1. Kidney and Cardiovascular Effects of Canagliflozin According to Age and Sex: A Post Hoc Analysis of the CREDENCE Randomized Clinical Trial
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Yi, T, Smyth, B, Di Tanna, G, Arnott, C, Cardoza, K, Kang, A, Pollock, C, Agarwal, R, Bakris, G, Charytan, D, de Zeeuw, D, Heerspink, H, Neal, B, Wheeler, D, Cannon, C, Zhang, H, Zinman, B, Perkovic, V, Levin, A, Mahaffey, K, Jardine, M, Brenner, B, Greene, T, Meininger, G, Li, N, Kolesnyk, I, Aizenberg, D, Pecoits-Filho, R, Cherney, D, Obrador, G, Chertow, G, Chang, T, Hawley, C, Ji, L, Wada, T, Jha, V, Lim, S, Lim-Abrahan, M, Santos, F, Chae, D, Hwang, S, Vazelov, E, Rychlik, I, Hadjadj, S, Krane, V, Rosivall, L, De Nicola, L, Dreval, A, Nowicki, M, Schiller, A, Distiller, L, Gorriz, J, Kolesnyk, M, David, Wheeler, C, Guerrero, R, Albisu, J, Alvarisqueta, A, Bartolacci, I, Berli, M, Bordonava, A, Calella, P, Cantero, M, Cartasegna, L, Cercos, E, Coloma, G, Colombo, H, Commendatore, V, Cuadrado, J, Cuneo, C, Cusumano, A, Douthat, W, Dran, R, Farias, E, Fernandez, M, Finkelstein, H, Fragale, G, Fretes, J, Garcia, N, Gastaldi, A, Gelersztein, E, Glenny, J, Gonzalez, J, Colaso, P, Goycoa, C, Greloni, G, Guinsburg, A, Hermida, S, Juncos, L, Klyver, M, Kraft, F, Krynski, F, Lanchiotti, P, Leon de la Fuente, R, Marchetta, N, Mele, P, Nicolai, S, Novoa, P, Orio, S, Otreras, F, Oviedo, A, Raffaele, P, Resk, J, Rista, L, Papini, N, Sala, J, Santos, J, Schiavi, L, Sessa, H, Casabella, T, Ulla, M, Valdez, M, Vallejos, A, Villarino, A, Visco, V, Wassermann, A, Zaidman, C, Cheung, N, Droste, C, Fraser, I, Johnson, D, Mah, P, Nicholls, K, Packham, D, Proietto, J, Roberts, A, Roger, S, Tsang, V, Raduan, R, Costa, F, Amodeo, C, Turatti, L, Bregman, R, Sanches, F, Canani, L, Chacra, A, Borges, J, Vencio, S, Franco, R, D'Avila, D, Portes, E, de Souza, P, Deboni, L, Fraige Filho, F, Neto, B, Gomes, M, Kohara, S, Keitel, E, Saraiva, J, Lisboa, H, Contieri, F, Milagres, R, Junior, R, de Brito, C, Hissa, M, Sabbag, A, Noronha, I, Panarotto, D, Filho, R, Pereira, M, Saporito, W, Scotton, A, Schuch, T, de Almeida, R, Ramos, C, Felicio, J, Thome, F, Hachmann, J, Yamada, S, Hayashida, 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Alonso, R, 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, Saudek, F, Tesar, V, Valis, M, Weiner, P, Zemek, S, Alamartine, E, Borot, S, Cariou, B, Dussol, B, Fauvel, J, Gourdy, P, Klein, A, Le Meur, Y, Penfornis, A, Roussel, R, Saulnier, P, Thervet, E, Zaoui, P, Burst, V, Faghih, M, Faulmann, G, Haller, H, Jerwan-Keim, R, Maxeiner, S, Paschen, B, Plassmann, G, Rose, L, Gonzalez Orellana, R, Haase, F, Moreira Diaz, J, Ramirez Roca, L, Sanchez Arenales, J, Sanchez Polo, J, 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, F, Gopalakrishnan, N, Gracious, N, Hansraj, A, Jain, D, Keshavamurthy, C, Khullar, D, Manisha, S, Peringat, J, Prasad, N, Satyanarayana, R, Sreedhar, R, Sreelatha, M, Sudhakar, B, Chandra Vyasam, R, Bonadonna, R, Castellino, P, Ceriello, A, Chiovato, L, De Cosmo, S, Derosa, G, Di Carlo, A, Di Cianni, G, Frasca, G, Fuiano, G, Gambaro, G, Garibotto, G, Giorda, C, Malberti, F, Mandreoli, M, Mannucci, E, Orsi, E, Piatti, P, Santoro, D, Sasso, F, Serviddio, G, Stella, A, Trevisan, R, Veronelli, A, Zanoli, L, Akiyama, H, Aoki, H, Asano, A, Iitsuka, T, Kajiyama, S, Kashine, S, Kawada, T, Kodera, T, Kono, H, Koyama, K, Kumeda, Y, Miyauchi, S, Mizuyama, K, Niiya, T, Oishi, H, Ota, S, Sakakibara, T, Takai, M, Tomonaga, O, Tsujimoto, M, Wakasugi, M, Wakida, Y, Watanabe, T, Yamada, M, Yanagida, K, Yanase, T, Yumita, W, Gaupsiene, E, Kozloviene, D, Navickas, A, Urbanaviciene, E, Abdul Ghani, R, Kadir, K, Ali, N, Che Yusof, M, Gan, C, Ismail, M, Kong, W, Lam, S, Lee, L, Loh, C, Manocha, A, Ng, K, Ahmad, N, Ratnasingam, V, Shudim, S, Vengadasalam, P, Abraira Munoz, L, Salazar, M, Cruz, J, Soto, M, Ramos, J, Wong, A, Correa Rotter, J, Escalante, T, Enriquez Sosa, F, Lozano, F, Flota Cervera, L, Baron, P, Ballesteros, C, Gomez Rangel, J, Herrera Jimenez, L, Irizar Santana, S, Flores, F, Molina, H, Luna Ceballos, R, del Campo Blanco, B, Franco, G, Moreno Loza, O, Rocha, C, Vera, G, Castellanos, R, Calcaneo, J, Reyes Rosano, M, Pattzi, H, Guzman, J, Rucker Joerg, I, Saavedra Sanchez, S, Sanchez Mijangos, J, Sanson, P, Tamayo y Orozco, J, Chavez, E, Cepeda, A, Carrillo, L, Mesa, J, 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, R, Santos, L, Gomez, O, Jimeno, C, Tan, G, Tolentino, M, Yao, C, Yap, Y, Lallaine Ygpuara, M, 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, L, Anghel, V, Avram, R, 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Deck, K, Desouza, C, Dev, D, Dhillon, M, Dua, S, Eder, F, Elosegui, A, 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, 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, Trenche, S, Narayanan, M, Narvarte, J, Nassar, T, Newman, G, Nichol, B, Nicol, P, Nisnisan, J, Nossuli, A, 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, 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W., Smyth B., Di Tanna G. L., Arnott C., Cardoza K., Kang A., Pollock C., Agarwal R., Bakris G., Charytan D. M., de Zeeuw D., Heerspink H. J. L., Neal B., Wheeler D. C., Cannon C. P., Zhang H., Zinman B., Perkovic V., Levin A., Mahaffey K. W., Jardine M., Brenner B. M., Greene T., Meininger G., Li N., Kolesnyk I., Aizenberg D., Pecoits-Filho R., Cherney D., Obrador G., Chertow G., Chang T., Hawley C., Ji L., Wada T., Jha V., Lim S. K., Lim-Abrahan M. A., Santos F., Chae D. -W., Hwang S. -J., Vazelov E., Rychlik I., Hadjadj S., Krane V., Rosivall L., De Nicola L., Dreval A., Nowicki M., Schiller A., Distiller L., Gorriz J. L., Kolesnyk M., Wheeler C., Guerrero R. A. A., Albisu J. P., Alvarisqueta A., Bartolacci I., Berli M. A., Bordonava A., Calella P., Cantero M. C., Cartasegna L. R., Cercos E., Coloma G. C., Colombo H., Commendatore V., Cuadrado J., Cuneo C. A., Cusumano A. M., Douthat W. G., Dran R. D., Farias E., Fernandez M. F., Finkelstein H., Fragale G., Fretes J. O., Garcia N. H., Gastaldi A., Gelersztein E., Glenny J. A., Gonzalez J. P., Colaso P. D. C. G., Goycoa C., Greloni G. C., Guinsburg A., Hermida S., Juncos L. I., Klyver M. I., Kraft F., Krynski F., Lanchiotti P. V., Leon de la Fuente R. A., Marchetta N., Mele P., Nicolai S., Novoa P. A., Orio S. I., Otreras F., Oviedo A., Raffaele P., Resk J. H., Rista L., Papini N. R., Sala J., Santos J. C., Schiavi L. B., Sessa H., Casabella T. S., Ulla M. R., Valdez M., Vallejos A., Villarino A., Visco V. E., Wassermann A., Zaidman C. J., Cheung N. W., Droste C., Fraser I., Johnson D., Mah P. M., Nicholls K., Packham D., Proietto J., Roberts A., Roger S., Tsang V., Raduan R. A., Costa F. A. A. D., Amodeo C., Turatti L. A. A., Bregman R., Sanches F. C. C., Canani L. H., Chacra A. R., Borges J. L. C., Vencio S. A. C., Franco R. J. D. S., d'Avila D., Portes E. D. S., de Souza P., Deboni L. M., Fraige Filho F., Neto B. G., Gomes M., Kohara S. K., Keitel E., Saraiva J. F. K., Lisboa H. R. K., Contieri F. L. D. 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- 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 100mg/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=0.3for 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=0.8for 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, t
- Published
- 2023