Serum cholesterol was significantly increased in bGH mice at 5 months, but triglycerides were lower than control levels at both 5 and 11 months. Renal cortex HMGR expression was elevated at the mRNA but not at the protein level in the 11-month-old bGH group compared to controls. However, glomerular neutral lipid staining and scavenger receptor mRNA expression were markedly increased in all bGH mice, including those at 5 weeks of age compared to respective controls., Conclusion: The bGH mouse exhibits an increased mesangial lipid content and elevated scavenger receptor mRNA expression as early as at 5 weeks of age, suggesting that an increased kidney uptake of oxidized LDL could play a role in the development of glomerulosclerosis in this mouse model.

Published
2005
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22. Identification of hepatitis C virus RNA in peritoneal dialysis fluid of patients with viremia.

Author

Cusumano AM, Poratto F, del Pino N, Fernández JL, and Vilches A

Subjects
Adolescent, Adult, Female, Hepacivirus genetics, Hepatitis C complications, Hepatitis C transmission, Humans, Kidney Diseases complications, Kidney Diseases therapy, Male, Middle Aged, Viral Load, Viremia complications, Viremia transmission, Ascitic Fluid virology, Hepacivirus isolation & purification, Hepatitis C diagnosis, Peritoneal Dialysis, RNA, Viral isolation & purification, Viremia diagnosis
Abstract

Background: The potential risk for transmission of hepatitis C virus (HCV) by peritoneal dialysis (PD) has been studied previously, with conflicting results., Methods: To assess whether HCV crosses the peritoneal membrane, the following determinations were performed in 16 patients (7 males, 9 females; mean age 41.8 years; mean time on PD 14 +/- 15 months) undergoing PD: serum anti-HCV using second-generation enzyme-linked immunosorbent assay (ELISA), serum and PD fluid HCV RNA by nested polymerase chain reaction, HCV genotyping by restriction fragment length polymorphism, and serum HCV load by branched DNA assay., Results: Anti-HCV was positive in 10 patients. Serum HCV RNA was positive in 7 anti-HCV-positive patients and negative in all anti-HCV-negative patients. Fluid HCV RNA was detected in 5 (71.4%) patients testing positive for serum HCV RNA and in none testing negative for serum HCV RNA. Serum HCV genotype was 1a in 3 patients and 1b in 4; PD fluid HCV genotype was 1a in 1 patient and 1b in 4. Genotypes in serum and fluid were concordant when both were positive. Serum viral load ranged from nondetectable by the quantitative method to 5.1 MEq genome/mL in patients with fluid infection, and 1.05 MEq and 29 MEq genome/mL in the remaining 2 patients without detectable HCV in PD fLuid., Conclusions: HCV crosses the peritoneal membrane and may be detected in the dialysate of PD patients with proven viremia. Although our study population was small for firm conclusions to be drawn, this passage does not seem to depend upon the serum viral load. Our data support the notion that PD fluid needs careful handling and local disinfection to prevent possible spreading of viruses, in the institutional and the domestic environments.

Published
2005

23. The Latin American Dialysis and Renal Transplantation Registry Annual Report 2002.

Author

Cusumano AM, Di Gioia C, Hermida O, and Lavorato C

Subjects
Adult, Aged, Diabetic Nephropathies epidemiology, Female, Humans, Kidney Diseases epidemiology, Kidney Diseases therapy, Kidney Failure, Chronic epidemiology, Kidney Failure, Chronic therapy, Latin America epidemiology, Male, Middle Aged, National Health Programs, Registries, Kidney Transplantation statistics & numerical data, Renal Dialysis statistics & numerical data
Abstract

Latin America is a conglomerate of adjacent countries having in common a Latin extraction and language (Spanish or Portuguese) and exhibiting extreme variations in socioeconomic status. The Latin American Society of Nephrology and Hypertension Dialysis and Renal Transplantation Registry was created in 1991. Annual data are sent by local societies in 3 forms: patient, center, and country. The prevalence of renal replacement therapy (RRT) (all modalities) increased from 119 patients per million population (pmp) in 1991 to 349 pmp in 2001; the acceptance rate was 91.7 pmp in 2001. Dialysis prevalence was 277 pmp; hemodialysis was the predominant modality, except in Mexico (86% on peritoneal dialysis). The highest dialysis prevalence and acceptance rates were reported by Puerto Rico, Uruguay, and Chile. Among incident patients, diabetic nephropathy (33%) and nephroangioesclerosis (32%) were the primary causes; 38% were older than 65 years old. Renal transplants increased from 3.7 pmp in 1987 to 13.7 pmp in 2001. In 2003, 6357 transplants were performed (55% living donor); the cumulative number performed since 1987 reached 55,947. Prevalence and incidence are low because not all patients with end-stage renal disease have access to RRT because of restricted availability, difficulties in referral, and inequities in coverage. The annual increase in the number of patients on RRT (8%-10%) is higher, proportionally, than the annual growth of the Latin American population in general (1.5%). Efforts must be focused on prevention and treatment of chronic kidney disease, especially in diabetic and older patients, and in implementing better organ donation programs to improve the pool of cadaveric donors.

Published
2005
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24. Glomerular hypertrophy is associated with hyperinsulinemia and precedes overt diabetes in aging rhesus monkeys.

Author

Cusumano AM, Bodkin NL, Hansen BC, Iotti R, Owens J, Klotman PE, and Kopp JB

Subjects
Animals, Animals, Outbred Strains, Diabetic Nephropathies pathology, Female, Hyperinsulinism pathology, Hypertrophy complications, Kidney Glomerulus ultrastructure, Longitudinal Studies, Macaca mulatta, Male, Microscopy, Electron methods, Regression Analysis, Aging pathology, Diabetes Mellitus, Type 2 etiology, Hyperinsulinism complications, Hypertrophy pathology, Kidney Glomerulus pathology
Abstract

Background: Rhesus monkeys have a high prevalence of obesity and spontaneous type 2 diabetes mellitus after the age of 10 years. These monkeys go through a defined, sequential set of metabolic phases, including fasting hyperinsulinemia, impaired glucose tolerance, and fasting hyperglycemia. Using these monkeys, we addressed the hypothesis that renal structural features characteristic of diabetic nephropathy might precede the appearance of overt diabetes., Methods: We carried out a quantitative analysis of renal tissue, using light microscopy and electron microscopy, from 6 metabolically normal young monkeys, 7 metabolically normal aged monkeys, 7 hyperinsulinemic monkeys, and 18 diabetic monkeys., Results: Glomerular volume was increased significantly in hyperinsulinemic monkeys and diabetic monkeys compared with aged normal monkeys. In the normal monkey, glomerular basement membrane (GBM) width rises with age but reaches a plateau at about 20 years of age; the presence of diabetes was associated with markedly increased GBM width. Glomerular tuft volume and GBM width were correlated most closely with age and with glucose tolerance., Conclusion: Diabetic monkey kidneys are characterized by glomerular enlargement, glomerulosclerosis, and thickening of the GBM. Glomerular hypertrophy begins in the prediabetic hyperinsulinemic phase. This finding suggests that early intervention may be required in human patients to preserve normal glomerular structure., (Copyright 2002 by the National Kidney Foundation, Inc.)

Published
2002
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25. Energy supplementation in chronic hemodialysis patients with moderate and severe malnutrition.

Author

Milano MC, Cusumano AM, Navarro ET, and Turín M

Subjects
Adult, Cross-Sectional Studies, Female, Humans, Male, Middle Aged, Nutrition Disorders etiology, Time Factors, Dietary Supplements, Energy Metabolism physiology, Nutrition Disorders diet therapy, Renal Dialysis adverse effects
Abstract

Objective: Prospectively evaluate the effect on the nutritional status of a glucose polymer as energy supplementation alone in chronic hemodialysis patients with moderate and severe malnutrition., Material and Methods: The nutritional status of 55 hemodialysis patients was assessed by using a score that included Iron binding capacity, albumin, cholesterol, body mass index, mid brachial circumference, arm muscle area, triceps skinfold, and clinical impression. Twenty-two of 27 patients (14 men and 8 women, mean age 43 +/- 15 years, time on dialysis 65 +/- 49 months) were classified as moderately or severely malnourished and were supplemented for 6 months with 100 g of glucose polymers per day (equivalent to 380 kcal or 1590 kJ) added to the usual food intake. The patients were reevaluated at 3 and 6 months., Results: Only body weight, body mass index, triceps skinfold, and brachial circumference and clinical impression increased significantly at the end of the third month (P < .05) in the 22 patients. These results were confirmed at 6 months in 18 patients that completed the study. Mean body weight increase was 2.4 kg (range, .2 to 6.3 kg). The nutritional status, evaluated through the score, improved in only 4 patients at the end of the study. Few gastrointestinal side effects were observed. Triglycerides increased from 136 +/- 40 mg/dL to 235 +/- 120 mg/dL. Follow-up of the patients showed that fat mass (assessed by anthropometry) was maintained for 6 months after supplementation was discontinued., Conclusion: Energy supplementation alone in patients with moderate and severe malnutrition on chronic hemodialysis resulted in an increase in body weight, owing to an increase in body fat, but the nutritional status did not improve.

Published
1998
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26. Latin American Registry of dialysis and renal transplantation: 1993 annual dialysis data report.

Author

Mazzuchi N, Schwedt E, Fernández JM, Cusumano AM, Anção MS, Poblete H, Saldaña-Arévalo M, Espinosa NR, Centurión C, Castillo H, González F, Milanés CL, Infante M, and Ariza M

Subjects
Adolescent, Adult, Age Distribution, Aged, Humans, Kidney Diseases epidemiology, Kidney Diseases mortality, Kidney Diseases therapy, Latin America, Middle Aged, Mortality, Prevalence, Risk Factors, Kidney Transplantation, Registries, Renal Replacement Therapy
Abstract

Background: The Latin American Registry of Dialysis and Transplantation was created in October 1991 and comprises the National Societies of Nephrology from 21 countries with a total population of 468.56 million inhabitants., Methods: This report includes data from 21,181 patients from Argentina, Brazil, Chile, El Salvador, Panama, Paraguay, Peru, Puerto Rico, Uruguay, and Venezuela who were receiving chronic dialysis treatment during 1993. Data was collected by individual patient questionnaires except from Chile and Brazil where the data was obtained from a local centre questionnaire., Results: The prevalence rate averaged 131.1 per million population. The mean age of the 8972 incident patients was 50.5 years, with 58.2% males. The more frequent causes of renal failure were glomerulopathies (22.6%), vascular nephropathy (20.9%) and diabetes (16.9%). Haemodialysis was the most used treatment (88.3%). Gross mortality was 21.1% and the more frequent causes of death were cardiac complications and infections. The analysis of mortality risk factors using a logistic regression model showed that diabetics patients older than 65 years had the highest probability of death (43.0%) and patients with glomerulonephritis, younger than 65 years had the lowest (8.0%). The adjusted mortality rate was 241 deaths/1000 patient-years at risk when the USRDS 1987-1989 white mortality rate by age groups and primary diseases was used as standard., Conclusion: In spite of the economic difficulties, very important efforts have been made to treat ESRD patients and gross mortality statistics in some countries are similar to those reported by other regional registries.

Published
1997
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27. [Outcome of diabetic patients on chronic hemodialysis. Comparative analysis of survival and morbidity of polycystic and elderly patients].

Author

Mascheroni C, Puentes MA, and Cusumano AM

Subjects
Age Factors, Aged, Analysis of Variance, Cause of Death, Creatinine blood, Critical Illness therapy, Diabetic Nephropathies therapy, Female, Humans, Hypertension, Male, Middle Aged, Polycystic Kidney Diseases therapy, Retrospective Studies, Risk Factors, Survival Analysis, Diabetic Nephropathies complications, Diabetic Nephropathies mortality, Polycystic Kidney Diseases complications, Polycystic Kidney Diseases mortality, Renal Dialysis
Abstract

We analyzed retrospectively the outcome of 169 patients in chronic hemodialysis (CHD), divided into four groups: 1) 24 patients with diabetic nephropathy (age 53.7 +/- 11 years); 2) 19 with polycystic kidney disease (age 55.3 +/- 9 years) 3) 43 patients older than 60 when starting chronic hemodialysis with etiologies different from diabetes and polycystic kidney disease (age 69.2 +/- 5.8 years) and 4) 83 patients younger than 60 with diverse etiologies (age 42.8 +/- 12.4 years). In groups 1, 2 and 3 serum creatinine, arterial hypertension at the beginning, morbility, mortality and its causes were registered. In group 1, the prevalence of severe diabetic retinopathy and cardiovascular disease at the beginning were also analyzed. In all groups survival was determined. Of the diabetics, 92% presented severe diabetic retinopathy and 88% cardiovascular disease. The prevalence of hypertension was 100, 74 and 67% in groups 1, 2 and 3, respectively (p = 0.13). Twelve diabetics died before the first year of treatment; there was no difference in creatinine, age, cardiovascular disease, severe retinopathy and hypertension with those who lived more than one year. The percentage of time in risk hospitalized and the days/patients/year hospitalized were significantly different between group 1 and 3 and group 2 (p < 0.001). Patients were hospitalized for similar causes in groups 1 and 3: the initiation of CHD, cardiovascular and neurological diseases. The main causes of death in groups 1 and 3 were: cardiovascular disease and sudden death at home. Survival was better in group 2 compared with group 1 (p = 0.0014) but was similar between groups 1 and 3 (p = 0.21) even though there was a difference of 15 years between them. The Cox's proportional hazard model identified as risk factors diabetes, age, year of starting chronic hemodialysis and hospitalization episodes, adjusted for covariates. The outcome of diabetic patients in chronic hemodialysis showed high morbidity and mortality and was quite similar to that of elderly patients.

Published
1997

28. [Incidence, etiology and prognostic value of persistent significant proteinuria in kidney transplants].

Author

Cusumano AM, Iotti R, Turín M, Dávalos M, Jost L, and Vilches A

Subjects
Actuarial Analysis, Adolescent, Adult, Child, Child, Preschool, Female, Graft Survival, Humans, Incidence, Male, Middle Aged, Prognosis, Retrospective Studies, Kidney Transplantation adverse effects, Proteinuria epidemiology, Proteinuria etiology
Abstract

We investigated persistent significant proteinuria (PSP), defined as proteinuria > 1 gr/24 hours on three consecutive months, in renal allograft recipients. The clinical records of 273 patients (288 grafts) were reviewed and 236 grafts (178 live related, 58 cadaver donor) that functioned for at least 4 months (230 patients, 148 men and 82 women) were selected for analysis. The histological diagnoses of 226 grafts and 35 native kidneys were also reviewed. PSP was present in 67 grafts (28.4%); 43 of these grafts were studied histologically (transplant glomerulopathy (TxGPT) 19, idiopathic glomerulopathy (GP) 13, and chronic rejection 11). Patients with an idiopathic GP in the graft usually presented with the nephrotic syndrome (65%); this presentation was infrequent in patients with chronic rejection. The appearance of proteinuria was strongly associated with functional deterioration in grafts with chronic rejection and TxGPT; in grafts with PSP and a histological diagnosis of idiopathic GP, renal function was usually normal. Within grafts with PSP no statistically significant differences in actuarial survival (AS) could be established when the time of appearance or magnitude of PSP, the presence or absence of arterial hypertension, the immunosuppressive regimen, and the histological diagnosis were considered. Contrariwise, the difference in AS was highly significant (p < 0.0001) when grafts with and without PSP were compared. The former had an AS at 5 and 10 years of 74.6% and 55.7%, while in the case of the latter AS was 57.3% and 32.1%, respectively. In conclusion, in the present series 28.4% of grafts that functioned 4 months or more presented PSP. The most frequent glomerular lesion was TxGPT. The presence of PSP was a marker for poorer prognosis, since AS at 5 and 10 years was significantly less in this group.

Published
1996

29. Epidemiology and prevention of diabetic nephropathy.

Author

Brancati FL and Cusumano AM

Subjects
Angiotensin-Converting Enzyme Inhibitors therapeutic use, Diabetes Mellitus drug therapy, Diabetic Nephropathies drug therapy, Diabetic Nephropathies therapy, Humans, Risk Factors, United States epidemiology, Diabetic Nephropathies epidemiology, Diabetic Nephropathies prevention & control
Abstract

Diabetes mellitus is the leading underlying cause of end-stage renal disease in the USA. To develop preventive strategies aimed at combatting diabetic end-stage renal disease, three steps are required: first, the delineation of the natural history of diabetic nephropathy; second, the identification of modifiable risk factors for the development and progression of diabetic nephropathy; and third, the demonstration that manipulation of these factors does indeed reduce risk. A review of the literature regarding the epidemiology and prevention of diabetic renal disease in humans published during the past year revealed a wealth of data which may guide preventive efforts. Prospective cohort studies confirmed that microalbuminuria is a strong predictor of nephropathy and that blood pressure is an important modifiable risk factor for the progression of diabetic renal disease. In addition, observational studies identified several novel factors which might also increase risk. Randomized controlled trials provided convincing evidence that strict glycemic control reduces the risk of progression to diabetic nephropathy by 50%. Data from trials also demonstrated that angiotensin-converting enzyme inhibitors slow the progression of renal disease beyond their effect on blood pressure alone. Future research should further evaluate novel modifiable risk factors, define optimal treatment strategies for the use of angiotensin-converting enzyme inhibitors and antihypertensive agents, and develop methods to translate these findings into practice for the general population.

Published
1995
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