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2. Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials
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Teerlink, John R., Diaz, Rafael, Felker, G. Michael, McMurray, John J.V., Metra, Marco, Solomon, Scott D., Adams, Kirkwood F., Anand, Inder, Arias‐Mendoza, Alexandra, Biering‐Sørensen, Tor, Böhm, Michael, Bonderman, Diana, Cleland, John G.F., Corbalan, Ramon, Crespo‐Leiro, Maria G., Dahlström, Ulf, Echeverria Correa, Luis E., Fang, James C., Filippatos, Gerasimos, Fonseca, Cândida, Goncalvesova, Eva, Goudev, Assen R., Howlett, Jonathan G., Lanfear, David E., Lund, Mayanna, Macdonald, Peter, Mareev, Vyacheslav, Momomura, Shin‐ichi, O'Meara, Eileen, Parkhomenko, Alexander, Ponikowski, Piotr, Ramires, Felix J. A., Serpytis, Pranas, Sliwa, Karen, Spinar, Jindrich, Suter, Thomas M., Tomcsanyi, Janos, Vandekerckhove, Hans, Vinereanu, Dragos, Voors, Adriaan A., Yilmaz, Mehmet B., Zannad, Faiez, Sharpsten, Lucie, Legg, Jason C., Abbasi, Siddique A., Varin, Claire, Malik, Fady I., Kurtz, Christopher E., Besada, Diego Alejandro, Majul, Claudio Rodolfo, Bruno, Marco Raul Litvak, Sassone, Sonia, Avaca, Horacio Alberto, Rasmussen, Mariela, Aiub, Jorge Roberto, Hominal, Miguel Angel, Perna, Eduardo, Duran, Ruben Omar Garcia, Schiavi, Lilia, Marquez, Lilia Luz Lobo, Vilamajo, Oscar Alberto Gomez, Mackinnon, Ignacio, Fuente, Ricardo Alfonso Leon, Montana, Oscar Romano, Novaretto, Leonardo, Guerrero, Rodolfo Andres Ahuad, Brasca, Daniela Garcia, Prado, Aldo, Garrido, Marcelo Alejandro, Luquez, Hugo, Martinez, Diego Felipe, Nicolosi, Liliana, Parody, Maria Leonor, Zaidman, Cesar, Berra, Fernando Colombo, Ibañez, Julio, Zapata, Gerardo, Caccavo, Alberto, Colque, Roberto, Diez, Mirta, Poy, Carlos, Salomone, Oscar Alejandro, Vogel, Daniel, Bordonava, Anselmo Paulino, Fernandez, Alberto, French, John, Atherton, John, Hamilton, Andrew, Begg, Alistair, Abhayaratna, Walter, Judkins, Christopher, De Pasquale, Carmine, McKenzie, Scott, Amerena, John, Szto, Gregory, Kearney, Leighton, Zimmet, Hendrik, Sverdlov, Aaron, Beltrame, John, Korczyk, Dariusz, Sindone, Andrew, Moertl, Deddo, Huber, Kurt, Huelsmann, Martin, Ablasser, Klemens, Ebner, Christian, Siostrzonek, Peter, Drexel, Heinz, Poelzl, Gerhard, Dujardin, Karl, Dupont, Matthias, Buysschaert, Ian, Lancellotti, Patrizio, Droogne, Walter, Chouchane, Iman, Silveira, Fabio, Rassi, Salvador, Reis, Gilmar, Filho, Pedro Pimentel, Simoes, Marcus Vinicius, Braga, Joao Carlos, Giorgeto, Flavio Eduardo, Ferraz, Almir, Jaeger, Cristiano Pederneiras, Saraiva, Jose Francisco, Tognon, Alexandre, Cardoso, Juliano, Greco, Oswaldo, Paiva, Maria Sanali, Paolino, Bruno, Filho, Otavio Coelho, Maia, Lilia Nigro, Silva, Rodrigo, Canesin, Manoel, Rossi, Paulo Roberto Ferreira, Fortes, Jose Augusto Ribas, Cerci, Rodrigo Julio, Manenti, Euler Roberto Fernandes, Leaes, Paulo Ernesto, Silva Neto, Luis Beck, Souza, Weimar Kunz Barroso, Bacal, Fernando, Chaves, Renato, Ramires, Felix, Vidotti, Maria Helena, Barros e Silva, Pedro Gabriel Melo, Piegas, Leopoldo Soares, Todorov, Georgi, Tzekova, Maria, Goudev, Assen, Mincheva, Valentina, Vasilev, Ivaylo, Tisheva‐ Gospodinova, Snezhanka, Petrov, Ivo, Postadzhiyan, Arman, Velikov, Chavdar, Dimov, Bojidar, Constance, Christian, Phaneuf, Denis‐Carl, Mielniczuk, Lisa, Pandey, A Shekhar, Senaratne, Manohara, Zieroth, Shelley, Savard, Daniel, Stewart, Robert, Huynh, Thao, Giannetti, Nadia, Moe, Gordon, Bourgeois, Ronald, Ezekowitz, Justin, Hartleib, Michael, Sussex, Bruce, Babapulle, Mohan, Chehayeb, Raja, Gaudet, Daniel, McKelvie, Robert, Nguyen, Viviane, Roth, Sherryn, Gupta, Milan, Pesant, Yves, Rupka, Dennis, Bhargava, Rakesh, Costa‐Vitali, Atilio, Proulx, Guy, Vega, Mario, Potthoff, Sergio, Cid, Maria Cristina Schnettler, Sepulveda, Alex Mauricio Villablanca, Zanetti, Fernando Tomas Lanas, Gajardo, Victor Areli Saavedra, Kindel, Carlos Conejeros, Jofre, Christian Paolo Pincetti, Segarra, Jorge Leonardo Cobos, Venegas, Manuel Eduardo Rodriguez, Hidalgo, Mario Yanez, Jalaf, Margarita Gertrudis Vejar, Li, Weimin, Zhang, Jinguo, Fu, Xin, Zhang, Xuelian, Li, Dongye, Wang, Zhifang, Qu, Yanling, Zheng, Zhe, Tang, Huifang, Yang, Ping, Zhang, Yuhui, Zheng, Yang, Mi, Yafei, Huang, He, Bu, Peili, Chen, Guoqin, Chen, Jiyan, Han, Yajun, Li, Zhangquan, Ma, Shumei, Yang, Xuming, Yuan, Zuyi, Dong, Yugang, Li, Zhaoping, Mahemuti, Ailiman, Niu, Wentang, Yang, Zhenyu, Zhang, Yuqing, Sun, Yuemin, Wu, Weiheng, Liu, Feng, Yan, Jing, Li, Yinjun, Wang, Yi, Zhang, Shouyan, Zhou, Changyong, Cui, Hanbin, Li, Jianjun, Li, Tianfa, Han, Qinghua, Wei, Yu, Correa, Luis Eduardo Echeverria, Mendoza, Jose Luis Accini, Jattin, Fernando Manzur, Osorio, Wilder Castaño, Luengas, Carlos Alberto, Arroyo, Julian Alonso 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Kaluski, Edo, Karim, Amin, Kono, Alan, Lader, Ellis, Lakshminarayanan, Batlagundu, Lewis, Neil, Malhotra, Vinay, Mayer, Nolan, Mohapatra, Robert, Nair, Nandini, O'Brien, Terrence, Pauwaa, Sunil, Rowan, Christopher, Saxena, Sanjeev, Seto, Arnold, Shah, Nishant, Singh, Pradeep, Skopicki, Hal, Stoddard, Marcus, and Sweitzer, Nancy
- Subjects
R1 - Abstract
Aims:\ud The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials.\ud \ud Methods and Results:\ud Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure
- Published
- 2020
3. CAPTURE: a multinational, cross-sectional study of cardiovascular disease prevalence in adults with type 2 diabetes across 13 countries.
- Author
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Mosenzon, Ofri, Alguwaihes, Abdullah, Leon, Jose Luis Arenas, Bayram, Fahri, Darmon, Patrice, Davis, Timothy M. E., Dieuzeide, Guillermo, Eriksen, Kirsten T., Hong, Tianpei, Kaltoft, Margit S., Lengyel, Csaba, Rhee, Nicolai A., Russo, Giuseppina T., Shirabe, Shinichiro, Urbancova, Katerina, and Vencio, Sergio
- Subjects
CARDIOVASCULAR diseases ,TYPE 2 diabetes ,ADULTS ,GLUCAGON-like peptide-1 receptor ,DISEASE prevalence - Abstract
Background: There is a paucity of global data on cardiovascular disease (CVD) prevalence in people with type 2 diabetes (T2D). The primary objective of the CAPTURE study was to estimate the prevalence of established CVD and its management in adults with T2D across 13 countries from five continents. Additional objectives were to further characterize the study sample regarding demographics, clinical parameters and medication usage, with particular reference to blood glucose-lowering agents (GLAs: glucagon-like peptide-1 receptor agonists and sodium-glucose co-transporter-2 inhibitors) with demonstrated cardiovascular benefit in randomized intervention trials. Methods: Data were collected from adults with T2D managed in primary or specialist care in Australia, China, Japan, Czech Republic, France, Hungary, Italy, Argentina, Brazil, Mexico, Israel, Kingdom of Saudi Arabia, and Turkey in 2019, using standardized methodology. CVD prevalence, weighted by diabetes prevalence in each country, was estimated for the overall CAPTURE sample and participating countries. Country-specific odds ratios for CVD prevalence were further adjusted for relevant demographic and clinical parameters. Results: The overall CAPTURE sample included 9823 adults with T2D (n = 4502 from primary care; n = 5321 from specialist care). The overall CAPTURE sample had median (interquartile range) diabetes duration 10.7 years (5.6–17.9 years) and glycated hemoglobin 7.3% (6.6–8.4%) [56 mmol/mol (49–68 mmol/mol)]. Overall weighted CVD and atherosclerotic CVD prevalence estimates were 34.8% (95% confidence interval [CI] 32.7–36.8) and 31.8% (95% CI 29.7–33.8%), respectively. Age, gender, and clinical parameters accounted for some of the between-country variation in CVD prevalence. GLAs with demonstrated cardiovascular benefit were used by 21.9% of participants, which was similar in participants with and without CVD: 21.5% and 22.2%, respectively. Conclusions: In 2019, approximately one in three adults with T2D in CAPTURE had diagnosed CVD. The low use of GLAs with demonstrated cardiovascular benefit even in participants with established CVD suggested that most were not managed according to contemporary diabetes and cardiology guidelines. Study registration NCT03786406 (registered on December 20, 2018), NCT03811288 (registered on January 18, 2019). [ABSTRACT FROM AUTHOR]
- Published
- 2021
- Full Text
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