1. Effect of aliskiren on post-discharge outcomes among diabetic and non-diabetic patients hospitalized for heart failure: insights from the ASTRONAUT trial
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Maggioni, Aldo P., Greene, Stephen J., Fonarow, Gregg C., Böhm, Michael, Zannad, Faiez, Solomon, Scott D., Lewis, Eldrin F., Baschiera, Fabio, Hua, Tsushung A., Gimpelewicz, Claudio R., Lesogor, Anastasia, Gheorghiade, Mihai, Ramos, Silvina, Luna, Alejandra, Miriuka, Santiago, Diez, Mirta, Perna, Eduardo, Luquez, Hugo, Pinna, Jorge Garcia, Castagnino, Jorge, Alvarenga, Pablo, Ibañez, Julio, Blumberg, Eduardo Salmon, Dizeo, Claudio, Guerrero, Rodolfo Ahuad, Schygiel, Pablo, Milesi, Rodolfo, Sosa, Carlos, Hominal, Miguel, Marquez, Lilia Lobo, Poy, Carlos, Hasbani, Eduardo, Vico, Marisa, Fernandez, Alberto, Vita, Nestor, Vanhaecke, Johan, De Keulenaer, Gilles, Striekwold, Harry, Vervoort, Geert, Vrolix, Mathias, Henry, Philippe, Dendale, Paul, Smolders, Walter, Marechal, Patrick, Vandekerckhove, Hans, Oliveira, Mucio, Neuenschwande, Fernando, Reis, Gilmar, Saraiva, Jose, Bodanese, Luiz, Canesin, Manoel, Greco, Oswaldo, Bassan, Roberto, Marino, Roberto Luis, Giannetti, Nadia, Moe, Gordon, Sussex, Bruce, Sheppard, Richard, Huynh, Thao, Stewart, Robert, Haddad, Haissam, Echeverria, Luis, Quintero, Adalberto, Torres, Adriana, Jaramillo, Mónica, Lopez, Mónica, Mendoza, Fernan, Florez, Noel, Cotes, Carlos, Garcia, Magali, Belohlavek, Jan, Hradec, Jaromir, Peterka, Martin, Gregor, Pavel, Monhart, Zdenek, Jansky, Petr, Kettner, Jiri, Reichert, Petr, Spinar, Jindrich, Brabec, Tomas, Hutyra, Martin, Solar, Miroslav, Pietilä, Mikko, Nyman, Kai, Pajari, Risto, Cohen, Ariel, Galinier, Michel, Gosse, Philippe, Livarek, Bernard, Neuder, Yannick, Jourdain, Patrick, Picard, François, Isnard, Richard, Hoppe, Uta, Kaeaeb, Stefan, Rosocha, Stefan, Prondzinsky, Roland, Felix, Stephan, Duengen, Hans-Dirk, Figulla, Hans-Reiner, Fischer, Sven, Behrens, Steffen, Stawowy, Philipp, Kruells-Muench, Juergen, Knebel, Fabian, Nienaber, Christoph, Werner, Dierk, Aron, Wilma, Remppis, Bjoern, Hambrecht, Rainer, Kisters, Klaus, Werner, Nikos, Hoffmann, Stefan, Rossol, Siegbert, Geiss, Ernst, Graf, Kristof, Hamann, Frank, von Scheidt, Wolfgang, Schwinger, Robert, Tebbe, Ulrich, Costard-Jaeckle, Angelika, Lueders, Stephan, Heitzer, Thomas, Leutermann-Oei, Marie-Louise, Braun-Dullaeus, Ruediger, Roehnisch, Jens-Uwe, Muth, Gerhard, Goette, Andreas, Rotter, Achim, Ebelt, Henning, Olbrich, Hans-Georg, Mitrovic, Veselin, Hengstenberg, Christian, Schellong, Sebastian, Zamolyi, Karoly, Vertes, Andras, Matoltsy, Andras, Palinkas, Attila, Herczeg, Bela, Apro, Dezso, Lupkovics, Geza, Tomcsanyi, Janos, Toth, Kalman, Mathur, Atul, Banker, Darshan, Bharani, Anil, Arneja, Jaspal, Khan, Aziz, Gadkari, Milind, Hiremath, Jagdish, Patki, Nitin, Kumbla, Makund, Santosh, M.J., Ravikishore, A.G., Abhaichand, Rajpal, Maniyal, Vijayakukmar, Nanjappa, Manjunath, Reddy, P. Naveen, Chockalingam, Kulasekaran, Premchand, Rajendra, Mahajan, Vijay, Lewis, Basil, Wexler, Dov, Shochat, Michael, Keren, Andre, Omary, Muhamad, Katz, Amos, Marmor, Alon, Lembo, Giuseppe, Di Somma, Salvatore, Boccanelli, Alessandro, Barbiero, Mario, Pajes, Giuseppe, De Servi, Stefano, Greco, Dott Cosimo, De Santis, Fernando, Floresta, Agata, Visconti, Luigi Oltrona, Piovaccari, Giancarlo, Cavallini, Claudio, Di Biase, Matteo, Masini, Dott Franco, Vassanelli, Corrado, Viecca, Maurizio, Cangemi, Dott Francesco, Pirelli, Salvatore, Borghi, Claudio, Volpe, Massimo, Branzi, Angelo, Percoco, Dott Giovanni, Severi, Silvia, Santini, Alberto, De Lorenzi, Ettore, Metra, Marco, Zacà, Valerio, Mortara, Andrea, Tranquilino, Francisco P., Babilonia, Noe A., Ferrolino, Arthur M., Manlutac, Benjamin, Dluzniewski, Miroslaw, Dzielinska, Zofia, Nowalany-Kozie, Ewa, Mazurek, Walentyna, Wierzchowiecki, Jerzy, Wysokinski, Andrzej, Szachniewicz, Joanna, Romanowski, Witold, Krauze-Wielicka, Magdalena, Jankowski, Piotr, Berkowski, Piotr, Szelemej, Roman, Kleinrok, Andrzej, Kornacewicz-Jac, Zdzislawa, Vintila, Marius, Vladoianu, Mircea, Militaru, Constantin, Dan, Gheorghe, Dorobantu, Maria, Dragulescu, Stefan, Kostenko, Victor, Vishnevsky, Alexandr, Goloschekin, Boris, Tyrenko, Vadim, Gordienko, Alexander, Kislyak, Oxana, Martsevich, Sergey, Kuchmin, Alexey, Karpov, Yurii, Fomin, Igor, Shvarts, Yury, Orlikova, Olga, Ershova, Olga, Berkovich, Olga, Sitnikova, Maria, Pakhomova, Inna, Boldueva, Svetlana, Tyurina, Tatiana, Simanenkov, Vladimir, Boyarkin, Mikhail, Novikova, Nina, Tereschenko, Sergey, Zadionchenko, Vladimir, Shogenov, Zaur, Gordeev, Ivan, Moiseev, Valentin, Wong, Raymond, Ong, Hean Yee, Le Tan, Ju, Goncalvesova, Eva, Kovar, Frantisek, Skalina, Ivan, Kasperova, Viera, Hojerova, Silvia, Szentivanyi, Miroslav, Stancak, Branislav, Babcak, Marian, Kycina, Peter, Poliacik, Pavol, Toth, Peter, Sirotiakova, Jana, de Sa, Esteban Lopez, Bueno, Manuel Gomez, Selles, Manuel Martinez, Cabrera, Jose Angel, Freire, Ramon Bover, Gonzalez Juanatey, Jose Ramon, Comin, Josep, Soriano, FranciscoRidocci, Lopez, Alejandro, Vicho, Raul, Lama, Manuel Geraldia, Schaufelberger, Maria, Brunotte, Richard, Ullman, Bengt, Hagerman, Inger, Cizinsky, Stella, Cherng, Wen-Jin, Yu, Wen-Chung, Kuo, Chi-Tai, Chang, Kuan-Cheng, Lai, Wen-Ter, Kuo, Jen-Yuan, Ural, Dilek, Badak, Ozer, Akin, Mustafa, Yigit, Zerrin, Yokusoglu, Mehmet, Yilmaz, Mehmet, Abaci, Adnan, Ebinc, Haksun, Perlman, Richard, Parish, David, Bergin, James, Burnham, Kenneth, Brown, Christopher, Lundbye, Justin, Williams, Celeste, Eisen, Howard, Juneman, Elizabeth, Joseph, Susan, Peberdy, Mary Ann, Peura, Jennifer, Gupta, Vishal, Habet, Kalim, French, William, Mody, Freny, Graham, Susan, Hazelrigg, Monica, Chung, Eugene, Dunlap, Stephanie, Nikolaidis, Lazaros, Najjar, Samer, Katz, Richard, Murali, Srinivas, Izzo, Joseph L., Callister, Tracy, Phillips, Roland, Lippolis, Nicholas, Winterton, John, Meymandi, Sheba, Heilman, Karl, Oren, Ron, Zolty, Ronald, Brottman, Michael, Gunawardena, D.R., Adams, Kirkwood, Barnard, Denise, Klapholz, Marc, Fulmer, James, Maggioni, Aldo P., Greene, Stephen J., Fonarow, Gregg C., Böhm, Michael, Zannad, Faiez, Solomon, Scott D., Lewis, Eldrin F., Baschiera, Fabio, Hua, Tsushung A., Gimpelewicz, Claudio R., Lesogor, Anastasia, Gheorghiade, Mihai, Ramos, Silvina, Luna, Alejandra, Miriuka, Santiago, Diez, Mirta, Perna, Eduardo, Luquez, Hugo, Pinna, Jorge Garcia, Castagnino, Jorge, Alvarenga, Pablo, Ibañez, Julio, Blumberg, Eduardo Salmon, Dizeo, Claudio, Guerrero, Rodolfo Ahuad, Schygiel, Pablo, Milesi, Rodolfo, Sosa, Carlos, Hominal, Miguel, Marquez, Lilia Lobo, Poy, Carlos, Hasbani, Eduardo, Vico, Marisa, Fernandez, Alberto, Vita, Nestor, Vanhaecke, Johan, De Keulenaer, Gilles, Striekwold, Harry, Vervoort, Geert, Vrolix, Mathias, Henry, Philippe, Dendale, Paul, Smolders, Walter, Marechal, Patrick, Vandekerckhove, Hans, Oliveira, Mucio, Neuenschwande, Fernando, Reis, Gilmar, Saraiva, Jose, Bodanese, Luiz, Canesin, Manoel, Greco, Oswaldo, Bassan, Roberto, Marino, Roberto Luis, Giannetti, Nadia, Moe, Gordon, Sussex, Bruce, Sheppard, Richard, Huynh, Thao, Stewart, Robert, Haddad, Haissam, Echeverria, Luis, Quintero, Adalberto, Torres, Adriana, Jaramillo, Mónica, Lopez, Mónica, Mendoza, Fernan, Florez, Noel, Cotes, Carlos, Garcia, Magali, Belohlavek, Jan, Hradec, Jaromir, Peterka, Martin, Gregor, Pavel, Monhart, Zdenek, Jansky, Petr, Kettner, Jiri, Reichert, Petr, Spinar, Jindrich, Brabec, Tomas, Hutyra, Martin, Solar, Miroslav, Pietilä, Mikko, Nyman, Kai, Pajari, Risto, Cohen, Ariel, Galinier, Michel, Gosse, Philippe, Livarek, Bernard, Neuder, Yannick, Jourdain, Patrick, Picard, François, Isnard, Richard, Hoppe, Uta, Kaeaeb, Stefan, Rosocha, Stefan, Prondzinsky, Roland, Felix, Stephan, Duengen, Hans-Dirk, Figulla, Hans-Reiner, Fischer, Sven, Behrens, Steffen, Stawowy, Philipp, Kruells-Muench, Juergen, Knebel, Fabian, Nienaber, Christoph, Werner, Dierk, Aron, Wilma, Remppis, Bjoern, Hambrecht, Rainer, Kisters, Klaus, Werner, Nikos, Hoffmann, Stefan, Rossol, Siegbert, Geiss, Ernst, Graf, Kristof, Hamann, Frank, von Scheidt, Wolfgang, Schwinger, Robert, Tebbe, Ulrich, Costard-Jaeckle, Angelika, Lueders, Stephan, Heitzer, Thomas, Leutermann-Oei, Marie-Louise, Braun-Dullaeus, Ruediger, Roehnisch, Jens-Uwe, Muth, Gerhard, Goette, Andreas, Rotter, Achim, Ebelt, Henning, Olbrich, Hans-Georg, Mitrovic, Veselin, Hengstenberg, Christian, Schellong, Sebastian, Zamolyi, Karoly, Vertes, Andras, Matoltsy, Andras, Palinkas, Attila, Herczeg, Bela, Apro, Dezso, Lupkovics, Geza, Tomcsanyi, Janos, Toth, Kalman, Mathur, Atul, Banker, Darshan, Bharani, Anil, Arneja, Jaspal, Khan, Aziz, Gadkari, Milind, Hiremath, Jagdish, Patki, Nitin, Kumbla, Makund, Santosh, M.J., Ravikishore, A.G., Abhaichand, Rajpal, Maniyal, Vijayakukmar, Nanjappa, Manjunath, Reddy, P. Naveen, Chockalingam, Kulasekaran, Premchand, Rajendra, Mahajan, Vijay, Lewis, Basil, Wexler, Dov, Shochat, Michael, Keren, Andre, Omary, Muhamad, Katz, Amos, Marmor, Alon, Lembo, Giuseppe, Di Somma, Salvatore, Boccanelli, Alessandro, Barbiero, Mario, Pajes, Giuseppe, De Servi, Stefano, Greco, Dott Cosimo, De Santis, Fernando, Floresta, Agata, Visconti, Luigi Oltrona, Piovaccari, Giancarlo, Cavallini, Claudio, Di Biase, Matteo, Masini, Dott Franco, Vassanelli, Corrado, Viecca, Maurizio, Cangemi, Dott Francesco, Pirelli, Salvatore, Borghi, Claudio, Volpe, Massimo, Branzi, Angelo, Percoco, Dott Giovanni, Severi, Silvia, Santini, Alberto, De Lorenzi, Ettore, Metra, Marco, Zacà, Valerio, Mortara, Andrea, Tranquilino, Francisco P., Babilonia, Noe A., Ferrolino, Arthur M., Manlutac, Benjamin, Dluzniewski, Miroslaw, Dzielinska, Zofia, Nowalany-Kozie, Ewa, Mazurek, Walentyna, Wierzchowiecki, Jerzy, Wysokinski, Andrzej, Szachniewicz, Joanna, Romanowski, Witold, Krauze-Wielicka, Magdalena, Jankowski, Piotr, Berkowski, Piotr, Szelemej, Roman, Kleinrok, Andrzej, Kornacewicz-Jac, Zdzislawa, Vintila, Marius, Vladoianu, Mircea, Militaru, Constantin, Dan, Gheorghe, Dorobantu, Maria, Dragulescu, Stefan, Kostenko, Victor, Vishnevsky, Alexandr, Goloschekin, Boris, Tyrenko, Vadim, Gordienko, Alexander, Kislyak, Oxana, Martsevich, Sergey, Kuchmin, Alexey, Karpov, Yurii, Fomin, Igor, Shvarts, Yury, Orlikova, Olga, Ershova, Olga, Berkovich, Olga, Sitnikova, Maria, Pakhomova, Inna, Boldueva, Svetlana, Tyurina, Tatiana, Simanenkov, Vladimir, Boyarkin, Mikhail, Novikova, Nina, Tereschenko, Sergey, Zadionchenko, Vladimir, Shogenov, Zaur, Gordeev, Ivan, Moiseev, Valentin, Wong, Raymond, Ong, Hean Yee, Le Tan, Ju, Goncalvesova, Eva, Kovar, Frantisek, Skalina, Ivan, Kasperova, Viera, Hojerova, Silvia, Szentivanyi, Miroslav, Stancak, Branislav, Babcak, Marian, Kycina, Peter, Poliacik, Pavol, Toth, Peter, Sirotiakova, Jana, de Sa, Esteban Lopez, Bueno, Manuel Gomez, Selles, Manuel Martinez, Cabrera, Jose Angel, Freire, Ramon Bover, Gonzalez Juanatey, Jose Ramon, Comin, Josep, Soriano, FranciscoRidocci, Lopez, Alejandro, Vicho, Raul, Lama, Manuel Geraldia, Schaufelberger, Maria, Brunotte, Richard, Ullman, Bengt, Hagerman, Inger, Cizinsky, Stella, Cherng, Wen-Jin, Yu, Wen-Chung, Kuo, Chi-Tai, Chang, Kuan-Cheng, Lai, Wen-Ter, Kuo, Jen-Yuan, Ural, Dilek, Badak, Ozer, Akin, Mustafa, Yigit, Zerrin, Yokusoglu, Mehmet, Yilmaz, Mehmet, Abaci, Adnan, Ebinc, Haksun, Perlman, Richard, Parish, David, Bergin, James, Burnham, Kenneth, Brown, Christopher, Lundbye, Justin, Williams, Celeste, Eisen, Howard, Juneman, Elizabeth, Joseph, Susan, Peberdy, Mary Ann, Peura, Jennifer, Gupta, Vishal, Habet, Kalim, French, William, Mody, Freny, Graham, Susan, Hazelrigg, Monica, Chung, Eugene, Dunlap, Stephanie, Nikolaidis, Lazaros, Najjar, Samer, Katz, Richard, Murali, Srinivas, Izzo, Joseph L., Callister, Tracy, Phillips, Roland, Lippolis, Nicholas, Winterton, John, Meymandi, Sheba, Heilman, Karl, Oren, Ron, Zolty, Ronald, Brottman, Michael, Gunawardena, D.R., Adams, Kirkwood, Barnard, Denise, Klapholz, Marc, and Fulmer, James
- Abstract
Aims The objective of the Aliskiren Trial on Acute Heart Failure Outcomes (ASTRONAUT) was to determine whether aliskiren, a direct renin inhibitor, would improve post-discharge outcomes in patients with hospitalization for heart failure (HHF) with reduced ejection fraction. Pre-specified subgroup analyses suggested potential heterogeneity in post-discharge outcomes with aliskiren in patients with and without baseline diabetes mellitus (DM). Methods and results ASTRONAUT included 953 patients without DM (aliskiren 489; placebo 464) and 662 patients with DM (aliskiren 319; placebo 343) (as reported by study investigators). Study endpoints included the first occurrence of cardiovascular death or HHF within 6 and 12 months, all-cause death within 6 and 12 months, and change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 1, 6, and 12 months. Data regarding risk of hyperkalaemia, renal impairment, and hypotension, and changes in additional serum biomarkers were collected. The effect of aliskiren on cardiovascular death or HHF within 6 months (primary endpoint) did not significantly differ by baseline DM status (P = 0.08 for interaction), but reached statistical significance at 12 months (non-DM: HR: 0.80, 95% CI: 0.64-0.99; DM: HR: 1.16, 95% CI: 0.91-1.47; P = 0.03 for interaction). Risk of 12-month all-cause death with aliskiren significantly differed by the presence of baseline DM (non-DM: HR: 0.69, 95% CI: 0.50-0.94; DM: HR: 1.64, 95% CI: 1.15-2.33; P < 0.01 for interaction). Among non-diabetics, aliskiren significantly reduced NT-proBNP through 6 months and plasma troponin I and aldosterone through 12 months, as compared to placebo. Among diabetic patients, aliskiren reduced plasma troponin I and aldosterone relative to placebo through 1 month only. There was a trend towards differing risk of post-baseline potassium ≥6 mmol/L with aliskiren by underlying DM status (non-DM: HR: 1.17, 95% CI: 0.71-1.93; DM: HR: 2.39, 95% CI: 1.30-4.42; P = 0.0
- Published
- 2017