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168 results on '"Mosenzon, Ofri"'

1. Risk Assessment of Kidney Disease Progression and Efficacy of SGLT2 inhibition in Patients with Type 2 Diabetes

Author

Moura, Filipe A., primary, Berg, David D., primary, Bellavia, Andrea, primary, Dwyer, Jamie P., primary, Mosenzon, Ofri, primary, A. Scirica, Benjamin, primary, Wiviott, Stephen D., primary, Bhatt, Deepak L., primary, Raz, Itamar, primary, Feinberg, Mark W., primary, Braunwald, Eugene, primary, Morrow, David A., primary, and Sabatine, Marc S., primary

Published
2023
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2. Risk Assessment of Kidney Disease Progression and Efficacy of SGLT2 Inhibition in Patients With Type 2 Diabetes.

Author

Moura, Filipe A., Berg, David D., Bellavia, Andrea, Dwyer, Jamie P., Mosenzon, Ofri, Scirica, Benjamin M., Wiviott, Stephen D., Bhatt, Deepak L., Raz, Itamar, Feinberg, Mark W., Braunwald, Eugene, Morrow, David A., and Sabatine, Marc S.

Subjects
DISEASE risk factors, DAPAGLIFLOZIN, CANAGLIFLOZIN, TYPE 2 diabetes, DISEASE progression, CHRONIC kidney failure, SYSTOLIC blood pressure
Abstract

OBJECTIVE: To develop a risk assessment tool to identify patients with type 2 diabetes (T2D) at higher risk for kidney disease progression and who might benefit more from sodium–glucose cotransporter 2 (SGLT2) inhibition. RESEARCH DESIGN AND METHODS: A total of 41,204 patients with T2D from four Thrombolysis In Myocardial Infarction (TIMI) clinical trials were divided into derivation (70%) and validation cohorts (30%). Candidate predictors of kidney disease progression (composite of sustained ≥40% decline in estimated glomerular filtration rate [eGFR], end-stage kidney disease, or kidney death) were selected with multivariable Cox regression. Efficacy of dapagliflozin was assessed by risk categories (low: <0.5%; intermediate: 0.5 to <2%; high: ≥2%) in Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58. RESULTS: There were 695 events over a median follow-up of 2.4 years. The final model comprised eight independent predictors of kidney disease progression: atherosclerotic cardiovascular disease, heart failure, systolic blood pressure, T2D duration, glycated hemoglobin, eGFR, urine albumin-to-creatinine ratio, and hemoglobin. The c-indices were 0.798 (95% CI, 0.774–0.821) and 0.798 (95% CI, 0.765–0.831) in the derivation and validation cohort, respectively. The calibration plot slope (deciles of predicted vs. observed risk) was 0.98 (95% CI, 0.93–1.04) in the validation cohort. Whereas relative risk reductions with dapagliflozin did not differ across risk categories, there was greater absolute risk reduction in patients with higher baseline risk, with a 3.5% absolute risk reduction in kidney disease progression at 4 years in the highest risk group (≥1%/year). Results were similar with the 2022 Chronic Kidney Disease Prognosis Consortium risk prediction model. CONCLUSIONS: Risk models for kidney disease progression can be applied in patients with T2D to stratify risk and identify those who experience a greater magnitude of benefit from SGLT2 inhibition. [ABSTRACT FROM AUTHOR]

Published
2023
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3. Efficacy and Safety of Dapagliflozin by Baseline Insulin Regimen and Dose: Post Hoc Analyses From DECLARE-TIMI 58

Author

Pollack, Rena, primary, Raz, Itamar, additional, Wiviott, Stephen D., additional, Goodrich, Erica L., additional, Murphy, Sabina A., additional, Yanuv, Ilan, additional, Rozenberg, Aliza, additional, Mosenzon, Ofri, additional, Langkilde, Anna Maria, additional, Gause-Nilsson, Ingrid A.M., additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John P.H., additional, Sabatine, Marc S., additional, and Cahn, Avivit, additional

Published
2022
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4. Dapagliflozin and prevention of kidney disease among patients with type 2 diabetes– post hoc analyses from the DECLARE-TIMI 58 trial

Author

Mosenzon, Ofri, primary, Raz, Itamar, primary, Wiviott, Stephen D., primary, Schechter, Meir, primary, Goodrich, Erica L., primary, Yanuv, Ilan, primary, Rozenberg, Aliza, primary, Murphy, Sabina A., primary, Zelniker, Thomas A., primary, Langkilde, Anna Maria, primary, Gause-Nilsson, Ingrid A.M., primary, Fredriksson, Martin, primary, Johansson, Peter A., primary, Wilding, John P.H., primary, McGuire, Darren K., primary, Bhatt, Deepak L., primary, Leiter, Lawrence A., primary, Cahn, Avivit, primary, Dwyer, Jamie P., primary, Heerspink, Hiddo J.L., primary, and Sabatine, Marc S., primary

Published
2022
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7. Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes According to Baseline HbA1c and Insulin Use: An Analysis From the FIDELIO-DKD Study

Author

Rossing, Peter, primary, Burgess, Ellen, additional, Agarwal, Rajiv, additional, Anker, Stefan D., additional, Filippatos, Gerasimos, additional, Pitt, Bertram, additional, Ruilope, Luis M., additional, Gillard, Pieter, additional, MacIsaac, Richard J., additional, Wainstein, Julio, additional, Joseph, Amer, additional, Brinker, Meike, additional, Roessig, Lothar, additional, Scott, Charlie, additional, Bakris, George L., additional, Vallejos, Augusto, additional, MacIsaac, Richard, additional, Schernthaner, Guntram, additional, Canziani, Maria Eugenia F., additional, Temelkova-Kurktschiev, Theodora, additional, Tobe, Sheldon, additional, González, Fernando, additional, Liu, Zhi-Hong, additional, Ángelo, Andrés, additional, Bonfanti, Cadena, additional, Francisco Jaramillo, Carlos, additional, Prazny, Martin, additional, Rossing, Peter, additional, Strand, Jorma, additional, Marre, Michel, additional, Schmieder, Roland, additional, Wanner, Christoph, additional, Sarafidis, Pantelis A., additional, Chan, Juliana, additional, Rosivall, László, additional, Eustace, Joseph, additional, Grossman, Ehud, additional, Yagil, Yoram, additional, Remuzzi, Giuseppe, additional, Koya, Daisuke, additional, Wada, Takashi, additional, Madero Rovalo, Magdalena, additional, Gansevoort, Ron, additional, Kooy, Adriaan, additional, Finnes, Trine, additional, De Leon, Froilan, additional, Gumprecht, Janusz, additional, Teixeira e Costa, Fernando, additional, Dreval, Alexander, additional, Vathsala, Anantharaman, additional, Amod, Aslam, additional, Gon Kim, Sin, additional, Wan Lee, Byung, additional, Pascual Santos, Julio, additional, Tengmark, Bengt-Olov, additional, Burnier, Michel, additional, Lee, Chien-Te, additional, Yamwong, Sukit, additional, Sari, Ramazan, additional, McCafferty, Kieran, additional, Mankovsky, Borys, additional, Adler, Sharon, additional, Fried, Linda, additional, Toto, Robert, additional, Williams, Mark, additional, Quang Khanh, Tran, additional, Aizenberg, Diego, additional, Bartolacci, Inés, additional, Besada, Diego, additional, Bittar, Julio, additional, Chahin, Mariano, additional, Elbert, Alicia, additional, Gelersztein, Elizabeth, additional, Liberman, Alberto, additional, Maffei, Laura, additional, Pérez Manghi, Federico, additional, Sanabria, Hugo, additional, Viñes, Gloria, additional, Wassermann, Alfredo, additional, Abhayaratna, Walter, additional, Acharya, Shamasunder, additional, Ekinci, Elif, additional, Lee, Darren, additional, Mann Mah, Peak, additional, Nelson, Craig, additional, Packham, David, additional, Pape, Alexia, additional, Roger, Simon, additional, Stephenson, Hugo, additional, Suranyi, Michael, additional, Wittert, Gary, additional, Vale, Elizabeth, additional, Clodi, Martin, additional, Ebenbichler, Christoph, additional, Fliesser-Görzer, Evelyn, additional, Hanusch, Ursula, additional, Krebs, Michael, additional, Lhotta, Karl, additional, Ludvik, Bernhard, additional, Mayer, Gert, additional, Neudorfer, Peter, additional, Paulweber, Bernhard, additional, Prager, Rudolf, additional, Preiß, Wolfgang, additional, Prischl, Friedrich, additional, Schernthaner, Gerit-Holger, additional, Sourij, Harald, additional, Wiesholzer, Martin, additional, Doubel, Peter, additional, Engelen, Wendy, additional, Hougardy, Jean-Michel, additional, Krzesinski, Jean-Marie, additional, Maes, Bart, additional, Speeckaert, Marijn, additional, Stas, Koen, additional, van Gaal, Luc, additional, Vanbelleghem, Hilde, additional, Antunes, Daniela, additional, Botelho, Roberto, additional, Brito, Claudia, additional, Canani, Luis, additional, Eugenia Canziani, Maria, additional, Cerqueira, Maria, additional, de Paula, Rogerio, additional, Eliaschewitz, Freddy, additional, Eduardo Figueiredo, Carlos, additional, Forti, Adriana, additional, Hissa, Miguel, additional, Leite Jr, Maurilo, additional, Lima, Emerson, additional, Noronha, Irene, additional, Paolino, Bruno, additional, Paschoalin, Nathalia, additional, Paschoalin, Raphael, additional, Pecoits Filho, Roberto, additional, Pereira, Marcio, additional, Portes, Evandro, additional, Precoma, Dalton, additional, Rea, Rosangela, additional, Riella, Miguel, additional, Eduardo Salles, Joao, additional, Vasconcellos, Eduardo, additional, Vencio, Sergio, additional, Apostolova, Emiliya, additional, Boshnyashka, Radostina, additional, Farah, Ghassan, additional, Georgiev, Dimitar, additional, Gushterova, Valentina, additional, Klyuchkova, Neli, additional, Lucheva, Mariya, additional, Manova, Petya, additional, Minkova, Dotska, additional, Nonchev, Boyan, additional, Pichmanova, Mariyana, additional, Prakova, Zhulieta, additional, Rangelov, Rangel, additional, Rashkov, Rosen, additional, Stanchev, Pavel, additional, Stoyanovska-Elencheva, Bilyana, additional, Tagarev, Zhivko, additional, Temelkova-Kurktschieva, Theodora, additional, Vasileva, Svetla, additional, Yoncheva-Mihaylova, Mariana, additional, Barre, Paul, additional, Carlson, Brian, additional, Conway, James, additional, Cournoyer, Serge, additional, Dumas, Richard, additional, Fikry, Sameh, additional, Goluch, Richard, additional, Hamet, Pavel, additional, Hart, Randolph, additional, Henein, Sam, additional, Liutkus, Joanne, additional, Madore, Francois, additional, Martinho, Valdemar, additional, Mazza, Giuseppe, additional, McFarlane, Philip, additional, O'Keefe, Dennis, additional, Peterson, Sean, additional, Schwartz, Daniel, additional, Shu, Daniel, additional, Steele, Andrew, additional, Tellier, Guy, additional, Tennankore, Karthik, additional, Tsoukas, George, additional, Tytus, Richard, additional, Vitou, Louise, additional, Walsh, Michael, additional, Weisnagel, Stanley, additional, Wilderman, Igor, additional, Yale, Jean-Francois, additional, Cobos, Jorge, additional, Godoy, Juan, additional, Lobos, Sergio, additional, Carlos Palma, Juan, additional, Carlos Prieto, Juan, additional, Reyes, Eliana, additional, Romero, Carmen, additional, Saavedra, Victor, additional, Vega, Mario, additional, Bu, Ruifang, additional, Cai, Hanqing, additional, Chen, Nan, additional, Chen, Qinkai, additional, Chen, Dejun, additional, Cheng, Jinluo, additional, Dong, Youping, additional, Dong, Junwu, additional, Guan, Tianjun, additional, Hao, Chuanming, additional, Huang, Wen, additional, Jiang, Fangfang, additional, Lei, Minxiang, additional, Li, Ling, additional, Li, Zhonghe, additional, Li, Xuemei, additional, Li, Jingmei, additional, Li, Yan, additional, Liang, Xinling, additional, Liang, Bo, additional, Liu, Fang, additional, Liu, Yinghong, additional, Liu, Yuantao, additional, Liu, Zhihong, additional, Long, Gang, additional, Lu, Guoyuan, additional, Lu, Weiping, additional, Lu, Yibing, additional, Luo, Ping, additional, Ma, Jianhua, additional, Mo, Zhaohui, additional, Niu, Jianying, additional, Peng, Ai, additional, Shen, Jiansong, additional, Shen, Feixia, additional, Shi, Bingyin, additional, Su, Qing, additional, Sun, Zhuxing, additional, Tang, Shuifu, additional, Tong, Nanwei, additional, Wang, Hao, additional, Wang, Xinjun, additional, Wang, Lihua, additional, Wang, Guixia, additional, Wang, Jianqin, additional, Wang, Yangang, additional, Wang, Li, additional, Wei, Jiali, additional, Wu, Tianfeng, additional, Wu, Chaoqing, additional, Xing, Changying, additional, Xiong, Fei, additional, Xu, Xudong, additional, Xu, Ning, additional, Yan, Tiekun, additional, Yang, Jinkui, additional, Yin, Aiping, additional, Zeng, Longyi, additional, Zhang, Hao, additional, Zhang, Yanlin, additional, Zhang, Ying, additional, Zhao, Wenjing, additional, Zhao, Zhiquan, additional, Zheng, Hongguang, additional, Zhong, Ling, additional, Zhu, Dalong, additional, Zhuang, Yongze, additional, Arango, Clara, additional, Barrera, Sandra, additional, Beltrán López, Nelly, additional, Benitez, Diego, additional, Blanco, Guillermo, additional, Cadena, Andrés, additional, Coronel, Julian, additional, Cure, Carlos, additional, Durán, Carlos, additional, González, Alexander, additional, Guzmán, Gustavo, additional, Hernández, Eric, additional, Ibarra, Jaime, additional, Jaramillo, Carlos, additional, Jaramillo, Nicolás, additional, Kattah, William, additional, Molina, Dora, additional, Sánchez, Gregorio, additional, Terront, Mónica, additional, Trujillo, Freddy, additional, Urina, Miguel, additional, Vargas, Ruben, additional, Villegas, Iván, additional, Yupanqui, Hernán, additional, Alferi, Dino, additional, Brada, Michal, additional, Brezina, Jiri, additional, Bucek, Petr, additional, Edelsberger, Tomas, additional, Gulakova, Drahomira, additional, Hasalova Zapletalova, Jitka, additional, Hola, Olga, additional, Hornova, Lucie, additional, Houdova, Jana, additional, Hrmova, Helena, additional, Karasek, David, additional, Kopecka, Sarka, additional, Kovar, Richard, additional, Krcova, Eva, additional, Kuchar, Jiri, additional, Kutejova, Vlasta, additional, Lubanda, Hana, additional, Matyasek, Ivo, additional, Mokrejsova, Magdalena, additional, Okenka, Libor, additional, Pumprla, Jiri, additional, Tomanek, Pavel, additional, Bech, Jesper, additional, Faber, Jens, additional, Gislason, Gunnar, additional, Hangaard, Jørgen, additional, Jaroslaw Pacyk, Grzegorz, additional, Juhl, Claus, additional, Krarup, Thure, additional, Lindhardt, Morten, additional, Madsbad, Sten, additional, Nielsen, Joan, additional, Pedersen-Bjergaard, Ulrik, additional, Poulsen, Per, additional, Rasmussen, Ole, additional, Schousboe, Karoline, additional, Honkasalo, Mikko, additional, Humaloja, Kari, additional, Kananen, Kristiina, additional, Kantola, Ilkka, additional, Koistinen, Arvo, additional, Korsoff, Pirkko, additional, Lahtela, Jorma, additional, Nieminen, Sakari, additional, Nieminen, Tuomo, additional, Sadeharju, Karita, additional, Sulosaari, Sakari, additional, Cariou, Bertrand, additional, Chantrel, François, additional, Clavel, Sylvaine, additional, Combe, Christian, additional, Fauvel, Jean-Pierre, additional, Gallouj, Karim, additional, Gouet, Didier, additional, Guerci, Bruno, additional, Guerrot, Dominique, additional, Hourmant, Maryvonne, additional, Klein, Alexandre, additional, Mariat, Christophe, additional, Mesbah, Rafik, additional, Le Meur, Yannick, additional, Monier, Arnaud, additional, Moranne, Olivier, additional, Serusclat, Pierre, additional, Vendrely, Benoit, additional, Verges, Bruno, additional, Zaoui, Philippe, additional, Axthelm, Christoph, additional, Bergmann, Andreas, additional, Birkenfeld, Andreas L., additional, Braun, Hermann, additional, Busch, Klaus, additional, Contzen, Christel, additional, Degenhardt, Stefan, additional, Derwahl, Karl, additional, Giebel, Thomas, additional, Hagenow, Andreas, additional, Haller, Hermann, additional, Hasslacher, Christoph, additional, Horacek, Thomas, additional, Jungmair, Wolfgang, additional, Kloos, Christof, additional, Koch, Thorsten, additional, Krüger, Thilo, additional, Mühlfeld, Anja, additional, Müller, Joachim, additional, Pfützner, Andreas, additional, Pistrosch, Frank, additional, Rose, Ludger, additional, Rump, Lars, additional, Schettler, Volker, additional, Schiefke, Ingolf, additional, Schlichthaar, Heike, additional, Schröppel, Bernd, additional, Schürholz, Thomas, additional, Sigal, Helena, additional, Stemler, Lutz, additional, Strack, Georg, additional, Täschner, Heidrun, additional, Toursarkissian, Nicole, additional, Tschöpe, Diethelm, additional, Ulmer, Achim, additional, van der Giet, Markus, additional, Winkelmann, Bernhard R., additional, Boletis, Ioannis, additional, Hatziagelaki, Erifili, additional, Ioannidis, Ioannis, additional, Kounadi, Theodora, additional, Makriniotou, Ioanna, additional, Papadopoulou, Dorothea, additional, Papagianni, Aikaterini, additional, Passadakis, Ploumis, additional, Stefanidis, Ioannis, additional, Pang Ip, Tai, additional, Lee, Paul, additional, Yan Andrea Luk, On, additional, Wang, Angela, additional, Yeung, Vincent, additional, Bajcsi, Dora, additional, Danos, Peter, additional, Harcsa, Eleonora, additional, Kazup, Szilvia, additional, Keltai, Katalin, additional, Kirschner, Robert, additional, Kiss, Julianna, additional, Kovacs, Laszlo, additional, Lamboy, Beata, additional, Literati-Nagy, Botond, additional, Mileder, Margit, additional, Nagy, Laszlo, additional, Noori, Ebrahim, additional, Nyirati, Gabor, additional, Petro, Gizella, additional, Schneider, Karoly, additional, Szocs, Albert, additional, Vasas, Szilard, additional, Wudi, Krisztina, additional, Zilahi, Zsolt, additional, Zsom, Marianna, additional, Eustace, Joe, additional, Holian, John, additional, Reddan, Donal, additional, O'Meara, Yvonne, additional, Abramof Ness, Rosane, additional, Adawi, Faiad, additional, Armaly, Zaher, additional, Atar, Shaul, additional, Ben Chetrit, Sydney, additional, Berar Yanay, Noa, additional, Chernin, Gil, additional, Darawsha, Mahmud, additional, Efrati, Shai, additional, Elias, Mazen, additional, Farber, Evgeny, additional, Glandt, Mariela, additional, Halabi, Majdi, additional, Khazim, Khaled, additional, Liberty, Idit, additional, Mosenzon, Ofri, additional, Nimer, Assy, additional, Schwartz, Doron, additional, Zukermann, Robert, additional, Ilieva Parvanova, Aneliya, additional, Avogaro, Angelo, additional, Giorgio Battaglia, Giovanni, additional, Tiziano Bevilacqua, Maurizio, additional, Bonora, Enzo, additional, Antonio Bossi, Carlo, additional, Calabrò, Paolo, additional, Luigi Cavalot, Franco, additional, Cimino, Roberto, additional, Gennaro Cozzolino, Mario, additional, David, Salvatore, additional, Emdin, Michele, additional, Fiaccadori, Enrico, additional, Fiorina, Paolo, additional, Bruno Giorda, Carlo, additional, Cristina Gregorini, Maria, additional, La Manna, Gaetano, additional, Carlo Maggi, Davide, additional, Manti, Roberta, additional, Meregalli, Giancarla, additional, Pani, Antonello, additional, Perico, Norberto, additional, Piatti, PierMarco, additional, Pisani, Antonio, additional, Ettore Pontiroli, Antonio, additional, Ponzani, Paola, additional, Santorelli, Gennaro, additional, Santoro, Domenico, additional, Scanziani, Renzo, additional, Teatini, Ugo, additional, Tonolo, Giancarlo, additional, Trevisan, Roberto, additional, Maria Veronelli, Anna, additional, Luciano Viviani, Giorgio, additional, Araki, Hideo, additional, Ebisui, Osamu, additional, Fujita, Naruhiro, additional, Furuya, Ryuichi, additional, Hamamoto, Yoshiyuki, additional, Hatazaki, Masahiro, additional, Hayashi, Terumasa, additional, Higashi, Takayuki, additional, Hirohata, Yoshihide, additional, Horinouchi, Shuji, additional, Inagaki, Masayuki, additional, Ishii, Masao, additional, Ishiko, Tamayo, additional, Jinnouchi, Hideaki, additional, Kanai, Hidetoshi, additional, Kanda, Daisuke, additional, Kanehara, Hideo, additional, Kashima, Masayuki, additional, Kato, Kiyoe, additional, Katsuki, Takeshi, additional, Kawamitsu, Katsunori, additional, Kawasaki, Satsuki, additional, Kikuchi, Fumi, additional, Kikuchi, Hidetoshi, additional, Kobayashi, Kunihisa, additional, Koide, Junko, additional, Kubota, Miyuki, additional, Kusano, Yoshiro, additional, Maeda, Hajime, additional, Matsubayashi, Sunao, additional, Matsumoto, Kazunari, additional, Matsuo, Yasuto, additional, Matsuoka, Naoki, additional, Miyaoka, Hiroaki, additional, Murao, Satoshi, additional, Nakayama, Mikihiro, additional, Nakazawa, Jun, additional, Nomiyama, Takashi, additional, Noritake, Masayuki, additional, Ogiwara, Takayuki, additional, Ohashi, Hiroshi, additional, Okamoto, Hideki, additional, Osonoi, Takeshi, additional, Sasaki, Nobuhiro, additional, Sekigami, Taiji, additional, Shibasaki, Taro, additional, Shibata, Hirotaka, additional, Shinoda, Junji, additional, Sobajima, Hiroshi, additional, Sugitatsu, Kazuya, additional, Sugiura, Toshiyuki, additional, Sugiyama, Toru, additional, Suzuki, Daisuke, additional, Suzuki, Hiroyuki, additional, Suzuki, Masaaki, additional, Takeda, Asami, additional, Tanaka, Asami, additional, Tanaka, Seiichi, additional, Tsunematsu, Izumi, additional, Ujihara, Makoto, additional, Yamada, Daishiro, additional, Yamada, Masayo, additional, Yamagata, Kazuo, additional, Yamakawa, Ken, additional, Yamakawa, Fumiko, additional, Yamasaki, Yoshimitsu, additional, Yambe, Yuko, additional, Yanagida, Taihei, additional, Yanai, Hidekatsu, additional, Yasuda, Tetsuyuki, additional, Kriauciuniene, Dovile, additional, Lasiene, Jurate, additional, Navickas, Antanas, additional, Radzeviciene, Lina, additional, Urbanaviciene, Egle, additional, Urbonas, Gediminas, additional, Velaviciene, Audrone, additional, Abd Ghani, Rohana, additional, Azizah Aziz, Nor, additional, Yuan Lee, Li, additional, Loong Loh, Chek, additional, Mohd Ali, Norhaliza, additional, Mohd Noor, Nurain, additional, Nur Fatnoon, Nik, additional, Ahmad, Nik, additional, Ratnasingam, Jeyakantha, additional, Hasnul Halimi Bin, Wan, additional, Hasan, Wan, additional, Mohd Izani, Wan, additional, Mohamed, Wan, additional, Avila Pardo, Sandro, additional, Bastidas Adrian, Miriam, additional, Chew Wong, Alfredo, additional, Escobedo de la Peña, Jorge, additional, Fanghänel Salmón, Guillermo, additional, González Gálvez, Guillermo, additional, Gutiérrez Ochoa, Ramiro, additional, Irizar Santana, Saúl, additional, Méndez Machado, Gustavo, additional, Nevarez Ruiz, Luis, additional, Ramos Ibarra, Denisse, additional, Ramos López, Gabriel, additional, Sauque Reyna, Leobardo, additional, Solache Ortiz, Gustavo, additional, Valdez Ortiz, Rafael, additional, Villagordoa Mesa, Juan, additional, Bakker, R.C., additional, Barendregt, J.N.M., additional, Boonstra, A.H., additional, Bos, Willem, additional, Brouwer, C.B., additional, van Buren, M., additional, Krekels, Marielle, additional, van Leendert, Ruud J.M., additional, Lieverse, Louis A.G., additional, Luik, P.T., additional, Lars Penne, E., additional, Smak Gregoor, Peter, additional, Vogt, Liffert, additional, Baker, John, additional, Crawford, Veronica, additional, Cutfield, Rick, additional, Dunn, Peter, additional, Krebs, Jeremy, additional, Nirmalaraj, Kingsley, additional, Scott, Russell, additional, Smuts, Nine, additional, Eriksen, Erik, additional, Høivik, Hans, additional, Karlsson, Thomas, additional, Scott Munk, Peter, additional, Radtke, Maria, additional, Risberg, Knut, additional, Rocke, Jan, additional, Solnør, Leidulv, additional, Stenehjem, Aud-Eldrid, additional, Tafjord, Anne-Beathe, additional, Pamugas, Glenda, additional, Panelo, Araceli, additional, Perez, Ronald, additional, Tanque, Maribel, additional, Tirador, Louie, additional, Villa, Michael, additional, Butrymowicz, Patrycja, additional, Ciechanowski, Kazimierz, additional, Cieslik, Grazyna, additional, Franek, Edward, additional, Hoffmann, Michal, additional, Krzykowska, Jolanta, additional, Kurnatowska, Ilona, additional, Landa, Katarzyna, additional, Madrzejewski, Adam, additional, Madziarska, Katarzyna, additional, Mazur, Stanislaw, additional, Napora, Piotr, additional, Nowicki, Michal, additional, Ocicka-Kozakiewicz, Anna, additional, Rewerska, Barbara, additional, Rusicka, Teresa, additional, Ruxer, Jan, additional, Skokowska, Ewa, additional, Stankiewicz, Andrzej, additional, Stompor, Tomasz, additional, Tiuryn-Petrulewicz, Agnieszka, additional, Wasilewska, Katarzyna, additional, Wierusz-Wysocka, Bogna, additional, Wnetrzak-Michalska, Renata, additional, Almeida, Edgar, additional, Ballesteros, Rosa, additional, Barreto, Carlos, additional, Beirao, Idalina, additional, Birne, Rita, additional, Esteves, Cesar, additional, Guia, Jose, additional, Heitor, Susana, additional, Marques, Olinda, additional, Melo, Pedro, additional, Nolasco, Fernando, additional, Pereira, Amalia, additional, Roque, Cristina, additional, Rosario, Francisco, additional, Silva, Gil, additional, Silva, Ana, additional, Vila Lobos, Ana, additional, Cortes-Maisonet, Gregorio, additional, Roman-Miranda, Amaury, additional, Albota, Adrian, additional, Bala, Cornelia, additional, Barbonta, Hortensia, additional, Caceaune, Elena, additional, Catrinoui, Doina, additional, Constantin, Ciprian, additional, Dumitrescu, Adriana, additional, Mindrescu, Nicoleta, additional, Mistode, Cristina, additional, Negrisanu, Gabriela, additional, Onaca, Adriana, additional, Paveliu, Silvia, additional, Pintilei, Ella, additional, Pop, Lavinia, additional, Popa, Amorin, additional, Popescu, Alexandrina, additional, Radulian, Gabriela, additional, Szilagyi, Iosif, additional, Turcu, Liana, additional, Vacaru, Georgeta, additional, Vlad, Adrian, additional, Antsiferov, Mikhail, additional, Arkhipov, Mikhail, additional, Babkin, Andrey, additional, Barbarash, Olga, additional, Baranov, Vitaliy, additional, Chernyavskaya, Elena, additional, Demko, Arkadiy, additional, Edin, Anton, additional, Ermakova, Polina, additional, Fadeev, Valentin, additional, Galyavich, Albert, additional, Gaysina, Leyla, additional, Gordeev, Ivan, additional, Ipatko, Irina, additional, Kalashnikova, Marina, additional, Khalimov, Yuriy, additional, Klimontov, Vadim, additional, Kobalava, Zhanna, additional, Kosmacheva, Elena, additional, Koziolova, Natalya, additional, Kvitkova Sergey Levashov, Lyudmila, additional, Libis, Roman, additional, Marasaev, Vyacheslav, additional, Malykh, Natalia, additional, Martynenko, Vladimir, additional, Malyutina, Sofya, additional, Merai, Imad, additional, Mkrtumyan, Ashot, additional, Nechaeva, Galina, additional, Petunina, Nina, additional, Palyutin, Shamil, additional, Pimenov, Leonid, additional, Rechkova, Elena, additional, Rodionova, Tatyana, additional, Rymar, Oksana, additional, Sardinov, Ruslan, additional, Semenova, Olga, additional, Sherenkov, Alexander, additional, Solovev, Oleg, additional, Smolyarchuk, Elena, additional, Strongin, Leonid, additional, Ukhanova, Olga, additional, Verlan, Nadezhda, additional, Vorokhobina, Natalya, additional, Yakhontov, Davyd, additional, Yakushin, Sergey, additional, Zakharova, Elena, additional, Zalevskaya, Alsu, additional, Zanozina, Olga, additional, Zhdanova, Elena, additional, Zhukova, Larisa, additional, Zykova, Tatyana, additional, Fang Sum, Chee, additional, Muhummad Suhail, Sufi, additional, San Tan, Ru, additional, Wong, Edmund, additional, Babikova, Jana, additional, Buganova, Ingrid, additional, Dzupina, Andrej, additional, Ochodnicka, Zuzana, additional, Sosovec, Dalibor, additional, Spodniakova, Denisa, additional, Ahmed, Fayzal, additional, Bhana, Sindeep, additional, Distiller, Larry, additional, Jansen van Rensburg, Dirkie, additional, Joshi, Mukesh, additional, Joshi, Shaifali, additional, Lakha, Deepak, additional, Mitha, Essack, additional, Podgorski, Gracjan, additional, Ranjith, Naresh, additional, Rayner, Brian, additional, Rheeder, Paul, additional, Sarvan, Mohamed, additional, Seeber, Mary, additional, Siebert, Heidi, additional, Tayob, Mohammed, additional, Trokis, Julien, additional, Urbach, Dorothea, additional, van Zyl, Louis, additional, Choi, Bum-Soon, additional, Gi Choi, Moon, additional, Chung, ChoonHee, additional, Hwang, YouCheol, additional, Kim, ChongHwa, additional, Kim, InJoo, additional, Kim, JaeHyeon, additional, Kim, SinGon, additional, Kim, SungGyun, additional, Hee Kim, Tae, additional, Lee, WooJe, additional, Lee, ByungWan, additional, Wook Lee, Kang, additional, Oh, Kook-Hwan, additional, Eun Oh, Ji, additional, Kyu Oh, Yun, additional, Oh, Dong-Jin, additional, Park, Junbeom, additional, Joon Shin, Seok, additional, Sung, Su-Ah, additional, Myung Yu, Jae, additional, Agraz, Irene, additional, Javier Ampudia, Francisco, additional, Bouarich, Hanane, additional, Calero, Francesca, additional, Castro, Cristina, additional, Cigarrán Guldris, Secundino, additional, Cruzado Garrit, Josep, additional, de Álvaro, Fernando, additional, Galcerán, Josep, additional, González Albarrán, Olga, additional, Hernández Jaras, Julio, additional, Ibernón, Meritxell, additional, Martínez Deben, Francisco, additional, Dolores Martínez Esteban, Ma, additional, María Pascual Izuel, José, additional, Martins, Judith, additional, Mediavilla, Juan, additional, Michán, Alfredo, additional, Poch, Esteban, additional, Polaina Rusillo, Manuel, additional, Sánchez Juan, Carlos, additional, Santamaría Olmo, Rafael, additional, Julián, José, additional, de la Morena, Segura, additional, Soto, Alfonso, additional, Troya, Maribel, additional, Bruchfeld, Annette, additional, Curiac, Dan, additional, Eliasson, Ken, additional, Frank, Malin, additional, Guron, Gregor, additional, Hellberg, Olof, additional, Hellgren, Margareta, additional, Larnefeldt, Hans, additional, Lindholm, Carl-Johan, additional, Löndahl, Magnus, additional, Rein-Hedin, Erik, additional, Soveri, Inga, additional, Spaak, Jonas, additional, Ackermann, Daniel, additional, Bilz, Stefan, additional, Forster, Christian, additional, Kalbermatter, Stefan, additional, Kistler, Andreas, additional, Pechére-Bertschi, Antoinette, additional, Schultes, Bernd, additional, Chang, Chiz-Tzung, additional, Hung, Cheng-Chieh, additional, Jiang, Ju-Ying, additional, Lin, Shuei-Liong, additional, Tarng, Der-Cherng, additional, Tu, Shih-Te, additional, Wu, Mai-Szu, additional, Wu, Ming-Ju, additional, Deerochanawong, Chaicharn, additional, Kitiyakara, Chagriya, additional, Ophascharoensuk, Vuddhidej, additional, Pongchaiyakul, Chatlert, additional, Satirapoj, Bancha, additional, Eren, Necmi, additional, Gul, Ibrahim, additional, Gulel, Okan, additional, Kocyigit, Ismail, additional, Kumbasar, Abdulbaki, additional, Sahin, Idris, additional, Sayin, Burak, additional, Tavli, Talat, additional, Ustundag, Sedat, additional, Yenicerioglu, Yavuz, additional, Bondarets, Iryna, additional, Botsyurko, Volodymyr, additional, Chernikova, Viktoriia, additional, Donets, Oleksandra, additional, Fushtey, Ivan, additional, Grachova, Mariia, additional, Isayeva, Anna, additional, Kogut, Dmytro, additional, Komisarenko, Julia, additional, Kravchun, Nonna, additional, Malyar, Kateryna, additional, Martynyuk, Liliya, additional, Maslyanko, Vitaliy, additional, Myshanych, Halyna, additional, Pererva, Larysa, additional, Pertseva, Nataliia, additional, Serhiyenko, Oleksandr, additional, Smirnov, Ivan, additional, Sokolova, Liubov, additional, Stryzhak, Vasyl, additional, Vlasenko, Maryna, additional, AbouSaleh, Ahmad, additional, Barratt, Jonathan, additional, Dang, Cuong, additional, Kahal, Hassan, additional, Kirk, Adam, additional, Kilvert, Anne, additional, Phi Kon, Sui, additional, Patel, Dipesh, additional, Rice, Sam, additional, Vijayaraman, Arutchelvam, additional, Wong, Yuk-ki, additional, Gibson, Martin, additional, Wahba, Mona, additional, Zaidi, Reza, additional, Acosta, Idalia, additional, Adams, Atoya, additional, Ajani, Dilawar, additional, Ali, Slamat, additional, Alicic, Radica, additional, Al-Karadsheh, Amer, additional, Alla, Sreedhara, additional, Allison, D., additional, Andrawis, Nabil, additional, Arif, Ahmed, additional, Awad, Ahmed, additional, Azizad, Masoud, additional, Bahrami, Michael, additional, Bansal, Shweta, additional, Barag, Steven, additional, Barakzoy, Ahmad, additional, Barney, Mark, additional, Barzilay, Joshua, additional, Bashir, Khalid, additional, Bautista, Jose, additional, Beddhu, Srinivasan, additional, Belo, Diogo, additional, Benjamin, Sabrina, additional, Berenji, Ramin, additional, Bhargava, Anuj, additional, Birriel, Jose, additional, Brietzke, Stephen, additional, Brosius, Frank, additional, Brusco, Osvaldo, additional, Burgner, Anna, additional, Busch, Robert, additional, Canadas, Rafael, additional, Caramori, Maria, additional, Cardona, Jose, additional, Case, Christopher, additional, Cruz, Humberto, additional, Dandillaya, Ramprasad, additional, Dawoud, Dalia, additional, Din, Zia, additional, Dixon, Bradley, additional, Doshi, Ankur, additional, Drakakis, James, additional, El Shahawy, Mahfouz, additional, El-Meanawy, Ashraf, additional, El-Shahawy, Mohammed, additional, Evans, John, additional, Fadda, George, additional, Farooq, Umar, additional, Fernando, Roland, additional, Fink, Raymond, additional, First, Brian, additional, Fitz-Patrick, David, additional, Flack, John, additional, Fluck, Patrick, additional, Fogelfeld, Leon, additional, Fonseca, Vivian, additional, Frias, Juan, additional, Galphin, Claude, additional, Garcia-Mayol, Luis, additional, Goldstein, Gary, additional, Gonzalez, Edgar, additional, Gonzalez-Abreu, Francisco, additional, Gore, Ashwini, additional, Grant, David, additional, Habwe, Violet, additional, Hamilton, Maxine, additional, Hammoud, Jamal, additional, Handelsman, Stuart, additional, Hartman, Israel, additional, Heigerick, Glenn, additional, Henry, Andrew, additional, Hernandez, German, additional, Hernandez-Cassis, Carlos, additional, Herrera, Carlos, additional, Hertel, Joachim, additional, Huang, Wenyu, additional, Iglesias, Rogelio, additional, Iranmanesh, Ali, additional, Jackson, Timothy, additional, Jain, Mahendra, additional, Jamerson, Kenneth, additional, Johnson, Karen, additional, Judd, Eric, additional, Kaplan, Joshua, additional, Kayali, Zeid, additional, Khan, Bobby, additional, Khan, Muhammad, additional, Kharait, Sourabh, additional, Sue Kirkman, M., additional, Kopyt, Nelson, additional, Kotzker, Wayne, additional, Kovesdy, Csaba, additional, Kreit, Camil, additional, Krishna, Arvind, additional, Kronfli, Saeed, additional, Lee, Keung, additional, LeJeune, Derek, additional, Lemus, Brenda, additional, Leon-Forero, Carlos, additional, Linfert, Douglas, additional, Lora, Henry, additional, Lurie, Alexander, additional, Maddukuri, Geetha, additional, Magno, Alexander, additional, Maletz, Louis, additional, Mandayam, Sreedhar, additional, Markell, Mariana, additional, Mayfield, Ronald, additional, Mbogua, Caroline, additional, McMullen, Dierdre, additional, Meisner, Carl, additional, Minton, Stephen, additional, Mocherla, Bharat, additional, Mohandas, Rajesh, additional, Montero, Manuel, additional, Moustafa, Moustafa, additional, Nadkarni, Salil, additional, Nakhle, Samer, additional, Navarro, Jesus, additional, Neyra, Nilda, additional, Nica, Romanita, additional, Nicol, Philip, additional, Norwood, Paul, additional, Numrungroad, Visal, additional, O'Donovan, Richard, additional, Odugbesan, A., additional, Paoli-Bruno, Jorge, additional, Parikh, Samir, additional, Patel, Rakesh, additional, Peixoto, Aldo, additional, Pergola, Pablo, additional, Perlman, Alan, additional, Pettis, Karlton, additional, Pisoni, Roberto, additional, Ponduchi, Mirela, additional, Posada, Jorge, additional, Prabhakar, Sharma, additional, Radhakrishnan, Jai, additional, Rahman, Mahboob, additional, Raina, Rupesh, additional, Rastogi, Anjay, additional, Reisin, Efrain, additional, Rendell, Marc, additional, Robertson, David, additional, Rocco, Michael, additional, Romeu, Hugo, additional, Rosas, Sylvia, additional, Rosenfeld, Jack, additional, Ross, Dennis, additional, Rothman, Jeffrey, additional, Rudolph, Lance, additional, Ruhullah, Yusuf, additional, Ruoff, Gary, additional, Ryu, Jeffrey, additional, Sahani, Mandeep, additional, Sam, Ramin, additional, Samuels, Garfield, additional, Sanchez, William, additional, Santos, Vladimir, additional, Satko, Scott, additional, Saxena, Sanjeev, additional, Scott, David, additional, Seco, Gilberto, additional, Seek, Melvin, additional, Serota, Harvey, additional, Shafi, Tariq, additional, Shahid, Nauman, additional, Shanik, Michael, additional, Sharma, Santosh, additional, Sinha, Arjun, additional, Smelser, James, additional, Smith, Mark, additional, Soe, Kyaw, additional, Solomon, Richard, additional, Soroka, Eugene, additional, Soufer, Joseph, additional, Spinowitz, Bruce, additional, Spry, Leslie, additional, Suarez, Rosa, additional, Subramanian, Bala, additional, Szerlip, Harold, additional, Tamirisa, Aparna, additional, Thomson, Stephen, additional, Tran, Tuan-Huy, additional, Treger, Richard, additional, Trullenque, Gretel, additional, Turk, Thomas, additional, Umpierrez, Guillermo, additional, Urbach, Daniel, additional, Valdes, Martin, additional, Valika, Shujauddin, additional, Vega, Damaris, additional, Weissman, Peter, additional, Whaley-Connell, Adam, additional, Winston, Jonathan, additional, Wise, Jonathan, additional, Wynne, Alan, additional, Zeig, Steven, additional, Chu, Phuong, additional, Van Hoang, Lam, additional, Khanh, Tran, additional, Thi Phi Nga, Nguyen, additional, Nguyen Son, Pham, additional, and Phuong Tran, Lan, additional

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2022
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8. Effect of Dapagliflozin on Hematocrit in Patients With Type 2 Diabetes at High Cardiovascular Risk: Observations From DECLARE-TIMI 58

Author

Kolkailah, Ahmed A., primary, Wiviott, Stephen D., additional, Raz, Itamar, additional, Murphy, Sabina A., additional, Mosenzon, Ofri, additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, Wilding, John P.H., additional, Gause-Nilsson, Ingrid, additional, Sabatine, Marc S., additional, and McGuire, Darren K., additional

Published
2022
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9. Association of Baseline HbA1c With Cardiovascular and Renal Outcomes: Analyses From DECLARE-TIMI 58

Author

Cahn, Avivit, primary, Wiviott, Stephen D., additional, Mosenzon, Ofri, additional, Goodrich, Erica L., additional, Murphy, Sabina A., additional, Yanuv, Ilan, additional, Rozenberg, Aliza, additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John P.H., additional, Gause-Nilsson, Ingrid A.M., additional, Langkilde, Anna Maria, additional, Sabatine, Marc S., additional, and Raz, Itamar, additional

Published
2022
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10. Efficacy and Safety of Dapagliflozin by Baseline Insulin Regimen and Dose: Post Hoc Analyses From DECLARE-TIMI 58.

Author

Pollack, Rena, Raz, Itamar, Wiviott, Stephen D., Goodrich, Erica L., Murphy, Sabina A., Yanuv, Ilan, Rozenberg, Aliza, Mosenzon, Ofri, Langkilde, Anna Maria, Gause-Nilsson, Ingrid A.M., Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Wilding, John P.H., Sabatine, Marc S., and Cahn, Avivit

Subjects
INSULIN therapy, DAPAGLIFLOZIN, SODIUM-glucose cotransporter 2 inhibitors, SYSTOLIC blood pressure, SALT-free diet, DIABETIC acidosis, INSULIN pumps
Abstract

Objective: The cardiorenal benefits of adding sodium-glucose cotransporter 2 (SGLT2) inhibitor therapy for patients on insulin, particularly those on intensive regimens that include short-acting (SA) insulin, have not been explored.Research Design and Methods: In Dapagliflozin Effect on Cardiovascular Events trial (DECLARE-TIMI 58), 17,160 patients with type 2 diabetes were randomized to dapagliflozin or placebo for a median follow-up of 4.2 years. Cardiovascular (CV), renal, metabolic, and safety outcomes with dapagliflozin versus placebo by insulin dose and regimen were studied with Cox regression models.Results: The study included 7,013 insulin users at baseline, with 4,650 (66.3%) patients on regimens including SA insulin. Insulin doses varied, with 2,443 (34.8%) patients receiving <0.5 IU/kg, 2,795 (39.9%) 0.5 to ≤1 IU/kg, and 1,339 (19.1%) >1 IU/kg. Dapagliflozin reduced CV death/hospitalization for heart failure among overall insulin users (hazard ratio [HR] 0.82 [95% CI 0.69-0.97]) and consistently in patients on insulin regimens with or without SA insulin (0.83 [0.67-1.03] and 0.78 [0.57-1.07], respectively, Pinteraction = 0.75). No heterogeneity was observed by insulin dose (Pinteraction = 0.43). The HR for major adverse CV events with dapagliflozin among insulin users (0.84 [0.74-0.97]) was similar irrespective of regimen or dose (Pinteraction = 0.75 and 0.07). Dapagliflozin reduced the rate of adverse renal outcomes overall and consistently across subgroups of insulin users. Decreases in HbA1c, weight, and systolic blood pressure with dapagliflozin were seen regardless of insulin dose or regimen. The known safety profile of dapagliflozin was unchanged in patients on intensive insulin regimens.Conclusions: The benefits and safety of dapagliflozin were maintained in high-risk patients receiving high-dose or intensive insulin regimens including SA insulin.Article Highlights: Limited data exist regarding the cardiorenal, metabolic, and safety outcomes of SGLT2 inhibitors in patients on high-dose or intensive insulin regimens including short-acting insulin. In DECLARE-TIMI 58, 17,160 patients including 7,013 baseline insulin users were randomized to dapagliflozin versus placebo. Outcomes among insulin users by insulin dose and regimen were studied. Our results suggest that use of dapagliflozin by patients with type 2 diabetes managed with insulin, including high-dose or intensive insulin regimens, provided significant cardiovascular, renal, and metabolic benefits, in line with overall trial results. Adverse events associated with dapagliflozin, including hypoglycemia and diabetic ketoacidosis, were rare in this cohort. [ABSTRACT FROM AUTHOR]

Published
2023
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11. A Biomarker-Based Score for Risk of Hospitalization for Heart Failure in Patients With Diabetes

Author

Berg, David D., primary, Wiviott, Stephen D., primary, Scirica, Benjamin M., primary, Zelniker, Thomas A., primary, Goodrich, Erica L., primary, Jarolim, Petr, primary, Mosenzon, Ofri, primary, Cahn, Avivit, primary, Bhatt, Deepak L., primary, Leiter, Lawrence A., primary, McGuire, Darren K., primary, Wilding, John P.H., primary, Johanson, Per, primary, Langkilde, Anna Maria, primary, Raz, Itamar, primary, Braunwald, Eugene, primary, Sabatine, Marc S., primary, and Morrow, David A., primary

Published
2021
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12. The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58

Author

Mosenzon, Ofri, primary, Wiviott, Stephen D., additional, Heerspink, Hiddo J.L., additional, Dwyer, Jamie P., additional, Cahn, Avivit, additional, Goodrich, Erica L., additional, Rozenberg, Aliza, additional, Schechter, Meir, additional, Yanuv, Ilan, additional, Murphy, Sabina A., additional, Zelniker, Thomas A., additional, Gause-Nilsson, Ingrid A.M., additional, Langkilde, Anna Maria, additional, Fredriksson, Martin, additional, Johansson, Peter A., additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John P.H., additional, Sabatine, Marc S., additional, and Raz, Itamar, additional

Published
2021
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13. Dapagliflozin and Prevention of Kidney Disease Among Patients With Type 2 Diabetes: Post Hoc Analyses From the DECLARE-TIMI 58 Trial.

Author

Mosenzon, Ofri, Raz, Itamar, Wiviott, Stephen D., Schechter, Meir, Goodrich, Erica L., Yanuv, Ilan, Rozenberg, Aliza, Murphy, Sabina A., Zelniker, Thomas A., Langkilde, Anna Maria, Gause-Nilsson, Ingrid A.M., Fredriksson, Martin, Johansson, Peter A., Wilding, John P.H., McGuire, Darren K., Bhatt, Deepak L., Leiter, Lawrence A., Cahn, Avivit, Dwyer, Jamie P., and Heerspink, Hiddo J.L.

Subjects
*MYOCARDIAL infarction complications, *GLOMERULAR filtration rate, *BENZENE, *RESEARCH, *SODIUM, *RESEARCH methodology, *GLYCOSIDES, *EVALUATION research, *TYPE 2 diabetes, *COMPARATIVE studies, *RANDOMIZED controlled trials, *GLUCOSE, *DIABETIC nephropathies, *DISEASE complications
Abstract

Objective: In patients with moderate to severe albuminuric kidney disease, sodium-glucose cotransporter 2 inhibitors reduce the risk of kidney disease progression. These post hoc analyses assess the effects of dapagliflozin on kidney function decline in patients with type 2 diabetes (T2D), focusing on populations with low kidney risk.Research Design and Methods: In the Dapagliflozin Effect on Cardiovascular Events-Thrombolysis in Myocardial Infarction 58 (DECLARE-TIMI 58) trial, patients with T2D at high cardiovascular risk were randomly assigned to dapagliflozin versus placebo. Outcomes were analyzed by treatment arms, overall, and by Kidney Disease: Improving Global Outcomes (KDIGO) risk categories. The prespecified kidney-specific composite outcome was a sustained decline ≥40% in the estimated glomerular filtration rate (eGFR) to <60 mL/min/1.73 m2, end-stage kidney disease, and kidney-related death. Other outcomes included incidence of categorical eGFR decline of different thresholds and chronic (6 month to 4 year) or total (baseline to 4 year) eGFR slopes.Results: Most participants were in the low-moderate KDIGO risk categories (n = 15,201 [90.3%]). The hazard for the kidney-specific composite outcome was lower with dapagliflozin across all KDIGO risk categories (P-interaction = 0.97), including those at low risk (hazard ratio [HR] 0.54, 95% CI 0.38-0.77). Risks for categorical eGFR reductions (≥57% [in those with baseline eGFR ≥60 mL/min/1.73 m2], ≥50%, ≥40%, and ≥30%) were lower with dapagliflozin (HRs 0.52, 0.57, 0.55, and 0.70, respectively; P < 0.05). Slopes of eGFR decline favored dapagliflozin across KDIGO risk categories, including the low KDIGO risk (between-arm differences of 0.87 [chronic] and 0.55 [total] mL/min/1.73 m2/year; P < 0.0001).Conclusions: Dapagliflozin mitigated kidney function decline in patients with T2D at high cardiovascular risk, including those with low KDIGO risk, suggesting a role of dapagliflozin in the early prevention of diabetic kidney disease. [ABSTRACT FROM AUTHOR]

Published
2022
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14. 990-P: Use of Glucose-Lowering Agents According to Cardiovascular Risk Factors in People with T2D and with or without CVD in the CAPTURE Study

Author

DIEUZEIDE, GUILLERMO, primary, ALGUWAIHES, ABDULLAH M., additional, LEON, JOSE LUIS A., additional, BAYRAM, FAHRI, additional, DARMON, PATRICE, additional, DAVIS, TIMOTHY, additional, ERIKSEN, KIRSTEN T., additional, HONG, TIANPEI, additional, JENSEN, THOMAS J., additional, LENGYEL, CSABA, additional, MOSENZON, OFRI, additional, RUSSO, GIUSEPPINA T., additional, SHIRABE, SHINICHIRO, additional, URBANCOVA, KATERINA, additional, VENCIO, SERGIO, additional, and YADAV, GOURAV, additional

Published
2021
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16. 788-P: The Cardiovascular and Renal Benefits of Dapagliflozin Are Independent of Baseline HbA1c: Analyses from DECLARE-TIMI 58

Author

CAHN, AVIVIT, primary, WIVIOTT, STEPHEN D., additional, MOSENZON, OFRI, additional, MURPHY, SABINA, additional, GOODRICH, ERICA L., additional, BHATT, DEEPAK L., additional, LEITER, LAWRENCE A., additional, MCGUIRE, DARREN K., additional, WILDING, JOHN, additional, GAUSE-NILSSON, INGRID A., additional, LANGKILDE, ANNA MARIA, additional, SABATINE, MARC S., additional, and RAZ, ITAMAR, additional

Published
2021
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17. 974-P: Associations between Patient Characteristics and Cardiovascular Disease: A Post-hoc Analysis from the CAPTURE Study

Author

ALGUWAIHES, ABDULLAH M., primary, LEON, JOSE LUIS A., additional, BAYRAM, FAHRI, additional, DARMON, PATRICE, additional, DAVIS, TIMOTHY, additional, DIEUZEIDE, GUILLERMO, additional, ERIKSEN, KIRSTEN T., additional, HONG, TIANPEI, additional, JENSEN, THOMAS J., additional, LENGYEL, CSABA, additional, MOSENZON, OFRI, additional, RUSSO, GIUSEPPINA T., additional, SHIRABE, SHINICHIRO, additional, URBANCOVA, KATERINA, additional, VENCIO, SERGIO, additional, and YADAV, GOURAV, additional

Published
2021
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18. Cardiovascular, Renal, and Metabolic Outcomes of Dapagliflozin Versus Placebo in a Primary Cardiovascular Prevention Cohort: Analyses From DECLARE-TIMI 58

Author

Cahn, Avivit, primary, Raz, Itamar, primary, Leiter, Lawrence A., primary, Mosenzon, Ofri, primary, Murphy, Sabina A., primary, Goodrich, Erica L., primary, Yanuv, Ilan, primary, Rozenberg, Aliza, primary, Bhatt, Deepak L., primary, McGuire, Darren K., primary, Wilding, John P.H., primary, Gause-Nilsson, Ingrid A. M., primary, Langkilde, Anna Maria, primary, Sabatine, Marc S., primary, and Wiviott, Stephen D., primary

Published
2021
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19. Changes in Albuminuria Predict Cardiovascular and Renal Outcomes in Type 2 Diabetes: A Post Hoc Analysis of the LEADER Trial

Author

Persson, Frederik, primary, Bain, Stephen C, primary, Mosenzon, Ofri, primary, Heerspink, Hiddo J.L., primary, Mann, Johannes F. E., primary, Pratley, Richard, primary, Raz, Itamar, primary, Idorn, Thomas, primary, Rasmussen, Søren, primary, Scholten, Bernt Johan von, primary, Rossing, Peter, primary, and Investigators, the LEADER Trial, primary

Published
2021
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20. Adolescent Hypertension and Risk for Early-Onset Type 2 Diabetes: A Nationwide Study of 1.9 Million Israeli Adolescents

Author

Fishman, Boris, primary, Grossman, Ehud, additional, Zucker, Inbar, additional, Orr, Omri, additional, Lutski, Miri, additional, Bardugo, Aya, additional, Bendor, Cole D., additional, Leiba, Yoav, additional, Cukierman-Yaffe, Tali, additional, Derazne, Estela, additional, Mosenzon, Ofri, additional, Tzur, Dorit, additional, Beer, Zivan, additional, Pinhas-Hamiel, Orit, additional, Fishman, Tamar, additional, Afek, Arnon, additional, Tirosh, Amir, additional, Raz, Itamar, additional, Gerstein, Hertzel C., additional, and Twig, Gilad, additional

Published
2020
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21. Intensification of insulin therapy for type 2 diabetic patients in primary care: basal-bolus Regimen versus Premix insulin analogs: when and for whom?

Author

Mosenzon, Ofri and Raz, Itamar

Subjects
Bristol-Myers Squibb Co., AstraZeneca PLC, Eli Lilly and Co., Family medicine, Insulin, Type 2 diabetes -- Development and progression -- Drug therapy, Diabetics -- Drug therapy, Pharmaceutical industry, Health, American Diabetes Association, European Association for the Study of Diabetes
Abstract

In April 2012, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) published a joint position statement regarding treatment of hyperglycemia in type 2 [...]

Published
2013
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22. Early insulinization to prevent diabetes progression

Author

Raz, Itamar and Mosenzon, Ofri

Subjects
Bristol-Myers Squibb Co., AstraZeneca PLC, Eli Lilly and Co., Diabetes therapy, Diabetes -- Prevention -- Development and progression, Diabetics, Pharmaceutical industry, Health
Abstract

This article reviews data collected from clinical studies regarding the place of early insulin treatment in preservation of β-cell function in type 2 diabetic patients. It emphasizes the stepwise progression [...]

Published
2013
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23. 278-OR: Efficacy and Safety of Anti-interleukin (IL)-21 in Combination with Liraglutide in Adults Recently Diagnosed with Type 1 Diabetes

Author

VON HERRATH, MATTHIAS G., primary, BAIN, STEPHEN C., additional, BODE, BRUCE W., additional, CLAUSEN, JESPER OLE, additional, COPPIETERS, KEN, additional, GAYSINA, LEYLYA, additional, GUMPRECHT, JANUSZ, additional, HANSEN, TROELS K., additional, MATHIEU, CHANTAL, additional, PORTILLO, CRISTOBAL MORALES, additional, MOSENZON, OFRI, additional, SEGEL, STINE, additional, TSOUKAS, GEORGE M., additional, and PIEBER, THOMAS, additional

Published
2020
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25. 303-OR: Effect of Dapagliflozin on Risk for Fast Decline in EGFR: Analyses from the DECLARE-TIMI 58 Trial

Author

RAZ, ITAMAR, primary, WIVIOTT, STEPHEN D., additional, HEERSPINK, HIDDO L., additional, DWYER, JAMIE P., additional, CAHN, AVIVIT, additional, GOODRICH, ERICA L., additional, MURPHY, SABINA, additional, ROZENBERG, ALIZA, additional, YANUV, ILAN, additional, WILDING, JOHN, additional, LEITER, LAWRENCE A., additional, BHATT, DEEPAK L., additional, MCGUIRE, DARREN K., additional, MA, RONALD C., additional, TANKOVA, TSVETALINA, additional, FREDRIKSSON, MARTIN, additional, GAUSE-NILSSON, INGRID A., additional, LANGKILDE, ANNA MARIA, additional, SABATINE, MARC S., additional, and MOSENZON, OFRI, additional

Published
2020
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26. 1101-P: Cardiorenal Outcomes with Dapagliflozin by Baseline Glucose Lowering Agents: Analyses from DECLARE-TIMI 58

Author

CAHN, AVIVIT, primary, WIVIOTT, STEPHEN D., additional, MOSENZON, OFRI, additional, MURPHY, SABINA, additional, GOODRICH, ERICA L., additional, YANUV, ILAN, additional, ROZENBERG, ALIZA, additional, WILDING, JOHN, additional, LEITER, LAWRENCE A., additional, BHATT, DEEPAK L., additional, MCGUIRE, DARREN K., additional, LITWAK, LEON, additional, KOOY, ADRIAAN, additional, GAUSE-NILSSON, INGRID A., additional, FREDRIKSSON, MARTIN, additional, LANGKILDE, ANNA MARIA, additional, SABATINE, MARC S., additional, and RAZ, ITAMAR, additional

Published
2020
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27. Adolescent Obesity and Early-Onset Type 2 Diabetes

Author

Twig, Gilad, primary, Zucker, Inbar, additional, Afek, Arnon, additional, Cukierman-Yaffe, Tali, additional, Bendor, Cole D., additional, Derazne, Estela, additional, Lutski, Miri, additional, Shohat, Tammy, additional, Mosenzon, Ofri, additional, Tzur, Dorit, additional, Pinhas-Hamiel, Orit, additional, Tiosano, Shmuel, additional, Raz, Itamar, additional, Gerstein, Hertzel C., additional, and Tirosh, Amir, additional

Published
2020
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28. Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial

Author

Garvey, W. Timothy, primary, Birkenfeld, Andreas L., additional, Dicker, Dror, additional, Mingrone, Geltrude, additional, Pedersen, Sue D., additional, Satylganova, Altynai, additional, Skovgaard, Dorthe, additional, Sugimoto, Danny, additional, Jensen, Camilla, additional, and Mosenzon, Ofri, additional

Published
2020
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29. Efficacy and Safety of Dapagliflozin in the Elderly: Analysis From the DECLARE–TIMI 58 Study

Author

Cahn, Avivit, primary, Mosenzon, Ofri, additional, Wiviott, Stephen D., additional, Rozenberg, Aliza, additional, Yanuv, Ilan, additional, Goodrich, Erica L., additional, Murphy, Sabina A., additional, Bhatt, Deepak L., additional, Leiter, Lawrence A., additional, McGuire, Darren K., additional, Wilding, John P.H., additional, Gause-Nilsson, Ingrid A.M., additional, Fredriksson, Martin, additional, Johansson, Peter A., additional, Langkilde, Anna Maria, additional, Sabatine, Marc S., additional, and Raz, Itamar, additional

Published
2019
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30. Childhood Pancreatitis and Risk for Incident Diabetes in Adulthood

Author

Bendor, Cole D., primary, Bardugo, Aya, additional, Zucker, Inbar, additional, Cukierman-Yaffe, Tali, additional, Lutski, Miri, additional, Derazne, Estela, additional, Shohat, Tammy, additional, Mosenzon, Ofri, additional, Tzur, Dorit, additional, Sapir, Ari, additional, Pinhas-Hamiel, Orit, additional, Kibbey, Richard G., additional, Raz, Itamar, additional, Afek, Arnon, additional, Gerstein, Hertzel C., additional, Tirosh, Amir, additional, and Twig, Gilad, additional

Published
2019
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31. A Biomarker-Based Score for Risk of Hospitalization for Heart Failure in Patients With Diabetes.

Author

Berg, David D., Wiviott, Stephen D., Scirica, Benjamin M., Zelniker, Thomas A., Goodrich, Erica L., Jarolim, Petr, Mosenzon, Ofri, Cahn, Avivit, Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Wilding, John P.H., Johanson, Per, Langkilde, Anna Maria, Raz, Itamar, Braunwald, Eugene, Sabatine, Marc S., and Morrow, David A.

Subjects
HEART failure patients, PEOPLE with diabetes, TYPE 2 diabetes, MYOCARDIAL infarction, TREATMENT effectiveness, RESEARCH, RESEARCH methodology, EVALUATION research, RISK assessment, COMPARATIVE studies, HOSPITAL care, RESEARCH funding, HEART failure, DISEASE complications
Abstract

Objective: Heart failure (HF) is an impactful complication of type 2 diabetes mellitus (T2DM). We aimed to develop and validate a risk score for hospitalization for HF (HHF) incorporating biomarkers and clinical factor(s) in patients with T2DM.Research Design and Methods: We derived a risk score for HHF using clinical data, high-sensitivity troponin T (hsTnT), and N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) from 6,106 placebo-treated patients with T2DM in SAVOR-TIMI 53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53). Candidate variables were assessed using Cox regression. The strongest indicators of HHF risk were included in the score using integer weights. The score was externally validated in 7,251 placebo-treated patients in DECLARE-TIMI 58 (Dapagliflozin Effect on CardiovascuLAR Events-Thrombolysis in Myocardial Infarction 58). The effect of dapagliflozin on HHF was assessed by risk category in DECLARE-TIMI 58.Results: The strongest indicators of HHF risk were NT-proBNP, prior HF, and hsTnT (each P < 0.001). A risk score using these three variables identified a gradient of HHF risk (P-trend <0.001) in the derivation and validation cohorts, with C-indices of 0.87 (95% CI, 0.84-0.89) and 0.84 (0.81-0.86), respectively. Whereas there was no significant effect of dapagliflozin versus placebo on HHF in the low-risk group (hazard ratio [HR] 0.98 [95% CI 0.50-1.92]), dapagliflozin significantly reduced HHF in the intermediate-, high-, and very-high-risk groups (HR 0.64 [0.43-0.95], 0.63 [0.43-0.94], and 0.72 [0.54-0.96], respectively). Correspondingly, absolute risk reductions (95% CI) increased across these latter 3 groups: 1.0% (0.0-1.9), 3.0% (0.7-5.3), and 4.4% (-0.2 to 8.9) (P-trend <0.001).Conclusions: We developed and validated a risk score for HHF in T2DM that incorporated NT-proBNP, prior HF, and hsTnT. The risk score identifies patients at higher risk of HHF who derive greater absolute benefit from dapagliflozin. [ABSTRACT FROM AUTHOR]

Published
2021
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32. Cardiovascular, Renal, and Metabolic Outcomes of Dapagliflozin Versus Placebo in a Primary Cardiovascular Prevention Cohort: Analyses From DECLARE-TIMI 58.

Author

Cahn, Avivit, Raz, Itamar, Leiter, Lawrence A., Mosenzon, Ofri, Murphy, Sabina A., Goodrich, Erica L., Yanuv, Ilan, Rozenberg, Aliza, Bhatt, Deepak L., McGuire, Darren K., Wilding, John P.H., Gause-Nilsson, Ingrid A.M., Langkilde, Anna Maria, Sabatine, Marc S., and Wiviott, Stephen D.

Subjects
TYPE 2 diabetes, DAPAGLIFLOZIN, COHORT analysis, SYSTOLIC blood pressure, SECONDARY prevention, HEART failure, CARDIOVASCULAR disease prevention, BENZENE, RESEARCH, RESEARCH methodology, GLYCOSIDES, MEDICAL cooperation, EVALUATION research, TREATMENT effectiveness, PREVENTIVE health services, COMPARATIVE studies
Abstract

Objective: International guidelines propose prescribing sodium-glucose cotransporter 2 (SGLT2) inhibitors to patients with type 2 diabetes (T2D) as secondary prevention in patients with established atherosclerotic cardiovascular disease (ASCVD) or for primary prevention of cardiovascular events in high-risk patients with multiple risk factors (MRF) for ASCVD. The current analyses expand on the cardiovascular renal and metabolic effects of SGLT2 inhibitors in MRF patients.Research Design and Methods: In DECLARE-TIMI 58, 17,160 patients with T2D and MRF (59.4%) or established ASCVD (40.6%) were randomized to dapagliflozin versus placebo; patients were followed for a median of 4.2 years. The cardiovascular and renal outcomes in the MRF cohort were studied across clinically relevant subgroups for treatment effect and subgroup-based treatment interaction.Results: Among patients with MRF, the reduction with dapagliflozin in risk of cardiovascular death or hospitalization for heart failure (CVD/HHF) (hazard ratio [HR] 0.84, 95% CI 0.67-1.04) and the renal-specific outcome (HR 0.51, 95% CI 0.37-0.69) did not differ from that for patients with ASCVD (Pinteraction 0.99 and 0.72, respectively). The effect on CVD/HHF was entirely driven by a reduction in HHF (HR 0.64, 95% CI 0.46-0.88). The benefits of dapagliflozin on HHF and on the renal-specific outcome, among the subset with MRF, were directionally consistent across clinically relevant subgroups. At 48 months, HbA1c, weight, systolic blood pressure, and urinary albumin-to-creatinine ratio were lower with dapagliflozin versus placebo and estimated glomerular filtration rate was higher (P < 0.001).Conclusions: In patients with T2D and MRF, dapagliflozin reduced the risk of HHF and adverse renal outcomes regardless of baseline characteristics. These analyses support the benefit of dapagliflozin for important outcomes in a broad primary prevention population. [ABSTRACT FROM AUTHOR]

Published
2021
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34. 244-OR: Effects of Dapagliflozin on the Urinary Albumin-to-Creatinine Ratio in Patients with Type 2 Diabetes: A Predefined Analysis from the DECLARE-TIMI 58 Randomised, Placebo-Controlled Trial

Author

RAZ, ITAMAR, primary, WIVIOTT, STEPHEN D., additional, YANUV, ILAN, additional, ROZENBERG, ALIZA, additional, ZELNIKER, THOMAS A., additional, CAHN, AVIVIT, additional, HEERSPINK, HIDDO L., additional, DWYER, JAMIE P., additional, GOODRICH, ERICA, additional, BHATT, DEEPAK L., additional, LEITER, LAWRENCE A., additional, MCGUIRE, DARREN K., additional, WILDING, JOHN P., additional, GAUSE-NILSSON, INGRID ANNA, additional, FREDRIKSSON, MARTIN, additional, JOHANSSON, PETER A., additional, LANGKILDE, ANNA MARIA, additional, SABATINE, MARC S., additional, and MOSENZON, OFRI, additional

Published
2019
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37. Changes in Albuminuria Predict Cardiovascular and Renal Outcomes in Type 2 Diabetes: A Post Hoc Analysis of the LEADER Trial.

Author

Persson, Frederik, Bain, Stephen C., Mosenzon, Ofri, Heerspink, Hiddo J.L., Mann, Johannes F.E., Pratley, Richard, Raz, Itamar, Idorn, Thomas, Rasmussen, Søren, von Scholten, Bernt Johan, Rossing, Peter, and LEADER Trial Investigators

Subjects
TYPE 2 diabetes, ALBUMINURIA, CARDIOVASCULAR diseases, KIDNEY diseases, GLOMERULAR filtration rate, RESEARCH, KIDNEYS, RESEARCH methodology, MEDICAL cooperation, EVALUATION research, COMPARATIVE studies, CREATININE, DISEASE complications
Abstract

Objective: A post hoc analysis to investigate the association between 1-year changes in albuminuria and subsequent risk of cardiovascular and renal events.Research Design and Methods: LEADER was a randomized trial of liraglutide up to 1.8 mg/day versus placebo added to standard care for 3.5-5 years in 9,340 participants with type 2 diabetes and high cardiovascular risk. We calculated change in urinary albumin-to-creatinine ratio (UACR) from baseline to 1 year in participants with >30% reduction (n = 2,928), 30-0% reduction (n = 1,218), or any increase in UACR (n = 4,124), irrespective of treatment. Using Cox regression, risks of major adverse cardiovascular events (MACE) and a composite nephropathy outcome (from 1 year to end of trial in subgroups by baseline UACR [<30 mg/g, 30-300 mg/g, or ≥300 mg/g]) were assessed. The analysis was adjusted for treatment allocation alone as a fixed factor and for baseline variables associated with cardiovascular and renal outcomes.Results: For MACE, hazard ratios (HRs) for those with >30% and 30-0% UACR reduction were 0.82 (95% CI 0.71, 0.94; P = 0.006) and 0.99 (0.82, 1.19; P = 0.912), respectively, compared with any increase in UACR (reference). For the composite nephropathy outcome, respective HRs were 0.67 (0.49, 0.93; P = 0.02) and 0.97 (0.66, 1.43; P = 0.881). Results were independent of baseline UACR and consistent in both treatment groups. After adjustment, HRs were significant and consistent in >30% reduction subgroups with baseline micro- or macroalbuminuria.Conclusions: A reduction in albuminuria during the 1st year was associated with fewer cardiovascular and renal outcomes, independent of treatment. Albuminuria monitoring remains an important part of diabetes care, with great unused potential. [ABSTRACT FROM AUTHOR]

Published
2021
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38. Efficacy and Safety of Dapagliflozin in the Elderly: Analysis From the DECLARE-TIMI 58 Study.

Author

Cahn, Avivit, Mosenzon, Ofri, Wiviott, Stephen D., Rozenberg, Aliza, Yanuv, Ilan, Goodrich, Erica L., Murphy, Sabina A., Bhatt, Deepak L., Leiter, Lawrence A., McGuire, Darren K., Wilding, John P. H., Gause-Nilsson, Ingrid A. M., Fredriksson, Martin, Johansson, Peter A., Langkilde, Anna Maria, Sabatine, Marc S., and Raz, Itamar

Subjects
*DAPAGLIFLOZIN, *URINARY tract infections, *DIABETIC acidosis, *ACUTE kidney failure, *TREATMENT effectiveness
Abstract

Objective: Data regarding the effects of sodium-glucose cotransporter 2 inhibitors in the elderly (age ≥65 years) and very elderly (age ≥75 years) are limited.Research Design and Methods: The Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 assessed cardiac and renal outcomes of dapagliflozin versus placebo in patients with type 2 diabetes. Efficacy and safety outcomes were studied within age subgroups for treatment effect and age-based treatment interaction.Results: Of the 17,160 patients, 9,253 were <65 years of age, 6,811 ≥65 to <75 years, and 1,096 ≥75 years. Dapagliflozin reduced the composite of cardiovascular death or hospitalization for heart failure consistently, with a hazard ratio (HR) of 0.88 (95% CI 0.72, 1.07), 0.77 (0.63, 0.94), and 0.94 (0.65, 1.36) in age-groups <65, ≥65 to <75, and ≥75 years, respectively (interaction P value 0.5277). Overall, dapagliflozin did not significantly decrease the rates of major adverse cardiovascular events, with HR 0.93 (95% CI 0.81, 1.08), 0.97 (0.83, 1.13), and 0.84 (0.61, 1.15) in age-groups <65, ≥65 to <75, and ≥75 years, respectively (interaction P value 0.7352). The relative risk reduction for the secondary prespecified cardiorenal composite outcome ranged from 18% to 28% in the different age-groups with no heterogeneity. Major hypoglycemia was less frequent with dapagliflozin versus placebo, with HR 0.97 (95% CI 0.58, 1.64), 0.50 (0.29, 0.84), and 0.68 (0.29, 1.57) in age-groups <65, ≥65 to <75, and ≥75 years, respectively (interaction P value 0.2107). Safety outcomes, including fractures, volume depletion, cancer, urinary tract infections, and amputations were balanced with dapagliflozin versus placebo, and acute kidney injury was reduced, all regardless of age. Genital infections that were serious or led to discontinuation of the study drug and diabetic ketoacidosis were uncommon, yet more frequent with dapagliflozin versus placebo, without heterogeneity (interaction P values 0.1058 and 0.8433, respectively).Conclusions: The overall efficacy and safety of dapagliflozin are consistent regardless of age. [ABSTRACT FROM AUTHOR]

Published
2020
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39. Childhood Pancreatitis and Risk for Incident Diabetes in Adulthood.

Author

Bendor, Cole D., Bardugo, Aya, Zucker, Inbar, Cukierman-Yaffe, Tali, Lutski, Miri, Derazne, Estela, Shohat, Tammy, Mosenzon, Ofri, Tzur, Dorit, Sapir, Ari, Pinhas-Hamiel, Orit, Kibbey, Richard G., Raz, Itamar, Afek, Arnon, Gerstein, Hertzel C., Tirosh, Amir, and Twig, Gilad

Abstract

OBJECTIVE The relationship between acute pancreatitis and incident diabetes is unclear. We assessed whether a resolved single event of acute pancreatitis in childhood was associated with incident diabetes in adulthood. RESEARCH DESIGN AND METHODS A nationwide, population-based study of 1,802,110 Israeli adolescents (mean age 17.4 years [range 16–20]) who were examined before compulsory military service between 1979 and 2008 and whose data were linked to the Israeli National Diabetes Registry (INDR). Resolved pancreatitis was defined as a history of a single event of acute pancreatitis with normal pancreatic function at enrollment. Logistic regression analysis was applied. RESULTS Incident diabetes developed in 4.6% of subjects with resolved pancreatitis (13 of 281; none of these cases were identified as type 1 diabetes) and 2.5% among the unexposed group (44,463 of 1,801,716). Resolved acute pancreatitis was associated with incident diabetes with an odds ratio (OR) of 2.23 (95% CI 1.25– 3.98) with adjustment for age, sex, and birth year. Findings persisted after further adjustments for baseline BMI and sociodemographic confounders (OR 2.10 [95% CI 1.15–3.84]). Childhood pancreatitis was associated with a diagnosis of diabetes at a younger age, with 92% of diabetes case subjects diagnosed before 40 years of age compared with 47% in the unexposed group (P 5 0.002). The association accentuated when the study sample was limited to individuals of unimpaired health or normal BMI at baseline. CONCLUSIONS A history of acute pancreatitis in childhood with normal pancreatic function in late adolescence is a risk factor for incident type 2 diabetes, especially at young adulthood. [ABSTRACT FROM AUTHOR]

Published
2020
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42. Adolescent Hypertension and Risk for Early-Onset Type 2 Diabetes: A Nationwide Study of 1.9 Million Israeli Adolescents.

Author

Fishman, Boris, Grossman, Ehud, Zucker, Inbar, Orr, Omri, Lutski, Miri, Bardugo, Aya, Bendor, Cole D., Leiba, Yoav, Cukierman-Yaffe, Tali, Derazne, Estela, Mosenzon, Ofri, Tzur, Dorit, Beer, Zivan, Pinhas-Hamiel, Orit, Fishman, Tamar, Afek, Arnon, Tirosh, Amir, Raz, Itamar, Gerstein, Hertzel C., and Twig, Gilad

Subjects
TYPE 2 diabetes, TEENAGERS, HYPERTENSION
Abstract

The article presents the incidence of adolescent hypertension is growing worldwide and mostly in conjunction with the growing obesity prevalence. Topics include the adolescent hypertension was shown to be a risk factor for cardiovascular and renal outcomes later in life, and the Israeli Defense Forces conscription center database with the Israeli National Diabetes Registry (INDR).

Published
2021
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43. Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial

Author

Mosenzon, Ofri, primary, Leibowitz, Gil, additional, Bhatt, Deepak L., additional, Cahn, Avivit, additional, Hirshberg, Boaz, additional, Wei, Cheryl, additional, Im, KyungAh, additional, Rozenberg, Aliza, additional, Yanuv, Ilan, additional, Stahre, Christina, additional, Ray, Kausik K., additional, Iqbal, Nayyar, additional, Braunwald, Eugene, additional, Scirica, Benjamin M., additional, and Raz, Itamar, additional

Published
2016
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46. Predisposing Factors for Any and Major Hypoglycemia With Saxagliptin Versus Placebo and Overall: Analysis From the SAVOR-TIMI 53 Trial

Author

Cahn, Avivit, primary, Raz, Itamar, additional, Mosenzon, Ofri, additional, Leibowitz, Gil, additional, Yanuv, Ilan, additional, Rozenberg, Aliza, additional, Iqbal, Nayyar, additional, Hirshberg, Boaz, additional, Sjostrand, Mikaela, additional, Stahre, Christina, additional, Im, KyungAh, additional, Kanevsky, Estella, additional, Scirica, Benjamin M., additional, Bhatt, Deepak L., additional, and Braunwald, Eugene, additional

Published
2016
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47. Risk Assessment in Patients With Diabetes With the TIMI Risk Score for Atherothrombotic Disease.

Author

Bergmark, Brian A., Bhatt, Deepak L., Braunwald, Eugene, Morrow, David A., Steg, Ph. Gabriel, Gurmu, Yared, Cahn, Avivit, Mosenzon, Ofri, Raz, Itamar, Bohula, Erin, and Scirica, Benjamin M.

Subjects
DIABETES risk factors, TYPE 2 diabetes, CARDIOVASCULAR diseases risk factors, THROMBOLYTIC therapy, MYOCARDIAL infarction, PEOPLE with diabetes, PATIENTS
Abstract

OBJECTIVE: Improved risk assessment for patients with type 2 diabetes and elevated cardiovascular (CV) risk is needed. The Thrombolysis in Myocardial Infarction (TIMI) Risk Score for Secondary Prevention (TRS 2°P) predicts a gradient of risk in patients with prior myocardial infarction (MI) but has not been evaluated in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: CV event rates were compared by baseline TRS 2°P in 16,488 patients enrolled in SAVORTIMI 53 (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53)with type 2 diabetes and high CV risk or established CV disease. Calibration was tested in the diabetes cohort from the REACH (REduction of Atherothrombosis for Continued Health) Registry. RESULTS: TRS 2°P revealed a robust risk gradient for the composite of CV death, MI, and ischemic stroke in the full trial population, with 2-year event rates of 0.9% in the lowestand 19.8% in the highest-risk groups (Ptrend < 0.001). A clear risk gradient was present within the subgroups of all coronary artery disease (CAD), CAD without prior MI, CAD with priorMI, peripheral artery disease, and prior stroke (Ptrend < 0.001 for each), with consistent risk relationships across subgroups. The C-statistic (0.71 for CV death and 0.66 for the composite end point) was consistent in each subgroup. There was close calibration with the type 2 diabetes cohort from the REACH Registry (goodness-of-fit P = 0.78). CONCLUSIONS: The expanded TRS 2°P provides a practical and well-calibrated risk prediction tool for patients with type 2 diabetes. [ABSTRACT FROM AUTHOR]

Published
2018
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49. Saxagliptin and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Moderate or Severe Renal Impairment: Observations From the SAVOR-TIMI 53 Trial

Author

Udell, Jacob A., primary, Bhatt, Deepak L., additional, Braunwald, Eugene, additional, Cavender, Matthew A., additional, Mosenzon, Ofri, additional, Steg, Ph. Gabriel, additional, Davidson, Jaime A., additional, Nicolau, Jose C., additional, Corbalan, Ramon, additional, Hirshberg, Boaz, additional, Frederich, Robert, additional, Im, KyungAh, additional, Umez-Eronini, Amarachi A., additional, He, Ping, additional, McGuire, Darren K., additional, Leiter, Lawrence A., additional, Raz, Itamar, additional, and Scirica, Benjamin M., additional

Published
2014
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50. Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial.

Author

Mosenzon, Ofri, Leibowitz, Gil, Bhatt, Deepak L., Cahn, Avivit, Hirshberg, Boaz, Wei, Cheryl, KyungAh Im, Rozenberg, Aliza, Yanuv, Ilan, Stahre, Christina, Ray, Kausik K., Iqbal, Nayyar, Braunwald, Eugene, Scirica, Benjamin M., Raz, Itamar, and Im, KyungAh

Subjects
*KIDNEY diseases, *CD26 antigen, *DIABETIC neuropathies, *THROMBOLYTIC therapy, *TREATMENT of diabetes
Abstract

Objective: Dipeptidyl peptidase 4 inhibitors may have a protective effect in diabetic nephropathy.Research Design and Methods: We studied renal outcomes of 16,492 patients with type 2 diabetes, randomized to saxagliptin versus placebo and followed for a median of 2.1 years in the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) trial.Results: At baseline, 9,696 (58.8%) subjects had normoalbuminuria (albumin/creatinine ratio [ACR] <30 mg/g), 4,426 (26.8%) had microalbuminuria (ACR 30-300 mg/g), and 1,638 (9.9%) had macroalbuminuria (ACR >300 mg/g). Treatment with saxagliptin was associated with improvement in and/or less deterioration in ACR categories from baseline to end of trial (EOT) (P = 0.021, P < 0.001, and P = 0.049 for individuals with baseline normoalbuminuria, microalbuminuria, and macroalbuminuria, respectively). At 2 years, the difference in mean ACR change between saxagliptin and placebo arms was -19.3 mg/g (P = 0.033) for estimated glomerular filtration rate (eGFR) >50 mL/min/body surface area per 1.73 m2 (BSA), -105 mg/g (P = 0.011) for 50 ≥ eGFR ≥ 30 mL/min/BSA, and -245.2 mg/g (P = 0.086) for eGFR <30 mL/min/BSA. Analyzing ACR as a continuous variable showed reduction in ACR with saxagliptin (1 year, P < 0.0001; 2 years, P = 0.0143; and EOT, P = 0.0158). The change in ACR did not correlate with that in HbA1c (r = 0.041, 0.052, and 0.036; 1 year, 2 years, and EOT, respectively). The change in eGFR was similar in the saxagliptin and placebo groups. Safety renal outcomes, including doubling of serum creatinine, initiation of chronic dialysis, renal transplantation, or serum creatinine >6.0 mg/dL, were similar as well.Conclusions: Treatment with saxagliptin improved ACR, even in the normoalbuminuric range, without affecting eGFR. The beneficial effect of saxagliptin on albuminuria could not be explained by its effect on glycemic control. [ABSTRACT FROM AUTHOR]

Published
2017
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