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2. Combination Treatment with Verinurad and Allopurinol in CKD: A Randomized Placebo and Active Controlled Trial

Author

Heerspink, Hiddo J.L., Stack, Austin G., Terkeltaub, Robert, Jongs, Niels, Inker, Lesley A., Bjursell, Magnus, Maklad, Noha, Perl, Shira, Eklund, Olof, Rikte, Tord, Sjöström, C. David, Perkovic, Vlado, Chmelickova, Hana, Lukac, Martin, Bucek, Petr, Drasnar, Tomas, Dussol, Bertrand, Guerrot, Dominique, Legrand, Eric, Boffa, Jean-Jacques, Halimi, Jean-Michel, Zaoui, Philippe, Letoha, Annamaria, Hajdu, Csaba, Pall, Denes, Peterfai, Eva, Csécsei, Gyöngyi, Bezzegh, Katalin, Deak, Laszlo, Konyves, Laszlo, Zsom, Marianna, Danos, Peter, Vangel, Sandor, Vasas, Szilard, Oroszlan, Tamas, Zilahi, Zsolt, Leiba, Adi, Grossman, Alon, Leibowitz, Avshalom, Itzhak, Baruch, Daoud, Deeb, Farber, Evgeny, Adawi, Faiad, Nakhoul, Farid M., Chernin, Gil, Kenis, Irina, Wainstein, Julio, Zeller, Lior, Elias, Mazen, Atar, Shaul, Frajewicki, Victor, Yagil, Yoram, Armaly, Zaher A., Esposito, Ciro, Viazzi, Francesca, Gambaro, Giovanni, Piatti, Piermarco, Bonadonna, Riccardo C., Arias Delgadillo, Cristhian Ronaldt, Flores, Fernando Jimenez, Aguilera Real, Manuel Enrique, Fajardo-Campos, Pedro, Violante Ortiz, Rafael Margarito, Luna Ceballos, Rosa Isela, Duran-Barragan, Sergio, Zytkiewicz-Jaruga, Danuta, Krzyzagorska, Ewa, Skokowska, Ewa, Klodawska, Katarzyna, Mordaka, Robert, Mazur, Stanislaw, Stasinska, Teresa, Sulowicz, Wladyslaw, Constantin, Ciprian, Negru, Doru, Paveliu, Fraga-Silvia, Negrisanu, Gabriela Doina, Szilagyi, Iosif, Busegeanu, Mihaela Magdalena G., Pena, Mihai Cosmin, Avram, Rodica Ioana, Ardelean, Silvia Luminita, Ilavska, Adriana, Dzupina, Andrej, Oroszova, Aniko, Kolesarova, Eva, Obetkova, Ida, Smatanova, Iveta, Babikova, Jana, Fulop, Peter, Haffner, Radovan, Rayner, Brian L., Kruger, Dawid Stephanus, Urbach, Dorothea Vera, Mitha, Essack, Vally Mahomed Latiff, Gulam Hoosain, Makan, Hemant, du Plessis, Hermanus, Jurgens, Jaco Cornelius, Reddy, Jeevren, Trokis, Julien S., McHarry, Kirsten, Distiller, Lawrence Allen, Mayet, Leila, Burgess, Lesley Jean, Van Zyl, Louis Johan, Joshi, Mukesh P., Sebastian, Peter John, Du Toit, Samantha Maria, Blignaut, Suzanne C., Serrano, Antonio Galan, Morales, Cristobal, Poch, Esteban, Mosquera, Eva Marquez, Castro, Fernando Cereto, Gonzalez Martinez, Francisco Javier, Perez- Contreras, Francisco Javier, Fernandez-Fresnedo, Gema, Garcia Mendez, Isabel Fuencisla, Perez, Jonay Pantoja, Martinez, Jordi Calabia, Gorriz Teruel, Jose Luis, Nieto Iglesias, Luis Javier, Munoz-Torres, Manuel, Munar Vila, Maria Antonia, Arenas Jimenez, Maria Dolores, Dominguez-Lopez, Marta E., Val, Miguel Hueso, Terrades, Natalia Ramos, Olmo, Rafael Santamaria, Malek Marin, Tamara Gelen, Arif, Ahmed A., Lee, Benjamin J., Mehta, Bhasker R., Baker, Bruce H., Jere, Charles S., Bains, David G., Stricklin, David G., Cheung, Deanna, Echeverri, Diego, Vera, Edgard, Heurich, Eva-Maria, Sterba, Gary A., Hernandez, German T., Paez, Henry E., Acosta, Idalia A., Ahmed, Intekhab, Sachmechi, Issac, Madu, Ivy-Joan E., Obhrai, Jagdeep Singh, Hammoud, Jamal A., Tumlin, James A., Cain, James, Moya-Hechevarria, Jaynier, Connaire, Jeffrey J., Haggiagi, Jehad, Odren, Jennifer A., Bellucci-Jackson, Jennifer M., Yan, Jieshi, Parker, John C., Tolins, Jonathan P., Gomez-Cortes, Jose D., Cardona, Jose F., Mandry, Jose M., Olivero, Juan Jorge, Hendon, Kendra S., Kaveh, Kianoosh, Kooienga, Laura A., Bermudez, Lidia R., Rich, Lisa M., Gold, Marina, Gonzalez, Marisela, Schaefer, Matthew E., Welch, Michelle, Moustafa, Moustafa A., Mussaji, Murtaza, Pergola, Pablo E., Phaosawasdi, Piangwarin, Silva, Ricardo A., Presas, Ricardo, Lynn, Robert I., Kronfli, Saeed J., Ventrapragada, Sailaja V., Niranjan, Sankar N., Husain, Sayed, Satko, Scott, Jabbour, Serge A., Rovner, Sergio F., Gouge, Steven F., Joshi, Sudhir S., Ramachandran Subramanian, Varagur Bala, Lane, Wendy, Calhoun, Wesley, and Durham, William

Published
2024
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7. A pre-specified analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial on the incidence of abrupt declines in kidney function

Author

Heerspink, Hiddo J.L., Wheeler, David C., Chertow, Glenn, Correa-Rotter, Ricardo, Greene, Tom, Hou, Fan Fan, McMurray, John, Rossing, Peter, Toto, Robert, Stefansson, Bergur, Langkilde, Anna Maria, Maffei, L.E., Raffaele, P., Solis, S.E., Arias, C.A., Aizenberg, D., Luquez, C., Zaidman, C., Cluigt, N., Mayer, M., Alvarisqueta, A., Wassermann, A., Maldonado, R., Bittar, J., Maurich, M., Gaite, L.E., Garcia, N., Sivak, L., Ramallo, P.O., Santos, J.C., Garcia Duran, R., Oddino, J.A., Maranon, A., Maia, L.N., Avila, D.D., Barros, E.J.G., Vidotti, M.H., Panarotto, D., Noronha, I.D.L., Turatti, L.A.A., Deboni, L., Canziani, M.E., Riella, M.C., Bacci, M.R., Paschoalin, R.P., Franco, R.J., Goldani, J.C., St-Amour, E., Steele, A.W., Goldenberg, R., Pandeya, S., Bajaj, H., Cherney, D., Kaiser, S.M., Conway, J.R., Chow, S.S., Bailey, G., Lafrance, J., Winterstein, J., Cournoyer, S., Gaudet, D., Madore, F., Houlden, R.L., Dowell, A., Langlois, M., Muirhead, N., Khandwala, H., Levin, A., Hou, F., Xue, Y., Zuo, L., Hao, C., Ni, Z., Xing, C., Chen, N., Dong, Y., Zhou, R., Xiao, X., Zou, Y., Wang, C., Liu, B., Chen, Q., Lin, M., Luo, Q., Zhang, D., Wang, J., Chen, M., Wang, X., Zhong, A., Dong, J., Zhu, C., Yan, T., Luo, P., Ren, Y., Pai, P., Li, D., Zhang, R., Zhang, J., Xu, M., Zhuang, Y., Kong, Y., Yao, X., Peng, X., Persson, F.I., Hansen, T.K., Borg, R., Pedersen Bjergaard, U., Hansen, D., Hornum, M., Haller, H., Klausmann, G., Tschope, D., Kruger, T., Gross, P., Hugo, C., Obermuller, N., Rose, L., Mertens, P., Zeller-Stefan, H., Fritsche, A., Renders, L., Muller, J., Budde, K., Schroppel, B., Wittmann, I., Voros, P., Dudas, M., Tabak, G.A., Kirschner, R., Letoha, A., Balku, I., Hermanyi, Z., Zakar, G., Mezei, I., Nagy, G.G., Lippai, J., Nemeth, A., Khullar, D., Gowdaiah, P.K., Fernando Mervin, E., Rao, V.A., Dewan, D., Goplani, K., Maddi, V.S.K., Vyawahare, M.S., Pulichikkat, R.K., Pandey, R., Sonkar, S.K., Gupta, V.K., Agarwal, S., Asirvatham, A.J., Ignatius, A., Chaubey, S., Melemadathil, S., Alva, H., Kadam, Y., Shimizu, H., Sueyoshi, A., Takeoka, H., Abe, Y., Imai, T., Onishi, Y., Fujita, Y., Tokita, Y., Oura, M., Makita, Y., Idogaki, A., Koyama, R., Kikuchi, H., Kashihara, N., Hayashi, T., Ando, Y., Tanaka, T., Shimizu, M., Hidaka, S., Gohda, T., Tamura, K., Abe, M., Kamijo, Y., Imasawa, T., Takahashi, Y., Nakayama, M., Tomita, M., Hirano, F., Fukushima, Y., Kiyosue, A., Kurioka, S., Imai, E., Kitagawa, K., Waki, M., Wada, J., Uehara, K., Iwatani, H., Ota, K., Shibazaki, S., Katayama, K., Narita, I., Iinuma, M., Matsueda, S., Sasaki, S., Yokochi, A., Tsukamoto, T., Yoshimura, T., Kang, S., Lee, S., Lim, C.S., Chin, H., Joo, K.W., Han, S.Y., Chang, T.I., Park, S., Park, H., Park, C.W., Han, B.G., Cha, D.R., Yoon, S.A., Kim, W., Kim, S.W., Ryu, D., Correa Rotter, R., Irizar Santana, S.S., Hernandez Llamas, G., Valdez Ortiz, R., Secchi Nicolas, N.C., Gonzalez Galvez, G., Lazcano Soto, J.R., Bochicchio Riccardelli, T., Bayram Llamas, E.A., Ramos Ibarra, D.R., Melo, M.G.S., Gonzalez Gonzalez, J.G., Sanchez Mijangos, J.H., Madero Robalo, M., Garcia Castillo, A., Manrique, H.A., Farfan, J.C., Vargas, R., Valdivia, A., Dextre, A., Escudero, E., Calderon Ticona, J.R., Gonzales, L., Villena, J., Leon, L., Molina, G., Saavedra, A., Garrido, E., Arbanil, H., Vargas Marquez, S., Rodriguez, J., Isidto, R., Villaflor, A.J., Gumba, M.A., Tirador, L., Comia, R.S., Sy, R.A., Guanzon, M.L.V.V., Aquitania, G., De Asis, N.C., Silva, A.A., Romero, C.M., Lim, M.E., Danguilan, R.A., Nowicki, M., Rudzki, H., Landa, K., Kucharczyk-Bauman, I., Gogola-Migdal, B., Golski, M., Olech-Cudzik, A., Stompor, T., Szczepanik, T., Miklaszewicz, B., Sciborski, R., Kuzniewski, M., Ciechanowski, K., Wronska, D., Klatko, W., Mazur, S., Popenda, G., Myslicki, M., Bolieva, L.Z., Berns, S., Galyavich, A., Abissova, T., Karpova, I., Platonov, D., Koziolova, N., Kvitkova, L., Nilk, R., Medina, T., Rebrov, A., Rossovskaya, M., Sinitsina, I., Vishneva, E., Zagidullin, N., Novikova, T., Krasnopeeva, N., Magnitskaya, O., Antropenko, N., Batiushin, M., Escudero Quesada, V., Barrios Barrea, C., Espinel Garauz, E., Cruzado Garrit, J.M., Morales Portillo, C., Gorriz Teruel, J.L., Cigarran Guldris, S., Praga Terente, M., Robles Perez-Monteoliva, N.R., Tinahones Madueno, F.J., Soto Gonzalez, A., Diaz Rodriguez, C., Furuland, H., Saeed, A., Dreja, K., Spaak, J., Bruchfeld, A., Kolesnyk, M., Levchenko, O., Pyvovarova, N., Stus, V., Doretskyy, V., Korobova, N., Horoshko, O., Katerenchuk, I., Mostovoy, Y.M., Orynchak, M., Legun, O., Dudar, I., Bilchenko, O., Andreychyn, S., Levchenko, A., Zub, L., Tereshchenko, N., Topchii, I., Ostapenko, T., Bezuglova, S., Kopytsya, M., Turenko, O., Mark, P., Barratt, J., Bhandari, S., Fraser, D., Kalra, P., Kon, S.P., Mccafferty, K., Mikhail, A., Alvarado, O.P., Anderson, R., Andrawis, N.S., Arif, A., Benjamin, S.A., Bueso, G., Busch, R.S., Carr, K.W., Crawford, P., Daboul, N., De La Calle, G.M., Delgado, B., Earl, J., El-Shahawy, M.A., Graf, R.J., Greenwood, G., Guevara, A., Wendland, E.M., Mayfield, R.K., Montero, M., Morin, D.J., Narayan, P., Numrungroad, V., Reddy, A.C., Reddy, R., Samson, M.B., Trejo, R., Butcher, M.B., Wise, J.K., Zemel, L.R., Raikhel, M., Weinstein, D., Hernandez, P., Wynne, A., Khan, B.V., Sterba, G.A., Jamal, A., Ross, D., Rovner, S.F., Tan, A., Ovalle, F., Patel, R.J., Talano, J., Patel, D.R., Burgner, A., Aslam, N., Elliott, M., Goral, S., Jovanovich, A., Manley, J.A., Umanath, K., Waguespack, D., Weiner, D., Yu, M., Schneider, L., Jalal, D., Le, T., Nguyen, N., Nguyen, H., Nguyen, D., Nguyen, V., Do, T., Chu, P., Ta, D., Tran, N., Pham, B., Pfeffer, Marc A., Pocock, Stuart, Swedberg, Karl, Rouleau, Jean L., Chaturvedi, Nishi, Ivanovich, Peter, Levey, Andrew S., Christ-Schmidt, Heidi, Held, Claes, Christersson, Christina, Mann, Johannes, Varenhorst, Christoph, Cherney, David, Postmus, Douwe, Stefánsson, Bergur V., Chertow, Glenn M., Dwyer, Jamie P., Kosiborod, Mikhail, McMurray, John J.V., Sjöström, C. David, and Toto, Robert D.

Published
2022
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8. The long-term effects of dapagliflozin in chronic kidney disease: a time-to-event analysis

Author

McEwan, Phil, primary, Gabb, Peter D, additional, Davis, Jason A, additional, Sanchez, Juan Jose Garcia, additional, Sjöström, C David, additional, Barone, Salvatore, additional, Kashioulis, Pavlos, additional, Ouwens, Mario, additional, Cassimaty, Syd, additional, Correa-Rotter, Ricardo, additional, Rossing, Peter, additional, Wheeler, David C, additional, and Heerspink, Hiddo J L, additional

Published
2024
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12. A pre-specified analysis of the DAPA-CKD trial demonstrates the effects of dapagliflozin on major adverse kidney events in patients with IgA nephropathy

Author

Wheeler, David C., Toto, Robert D., Stefánsson, Bergur V., Jongs, Niels, Chertow, Glenn M., Greene, Tom, Hou, Fan Fan, McMurray, John J.V., Pecoits-Filho, Roberto, Correa-Rotter, Ricardo, Rossing, Peter, Sjöström, C. David, Umanath, Kausik, Langkilde, Anna Maria, and Heerspink, Hiddo J.L.

Published
2021
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16. Parallel Narratives: Trauma, Relationality, and Dissociation in Psychoanalysis and Realist Fiction.

Author

Becker, Mona and Sjöström, C. Christina

Subjects
PSYCHOANALYSIS, POSTCOLONIAL literature, AUTHORSHIP
Abstract

The reciprocal relationship between cultural trauma studies and psychoanalytic discourse on the one hand, and trauma studies and fictional representations of trauma on the other, has been commented on by scholars within the field of literary studies. What connects the representation of trauma in cultural trauma theory, trauma fiction, and psychoanalysis is that it is regarded as something that overwhelms an individual's capacities for processing and functioning. However, while cultural trauma theory has come under scrutiny for prioritizing too narrow a view of trauma and its representations, the considerable critiques of and revisions to Freud's theories, developed in the 1980/90s, have been mostly ignored by cultural trauma theorists. In this interdisciplinary article, we draw on relational psychoanalytic perspectives to demonstrate how relational revisions to psychoanalytic theory and techniques, as well as views on dissociation, can offer new perspectives for approaching literary works of fiction, such as the realist novel, which engage with the subject of trauma outside of established trauma conventions. We demonstrate that trauma novels by Lisa Appignanesi and Aminatta Forna parallel these revisions to psychoanalytic theory and techniques, allowing for a more pluralistic and nuanced representation of responses to trauma and suffering. [ABSTRACT FROM AUTHOR]

Published
2024
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20. Mitochondrial metabolites predict adverse cardiovascular events in individuals with diabetes

Author

Regan, Jessica A., primary, Mentz, Robert J., additional, Nguyen, Maggie, additional, Green, Jennifer B., additional, Truby, Lauren K., additional, Ilkayeva, Olga, additional, Newgard, Christopher B., additional, Buse, John B., additional, Sourij, Harald, additional, Sjöström, C. David, additional, Sattar, Naveed, additional, McGarrah, Robert W., additional, Zheng, Yinggan, additional, McGuire, Darren K., additional, Standl, Eberhard, additional, Armstrong, Paul, additional, Peterson, Eric D., additional, Hernandez, Adrian F., additional, Holman, Rury R., additional, and Shah, Svati H., additional

Published
2023
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24. Extrapolated longer-term effects of the DAPA-CKD trial:a modelling analysis

Author

McEwan, Phil, Boyce, Rebecca, Sanchez, Juan Jose Garcia, Sjöström, C. David, Stefansson, Bergur, Nolan, Stephen, Correa-Rotter, Ricardo, Rossing, Peter, Chertow, Glenn M., McMurray, John J. V., Wheeler, David C., Heerspink, Hiddo J. L., McEwan, Phil, Boyce, Rebecca, Sanchez, Juan Jose Garcia, Sjöström, C. David, Stefansson, Bergur, Nolan, Stephen, Correa-Rotter, Ricardo, Rossing, Peter, Chertow, Glenn M., McMurray, John J. V., Wheeler, David C., and Heerspink, Hiddo J. L.

Abstract

Background The Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial assessed dapagliflozin versus placebo, in addition to standard therapy, in patients with chronic kidney disease (CKD) and albuminuria, and was terminated prematurely due to overwhelming efficacy. The study objective was to model the long-term clinical outcomes of DAPA-CKD beyond the trial follow-up. Methods A Markov model extrapolated event incidence per 1000 patients and CKD progression rates for patients receiving dapagliflozin or placebo over a 10-year time horizon. We derived treatment-specific CKD stage transition matrices using DAPA-CKD trial data. We extrapolated relevant efficacy endpoints using parametric survival equations for all-cause mortality and generalized estimating equations for recurrent events. Results When extrapolated over a 10-year period, patients randomized to dapagliflozin spent more time in CKD stages 1-3 and less in stages 4-5 than placebo [0.65 (95% CrI 0.41, 0.90) and -0.23 (95% CrI -0.45, 0.00) years per patient, respectively]. Dapagliflozin prevented an estimated 83 deaths and 51 patients initiating kidney replacement therapy per 1000 patients over 10 years. Predicted rates of hospitalized heart failure and abrupt declines in kidney function were reduced (19 and 39 estimated events per 1000 patients, respectively). Conclusions Adding dapagliflozin to standard therapeutic management of CKD is expected to have long-term cardiorenal benefit beyond what has been demonstrated in the DAPA-CKD trial, with patients predicted to live longer with fewer complications.

Published
2023

25. Efficacy of Dapagliflozin by Baseline Diabetes Medications:A Prespecified Analysis From the DAPA-CKD Study

Author

Beernink, Jelle M., Persson, Frederik, Jongs, Niels, Laverman, Gozewijn D., Chertow, Glenn M., McMurray, John J.V., Langkilde, Anna Maria, Correa-Rotter, Ricardo, Rossing, Peter, Sjöström, C. David, Toto, Robert D., Wheeler, David C., Heerspink, Hiddo J.L., Beernink, Jelle M., Persson, Frederik, Jongs, Niels, Laverman, Gozewijn D., Chertow, Glenn M., McMurray, John J.V., Langkilde, Anna Maria, Correa-Rotter, Ricardo, Rossing, Peter, Sjöström, C. David, Toto, Robert D., Wheeler, David C., and Heerspink, Hiddo J.L.

Abstract

OBJECTIVE To determine whether the benefits of dapagliflozin in patients with type 2 diabetes and chronic kidney disease (CKD) in the Dapagliflozin And Prevention of Adverse Outcomes in CKD trial (DAPA-CKD) varied by background glucose-lowering therapy (GLT). RESEARCH DESIGN AND METHODS We randomized 4,304 adults (including 2,906 with type 2 diabetes) with a baseline estimated glomerular filtration rate (eGFR) 25–75 mL/min/1.73 m2 and uri-nary albumin-to-creatinine ratio of 200–5,000 mg/g to dapagliflozin 10 mg or placebo once daily (NCT03036150). The primary end point was a composite of ‡50% eGFR decline, end-stage kidney disease, and kidney or cardiovascular cause of death. Secondary end points included a kidney composite end point (primary composite end point without cardiovascular death), a cardiovascular composite end point (hospitalized heart failure or cardiovascular death), and all-cause mor-tality. In this prespecified analysis, we investigated the effects of dapagliflozin on these and other outcomes according to baseline GLT class or number of GLTs. RESULTS The effects of dapagliflozin on the primary composite outcome were consistent across GLT classes and according to the number of GLTs (all interaction P > 0.08). Similarly, we found consistent benefit of dapagliflozin compared with placebo on the secondary end points regardless of background GLT class or number of GLTs. The same applied to the rate of decline in the eGFR rate and safety end points. Dapagliflozin reduced the initiation of insulin therapy during follow-up compared with placebo (hazard ratio 0.72; 95% CI 0.54–0.96; P = 0.025). CONCLUSIONS Dapagliflozin reduced kidney and cardiovascular events in patients with type 2 diabetes and CKD across baseline GLT class or classes in combination.

Published
2023

26. Effects of Dapagliflozin on Hospitalizations in Patients With Chronic Kidney Disease:A Post Hoc Analysis of DAPA-CKD

Author

Schechter, Meir, Jongs, Niels, Chertow, Glenn M., Mosenzon, Ofri, McMurray, John J.V., Correa-Rotter, Ricardo, Rossing, Peter, Langkilde, Anna Maria, Sjöström, C. David, Toto, Robert D., Wheeler, David C., Heerspink, Hiddo J.L., Schechter, Meir, Jongs, Niels, Chertow, Glenn M., Mosenzon, Ofri, McMurray, John J.V., Correa-Rotter, Ricardo, Rossing, Peter, Langkilde, Anna Maria, Sjöström, C. David, Toto, Robert D., Wheeler, David C., and Heerspink, Hiddo J.L.

Abstract

BACKGROUND: Acute hospitalizations are common in patients with chronic kidney disease (CKD) and often lead to decreases in health-related quality of life and increased care costs. OBJECTIVE: To determine the effects of dapagliflozin on first hospitalizations and all (first and subsequent) hospitalizations and to explore effects on cause-specific hospitalizations. DESIGN: Post hoc analysis of a randomized, double-blind, placebo-controlled clinical trial. (ClinicalTrials.gov: NCT03036150). SETTING: 386 ambulatory practice sites in 21 countries from 2 February 2017 through 12 June 2020. PARTICIPANTS: Adults with an estimated glomerular filtration rate of 25 to 75 mL/min/1.73 m2 and a urinary albumin-creatinine ratio of 200 to 5000 mg/g, with and without type 2 diabetes. INTERVENTION: Dapagliflozin, 10 mg once daily, or matching placebo (1:1 ratio). MEASUREMENTS: The effects of dapagliflozin on first hospitalizations for any cause, all hospitalizations, and cause-specific (first and recurrent) hospitalizations were determined. The reported system organ class was used to evaluate reasons for admission. Hospitalizations were analyzed using Cox proportional hazards regression models (first hospitalization), the Lin-Wei-Yang-Ying method (all hospitalizations or death), and negative binomial models (cause-specific hospitalizations). RESULTS: The study included 4304 patients (mean age, 61.8 years; 33.1% women). During a median follow-up of 2.4 years, 2072 hospitalizations were reported among 1224 (28.4%) participants. Compared with placebo, dapagliflozin reduced risk for a first hospitalization (hazard ratio, 0.84 [95% CI, 0.75 to 0.94]) and all hospitalizations or death (rate ratio, 0.79 [CI, 0.70 to 0.89]). There was no evidence that the effects of dapagliflozin on first and all hospitalizations varied by baseline presence of type 2 diabetes (P for interaction = 0.60 for each). Compared with placebo, dapagliflozin reduced the rate of admissions due to cardiac disorders

Published
2023

27. Effects of exenatide and open-label SGLT2 inhibitor treatment, given in parallel or sequentially, on mortality and cardiovascular and renal outcomes in type 2 diabetes: insights from the EXSCEL trial

Author

Clegg, Lindsay E., Penland, Robert C., Bachina, Srinivas, Boulton, David W., Thuresson, Marcus, Heerspink, Hiddo J. L., Gustavson, Stephanie, Sjöström, C. David, Ruggles, James A., Hernandez, Adrian F., Buse, John B., Mentz, Robert J., and Holman, Rury R.

Published
2019
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28. Albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes: a randomized cross‐over clinical study

Author

van der Aart ‐ van der Beek, Annemarie B, primary, Apperloo, Ellen, additional, Jongs, Niels, additional, Rouw, Dennis B, additional, Sjöström, C David, additional, Friedli, Iris, additional, Johansson, Lars, additional, van Raalte, Daniël H, additional, Hoogenberg, Klaas, additional, and Heerspink, Hiddo JL, additional

Published
2023
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29. Efficacy of Dapagliflozin by Baseline Diabetes Medications: A Prespecified Analysis From the DAPA-CKD Study

Author

Beernink, Jelle M., primary, Persson, Frederik, additional, Jongs, Niels, additional, Laverman, Gozewijn D., additional, Chertow, Glenn M., additional, McMurray, John J.V., additional, Langkilde, Anna Maria, additional, Correa-Rotter, Ricardo, additional, Rossing, Peter, additional, Sjöström, C. David, additional, Toto, Robert D., additional, Wheeler, David C., additional, and Heerspink, Hiddo J.L., additional

Published
2023
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30. Effects of Dapagliflozin on Hospitalizations in Patients With Chronic Kidney Disease

Author

Schechter, Meir, primary, Jongs, Niels, additional, Chertow, Glenn M., additional, Mosenzon, Ofri, additional, McMurray, John J.V., additional, Correa-Rotter, Ricardo, additional, Rossing, Peter, additional, Langkilde, Anna Maria, additional, Sjöström, C. David, additional, Toto, Robert D., additional, Wheeler, David C., additional, and Heerspink, Hiddo J.L., additional

Published
2023
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31. Safety and efficacy of dapagliflozin in patients with focal segmental glomerulosclerosis: a prespecified analysis of the DAPA-CKD trial

Author

Wheeler, David C, Jongs, Niels, Stefansson, Bergur V, Chertow, Glenn M, Greene, Tom, Hou, Fan Fan, Langkilde, Anna Maria, McMurray, John J.V., Rossing, Peter, Nowicki, Michal, Wittmann, István, Correa-Rotter, Ricardo, Sjöström, C David, Toto, Robert D, Heerspink, Hiddo J L, Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), and Groningen Kidney Center (GKC)

Abstract

Background: \ud Despite renin-angiotensin-aldosterone-system blockade and immunosuppressive treatment, focal segmental glomerulosclerosis (FSGS) often progresses to kidney failure. The objective of this pre-specified analysis of DAPA-CKD was to assess efficacy and safety of dapagliflozin in a small subgroup participants with FSGS confirmed by kidney biopsy.\ud \ud Methods: \ud In DAPA-CKD, patients with estimated glomerular filtration rate (eGFR) 25–75 mL/min/1.73m2 and urinary albumin-to-creatinine ratio (UACR) 200–5000 mg/g (22.6–565 mg/mol) were randomised to dapagliflozin 10mg once-daily or placebo as an adjunct to standard care, and followed for median 2.4 years. The primary composite endpoint was sustained eGFR decline ≥ 50%, end-stage kidney disease (ESKD), or kidney or cardiovascular death. The endpoint of interest for this analysis was eGFR slope (acute effects from baseline to Week 2 and chronic effects from Week 2 to end of treatment).\ud \ud Results: \ud Of 104 participants with biopsy-confirmed FSGS, 45 were randomised to dapagliflozin and 59 to placebo. Mean (SD) age was 54.0 (14.3) years, mean eGFR 41.9 (11.5) mL/min/1.73m2 and median (IQR) UACR 1248 (749–2211) mg/g. The primary outcome occurred in 4 (8.9%) and 7 (11.9%) participants randomised to dapagliflozin and placebo, respectively (HR 0.62, 95%CI 0.17–2.17). Dapagliflozin led to a larger acute reduction (SE) in eGFR compared to placebo (−4.5 [95% CI − 5.9-−3.1] vs − 0.9 [−2.1–0.4] mL/min/1.73m2 per 2 wks). Thereafter, mean rates of chronic eGFR decline with dapagliflozin and placebo were − 1.9 (−3.0-−0.9) and − 4.0 (−4.9-−3.0) mL/min/1.73m2/year, respectively (difference 2.0 [95%CI 0.6–3.5] mL/min/1.73m2/year). Adverse events leading to study drug discontinuation were similar in both groups; there were fewer serious adverse events with dapagliflozin.\ud \ud Conclusion: \ud Among DAPA-CKD participants with FSGS, dapagliflozin reduced the rate of chronic decline of eGFR compared to placebo, although this difference was not statistically significant.

Published
2022

33. Correlates and Consequences of an Acute Change in eGFR in Response to the SGLT2 Inhibitor Dapagliflozin in Patients with CKD

Author

Jongs, Niels, primary, Chertow, Glenn M., additional, Greene, Tom, additional, McMurray, John J.V., additional, Langkilde, Anna Maria, additional, Correa-Rotter, Ricardo, additional, Kashihara, Naoki, additional, Rossing, Peter, additional, Sjöström, C. David, additional, Stefánsson, Bergur V., additional, Toto, Robert D., additional, Wheeler, David C., additional, and Heerspink, Hiddo J.L., additional

Published
2022
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34. Extrapolated longer-term effects of the DAPA-CKD trial: a modelling analysis

Author

McEwan, Phil, primary, Boyce, Rebecca, additional, Sanchez, Juan Jose Garcia, additional, Sjöström, C David, additional, Stefansson, Bergur, additional, Nolan, Stephen, additional, Correa-Rotter, Ricardo, additional, Rossing, Peter, additional, Chertow, Glenn M, additional, McMurray, John J V, additional, Wheeler, David C, additional, and Heerspink, Hiddo J L, additional

Published
2022
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36. Once-Weekly Exenatide in Youth With Type 2 Diabetes

Author

Tamborlane, William V., primary, Bishai, Raafat, additional, Geller, David, additional, Shehadeh, Naim, additional, Al-Abdulrazzaq, Dalia, additional, Vazquez, Evelina Mánica, additional, Karoly, Eva, additional, Troja, Tünde, additional, Doehring, Orlando, additional, Carter, Debra, additional, Monyak, John, additional, and Sjöström, C. David, additional

Published
2022
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37. Effects of dapagliflozin on prevention of major clinical events and recovery in patients with respiratory failure because of COVID‐19: Design and rationale for the DARE‐19 study

Author

Kosiborod, Mikhail, Berwanger, Otavio, Koch, Gary G., Martinez, Felipe, Mukhtar, Omar, Verma, Subodh, Chopra, Vijay, Javaheri, Ali, Ambery, Philip, Gasparyan, Samvel B., Buenconsejo, Joan, Sjöström, C. David, Langkilde, Anna Maria, Oscarsson, Jan, and Esterline, Russell

Subjects
Comorbidity, Double-Blind Method, Glucosides, Cause of Death, randomized trial, Clinical Trial Design, Humans, Multicenter Studies as Topic, Benzhydryl Compounds, Mortality, Renal Insufficiency, Chronic, Sodium-Glucose Transporter 2 Inhibitors, Randomized Controlled Trials as Topic, Heart Failure, SARS-CoV-2, COVID-19, Cardiometabolic Risk Factors, clinical trial, SGLT2 inhibitor, dapagliflozin, Atherosclerosis, phase III study, COVID-19 Drug Treatment, Treatment Outcome, Diabetes Mellitus, Type 2, Cardiovascular Diseases, Hypertension, Disease Progression, Kidney Diseases, Respiratory Insufficiency
Abstract

Aims Coronavirus disease 2019 (COVID‐19) is caused by a novel severe acute respiratory syndrome coronavirus 2. It can lead to multiorgan failure, including respiratory and cardiovascular decompensation, and kidney injury, with significant associated morbidity and mortality, particularly in patients with underlying metabolic, cardiovascular, respiratory or kidney disease. Dapagliflozin, a sodium‐glucose cotransporter‐2 inhibitor, has shown significant cardio‐ and renoprotective benefits in patients with type 2 diabetes (with and without atherosclerotic cardiovascular disease), heart failure and chronic kidney disease, and may provide similar organ protection in high‐risk patients with COVID‐19. Materials and methods DARE‐19 (NCT04350593) is an investigator‐initiated, collaborative, international, multicentre, randomized, double‐blind, placebo‐controlled study testing the dual hypotheses that dapagliflozin can reduce the incidence of cardiovascular, kidney and/or respiratory complications or all‐cause mortality, or improve clinical recovery, in adult patients hospitalized with COVID‐19 but not critically ill on admission. Eligible patients will have ≥1 cardiometabolic risk factor for COVID‐19 complications. Patients will be randomized 1:1 to dapagliflozin 10 mg or placebo. Primary efficacy endpoints are time to development of new or worsened organ dysfunction during index hospitalization, or all‐cause mortality, and the hierarchical composite endpoint of change in clinical status through day 30 of treatment. Safety of dapagliflozin in individuals with COVID‐19 will be assessed. Conclusions DARE‐19 will evaluate whether dapagliflozin can prevent COVID‐19‐related complications and all‐cause mortality, or improve clinical recovery, and assess the safety profile of dapagliflozin in this patient population. Currently, DARE‐19 is the first large randomized controlled trial investigating use of sodium‐glucose cotransporter 2 inhibitors in patients with COVID‐19.

Published
2021

38. A pre-specified analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial on the incidence of abrupt declines in kidney function

Author

Heerspink, Hiddo J L, Cherney, David, Postmus, Douwe, Stefánsson, Bergur V, Chertow, Glenn M, Dwyer, Jamie P, Greene, Tom, Kosiborod, Mikhail, Langkilde, Anna Maria, McMurray, John J V, Correa-Rotter, Ricardo, Rossing, Peter, Sjöström, C David, Toto, Robert D, Wheeler, David C, Christersson, Christina, Held, Claes, Heerspink, Hiddo J L, Cherney, David, Postmus, Douwe, Stefánsson, Bergur V, Chertow, Glenn M, Dwyer, Jamie P, Greene, Tom, Kosiborod, Mikhail, Langkilde, Anna Maria, McMurray, John J V, Correa-Rotter, Ricardo, Rossing, Peter, Sjöström, C David, Toto, Robert D, Wheeler, David C, Christersson, Christina, and Held, Claes

Abstract

This pre-specified analysis of DAPA-CKD assessed the impact of sodium-glucose cotransporter 2 inhibition on abrupt declines in kidney function in high-risk patients based on having chronic kidney disease (CKD) and substantial albuminuria. DAPA-CKD was a randomized, double-blind, placebo-controlled trial that had a median follow-up of 2.4 years. Adults with CKD (urinary albumin-to-creatinine ratio 200-5000 mg/g and estimated glomerular filtration rate 25-75 mL/min/1.73m2) were randomized to dapagliflozin 10 mg/day matched to placebo (2152 individuals each). An abrupt decline in kidney function was defined as a pre-specified endpoint of doubling of serum creatinine between two subsequent study visits. We also assessed a post-hoc analysis of investigator-reported acute kidney injury-related serious adverse events. Doubling of serum creatinine between two subsequent visits (median time-interval 100 days) occurred in 63 (2.9%) and 91 (4.2%) participants in the dapagliflozin and placebo groups, respectively (hazard ratio 0.68 [95% confidence interval 0.49, 0.94]). Accounting for the competing risk of mortality did not alter our findings. There was no heterogeneity in the effect of dapagliflozin on abrupt declines in kidney function based on baseline subgroups. Acute kidney injury-related serious adverse events were not significantly different and occurred in 52 (2.5%) and 69 (3.2%) participants in the dapagliflozin and placebo groups, respectively (0.77 [0.54, 1.10]). Thus, in patients with CKD and substantial albuminuria, dapagliflozin reduced the risk of abrupt declines in kidney function., HJLH and DC are co-primary authors. The DAPA-CKD Trial Committees and Investigators are listed in the Appendix.

Published
2022
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39. Quételet (body mass) index and effects of dapagliflozin in chronic kidney disease

Author

Chertow, Glenn M., Vart, Priya, Jongs, Niels, Langkilde, Anna Maria, McMurray, John J.V., Correa-Rotter, Ricardo, Rossing, Peter, Sjöström, C. David, Stefansson, Bergur V., Toto, Robert D., Wheeler, David C., Heerspink, Hiddo J.L., Chertow, Glenn M., Vart, Priya, Jongs, Niels, Langkilde, Anna Maria, McMurray, John J.V., Correa-Rotter, Ricardo, Rossing, Peter, Sjöström, C. David, Stefansson, Bergur V., Toto, Robert D., Wheeler, David C., and Heerspink, Hiddo J.L.

Abstract

Aim: To assess the effects of dapagliflozin in patients with chronic kidney disease (CKD) and albuminuria, with and without type 2 diabetes, stratified by the Quételet (body mass) index (BMI). Methods: We randomized 4304 adult patients with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2 and urinary albumin-to-creatinine ratio of 200-5000 mg/g to dapagliflozin 10 mg/day or placebo. The primary outcome was a composite of sustained decline in eGFR of 50% or more, kidney failure, or death from kidney or cardiovascular causes. Secondary outcomes included kidney composite endpoint (primary composite endpoint without cardiovascular death), cardiovascular composite endpoint (hospitalized heart failure/ cardiovascular death), and all-cause mortality. We categorized participants according to World Health Organization BMI criteria: lean/ideal (<25 kg/m2), overweight (25-< 30 kg/m2), grade 1 obesity (30-<35 kg/m2), and grade 2/3 obesity (≥35 kg/m2). Results: Of 4296 (99.8%) randomized participants, 888 (20.7%), 1491 (34.7%), 1136 (26.4%), and 781 (18.2%) were categorized as lean/ideal, overweight, grade 1 obesity, and grade 2/3 obesity, respectively. Median follow-up was 2.4 years. Benefits of dapagliflozin were observed independent of baseline BMI for primary and secondary endpoints. Hazard ratios (95% CI) for dapagliflozin versus placebo for the primary composite endpoint were 0.60 (0.43, 0.85), 0.55 (0.40, 0.75), 0.71 (0.49, 1.04), and 0.57 (0.37, 0.87) among participants in the lean/ideal, overweight, grade 1 obesity, and grade 2/3 obesity groups (interaction P =.72). Conclusion: Among participants with CKD and albuminuria, with or without type 2 diabetes, kidney and cardiovascular benefits of dapagliflozin were evident and consistent across the BMI spectrum.

Published
2022

40. Effects of Dapagliflozin in People without Diabetes and with Microalbuminuria

Author

Heerspink, Hiddo J.L., Chertow, Glenn M., Jongs, Niels, Correa-Rotter, Ricardo, Rossing, Peter, Sjöström, C. David, Langkilde, Anna Maria, Wheeler, David C., Heerspink, Hiddo J.L., Chertow, Glenn M., Jongs, Niels, Correa-Rotter, Ricardo, Rossing, Peter, Sjöström, C. David, Langkilde, Anna Maria, and Wheeler, David C.

Published
2022

44. Extrapolated longer-term effects of the DAPA-CKD trial: a modelling analysis.

Author

McEwan, Phil, Boyce, Rebecca, Sanchez, Juan Jose Garcia, Sjöström, C David, Stefansson, Bergur, Nolan, Stephen, Correa-Rotter, Ricardo, Rossing, Peter, Chertow, Glenn M, McMurray, John J V, Wheeler, David C, and Heerspink, Hiddo J L

Subjects
RENAL replacement therapy, RECURRENT equations, GENERALIZED estimating equations, CHRONIC kidney failure, TERMINATION of treatment, PARAMETRIC equations
Abstract

Background The Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial assessed dapagliflozin versus placebo, in addition to standard therapy, in patients with chronic kidney disease (CKD) and albuminuria, and was terminated prematurely due to overwhelming efficacy. The study objective was to model the long-term clinical outcomes of DAPA-CKD beyond the trial follow-up. Methods A Markov model extrapolated event incidence per 1000 patients and CKD progression rates for patients receiving dapagliflozin or placebo over a 10-year time horizon. We derived treatment-specific CKD stage transition matrices using DAPA-CKD trial data. We extrapolated relevant efficacy endpoints using parametric survival equations for all-cause mortality and generalized estimating equations for recurrent events. Results When extrapolated over a 10-year period, patients randomized to dapagliflozin spent more time in CKD stages 1–3 and less in stages 4–5 than placebo [0.65 (95% CrI 0.41, 0.90) and –0.23 (95% CrI -0.45, 0.00) years per patient, respectively]. Dapagliflozin prevented an estimated 83 deaths and 51 patients initiating kidney replacement therapy per 1000 patients over 10 years. Predicted rates of hospitalized heart failure and abrupt declines in kidney function were reduced (19 and 39 estimated events per 1000 patients, respectively). Conclusions Adding dapagliflozin to standard therapeutic management of CKD is expected to have long-term cardiorenal benefit beyond what has been demonstrated in the DAPA-CKD trial, with patients predicted to live longer with fewer complications. [ABSTRACT FROM AUTHOR]

Published
2023
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46. Quételet (body mass) index and effects of dapagliflozin in chronic kidney disease

Author

Chertow, Glenn M., primary, Vart, Priya, additional, Jongs, Niels, additional, Langkilde, Anna Maria, additional, McMurray, John J. V., additional, Correa‐Rotter, Ricardo, additional, Rossing, Peter, additional, Sjöström, C. David, additional, Stefansson, Bergur V., additional, Toto, Robert D., additional, Wheeler, David C., additional, and Heerspink, Hiddo J. L., additional

Published
2022
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49. Effects of bariatric surgery on cancer incidence in obese patients in Sweden (Swedish Obese Subjects Study): a prospective, controlled intervention trial

Author

Sjöström, Lars, Gummesson, Anders, Sjöström, C David, Narbro, Kristina, Peltonen, Markku, Wedel, Hans, Bengtsson, Calle, Bouchard, Claude, Carlsson, Björn, Dahlgren, Sven, Jacobson, Peter, Karason, Kristjan, Karlsson, Jan, Larsson, Bo, Lindroos, Anna-Karin, Lönroth, Hans, Näslund, Ingmar, Olbers, Torsten, Stenlöf, Kaj, Torgerson, Jarl, and Carlsson, Lena MS

Published
2009
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