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1. Effect of Apabetalone on Cardiovascular Events in Diabetes, CKD, and Recent Acute Coronary Syndrome

Author

Kalantar-Zadeh, Kamyar, Schwartz, Gregory G., Nicholls, Stephen J., Buhr, Kevin A., Ginsberg, Henry N., Johansson, Jan O., Kulikowski, Ewelina, Lebioda, Kenneth, Toth, Peter P., Wong, Norman, Sweeney, Michael, Ray, Kausik K., Ray, Kausik K., Schwartz, Gregory G., Nicholls, Stephen J., Kalantar-Zadeh, Kaymar, Toth, Peter, Ginsberg, Henry, Sweeney, Michael, Wong, Norman, Johansson, Jan, Lorenzatti, Alberto, Vico, Marisa, Milanova, Maria, Milicevic, Goran, Popovic, Zeljko, Ebelt, Henning, Kiss, Róbert Gábor, Lewis, Basil, Llamas, Edmundo Bayram, Banach, Maciej, Tereschenko, Sergey, Pavlovic, Milan, Pella, Daniel, Chiang, Chern-En, Lonn, Eva, Watkins, Paul, Waters, David, Szarek, Michael, Currier, Judith, Leiter, Lawrence Alan, McMurray, John, Petrie, Mark, Jhund, Pardeep, Walters, Matthew, Connolly, Eugene, Lang, Ninian, Schiavi, Lilia, Vico, Marisa, Maffei, Laura, Bordonava, Anselmo, Prado, Aldo, Vallejos, Julio, Farias, Javier, Nardone, Lucrecia, Resk, Jorge, Caruso, Orlando, Lorenzatti, Alberto, Maldonado, Natacha, Padilla, Lucio, Hominal, Miguel, Luquez, Hugo, Sposetti, Georgina, Caccavo, Alberto, Glenny, Jorge, Mansilla, Virginia, Alvarez, Maria, Parody, Maria, Sarjanovich, Rodolfo, Klyver, Maria, Valdez, Maria Eugenia, Colombo, Hugo, Baccaro, Claudia, Visco, Virginia, Bono, Julio, Cuneo, Carlos, Pácora, Fredy Ferré, Guzman, Pablo, Piskorz, Daniel, Vogel, Daniel, Grigorov, Mladen, Gatzov, Plamen, Stoyanov, Miroslav, Apostolova, Emilya, Milanova, Maria, Petrov, Ivo, Angelov, Atanas, Lazov, Petar, Grigorova, Valentina, Yanev, Todor, Vuchkova, Emilena, Vassilev, Dobrin, Tisheva, Snezhanka, Gelev, Valeri, Canecki-Varzic, Silvia, Popovic, Zeljko, Tusek, Srecko, Šunić, Ema Drvodelić, Milicevic, Goran, Jandric-Balen, Marica, Marinic, Nikolina, Moser, Natasa, Ebelt, Henning, Natour, Mohammed, Schwimmbeck, Peter, Appel, Karl-Friedrich, Kleinertz, Klaus, Merkely, Béla, Papp, András, Kiss, Robert, Kovács, Zsolt, Vértes, András, Sárszegi, Zsolt, Kis, Ernö, Benedek, Amália, Takács, János, Papp, Aniko, Matoltsy, Andras, Andrassy, Peter, Ungi, Imre, Shechter, Michael, Atar, Shaul, Shotan, Avraham, Vazan, Alicia, Alcalai, Ronny, Lotan, Chaim, Lewis, Basil, Hayek, Tony, Moriel, Mady, Katz, Amos, Liberty, Idit, Harman-Boehm, Ilana, Schiff, Elad, Kracoff, Oscar, Rozenman, Yoseph, Mosseri, Morris, Slezak, Ladislav, Sabbah, Muhammad, Zeltser, David, Adawi, Khaled, Omary, Muhamed, Ness, Rosane Abramof, Adawi, Faiad, Ruiz, Jose Garza, Carrillo, Jorge, Nevarez Ruiz, Luis Alejandro, Hernandez, Pedro Garcia, Arechavaleta-Granell, Maria, los Rios Ibarra, Manuel De, Velasco-Sanchez, Raul, Molina, Hugo Laviada, Morales, Lucas Solis, Gonzalez, Efrain Montano, Esperón, Guillermo Llamas, Bayram Llamas, Edmundo Alfredo, Rocha, Cynthia Mustieles, Suarez-Otero, Rodrigo, Real, Manuel Aguilera, Cruz, Eliud Montes, Lopez, Humberto Alvarez, Vaca, Susano Lara, Fanghanel-Salmon, Guillermo, Herrera, Carlos Hernandez, Saldaña, Joel Rodriguez, Garcia, Elier Pedroza, Velázquez, Maricela Vidrio, Briones, Ignacio Rodriguez, Hamer, Bas, Slagboom, Ton, Zurakowski, Aleksander, Debinski, Marcin, Kobielusz-Gembala, Iwona, Bartkowiak, Radoslaw, Rajzer, Marek, Witkowski, Adam, Kowalisko, Alicja, Piepiorka, Marek, Stania, Karol, Domzal, Michal, Korecki, Janusz, Korzeniak, Romuald, Mazurkiewicz, Lukasz, Mirek-Bryniarska, Ewa, Banach, Maciej, Madziarska, Katarzyna, Mlodziankowski, Adam, Rewerska, Barbara, Gaciong, Zbigniew, Mazurkiewicz, Maciej, Maksimov, Ivan, Shvarts, Yuri, Khaisheva, Larisa, Samitin, Vasily, Boldueva, Svetlana, Zykov, Mikhail, Barbarash, Olga, Kostenko, Victor, Kulibaba, Elena, Smolenskaya, Olga, Tarasov, Nikolay, Shogenov, Zaur, Strongin, Leonid, Kuzin, Anatoly, Makukhin, Valeriy, Nikolaev, Konstantin, Tereschenko, Sergey, Vezikova, Natalya, Miloradovic, Vladimir, Pavlovic, Milan, Ilic, Marina Deljanin, Simic, Dragan, Pudar-Brankovic, Georgina, Jozic, Tanja, Dodic, Slobodan, Ristic, Arsen, Hinic, Sasa, Mitov, Vladimir, Stokuca-Korac, Natasa, Stokic, Edita, Celic, Vera, Despotovic, Nebojsa, Dincic, Dragan, Tosic, Biljana Putnikovic, Selakovic, Aleksandar, Pella, Daniel, Banik, Milan, Fedacko, Jan, Micko, Karol, Duris, Tibor, Kokles, Martin, Lachova, Beata, Dzupina, Andrej, Mazur, Juraj, Buganova, Ingrid, Behuncik, Milan, Vadinova, Silvia, Yeh, Hung-I, Chiang, Chern-En, Lee, Cheng-Hen, Hsieh, I-Chang, Jiunn-Lee, Lin, Lin, We-Hsiang, Wu, Yen-Wen, Hsia, Chien Hsun, and Lo, Ping Han

Published
2021
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2. Angiotensin Receptor Neprilysin Inhibition Compared With Enalapril on the Risk of Clinical Progression in Surviving Patients With Heart Failure

Author

Packer, Milton, Mcmurray, John J. V., Desai, Akshay S., Gong, Jianjian, Lefkowitz, Martin P., Rizkala, Adel R., Rouleau, Jean L., Shi, Victor C., Solomon, Scott D., Swedberg, Karl, Zile, Michael, Andersen, Karl, Arango, Juan Luis, Arnold, J. Malcolm, Belohlávek, Jan, Böhm, Michael, Boytsov, Sergey, Burgess, Lesley J., Cabrera, Walter, Calvo, Carlos, Chen, Chen Huan, Dukat, Andrej, Duarte, Yan Carlos, Erglis, Andrejs, Michael, Fu, Gomez, Efrain, Gonzàlez Medina, Angel, Hagège, Albert A., Huang, Jun, Katova, Tzvetana, Kiatchoosakun, Songsak, Kim, Kee Sik, Kozan, Ömer, Llamas, Edmundo Bayram, Martinez, Felipe, Merkely, Bela, Mendoza, Iván, Mosterd, Arend, Negrusz Kawecka, Marta, Peuhkurinen, Keijo, Ramires, Felix J. A., Refsgaard, Jens, Rosenthal, Arvo, Senni, Michele, Sibulo, Antonio S., Silva Cardoso, José, Squire, Iain B., Starling, Randall C., Teerlink, John R., Vanhaecke, Johan, Vinereanu, Dragos, Wong, Raymond Ching Chiew, PARADIGM HF Investigators, Coordinators, Lembo, Giuseppe, Neyses, Ludwig [collaborator], Packer, M, Mcmurray, J, Desai, A, Gong, J, Lefkowitz, M, Rizkala, A, Rouleau, J, Shi, V, Solomon, S, Swedberg, K, Zile, M, Andersen, K, Arango, J, Arnold, J, Belohlavek, J, Bohm, M, Boytsov, S, Burgess, L, Cabrera, W, Calvo, C, Chen, C, Dukat, A, Duarte, Y, Erglis, A, Fu, M, Gomez, E, Gonzalez-Medina, A, Hagege, A, Huang, J, Katova, T, Kiatchoosakun, S, Kim, K, Kozan, O, Llamas, E, Martinez, F, Merkely, B, Mendoza, I, Mosterd, A, Negrusz-Kawecka, M, Peuhkurinen, K, Ramires, F, Refsgaard, J, Rosenthal, A, Senni, M, Jr, A, Silva-Cardoso, J, Squire, I, Starling, R, Teerlink, J, Vanhaecke, J, Vinereanu, D, and Wong, R

Subjects
Angiotensin receptor, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], receptors, Tetrazoles, heart failure, Angiotensin-Converting Enzyme Inhibitors, Kaplan-Meier Estimate, Sacubitril, Angiotensin, Heart failure, Neprilysin, Receptors, Aminobutyrates, Angiotensin Receptor Antagonists, Biomarkers, Double-Blind Method, Enalapril, Heart Failure, Humans, Natriuretic Peptide, Brain, Peptide Fragments, Risk Factors, Stroke Volume, Survivors, Treatment Outcome, Troponin, Disease Progression, Medicine (all), Cardiology and Cardiovascular Medicine, Physiology (medical), Enalapril/therapeutic use, Heart Failure/blood, Receptor, Systèmes cardiovasculaire & respiratoire [D03] [Sciences de la santé humaine], Troponin/blood, Angiotensin Receptor Antagonists/therapeutic use, Drug Combinations, Angiotensin-Converting Enzyme Inhibitors/therapeutic use, Tetrazoles/therapeutic use, Cardiology, Valsartan, Heart Failure/blood/drug therapy/physiopathology, medicine.drug, medicine.medical_specialty, neprilysin, receptors, angiotensin, Internal medicine, Renin–angiotensin system, medicine, heart failure, neprilysin, receptors, angiotensin, business.industry, Biphenyl Compounds, medicine.disease, Endocrinology, Aminobutyrates/therapeutic use, Stroke Volume/physiology, Natriuretic Peptide, Brain/blood, Cardiovascular & respiratory systems [D03] [Human health sciences], business, Neprilysin/antagonists & inhibitors, Peptide Fragments/blood, Sacubitril, Valsartan, Biomarkers/blood
Abstract

Background— Clinical trials in heart failure have focused on the improvement in symptoms or decreases in the risk of death and other cardiovascular events. Little is known about the effect of drugs on the risk of clinical deterioration in surviving patients. Methods and Results— We compared the angiotensin-neprilysin inhibitor LCZ696 (400 mg daily) with the angiotensin-converting enzyme inhibitor enalapril (20 mg daily) in 8399 patients with heart failure and reduced ejection fraction in a double-blind trial. The analyses focused on prespecified measures of nonfatal clinical deterioration. In comparison with the enalapril group, fewer LCZ696-treated patients required intensification of medical treatment for heart failure (520 versus 604; hazard ratio, 0.84; 95% confidence interval, 0.74–0.94; P =0.003) or an emergency department visit for worsening heart failure (hazard ratio, 0.66; 95% confidence interval, 0.52–0.85; P =0.001). The patients in the LCZ696 group had 23% fewer hospitalizations for worsening heart failure (851 versus 1079; P P =0.005), to receive intravenous positive inotropic agents (31% risk reduction, P P =0.07). The reduction in heart failure hospitalization with LCZ696 was evident within the first 30 days after randomization. Worsening of symptom scores in surviving patients was consistently more common in the enalapril group. LCZ696 led to an early and sustained reduction in biomarkers of myocardial wall stress and injury (N-terminal pro–B-type natriuretic peptide and troponin) versus enalapril. Conclusions— Angiotensin-neprilysin inhibition prevents the clinical progression of surviving patients with heart failure more effectively than angiotensin-converting enzyme inhibition. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01035255.

Published
2015
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3. A putative placebo analysis of the effects of LCZ696 on clinical outcomes in heart failure

Author

Michael Böhm, Tzvetana Katova, Béla Merkely, Malcolm Arnold, Ivan Mendoza, Kee Sik Kim, Sergey Boytsov, John J.V. McMurray, Scott D. Solomon, Juan Luis Arango, Efrain Gomez, Felipe Martinez, Karl Andersen, John R. Teerlink, Chen Huan Chen, Nicola Greenlaw, Andrejs Erglis, Arend Mosterd, Milton Packer, Antonio S. Sibulo, Felix José Alvarez Ramires, Keijo Peuhkurinen, Ángel Fernández González, Iain B. Squire, Randall C. Starling, Walter Cabrera, Jens Refsgaard, Michael Fu, Songsak Kiatchoosakun, Jan Bělohlávek, Martin Lefkowitz, Karl Swedberg, Victor Shi, Adel R. Rizkala, Jianjian Gong, Akshay S. Desai, José Silva-Cardoso, Jean L. Rouleau, Michael R. Zile, Michele Senni, Raymond Wong, Lesley J. Burgess, Marta Negrusz-Kawecka, Dragos Vinereanu, Albert Hagège, Edmundo Bayram, Mcmurray, J, Packer, M, Desai, A, Gong, J, Greenlaw, N, Lefkowitz, M, Rizkala, A, Shi, V, Rouleau, J, Solomon, S, Swedberg, K, Zile, M, Andersen, K, Arango, J, Arnold, M, Belohlavek, J, Bohm, M, Boytsov, S, Burgess, L, Cabrera, W, Chen, C, Erglis, A, Fu, M, Gomez, E, Gonzalez, A, Hagege, A, Katova, T, Kiatchoosakun, S, Kim, K, Bayram, E, Martinez, F, Merkely, B, Mendoza, I, Mosterd, A, Negrusz-Kawecka, M, Peuhkurinen, K, Ramires, F, Refsgaard, J, Senni, M, Sibulo, A, Silva-Cardoso, J, Squire, I, Starling, R, Vinereanu, D, Teerlink, J, and Wong, R

Subjects
Male, Tetrazoles, Angiotensin-Converting Enzyme Inhibitors, Enalapril, Enalapril/therapeutic use, Medicine, Natriuretic peptides, Angiotensin II, Aminobutyrates, Heart Failure/Cardiomyopathy, Middle Aged, Angiotensin Receptor Antagonists/therapeutic use, Hospitalization, Angiotensin-Converting Enzyme Inhibitors/therapeutic use, Drug Combinations, Treatment Outcome, Tetrazoles/therapeutic use, Cardiology, Valsartan, Female, Cardiology and Cardiovascular Medicine, medicine.drug, Benzimidazoles/therapeutic use, medicine.medical_specialty, Angiotensin II Type 1 Receptor Blockers/therapeutic use, medicine.drug_class, Placebo, Angiotensin Receptor Antagonists, Internal medicine, Humans, FASTTrack Clinical Research, Beta blocker, Aged, Hospitalization/statistics & numerical data, Heart Failure, business.industry, Biphenyl Compounds, medicine.disease, Heart Failure/drug therapy, Placebo Effect, Candesartan, Endocrinology, Aminobutyrates/therapeutic use, Heart failure, ACE inhibitor, Benzimidazoles, business, Angiotensin II Type 1 Receptor Blockers, Sacubitril, Valsartan, Natriuretic peptide
Abstract

Aims: Although active-controlled trials with renin–angiotensin inhibitors are ethically mandated in heart failure with reduced ejection fraction, clinicians and regulators often want to know how the experimental therapy would perform compared with placebo. The angiotensin receptor-neprilysin inhibitor LCZ696 was compared with enalapril in PARADIGM-HF. We made indirect comparisons of the effects of LCZ696 with putative placebos.\ud \ud Methods and results: We used the treatment-arm of the Studies Of Left Ventricular Dysfunction (SOLVD-T) as the reference trial for comparison of an ACE inhibitor to placebo and the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity-Alternative trial (CHARM-Alternative) as the reference trial for comparison of an ARB to placebo. The hazard ratio of LCZ696 vs. a putative placebo was estimated through the product of the hazard ratio of LCZ696 vs. enalapril (active-control) and that of the historical active-control (enalapril or candesartan) vs. placebo. For the primary composite outcome of cardiovascular death or heart failure hospitalization in PARADIGM-HF, the relative risk reduction with LCZ696 vs. a putative placebo from SOLVD-T was 43% (95%CI 34–50%; P < 0.0001) with similarly large effects on cardiovascular death (34%, 21–44%; P < 0.0001) and heart failure hospitalization (49%, 39–58%; P < 0.0001). For all-cause mortality, the reduction compared with a putative placebo was 28% (95%CI 15–39%; P < 0.0001). Putative placebo analyses based on CHARM-Alternative gave relative risk reductions of 39% (95%CI 27–48%; P < 0.0001) for the composite outcome of cardiovascular death or heart failure hospitalization, 32% (95%CI 16–45%; P < 0.0001) for cardiovascular death, 46% (33–56%; P < 0.0001) for heart failure hospitalization, and 26% (95%CI 11–39%; P < 0.0001) for all-cause mortality.\ud \ud Conclusion: These indirect comparisons of LCZ696 with a putative placebo show that the strategy of combined angiotensin receptor blockade and neprilysin inhibition led to striking reductions in cardiovascular and all-cause mortality, as well as heart failure hospitalization. These benefits were obtained even though LCZ696 was added to comprehensive background beta-blocker and mineralocorticoid receptor antagonist therapy.

Published
2014
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4. Angiotensin receptor neprilysin inhibition compared with enalapril on the risk of clinical progression in surviving patients with heart failure.

Author

Neyses, Ludwig [collaborator], Packer, Milton, McMurray, John J. V., Desai, Akshay S., Gong, Jianjian, Lefkowitz, Martin P., Rizkala, Adel R., Rouleau, Jean L., Shi, Victor C., Solomon, Scott D., Swedberg, Karl, Zile, Michael, Andersen, Karl, Arango, Juan Luis, Arnold, J. Malcolm, Belohlavek, Jan, Bohm, Michael, Boytsov, Sergey, Burgess, Lesley J., Cabrera, Walter, Calvo, Carlos, Chen, Chen-Huan, Dukat, Andrej, Duarte, Yan Carlos, Erglis, Andrejs, Fu, Michael, Gomez, Efrain, Gonzalez-Medina, Angel, Hagege, Albert A., Huang, Jun, Katova, Tzvetana, Kiatchoosakun, Songsak, Kim, Kee-Sik, Kozan, Omer, Llamas, Edmundo Bayram, Martinez, Felipe, Merkely, Bela, Mendoza, Ivan, Mosterd, Arend, Negrusz-Kawecka, Marta, Peuhkurinen, Keijo, Ramires, Felix J. A., Refsgaard, Jens, Rosenthal, Arvo, Senni, Michele, Sibulo, Antonio S. Jr, Silva-Cardoso, Jose, Squire, Iain B., Starling, Randall C., Teerlink, John R., Vanhaecke, Johan, Vinereanu, Dragos, Wong, Raymond Ching-Chiew, Neyses, Ludwig [collaborator], Packer, Milton, McMurray, John J. V., Desai, Akshay S., Gong, Jianjian, Lefkowitz, Martin P., Rizkala, Adel R., Rouleau, Jean L., Shi, Victor C., Solomon, Scott D., Swedberg, Karl, Zile, Michael, Andersen, Karl, Arango, Juan Luis, Arnold, J. Malcolm, Belohlavek, Jan, Bohm, Michael, Boytsov, Sergey, Burgess, Lesley J., Cabrera, Walter, Calvo, Carlos, Chen, Chen-Huan, Dukat, Andrej, Duarte, Yan Carlos, Erglis, Andrejs, Fu, Michael, Gomez, Efrain, Gonzalez-Medina, Angel, Hagege, Albert A., Huang, Jun, Katova, Tzvetana, Kiatchoosakun, Songsak, Kim, Kee-Sik, Kozan, Omer, Llamas, Edmundo Bayram, Martinez, Felipe, Merkely, Bela, Mendoza, Ivan, Mosterd, Arend, Negrusz-Kawecka, Marta, Peuhkurinen, Keijo, Ramires, Felix J. A., Refsgaard, Jens, Rosenthal, Arvo, Senni, Michele, Sibulo, Antonio S. Jr, Silva-Cardoso, Jose, Squire, Iain B., Starling, Randall C., Teerlink, John R., Vanhaecke, Johan, Vinereanu, Dragos, and Wong, Raymond Ching-Chiew

Abstract

BACKGROUND: Clinical trials in heart failure have focused on the improvement in symptoms or decreases in the risk of death and other cardiovascular events. Little is known about the effect of drugs on the risk of clinical deterioration in surviving patients. METHODS AND RESULTS: We compared the angiotensin-neprilysin inhibitor LCZ696 (400 mg daily) with the angiotensin-converting enzyme inhibitor enalapril (20 mg daily) in 8399 patients with heart failure and reduced ejection fraction in a double-blind trial. The analyses focused on prespecified measures of nonfatal clinical deterioration. In comparison with the enalapril group, fewer LCZ696-treated patients required intensification of medical treatment for heart failure (520 versus 604; hazard ratio, 0.84; 95% confidence interval, 0.74-0.94; P=0.003) or an emergency department visit for worsening heart failure (hazard ratio, 0.66; 95% confidence interval, 0.52-0.85; P=0.001). The patients in the LCZ696 group had 23% fewer hospitalizations for worsening heart failure (851 versus 1079; P<0.001) and were less likely to require intensive care (768 versus 879; 18% rate reduction, P=0.005), to receive intravenous positive inotropic agents (31% risk reduction, P<0.001), and to have implantation of a heart failure device or cardiac transplantation (22% risk reduction, P=0.07). The reduction in heart failure hospitalization with LCZ696 was evident within the first 30 days after randomization. Worsening of symptom scores in surviving patients was consistently more common in the enalapril group. LCZ696 led to an early and sustained reduction in biomarkers of myocardial wall stress and injury (N-terminal pro-B-type natriuretic peptide and troponin) versus enalapril. CONCLUSIONS: Angiotensin-neprilysin inhibition prevents the clinical progression of surviving patients with heart failure more effectively than angiotensin-converting enzyme inhibition. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifi

Published
2015
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