Abstract

Summary Background

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.

Methods

The SELECT trial was a randomised, double-blind, multicentre, placebo-controlled, event-driven phase 3 trial in 41 countries. Adults aged 45 years and older, with a BMI of 27 kg/m2 or greater and established cardiovascular disease were eligible for the study. Patients were randomly assigned (1:1) with a block size of four using an interactive web response system in a double-blind manner to escalating doses of once-weekly subcutaneous semaglutide over 16 weeks to a target dose of 2·4 mg, or placebo. In a prespecified analysis, we examined the effect of semaglutide compared with placebo in patients with and without a history of heart failure at enrolment, subclassified as heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, or unclassified heart failure. Endpoints comprised MACE (a composite of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death); a composite heart failure outcome (cardiovascular death or hospitalisation or urgent hospital visit for heart failure); cardiovascular death; and all-cause death. The study is registered with ClinicalTrials.gov, NCT03574597.

Findings

Between Oct 31, 2018, and March 31, 2021, 17 604 patients with a mean age of 61·6 years (SD 8·9) and a mean BMI of 33·4 kg/m2 (5·0) were randomly assigned to receive semaglutide (8803 [50·0%] patients) or placebo (8801 [50·0%] patients). 4286 (24·3%) of 17 604 patients had a history of investigator-defined heart failure at enrolment: 2273 (53·0%) of 4286 patients had heart failure with preserved ejection fraction, 1347 (31·4%) had heart failure with reduced ejection fraction, and 666 (15·5%) had unclassified heart failure. Baseline characteristics were similar between patients with and without heart failure. Patients with heart failure had a higher incidence of clinical events. Semaglutide improved all outcome measures in patients with heart failure at random assignment compared with those without heart failure (hazard ratio [HR] 0·72, 95% CI 0·60–0·87 for MACE; 0·79, 0·64–0·98 for the heart failure composite endpoint; 0·76, 0·59–0·97 for cardiovascular death; and 0·81, 0·66–1·00 for all-cause death; all pinteraction>0·19). Treatment with semaglutide resulted in improved outcomes in both the heart failure with reduced ejection fraction (HR 0·65, 95% CI 0·49–0·87 for MACE; 0·79, 0·58–1·08 for the composite heart failure endpoint) and heart failure with preserved ejection fraction groups (0·69, 0·51–0·91 for MACE; 0·75, 0·52–1·07 for the composite heart failure endpoint), although patients with heart failure with reduced ejection fraction had higher absolute event rates than those with heart failure with preserved ejection fraction. For MACE and the heart failure composite, there were no significant differences in benefits across baseline age, sex, BMI, New York Heart Association status, and diuretic use. Serious adverse events were less frequent with semaglutide versus placebo, regardless of heart failure subtype.

Interpretation

In patients with atherosclerotic cardiovascular diease and overweight or obesity, treatment with semaglutide 2·4 mg reduced MACE and composite heart failure endpoints compared with placebo in those with and without clinical heart failure, regardless of heart failure subtype. Our findings could facilitate prescribing and result in improved clinical outcomes for this patient group.

Funding

Novo Nordisk.

Details

Title
Semaglutide and cardiovascular outcomes in patients with obesity and prevalent heart failure: a prespecified analysis of the SELECT trial
Author
Deanfield, John 1 ; Verma, Subodh 2 ; Scirica, Benjamin M 3 ; Kahn, Steven E 4 ; Emerson, Scott S 5 ; Ryan, Donna 6 ; Lingvay, Ildiko 7 ; Colhoun, Helen M 8 ; Plutzky, Jorge 3 ; Kosiborod, Mikhail N 9 ; G Kees Hovingh 10 ; Hardt-Lindberg, Søren 11 ; Frenkel, Ofir 11 ; Weeke, Peter E 11 ; Rasmussen, Søren 11 ; Goudev, Assen 12 ; Lang, Chim C 13 ; Urina-Triana, Miguel 14 ; Pietilä, Mikko 15 ; Lincoff, A Michael 16 ; Abe, Mitsunori; Abhaichand, Rajpal K; Abhayaratna, Walter P; Abhyankar, Atul; Zainal Abidin, Imran B; Hiba Abou Assi; Accini Mendoza, Jose L; Adas, Mine; Agaiby, John M; Agarwal, Devendra K; Agha, Maher; Azazuddin Ahmed; Ahtiainen, Petteri; Aigner, Elmar; Naik Ajay; Ali, Norsiah; Al-Karadsheh, Amer; Roy, Allison; Allison, Dale C; Alpenidze, Diana; Altuntas, Yuksel; Al-Zoebi, Ayham; Roy Ambuj; 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; Gilles Barone Rochette; 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; Rodrigo Botero Lopez; 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; Varzic, Silvija Canecki; 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; Johann, Christopher; Chrustowski, Witold; Cif, Adriana; Clark, Rebecca; Clark, Wayne; Clifford, Piers; Coetzee, Kathleen; Cogni, Giulia; Colao, Anna Maria; Colquhoun, David M; Concha, Mauricio; Condit, Jonathan; Christian, Constance; 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; Manuel O De Los Rios Ibarra; De Pablo, Carmen; De Pauw, Michel; Alexander Dela Llana; 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; Gandy, Winston; Garcia Hernandez, Pedro A; Raymundo García Reza; Garg, Naveen; Garg, Sandeep; Garvey, William T; Garza, Juan C; Gatta-Cherifi, Blandine; Gelev, Valeri; Geller, Steven A; Geohas, Jeffrey G; Georgiev, Borislav; Adline Ghazi; Gilbert, Matthew P; Gilinskaya, Olga; Gislason, Gunnar; Yavuz, Dilek Gogas; Olga González Albarrán; Gordeev, Ivan G; Gorton, Sidney C; Valderhaug, Tone Gretland; Groenemeijer, Bjorn; Ibrahim, Gul; 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; Lee, Herman; 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; I-Chang, Hsieh; 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; Sawhney Jitendra Pal Singh; 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; 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1  Institute of Cardiovascular Sciences, University College London, London, UK 
2  Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St Michael's Hospital, Unity Health Toronto, University of Toronto, Toronto, ON, Canada 
3  Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA 
4  Department of Medicine, VA Puget Sound Health Care System and University of Washington, Seattle, WA, USA 
5  Department of Biostatistics, University of Washington, Seattle, WA, USA 
6  Pennington Biomedical Research Center, Baton Rouge, LA, USA 
7  Department of Internal Medicine/Endocrinology and Peter O’Donnell Jr School of Public Health, UT Southwestern Medical Center, Dallas, TX, USA 
8  Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, UK 
9  Department of Cardiovascular Disease, Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City School of Medicine, Kansas City, MO, USA 
10  Novo Nordisk, Søborg, Denmark; Department of Vascular Medicine, Amsterdam University Medical Centers, Amsterdam, Netherlands 
11  Novo Nordisk, Søborg, Denmark 
12  Department of Cardiology, Queen Giovanna University Hospital, Sofia, Bulgaria 
13  Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, UK 
14  Faculty of Health Sciences, Universidad Simón Bolívar, Barranquilla, Colombia 
15  Heart Center, Turku University Hospital, University of Turku, Turku, Finland 
16  Department of Cardiovascular Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH, USA 
Pages
773-786
Section
Articles
Publication year
2024
Publication date
Aug 24, 2024
Publisher
Elsevier Limited
ISSN
01406736
e-ISSN
1474547X
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1016/S0140-6736(24)01498-3
ProQuest document ID
3095900456
Copyright
© 2024. The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. This work is published under https://creativecommons.org/licenses/by/3.0/ (theLicense”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.