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1. Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial

Author

Abe, Mitsunori, Abhaichand, Rajpal K, Abhayaratna, Walter P, Abhyankar, Atul, Abidin, Imran B Zainal, Abou Assi, Hiba, Accini Mendoza, Jose L, Adas, Mine, Agaiby, John M, Agarwal, Devendra K, Agha, Maher, Ahmed, Azazuddin, Ahtiainen, Petteri, Aigner, Elmar, Ajay, Naik, Ali, Norsiah, Al-Karadsheh, Amer, Allison, Roy, Allison, Dale C, Alpenidze, Diana, Altuntas, Yuksel, Al-Zoebi, Ayham, Ambuj, Roy, Amerena, John, Anderson, Robert J, Ando, Toshiaki, Andrews, Robert, Antonova, Elizaveta, Appel, Karl-Friedrich, Arantes, Flávia B, Araz, Mustafa, Arbel, Yaron, Arenas León, José L, Argyrakopoulou, Georgia, Ariani, Mehrdad, Arias Mendoza, Maria A, Arif, Ahmed A, Arneja, Jaspal, Aroda, Vanita R, Aronne, Louis J, Arstall, Margaret, Asamoah, Njaimeh, Asanin, Milika, Audish, Hanid, Avram, Rodica, Badat, Aysha, Badiu, Corin V, Bakdash, Wa'el, Bakiner, Okan S, Bandezi, Vuyokazi N, Bang, Liew H, Bansal, Sandeep, Baranyai, Marietta, Barbarash, Olga, Barber, Mark, Barnum, Otis, Barone Rochette, Gilles, Bashkin, Amir, Baum, Seth, Bays, Harold E, Bazzoni Ruiz, Alberto E, Beckowski, Maciej, Beerachee, Yaswin, Bellary, Srikanth, Belousova, Lidia, Berk, Martin, Bernstein, Marc, Berra, Cesare, Beshay, Isaac, Bhagwat, Ajit, Bhan, Arti, Biggs, William C, Billings, Liana, Bitar, Fahed, Block, Bradley, Bo, Simona, Bogdanski, Pawel, Bolshakova, Olga O, Boshchenko, Alla A, Bosworth, Hayden, Botero Lopez, Rodrigo, Bôttcher, Morten, Bourgeois, Ronald, Brautigam, Donald, Breton, Cristian F, Broadley, Andrew, Brockmyre, Andrew P, Brodie, Steven K, Bucci, Marco, Budincevic, Hrvoje, Budoff, Matthew J, Buffman, Barry, Buljubasic, Nediljka, Buranapin, Supawan, Burgess, Lesley, Burguera, Bartolomé, Buriakovska, Olena, Buscemi, Silvio, Busch, Robert, Buse, John B, Buynak, Robert, Byrne, Maria, Caceaune, Elena, Cadena Bonfanti, Alberto J, Calinescu, Cornell V, Call, Robert S, Canecki Varzic, Silvija, Cannon, Kevin, Capehorn, Matt, Cariou, Bertrand, Carr, Jeffrey, Carrillo-Jimenez, Rodolfo, Casas, Marcelo, Castro, Almudena, Celik, Ahmet, Cercato, Cintia, Cermak, Ondrej, Cha, James Y, Chacon, Carolina, Chaicha-Brom, Tira, Chandra, Sandeep, Chettibi, Mohamed, Chevts, Julia, Christopher, Johann, Chrustowski, Witold, Cif, Adriana, Clark, Rebecca, Clark, Wayne, Clifford, Piers, Coetzee, Kathleen, Cogni, Giulia, Colao, Anna Maria, Colquhoun, David M, Concha, Mauricio, Condit, Jonathan, Constance, Christian, Constantin, Ciprian, Constantinescu, Silviana, Corbett, Clive, Cornett, George M, Correia, Marcelo, Cortinovis, Fiorenzo, Cosma, Dana, Creely, Steven, Cross, David, Curtis, Brian, Czochra, Wojciech, Daboul, Nizar Y, Dagdelen, Selcuk, D'agostino, Ronald, Dang, Cuong, Datta, Sudip, Davuluri, Ashwini K, Dawood, Saleem Y, De Jong, Douwe M, De La Cuesta, Carmen, De Los Rios Ibarra, Manuel O, De Pablo, Carmen, De Pauw, Michel, Dela Llana, Alexander, Delibasic, Maja, Delic-Brkljacic, Diana, Demicheli, Thibaud, Denger, Ralf J, Desai, Devang, Desai, Piyush, Desouza, Cyrus V, Dicker, Dror, Djenic, Nemanja, Dobson, Simon, Doi, Masayuki, Doran, Jesse A, Dorman, Reinhart, Dotta, Francesco, Dukes, Carl E, Duronto, Ernesto, Durst, Ronen, Dvoryashina, Irina V, Ebrahim, Iftikhar O, Eggebrecht, Holger, Egstrup, Kenneth, Ekinci, Elif I, Eliasson, Björn, Eliasson, Ken, Enache, Georgiana, Enculescu, Dan, English, Patrick, Ermakova, Polina, Ershova, Olga, Ezaki, Hirotaka, Ezhov, Marat, Farias, Eduardo, Farias, Javier M, Farsky, Pedro S, Ferreira, Daniel, Filteau, Pierre, Finneran, Matthew P, Folkens, Eric M, Fonseca, Alberto G, Fonseca, Luisa, Fordan, Steven, Fourie, Nyda, França, Sara, Franco, Denise R, Franek, Edward, Friedman, Keith, Frittitta, Lucia, Froer, Michael, Fuckar, Krunoslav, Fujii, Kenshi, Fujita, Ryoko, Fukushima, Yasushi, Fulat, Mohamed, Fulwani, Mahesh, Gajos, Grzegorz, Galyavich, Albert, Gambill, Michael L, Gandotra, Dheeraj, Winston, Gandy, Jr., Garcia Hernandez, Pedro A, García Reza, Raymundo, Garg, Naveen, Garg, Sandeep, Garvey, William T, Garza, Juan C, Gatta-Cherifi, Blandine, Gelev, Valeri, Geller, Steven A, Geohas, Jeffrey G, Georgiev, Borislav, Ghazi, Adline, Gilbert, Matthew P, Gilinskaya, Olga, Gislason, Gunnar, Gogas Yavuz, Dilek, González Albarrán, Olga, Gordeev, Ivan G, Gorton, Sidney C, Goudev, Assen, Gretland Valderhaug, Tone, Groenemeijer, Bjorn, Gul, Ibrahim, Gullestad, Lars, Gurieva, Irina, Guseva, Galina N, Hagenow, Andreas, Haluzik, Martin, Halvorsen, Sigrun, Hammoudi, Naima, Hanaoka, Keiichi, Hancu, Nicolae, Hanusch, Ursula, Harris, Kathleen, Harris, Barry, Hartleib, Michael, Hartman, Aaron N, Hata, Yoshiki, Heimer, Brian, Herman, Lee, Herzog, William, Hewitt, Eric, Heymer, Peter, Hiremath, Shirish, Hjelmesaeth, Joeran, Høgalmen, Rasmus Geir, Høivik, Hans Olav, Holmer, Helene, Horoshko, Olha, Houser, Patricia M, Hove, Jens D, Hsieh, I-Chang, Hulot, Jean-Sébastien, Hussein, Zanariah, Ilashchuk, Tetiana, Ilveskoski, Erkki, Ipatko, Irina, Iranmanesh, Ali, Isawa, Tsuyoshi, Issa, Moises, Iteld, Bruce, Iwasawa, Takamasa, Jabbar, Danish, Jackson, Richard A, Jackson-Voyzey, Ewart, Jacob, Stephan, Jaffrani, Naseem A, Jardula, Michael F, Jastreboff, Ania, Jensen, Svend E, Jerkins, Terri, Jimenez-Ramos, Silvia A, Jitendra Pal Singh, Sawhney, Johnson, Wallace, Joyce, John M, Jozefowska, Malgorzata, Jugnundan, Prakash, Jungmair, Wolfgang, Jurowiecki, Jaroslaw, Kadokami, Toshiaki, Kahali, Dhiman, Kahrmann, Gerd, Kaiser, Sergio E, Kalmucki, Piotr, Kanadasi, Mehmet, Kandath, David, Kania, Grzegorz, Kannan, J, Kapp, Cornelia, Karczmarczyk, Agnieszka, Kartalis, Athanasios, Kaser, Susanne, Kasim, Sazzli Shahlan, Kastelic, Richard, Kato, Toshiaki, Katova, Tzvetana, Kaul, Upendra, Kautzky-Willer, Alexandra, Kawanishi, Masahiro, Kayikcioglu, Meral, Kazakova, Elena E, Keeling, Philip, Kempe, Hans-Peter, Kereiakes, Dean J, Kerneis, Mathieu, Keski-Opas, Tiina, Khadra, Suhail, Khaisheva, Larisa, Kharakhulakh, Marina, Khlevchuk, Tatiana, Khoo, Jeffrey, Kiatchoosakun, Songsak, Kinoshita, Noriyuki, Kinoshita, Masaharu, Kitamura, Ryoji, Kiyosue, Arihiro, Klavina, Irina, Klein, Eric J, Klimsa, Zdenek, Klonoff, David, Klug, Eric, Kobalava, Zhanna, Kodera, Satoshi, Koga, Tokushi, Kokkinos, Alexander, Koleckar, Pavel, Könyves, László, Koren, Michael J, Kormann, Adrian P, Kostner, Karam, Kreutzmann, Kristin, Krishinan, Saravanan, Krishnasamy, Sathya S, Krivosheeva, Inga, Kruljac, Ivan, Kubicki, Ted, Kuchar, Ladislav, Kujawiak, Monika, Kunishige, Hideyuki, Kurtinecz, Melinda, Kurtz Lisboa, Hugo R, Kushnir, Mykola, Kyyak, Yulian, Lace, Arija, Lakka, Timo, Lalic, Nebojsa, Lalic, Katarina, Lambadiari, Vaia, Lanaras, Leonidas, Lang, Chim, Langlois, Marie-France, Lash, Joseph, Latkovskis, Gustavs, Lau, David, Lazcano Soto, José Roberto, Le Roux, Carel, Ledesma, Gilbert N, Lee, Li Yuan, Lee, Thung-Lip, Lee, Kelvin, Lehrke, Michael, Leite, Silmara O, Leksycka, Agata, Lenzmeier, Thomas, Leonetti, Frida, Leonidova, Viktoriia, Lepor, Norman, Leung, Melissa, Levchenko, Olena, Levins, Peter, Levy, Louis J, Lewis, Matthew, Liberopoulos, Evangelos, Liberty, Idit, Lindholm, Carl-Johan, Lingvay, Ildiko, Linhart, Ales, Liu, Ming-En, Liu, Jenny, Lofton, Holly, Logemann, Timothy, Lombaard, Johannes J, Lombard, Landman, Lorraine, Richard, Lovell, Charles F, Ludvik, Bernhard, Lukaszewicz, Monika, Lupkovics, Géza, Lupovitch, Steven, Lupu, Sirona, Lynch, Mary, Lysak, Zoreslava, Lysenko, Tatyana A, Maeda, Hajime, Maeda, Itaru, Mæng, Michael, Mahajan, Ajay U, Maher, Vincent, Maia, Lilia N, Makotoko, Ellen M, Malavazos, Alexis, Malecha, Jan, Malicherova, Emilia, Manita, Mamoru, Mannucci, Edoardo, Mareev, Viacheslav, Marin, Liliana, Markova, Tatiana, Marso, Steven P, Martens, F.M.A.C., Martinez, Cuper, Martinez Cano, Carlos A, Martins, Cristina, Masmiquel Comas, Luis, Matsumoto, Takashi, Mcdonald, Kenneth, Mcgowan, Barbara, Mcgrew, Frank, Mclean, Barry K, Mcpherson, David D, Merino Torres, Juan Francisco, Meyers, Peter, Meyhöfer, Sebastian, Mezquita Raya, Pedro, Milanova, Maria, Milicic, Davor, Miller, Gary, Mills, Richard E, Mîndrescu, Nicoleta M, Mingrone, Geltrude, Minkova, Dotska A, Mirani, Marco, Miras, Alexander, Mistodie, Cristina V, Mitomo, Satoru, Mittal, Sanjay, Miyake, Taiji, Miyamoto, Naomasa, Molony, David, Monteiro, Pedro, Mooe, Thomas, Moosa, Naeem, Morales Portillo, Cristobal, Morales Villegas, Enrique C, Morawski, Emily J, Morbey, Claire, Morin, Robert P, Morisaki, Kuniaki, Morosanu, Magdalena, Mosenzon, Ofri, Mostovoy, Yuriy, Munir, Iqbal, Muratori, Fabrizio, Murray, Ryan, Murthy, Avinash, Myint, Min, Myshanych, Galyna, Nafornita, Valerica, Nagano, Takuya, Nair, Sunil, Nakhle, Samer N, Natsuaki, Masahiro, Nayak, Bindu M, Nibouche, Djamel Eddine, Nicholls, Stephen, Nicolau, José C, Nicolescu, Georgiana, Nierop, Peter, Niskanen, Leo, Ntaios, George, Nygård, Ottar Kjell, Oaks, Joshua B, Obrezan, Andrey, O'donnell, Philip, Oguri, Mitsutoshi, Oguzhan, Abdurrahman, Oh, Fumiki, Ohsugi, Mitsuru, Okada, Yoshio, Okayama, Hideki, Onaca, Adriana, Onaka, Haruhiko, Oneil, Patrick, Ong, Tiong Kiam, Ong, Stephen, Ono, Yasuhiro, Opsahl, Paul J, Ostrowska, Lucyna, Oviedo, Alejandra, Ozdogan, Oner, Ozpelit, Ebru, Pagkalos, Emmanouil, Pagotto, Uberto, Páll, Dénes, Pandey, Amritanshu- Shekhar, Parkhomenko, Oleksandr, Parvathareddy, Krishna Malakondareddy, Patel, Minesh B, Patsilinakos, Sotirios, Paul, Neil, Pedersen, Sue, Pereira, Isabel, Pereira, Edward Scott, Perez Terns, Paula, Perez-Vargas, Elba A, Pergaeva, Yulia, Perkelvald, Alexander, Peskov, Andrey B, Peter, Jonathan, Peters, Karina, Petit, Catherine, Petrov, Ivo, Philis-Tsimikas, Athena, Pietilä, Mikko, Pinto, Fausto, Piros, Annamária, Piyayotai, Dilok, Platonov, Dmitriy, Poirier, Paul, Pop, Lavinia, Popa, Bogdan, Pop-Busui, Rodica, Poremba, John, Porto, Alejandro, Postadzhiyan, Arman, Pothineni, Ramesh B, Potu, Ranganatha P, Powell, Talessa, Prafulla, Kerkar G, Prager, Rudolf, Prakova-Teneva, Zhulieta R, Pratley, Richard E, Price, Hermione, Pulka, Grazyna, Pullman, John, Punt, Zelda E, Purighalla, Raman S, Purnell, Peter, Qureshi, Mansoor, Rabasa-Lhoret, Remi, Raikhel, Marina A, Rancane, Gita, Randeva, Harpal, Rasouli, Neda, Reurean Pintilei, Delia V, Reyes, Ciro R, Rezgale, Inga, Rice, Eva, Riley, Thaddeus H, Risser, Joseph A, Ristic, Arsen, Rivas Fernández, Margarita, Robbins, David, Robitaille, Yves, Rodbard, Helena W, Rodriguez Plazas, Jaime A, Römer, T.J., Rosen, Glenn, Rosman, Dr Azhari, Rossi, Paulo, Rudenko, Leonid, Ruffin, Omari, Ruhani, Anwar Irawan, Runev, Nikolay, Ruyatkin, Dmitriy, Ruzic, Alen, Ryabov, Vyacheslav V, Rydén, Lars, Saggar, Suraj, Sakamoto, Tomohiro, Salter, Tim, Samal, Aditya K, Samoilova, Yulia, Sanabria, Hugo D, Sancak, Seda, Sangrigoli, Renee, Sansanayudh, Nakarin, Santini, Ferruccio, Saraiva, José F, Sardinov, Ruslan, Sargeant, William, Sari, Ramazan, Sathananthan, Airani, Sathyapalan, Thozhukat, Sato, Atsushi, Sauter, Joachim, Sbraccia, Paolo, Schaap, J., Schaum, Thomas, Schiele, François, Scott, John, Segal Lieberman, Gabriella, Segner, Alexander, Senior, Roxy, Sergeeva-Kondrachenko, Marina Y, Serota, Harvey, Serusclat, Pierre, Sethi, Rishi, Shah, Manoj K, Shah, Neerav, Shalaev, Sergey, Sharma, Raj, Sharma, Sumeet, Shaydyuk, Oksana, Shea, Heidi C, Shechter, Michael, Shehadeh, Naim, Shirazi, Mitra, Shlesinger, Yshay, Shneker, Ayham, Shutemova, Elena, Siasos, Gerasimos, Siddiqui, Imran A, Sidey, Jennifer, Sigal, Felix, Sime, Iveta, Singh, Narendra, Siraj, Elias, Sivalingam, Kanagaratnam, Skoczylas, Grzegorz, Smith, Stephen K, Smolenskaya, Olga, Snyder, Brian, Sofer, Yael, Sofley, C.W., Solano, Royce, Sonmez, Yusuf A, Sorokin, Maxim, Soto González, Alfonso, Sotolongo, Carlos, Soufer, Joseph, Soyluk Selcukbiricik, Ozlem, Spaic, Tamara, Spriggs, Douglas, Sreenan, Seamus, Stahl, Hans-Detlev, Stamatelopoulos, Kimon, Stanislavchuk, Mykola, Stankovic, Goran, Stasek, Josef, Steg, Gabriel, Steindorf, Joerg, Stephan, Dominique, Stewart, John, Still, Christopher, St-Maurice, Francois, Stogowska-Nikiciuk, Barbara, Stoker, Jeff, Stokic, Edita, Strzelecka, Anna, Sturm, Kerstin, Sueyoshi, Atsushi, Sugiura, Toshiyuki, Sultan, Senan, Suplotova, Lyudmila A, Suwanagool, Arisara, Suwanwalaikorn, Sompongse, Sveklina, Tatiana, Swanson, Neil, Swart, Henk, Swenson, Bradley P, Szyprowska, Ewa, Tait, Graeme, Takács, Róbert, Takeuchi, Yuzo, Tamirisa, Aparna, Tanaka, Hideki, Tatovic, Danijela, Tellier, Guy, Teragawa, Hiroki, Teterovska, Dace, Thomas, Nihal, Thuan, Jean-Francois, Tinahones, Francisco, Tisheva-Gospodinova, Snezhanka, Toarba, Cristina, Todoriuk, Liudmyla, Tokmakova, Mariya, Tonstad, Serena, Toplak, Hermann, Tran, Henry, Tripathy, Devjit, Trusau, Aliaksandr, Tsabedze, Nqoba, Tsougos, Elias, Tsoukas, George M, Tuccinardi, Dario, Tuna, Mazhar M, Turatti, Luiz A, Tziomalos, Konstantinos, Udommongkol, Chesda, Ueda, Osamu, Ukkola, Olavi, Unubol, Mustafa, Urbach, Dorothea, Urina Triana, Miguel A, Usdan, Lisa, Vaidya, Bijay, Vale, Noah, Vallieres, Gerald, Van Beek, Andre P, Van De Borne, Philippe, Van Der Walt, Eugene, Van Der Zwaan, C., Van Nieuwenhuizen, Elane, Van Zyl, Louis, Vanduynhoven, Philippe, Varghese, Kiron, Vasileva, Svetla P, Vassilev, Dobrin, Vathesatogkit, Prin, Velychko, Valentyna, Vercammen, Chris, Verges, Bruno, Verma, Subodh, Verwerft, Jan, Vesela, Alica, Veselovskaya, Nadezhda G, Vettor, Roberto, Veze, Irina, Vijan, Vinod, Vijayaraghavan, Ram, Villarino, Adriana, Vincent, Royce, Vinogradova, Oksana, Vishlitzky, Victor, Vlad, Adrian, Vladu, Ionela Mihaela, Vo, Anthony, Von Engelhardt, Charlotte, Von Münchhausen, Candy, Vorobyeva, Olga, Vossenberg, T., Vrolix, Mathias, Vukicevic, Marjana, Vyshnyvetskyy, Ivan, Wadvalla, Shahid, Wagner, Jan, Wakeling, John, Wallace, James, Wan Mohamed, Wan Mohd Izani, Wander, Gurpreet S, Ward, Kathleen, Warren, Mark L, Watanabe, Atsuyuki, Weber, Bruce, Weintraub, Howard, Weisnagel, John, Welker, James, Wendisch, Ulrich, Wenocur, Howard S, Wierum, Craig, Wilding, John, William, Maged, Wilson, Pete, Wilson, Jonathan P, Wong, Yuk-Ki, Wongcharoen, Wanwarang, Wozniak, Iwona, Wu, Chau-Chung, Wyatt, Nell, Wynne, Alan, Yamaguchi, Hiroshi, Yamasaki, Masahiro, Yazici, Dilek, Yeh, Hung-I, Yotov, Yoto, Yuan, Qingyang, Zacher, Jeffrey, Zagrebelnaya, Olga, Zaidman, Cesar J, Zalevskaya, Alsu, Zarich, Stuart, Zatelli, Maria Chiara, Zeller, Helga, Zhdanova, Elena A, Zornitzki, Taiba, Zrazhevskiy, Konstantin, Zykov, Mikhail, Lincoff, A Michael, Ryan, Donna H, Colhoun, Helen M, Deanfield, John E, Emerson, Scott S, Kahn, Steven E, Kushner, Robert F, Plutzky, Jorge, Brown-Frandsen, Kirstine, Hovingh, G Kees, Hardt-Lindberg, Soren, Tornøe, Christoffer W, Deanfield, John, Scirica, Benjamin M, Ryan, Donna, Kosiborod, Mikhail N, Hardt-Lindberg, Søren, Frenkel, Ofir, Weeke, Peter E, Rasmussen, Søren, Lang, Chim C, and Urina-Triana, Miguel

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2024
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4. Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial

Author

Deanfield, John, Verma, Subodh, Scirica, Benjamin M, Kahn, Steven E, Emerson, Scott S, Ryan, Donna, Lingvay, Ildiko, Colhoun, Helen M, Plutzky, Jorge, Kosiborod, Mikhail N, Hovingh, G Kees, Hardt-Lindberg, Søren, Frenkel, Ofir, Weeke, Peter E, Rasmussen, Søren, Goudev, Assen, Lang, Chim C, Urina-Triana, Miguel, Pietilä, Mikko, Lincoff, A Michael, Abe, Mitsunori, Abhaichand, Rajpal K, Abhayaratna, Walter P, Abhyankar, Atul, Abidin, Imran B Zainal, Abou Assi, Hiba, Accini Mendoza, Jose L, Adas, Mine, Agaiby, John M, Agarwal, Devendra K, Agha, Maher, Ahmed, Azazuddin, Ahtiainen, Petteri, Aigner, Elmar, Ajay, Naik, Ali, Norsiah, Al-Karadsheh, Amer, Allison, Roy, Allison, Dale C, Alpenidze, Diana, Altuntas, Yuksel, Al-Zoebi, Ayham, Ambuj, Roy, Amerena, John, Anderson, Robert J, Ando, Toshiaki, Andrews, Robert, Antonova, Elizaveta, Appel, Karl-Friedrich, Arantes, Flávia B, Araz, Mustafa, Arbel, Yaron, Arenas León, José L, Argyrakopoulou, Georgia, Ariani, Mehrdad, Arias Mendoza, Maria A, Arif, Ahmed A, Arneja, Jaspal, Aroda, Vanita R, Aronne, Louis J, Arstall, Margaret, Asamoah, Njaimeh, Asanin, Milika, Audish, Hanid, Avram, Rodica, Badat, Aysha, Badiu, Corin V, Bakdash, Wa'el, Bakiner, Okan S, Bandezi, Vuyokazi N, Bang, Liew H, Bansal, Sandeep, Baranyai, Marietta, Barbarash, Olga, Barber, Mark, Barnum, Otis, Barone Rochette, Gilles, Bashkin, Amir, Baum, Seth, Bays, Harold E, Bazzoni Ruiz, Alberto E, Beckowski, Maciej, Beerachee, Yaswin, Bellary, Srikanth, Belousova, Lidia, Berk, Martin, Bernstein, Marc, Berra, Cesare, Beshay, Isaac, Bhagwat, Ajit, Bhan, Arti, Biggs, William C, Billings, Liana, Bitar, Fahed, Block, Bradley, Bo, Simona, Bogdanski, Pawel, Bolshakova, Olga O, Boshchenko, Alla A, Bosworth, Hayden, Botero Lopez, Rodrigo, Bôttcher, Morten, Bourgeois, Ronald, Brautigam, Donald, Breton, Cristian F, Broadley, Andrew, Brockmyre, Andrew P, Brodie, Steven K, Bucci, Marco, Budincevic, Hrvoje, Budoff, Matthew J, Buffman, Barry, Buljubasic, Nediljka, Buranapin, Supawan, Burgess, Lesley, Burguera, Bartolomé, Buriakovska, Olena, Buscemi, Silvio, Busch, Robert, Buse, John B, Buynak, Robert, Byrne, Maria, Caceaune, Elena, Cadena Bonfanti, Alberto J, Calinescu, Cornell V, Call, Robert S, Canecki Varzic, Silvija, Cannon, Kevin, Capehorn, Matt, Cariou, Bertrand, Carr, Jeffrey, Carrillo-Jimenez, Rodolfo, Casas, Marcelo, Castro, Almudena, Celik, Ahmet, Cercato, Cintia, Cermak, Ondrej, Cha, James Y, Chacon, Carolina, Chaicha-Brom, Tira, Chandra, Sandeep, Chettibi, Mohamed, Chevts, Julia, Christopher, Johann, Chrustowski, Witold, Cif, Adriana, Clark, Rebecca, Clark, Wayne, Clifford, Piers, Coetzee, Kathleen, Cogni, Giulia, Colao, Anna Maria, Colquhoun, David M, Concha, Mauricio, Condit, Jonathan, Constance, Christian, Constantin, Ciprian, Constantinescu, Silviana, Corbett, Clive, Cornett, George M, Correia, Marcelo, Cortinovis, Fiorenzo, Cosma, Dana, Creely, Steven, Cross, David, Curtis, Brian, Czochra, Wojciech, Daboul, Nizar Y, Dagdelen, Selcuk, D'agostino, Ronald, Dang, Cuong, Datta, Sudip, Davuluri, Ashwini K, Dawood, Saleem Y, De Jong, Douwe M, De La Cuesta, Carmen, De Los Rios Ibarra, Manuel O, De Pablo, Carmen, De Pauw, Michel, Dela Llana, Alexander, Delibasic, Maja, Delic-Brkljacic, Diana, Demicheli, Thibaud, Denger, Ralf J, Desai, Devang, Desai, Piyush, Desouza, Cyrus V, Dicker, Dror, Djenic, Nemanja, Dobson, Simon, Doi, Masayuki, Doran, Jesse A, Dorman, Reinhart, Dotta, Francesco, Dukes, Carl E, Duronto, Ernesto, Durst, Ronen, Dvoryashina, Irina V, Ebrahim, Iftikhar O, Eggebrecht, Holger, Egstrup, Kenneth, Ekinci, Elif I, Eliasson, Björn, Eliasson, Ken, Enache, Georgiana, Enculescu, Dan, English, Patrick, Ermakova, Polina, Ershova, Olga, Ezaki, Hirotaka, Ezhov, Marat, Farias, Eduardo, Farias, Javier M, Farsky, Pedro S, Ferreira, Daniel, Filteau, Pierre, Finneran, Matthew P, Folkens, Eric M, Fonseca, Alberto G, Fonseca, Luisa, Fordan, Steven, Fourie, Nyda, França, Sara, Franco, Denise R, Franek, Edward, Friedman, Keith, Frittitta, Lucia, Froer, Michael, Fuckar, Krunoslav, Fujii, Kenshi, Fujita, Ryoko, Fukushima, Yasushi, Fulat, Mohamed, Fulwani, Mahesh, Gajos, Grzegorz, Galyavich, Albert, Gambill, Michael L, Gandotra, Dheeraj, Winston, Gandy, Garcia Hernandez, Pedro A, García Reza, Raymundo, Garg, Naveen, Garg, Sandeep, Garvey, William T, Garza, Juan C, Gatta-Cherifi, Blandine, Gelev, Valeri, Geller, Steven A, Geohas, Jeffrey G, Georgiev, Borislav, Ghazi, Adline, Gilbert, Matthew P, Gilinskaya, Olga, Gislason, Gunnar, Gogas Yavuz, Dilek, González Albarrán, Olga, Gordeev, Ivan G, Gorton, Sidney C, Goudev, Assen, Gretland Valderhaug, Tone, Groenemeijer, Bjorn, Gul, Ibrahim, Gullestad, Lars, Gurieva, Irina, Guseva, Galina N, Hagenow, Andreas, Haluzik, Martin, Halvorsen, Sigrun, Hammoudi, Naima, Hanaoka, Keiichi, Hancu, Nicolae, Hanusch, Ursula, Harris, Kathleen, Harris, Barry, Hartleib, Michael, Hartman, Aaron N, Hata, Yoshiki, Heimer, Brian, Herman, Lee, Herzog, William, Hewitt, Eric, Heymer, Peter, Hiremath, Shirish, Hjelmesaeth, Joeran, Høgalmen, Rasmus Geir, Høivik, Hans Olav, Holmer, Helene, Horoshko, Olha, Houser, Patricia M, Hove, Jens D, Hsieh, I-Chang, Hulot, Jean-Sébastien, Hussein, Zanariah, Ilashchuk, Tetiana, Ilveskoski, Erkki, Ipatko, Irina, Iranmanesh, Ali, Isawa, Tsuyoshi, Issa, Moises, Iteld, Bruce, Iwasawa, Takamasa, Jabbar, Danish, Jackson, Richard A, Jackson-Voyzey, Ewart, Jacob, Stephan, Jaffrani, Naseem A, Jardula, Michael F, Jastreboff, Ania, Jensen, Svend E, Jerkins, Terri, Jimenez-Ramos, Silvia A, Jitendra Pal Singh, Sawhney, Johnson, Wallace, Joyce, John M, Jozefowska, Malgorzata, Jugnundan, Prakash, Jungmair, Wolfgang, Jurowiecki, Jaroslaw, Kadokami, Toshiaki, Kahali, Dhiman, Kahrmann, Gerd, Kaiser, Sergio E, Kalmucki, Piotr, Kanadasi, Mehmet, Kandath, David, Kania, Grzegorz, Kannan, J, Kapp, Cornelia, Karczmarczyk, Agnieszka, Kartalis, Athanasios, Kaser, Susanne, Kasim, Sazzli Shahlan, Kastelic, Richard, Kato, Toshiaki, Katova, Tzvetana, Kaul, Upendra, Kautzky-Willer, Alexandra, Kawanishi, Masahiro, Kayikcioglu, Meral, Kazakova, Elena E, Keeling, Philip, Kempe, Hans-Peter, Kereiakes, Dean J, Kerneis, Mathieu, Keski-Opas, Tiina, Khadra, Suhail, Khaisheva, Larisa, Kharakhulakh, Marina, Khlevchuk, Tatiana, Khoo, Jeffrey, Kiatchoosakun, Songsak, Kinoshita, Noriyuki, Kinoshita, Masaharu, Kitamura, Ryoji, Kiyosue, Arihiro, Klavina, Irina, Klein, Eric J, Klimsa, Zdenek, Klonoff, David, Klug, Eric, Kobalava, Zhanna, Kodera, Satoshi, Koga, Tokushi, Kokkinos, Alexander, Koleckar, Pavel, Könyves, László, Koren, Michael J, Kormann, Adrian P, Kostner, Karam, Kreutzmann, Kristin, Krishinan, Saravanan, Krishnasamy, Sathya S, Krivosheeva, Inga, Kruljac, Ivan, Kubicki, Ted, Kuchar, Ladislav, Kujawiak, Monika, Kunishige, Hideyuki, Kurtinecz, Melinda, Kurtz Lisboa, Hugo R, Kushnir, Mykola, Kyyak, Yulian, Lace, Arija, Lakka, Timo, Lalic, Nebojsa, Lalic, Katarina, Lambadiari, Vaia, Lanaras, Leonidas, Lang, Chim, Langlois, Marie-France, Lash, Joseph, Latkovskis, Gustavs, Lau, David, Lazcano Soto, José Roberto, Le Roux, Carel, Ledesma, Gilbert N, Lee, Li Yuan, Lee, Thung-Lip, Lee, Kelvin, Lehrke, Michael, Leite, Silmara O, Leksycka, Agata, Lenzmeier, Thomas, Leonetti, Frida, Leonidova, Viktoriia, Lepor, Norman, Leung, Melissa, Levchenko, Olena, Levins, Peter, Levy, Louis J, Lewis, Matthew, Liberopoulos, Evangelos, Liberty, Idit, Lindholm, Carl-Johan, Lingvay, Ildiko, Linhart, Ales, Liu, Ming-En, Liu, Jenny, Lofton, Holly, Logemann, Timothy, Lombaard, Johannes J, Lombard, Landman, Lorraine, Richard, Lovell, Charles F, Ludvik, Bernhard, Lukaszewicz, Monika, Lupkovics, Géza, Lupovitch, Steven, Lupu, Sirona, Lynch, Mary, Lysak, Zoreslava, Lysenko, Tatyana A, Maeda, Hajime, Maeda, Itaru, Mæng, Michael, Mahajan, Ajay U, Maher, Vincent, Maia, Lilia N, Makotoko, Ellen M, Malavazos, Alexis, Malecha, Jan, Malicherova, Emilia, Manita, Mamoru, Mannucci, Edoardo, Mareev, Viacheslav, Marin, Liliana, Markova, Tatiana, Marso, Steven P, Martens, F.M.A.C., Martinez, Cuper, Martinez Cano, Carlos A, Martins, Cristina, Masmiquel Comas, Luis, Matsumoto, Takashi, Mcdonald, Kenneth, Mcgowan, Barbara, Mcgrew, Frank, Mclean, Barry K, Mcpherson, David D, Merino Torres, Juan Francisco, Meyers, Peter, Meyhöfer, Sebastian, Mezquita Raya, Pedro, Milanova, Maria, Milicic, Davor, Miller, Gary, Mills, Richard E, Mîndrescu, Nicoleta M, Mingrone, Geltrude, Minkova, Dotska A, Mirani, Marco, Miras, Alexander, Mistodie, Cristina V, Mitomo, Satoru, Mittal, Sanjay, Miyake, Taiji, Miyamoto, Naomasa, Molony, David, Monteiro, Pedro, Mooe, Thomas, Moosa, Naeem, Morales Portillo, Cristobal, Morales Villegas, Enrique C, Morawski, Emily J, Morbey, Claire, Morin, Robert P, Morisaki, Kuniaki, Morosanu, Magdalena, Mosenzon, Ofri, Mostovoy, Yuriy, Munir, Iqbal, Muratori, Fabrizio, Murray, Ryan, Murthy, Avinash, Myint, Min, Myshanych, Galyna, Nafornita, Valerica, Nagano, Takuya, Nair, Sunil, Nakhle, Samer N, Natsuaki, Masahiro, Nayak, Bindu M, Nibouche, Djamel Eddine, Nicholls, Stephen, Nicolau, José C, Nicolescu, Georgiana, Nierop, Peter, Niskanen, Leo, Ntaios, George, Nygård, Ottar Kjell, Oaks, Joshua B, Obrezan, Andrey, O'donnell, Philip, Oguri, Mitsutoshi, Oguzhan, Abdurrahman, Oh, Fumiki, Ohsugi, Mitsuru, Okada, Yoshio, Okayama, Hideki, Onaca, Adriana, Onaka, Haruhiko, Oneil, Patrick, Ong, Tiong Kiam, Ong, Stephen, Ono, Yasuhiro, Opsahl, Paul J, Ostrowska, Lucyna, Oviedo, Alejandra, Ozdogan, Oner, Ozpelit, Ebru, Pagkalos, Emmanouil, Pagotto, Uberto, Páll, Dénes, Pandey, Amritanshu- Shekhar, Parkhomenko, Oleksandr, Parvathareddy, Krishna Malakondareddy, Patel, Minesh B, Patsilinakos, Sotirios, Paul, Neil, Pedersen, Sue, Pereira, Isabel, Pereira, Edward Scott, Perez Terns, Paula, Perez-Vargas, Elba A, Pergaeva, Yulia, Perkelvald, Alexander, Peskov, Andrey B, Peter, Jonathan, Peters, Karina, Petit, Catherine, Petrov, Ivo, Philis-Tsimikas, Athena, Pietilä, Mikko, Pinto, Fausto, Piros, Annamária, Piyayotai, Dilok, Platonov, Dmitriy, Poirier, Paul, Pop, Lavinia, Popa, Bogdan, Pop-Busui, Rodica, Poremba, John, Porto, Alejandro, Postadzhiyan, Arman, Pothineni, Ramesh B, Potu, Ranganatha P, Powell, Talessa, Prafulla, Kerkar G, Prager, Rudolf, Prakova-Teneva, Zhulieta R, Pratley, Richard E, Price, Hermione, Pulka, Grazyna, Pullman, John, Punt, Zelda E, Purighalla, Raman S, Purnell, Peter, Qureshi, Mansoor, Rabasa-Lhoret, Remi, Raikhel, Marina A, Rancane, Gita, Randeva, Harpal, Rasouli, Neda, Reurean Pintilei, Delia V, Reyes, Ciro R, Rezgale, Inga, Rice, Eva, Riley, Thaddeus H, Risser, Joseph A, Ristic, Arsen, Rivas Fernández, Margarita, Robbins, David, Robitaille, Yves, Rodbard, Helena W, Rodriguez Plazas, Jaime A, Römer, T.J., Rosen, Glenn, Rosman, Dr Azhari, Rossi, Paulo, Rudenko, Leonid, Ruffin, Omari, Ruhani, Anwar Irawan, Runev, Nikolay, Ruyatkin, Dmitriy, Ruzic, Alen, Ryabov, Vyacheslav V, Rydén, Lars, Saggar, Suraj, Sakamoto, Tomohiro, Salter, Tim, Samal, Aditya K, Samoilova, Yulia, Sanabria, Hugo D, Sancak, Seda, Sangrigoli, Renee, Sansanayudh, Nakarin, Santini, Ferruccio, Saraiva, José F, Sardinov, Ruslan, Sargeant, William, Sari, Ramazan, Sathananthan, Airani, Sathyapalan, Thozhukat, Sato, Atsushi, Sauter, Joachim, Sbraccia, Paolo, Schaap, J., Schaum, Thomas, Schiele, François, Scott, John, Segal Lieberman, Gabriella, Segner, Alexander, Senior, Roxy, Sergeeva-Kondrachenko, Marina Y, Serota, Harvey, Serusclat, Pierre, Sethi, Rishi, Shah, Manoj K, Shah, Neerav, Shalaev, Sergey, Sharma, Raj, Sharma, Sumeet, Shaydyuk, Oksana, Shea, Heidi C, Shechter, Michael, Shehadeh, Naim, Shirazi, Mitra, Shlesinger, Yshay, Shneker, Ayham, Shutemova, Elena, Siasos, Gerasimos, Siddiqui, Imran A, Sidey, Jennifer, Sigal, Felix, Sime, Iveta, Singh, Narendra, Siraj, Elias, Sivalingam, Kanagaratnam, Skoczylas, Grzegorz, Smith, Stephen K, Smolenskaya, Olga, Snyder, Brian, Sofer, Yael, Sofley, C.W., Solano, Royce, Sonmez, Yusuf A, Sorokin, Maxim, Soto González, Alfonso, Sotolongo, Carlos, Soufer, Joseph, Soyluk Selcukbiricik, Ozlem, Spaic, Tamara, Spriggs, Douglas, Sreenan, Seamus, Stahl, Hans-Detlev, Stamatelopoulos, Kimon, Stanislavchuk, Mykola, Stankovic, Goran, Stasek, Josef, Steg, Gabriel, Steindorf, Joerg, Stephan, Dominique, Stewart, John, Still, Christopher, St-Maurice, Francois, Stogowska-Nikiciuk, Barbara, Stoker, Jeff, Stokic, Edita, Strzelecka, Anna, Sturm, Kerstin, Sueyoshi, Atsushi, Sugiura, Toshiyuki, Sultan, Senan, Suplotova, Lyudmila A, Suwanagool, Arisara, Suwanwalaikorn, Sompongse, Sveklina, Tatiana, Swanson, Neil, Swart, Henk, Swenson, Bradley P, Szyprowska, Ewa, Tait, Graeme, Takács, Róbert, Takeuchi, Yuzo, Tamirisa, Aparna, Tanaka, Hideki, Tatovic, Danijela, Tellier, Guy, Teragawa, Hiroki, Teterovska, Dace, Thomas, Nihal, Thuan, Jean-Francois, Tinahones, Francisco, Tisheva-Gospodinova, Snezhanka, Toarba, Cristina, Todoriuk, Liudmyla, Tokmakova, Mariya, Tonstad, Serena, Toplak, Hermann, Tran, Henry, Tripathy, Devjit, Trusau, Aliaksandr, Tsabedze, Nqoba, Tsougos, Elias, Tsoukas, George M, Tuccinardi, Dario, Tuna, Mazhar M, Turatti, Luiz A, Tziomalos, Konstantinos, Udommongkol, Chesda, Ueda, Osamu, Ukkola, Olavi, Unubol, Mustafa, Urbach, Dorothea, Urina Triana, Miguel A, Usdan, Lisa, Vaidya, Bijay, Vale, Noah, Vallieres, Gerald, Van Beek, Andre P, Van De Borne, Philippe, Van Der Walt, Eugene, Van Der Zwaan, C., Van Nieuwenhuizen, Elane, Van Zyl, Louis, Vanduynhoven, Philippe, Varghese, Kiron, Vasileva, Svetla P, Vassilev, Dobrin, Vathesatogkit, Prin, Velychko, Valentyna, Vercammen, Chris, Verges, Bruno, Verma, Subodh, Verwerft, Jan, Vesela, Alica, Veselovskaya, Nadezhda G, Vettor, Roberto, Veze, Irina, Vijan, Vinod, Vijayaraghavan, Ram, Villarino, Adriana, Vincent, Royce, Vinogradova, Oksana, Vishlitzky, Victor, Vlad, Adrian, Vladu, Ionela Mihaela, Vo, Anthony, Von Engelhardt, Charlotte, Von Münchhausen, Candy, Vorobyeva, Olga, Vossenberg, T., Vrolix, Mathias, Vukicevic, Marjana, Vyshnyvetskyy, Ivan, Wadvalla, Shahid, Wagner, Jan, Wakeling, John, Wallace, James, Wan Mohamed, Wan Mohd Izani, Wander, Gurpreet S, Ward, Kathleen, Warren, Mark L, Watanabe, Atsuyuki, Weber, Bruce, Weintraub, Howard, Weisnagel, John, Welker, James, Wendisch, Ulrich, Wenocur, Howard S, Wierum, Craig, Wilding, John, William, Maged, Wilson, Pete, Wilson, Jonathan P, Wong, Yuk-Ki, Wongcharoen, Wanwarang, Wozniak, Iwona, Wu, Chau-Chung, Wyatt, Nell, Wynne, Alan, Yamaguchi, Hiroshi, Yamasaki, Masahiro, Yazici, Dilek, Yeh, Hung-I, Yotov, Yoto, Yuan, Qingyang, Zacher, Jeffrey, Zagrebelnaya, Olga, Zaidman, Cesar J, Zalevskaya, Alsu, Zarich, Stuart, Zatelli, Maria Chiara, Zeller, Helga, Zhdanova, Elena A, Zornitzki, Taiba, Zrazhevskiy, Konstantin, Zykov, Mikhail, Lincoff, A Michael, Ryan, Donna H, Colhoun, Helen M, Deanfield, John E, Emerson, Scott S, Kahn, Steven E, Kushner, Robert F, Plutzky, Jorge, Brown-Frandsen, Kirstine, Hovingh, G Kees, Hardt-Lindberg, Soren, and Tornøe, Christoffer W

Abstract

Semaglutide, a GLP-1 receptor agonist, reduces the risk of major adverse cardiovascular events (MACE) in people with overweight or obesity, but the effects of this drug on outcomes in patients with atherosclerotic cardiovascular disease and heart failure are unknown. We report a prespecified analysis of the effect of once-weekly subcutaneous semaglutide 2·4 mg on ischaemic and heart failure cardiovascular outcomes. We aimed to investigate if semaglutide was beneficial in patients with atherosclerotic cardiovascular disease with a history of heart failure compared with placebo; if there was a difference in outcome in patients designated as having heart failure with preserved ejection fraction compared with heart failure with reduced ejection fraction; and if the efficacy and safety of semaglutide in patients with heart failure was related to baseline characteristics or subtype of heart failure.

Published
2024
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5. Phase I study of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B

Author

Orozco, Natalia Martin, primary, Vale, Noah, additional, Mihic, Alan, additional, Amor, Talya, additional, Reiter, Lawrence, additional, Arita, Yuko, additional, Samson, Reuben, additional, Hu, Queenie, additional, Gingras, Anne-Claude, additional, Sorenson, Brad, additional, Marcusson, Eric G., additional, and Patel, Piyush, additional

Published
2022
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6. Association between Change in High Density Lipoprotein Cholesterol and Cardiovascular Disease Morbidity and Mortality: Systematic Review and Meta-Regression Analysis

Author

Briel, Matthias, Ferreira-Gonzalez, Ignacio, You, John J., Karanicolas, Paul J., Akl, Elie A., Wu, Ping, Blechacz, Boris, Bassler, Dirk, Wei, Xinge, Sharman, Asheer, Whitt, Irene, Silva, Suzana Alves da, Khalid, Zahira, Nordmann, Alain J., Zhou, Qi, Walter, Stephen D., Vale, Noah, Bhatnagar, Neera, O'Regan, Christopher, Mills, Edward J., Bucher, Heiner C., Montori, Victor M., and Guyatt, Gordon H.

Published
2009
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9. Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

Author

Mullan Rebecca J, Bankhead Clare R, Kaur Jagdeep, Sood Amit, Raatz Heike, Mulla Sohail M, Burns Karen EA, Nordmann Alain J, Lampropulos Julianna F, Bucher Heiner C, Karanicolas Paul J, You John J, Elnour Nisrin, Soares Heloisa P, Kirpalani Haresh, Gwadry-Sridhar Femida, Mills Edward J, Adhikari Neill KJ, Djulbegovic Benjamin, Murad M Hassan, Strahm Brigitte, Elamin Mohamed B, Flynn David N, da Silva Suzana, Culebro Carolina, Kunz Regina, Urrutia Gerard, Alonso-Coello Pablo, Ferreira-Gonzalez Ignacio, Akl Elie A, Malaga German, Glasziou Paul, Bassler Dirk, Montori Victor M, Lane Melanie, Briel Matthias, Nerenberg Kara A, Vandvik Per, Coto-Yglesias Fernando, Schünemann Holger, Tuche Fabio, Chrispim Pedro, Cook Deborah J, Lutz Kristina, Ribic Christine M, Vale Noah, Erwin Patricia J, Perera Rafael, Zhou Qi, Heels-Ansdell Diane, Ramsay Tim, Walter Stephen D, and Guyatt Gordon H

Subjects
Medicine (General), R5-920
Abstract

Abstract Background Randomized clinical trials (RCTs) stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs) may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1), which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. Methods/Design We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation. Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic tRCTs can correct observed biases. Discussion A better understanding of the extent to which tRCTs exaggerate treatment effects and of the factors associated with the magnitude of this bias can optimize trial design and data monitoring charters, and may aid in the interpretation of the results from trials stopped early for benefit.

Published
2009
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10. Statins for acute coronary syndrome

Author

Vale, Noah, primary, Nordmann, Alain J, additional, Schwartz, Gregory G, additional, de Lemos, James, additional, Colivicchi, Furio, additional, den Hartog, Frank, additional, Ostadal, Petr, additional, Macin, Stella M, additional, Liem, Anho H, additional, Mills, Edward J, additional, Bhatnagar, Neera, additional, Bucher, Heiner C, additional, and Briel, Matthias, additional

Published
2014
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11. Estatinas para el síndrome coronario agudo

Author

Vale, Noah, primary, Nordmann, Alain J., additional, Schwartz, Gregory G., additional, Lemos, James De, additional, Colivicchi, Furio, additional, Hartog, Frank Den, additional, Ostadal, Petr, additional, Macin, Stella M., additional, Liem, Anho H., additional, Mills, Edward, additional, Bhatnagar, Neera, additional, Bucher, Heiner C., additional, briel, Matthias, additional, Vale, N., additional, Nordmann, A., additional, Schwartz, G., additional, De Lemos, J., additional, Colivicchi, F., additional, Den, Hartog F., additional, Ostadal, P., additional, Macin, S., additional, Liem, A., additional, Mills, E., additional, Bhatnagar, N., additional, Bugheb, H., additional, and Briel, M., additional

Published
2012
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12. Updated evidence on early statin therapy for acute coronary syndromes: Meta-analysis of 18 randomized trials involving over 14,000 patients

Author

Briel, Matthias, primary, Vale, Noah, additional, Schwartz, Gregory G., additional, de Lemos, James A., additional, Colivicchi, Furio, additional, den Hartog, Frank R., additional, Ostadal, Petr, additional, Macin, Stella M., additional, Liem, Anho, additional, Mills, Ed, additional, Bhatnagar, Neera, additional, Bucher, Heiner C., additional, and Nordmann, Alain J., additional

Published
2012
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13. Statins for acute coronary syndrome

Author

Vale, Noah, primary, Nordmann, Alain J, additional, Schwartz, Gregory G, additional, de Lemos, James, additional, Colivicchi, Furio, additional, den Hartog, Frank, additional, Ostadal, Petr, additional, Macin, Stella M, additional, Liem, Anho H, additional, Mills, Edward, additional, Bhatnagar, Neera, additional, Bucher, Heiner C, additional, and Briel, Matthias, additional

Published
2011
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14. Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

Author

Briel, Matthias, primary, Lane, Melanie, additional, Montori, Victor M, additional, Bassler, Dirk, additional, Glasziou, Paul, additional, Malaga, German, additional, Akl, Elie A, additional, Ferreira-Gonzalez, Ignacio, additional, Alonso-Coello, Pablo, additional, Urrutia, Gerard, additional, Kunz, Regina, additional, Culebro, Carolina Ruiz, additional, da Silva, Suzana Alves, additional, Flynn, David N, additional, Elamin, Mohamed B, additional, Strahm, Brigitte, additional, Murad, M Hassan, additional, Djulbegovic, Benjamin, additional, Adhikari, Neill KJ, additional, Mills, Edward J, additional, Gwadry-Sridhar, Femida, additional, Kirpalani, Haresh, additional, Soares, Heloisa P, additional, Elnour, Nisrin O Abu, additional, You, John J, additional, Karanicolas, Paul J, additional, Bucher, Heiner C, additional, Lampropulos, Julianna F, additional, Nordmann, Alain J, additional, Burns, Karen EA, additional, Mulla, Sohail M, additional, Raatz, Heike, additional, Sood, Amit, additional, Kaur, Jagdeep, additional, Bankhead, Clare R, additional, Mullan, Rebecca J, additional, Nerenberg, Kara A, additional, Vandvik, Per Olav, additional, Coto-Yglesias, Fernando, additional, Schünemann, Holger, additional, Tuche, Fabio, additional, Chrispim, Pedro Paulo M, additional, Cook, Deborah J, additional, Lutz, Kristina, additional, Ribic, Christine M, additional, Vale, Noah, additional, Erwin, Patricia J, additional, Perera, Rafael, additional, Zhou, Qi, additional, Heels-Ansdell, Diane, additional, Ramsay, Tim, additional, Walter, Stephen D, additional, and Guyatt, Gordon H, additional

Published
2009
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15. Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

Author

Briel, Matthias, Lane, Melanie, Montori, Victor M, Bassler, Dirk, Glasziou, Paul, Malaga, German, Akl, Elie A, Ferreira-Gonzalez, Ignacio, Alonso-Coello, Pablo, Urrutia, Gerard, Kunz, Regina, Culebro, Carolina R, Silva, Suzana D A, Flynn, David N, Elamin, Mohamed B, Strahm, Brigitte, Murad, M H, Djulbegovic, Benjamin, Adhikari, Neill K, Mills, Edward J, Gwadry-Sridhar, Femida, Kirpalani, Haresh, Soares, Heloisa P, Elnour, Nisrin O A, You, John J, Karanicolas, Paul J, Bucher, Heiner C, Lampropulos, Julianna F, Nordmann, Alain J, Burns, Karen E, Mulla, Sohail M, Raatz, Heike, Sood, Amit, Kaur, Jagdeep, Bankhead, Clare R, Mullan, Rebecca J, Nerenberg, Kara A, Vandvik, Per O, Coto-Yglesias, Fernando, Schünemann, Holger, Tuche, Fabio, Chrispim, Pedro P M, Cook, Deborah J, Lutz, Kristina, Ribic, Christine M, Vale, Noah, Erwin, Patricia J, Perera, Rafael, Zhou, Qi, Heels-Ansdell, Diane, Ramsay, Tim, Walter, Stephen D, and Guyatt, Gordon H

Subjects
3. Good health
Abstract

Background: Randomized clinical trials (RCTs) stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs) may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1), which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. Methods/Design: We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation. Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic tRCTs can correct observed biases. Discussion: A better understanding of the extent to which tRCTs exaggerate treatment effects and of the factors associated with the magnitude of this bias can optimize trial design and data monitoring charters, and may aid in the interpretation of the results from trials stopped early for benefit.

16. Stopping randomized trials early for benefit and estimation of treatment effects: systematic review and meta-regression analysis.

Author

Bassler D, Briel M, Montori VM, Lane M, Glasziou P, Zhou Q, Heels-Ansdell D, Walter SD, Guyatt GH, Flynn DN, Elamin MB, Murad MH, Abu Elnour NO, Lampropulos JF, Sood A, Mullan RJ, Erwin PJ, Bankhead CR, Perera R, Ruiz Culebro C, You JJ, Mulla SM, Kaur J, Nerenberg KA, Schünemann H, Cook DJ, Lutz K, Ribic CM, Vale N, Malaga G, Akl EA, Ferreira-Gonzalez I, Alonso-Coello P, Urrutia G, Kunz R, Bucher HC, Nordmann AJ, Raatz H, da Silva SA, Tuche F, Strahm B, Djulbegovic B, Adhikari NK, Mills EJ, Gwadry-Sridhar F, Kirpalani H, Soares HP, Karanicolas PJ, Burns KE, Vandvik PO, Coto-Yglesias F, Chrispim PP, and Ramsay T

Subjects
Bias, Clinical Trials Data Monitoring Committees, Data Collection, Randomized Controlled Trials as Topic methods, Randomized Controlled Trials as Topic statistics & numerical data, Treatment Outcome
Abstract

Context: Theory and simulation suggest that randomized controlled trials (RCTs) stopped early for benefit (truncated RCTs) systematically overestimate treatment effects for the outcome that precipitated early stopping., Objective: To compare the treatment effect from truncated RCTs with that from meta-analyses of RCTs addressing the same question but not stopped early (nontruncated RCTs) and to explore factors associated with overestimates of effect., Data Sources: Search of MEDLINE, EMBASE, Current Contents, and full-text journal content databases to identify truncated RCTs up to January 2007; search of MEDLINE, Cochrane Database of Systematic Reviews, and Database of Abstracts of Reviews of Effects to identify systematic reviews from which individual RCTs were extracted up to January 2008., Study Selection: Selected studies were RCTs reported as having stopped early for benefit and matching nontruncated RCTs from systematic reviews. Independent reviewers with medical content expertise, working blinded to trial results, judged the eligibility of the nontruncated RCTs based on their similarity to the truncated RCTs., Data Extraction: Reviewers with methodological expertise conducted data extraction independently., Results: The analysis included 91 truncated RCTs asking 63 different questions and 424 matching nontruncated RCTs. The pooled ratio of relative risks in truncated RCTs vs matching nontruncated RCTs was 0.71 (95% confidence interval, 0.65-0.77). This difference was independent of the presence of a statistical stopping rule and the methodological quality of the studies as assessed by allocation concealment and blinding. Large differences in treatment effect size between truncated and nontruncated RCTs (ratio of relative risks <0.75) occurred with truncated RCTs having fewer than 500 events. In 39 of the 63 questions (62%), the pooled effects of the nontruncated RCTs failed to demonstrate significant benefit., Conclusions: Truncated RCTs were associated with greater effect sizes than RCTs not stopped early. This difference was independent of the presence of statistical stopping rules and was greatest in smaller studies.

Published
2010
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