Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events
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BACKGROUND: The ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial compared alirocumab with placebo, added to high-intensity or maximum-tolerated statin treatment, after acute coronary syndrome (ACS) in 18,924 patients. Alirocumab reduced the first occurrence of the primary composite endpoint and was associated with fewer all-cause deaths. OBJECTIVES: This pre-specified analysis determined the extent to which alirocumab reduced total (first and subsequent) nonfatal cardiovascular events and all-cause deaths in ODYSSEY OUTCOMES. METHODS: Hazard functions for total nonfatal cardiovascular events (myocardial infarction, stroke, ischemia-driven coronary revascularization, and hospitalization for unstable angina or heart failure) and death were jointly estimated, linked by a shared frailty accounting for patient risk heterogeneity and correlated within-patient nonfatal events. An association parameter also quantified the strength of the linkage between risk of nonfatal events and death. The model provides accurate relative estimates of nonfatal event risk if nonfatal events are associated with increased risk for death. RESULTS: With 3,064 first and 5,425 total events, 190 fewer first and 385 fewer total nonfatal cardiovascular events or deaths were observed with alirocumab compared with placebo. Alirocumab reduced total nonfatal cardiovascular events (hazard ratio: 0.87; 95% confidence interval: 0.82 to 0.93) and death (hazard ratio: 0.83; 95% confidence interval: 0.71 to 0.97) in the presence of a strong association between nonfatal and fatal event risk. CONCLUSIONS: In patients with ACS, the total number of nonfatal cardiovascular events and deaths prevented with alirocumab was twice the number of first events prevented. Consequently, total event reduction is a more comprehensive metric to capture the totality of alirocumab clinical efficacy after ACS.
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Patients with elevated triglycerides, atherosclerosis, or diabetes receiving statins are at substantial risk for recurrent, potentially fatal ischemic events.
“In addition to their initial events, such patients are at substantial risk for recurrent, potentially fatal events.”
From Effects of Icosapent Ethyl on Total Ischemic Events (2019) · cites this paper as [11]
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- Authors
- Szarek, M., White, H. D., Schwartz, G. G., Alings, M., Bhatt, D. L., Bittner, V. A., Chiang, C.-E., Diaz, R., Edelberg, J. M., Goodman, S. G., Hanotin, C., Harrington, R. A., Jukema, J. W., Kimura, T., Kiss, R. G., Lecorps, G., Mahaffey, K. W., Moryusef, A., Pordy, R., Roe, M. T., Tricoci, P., Xavier, D., Zeiher, A. M., & Steg, P. G.
- Affiliations
- State University of New York (US)
- University of Auckland (NZ)
- University of Colorado Anschutz (US)
- Amphia Ziekenhuis (NL)
- Brigham and Women's Hospital (US)
- University of Alabama at Birmingham (US)
- Taipei Veterans General Hospital (TW)
- Sanofi (United States) (US)
- St. Michael's Hospital (CA)
- Sanofi (France) (FR)
- Stanford University (US)
- Leiden University Medical Center (NL)
- Kyoto University (JP)
- Regeneron (United States) (US)
- Duke University (US)
- Goethe University Frankfurt (DE)
- Corresponding author
- Szarek, Michael
- ORCID
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2019-02
- Volume
- 73
- Issue
- 4
- Pages
- 387-396
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W2900103074
- Cited by
- 173
- References
- 12
- Citations by year
- 2026: 5 · 2025: 12 · 2024: 18 · 2023: 15 · 2022: 18 · 2021: 17 · 2020: 45 · 2019: 42 · 2018: 1
- FWCI
- 27.31
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion, cc-by-nc-nd)
- Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, cc-by-nc-nd)
- Lirias (submittedVersion, cc-by-nc-nd)
- Publication Server of Goethe University Frankfurt am Main (Goethe University Frankfurt) (submittedVersion, cc-by-nc-nd)
- Lanzhou University Institutional Repository (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Uppsala University Publications (Uppsala University) (submittedVersion, other-oa)
- Leiden Repository (Leiden University) (submittedVersion)
- Institutional Repository of the University of Granada (University of Granada) (submittedVersion, cc-by-nc-nd)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-nc-nd)
- Institutional Repositories DataBase (IRDB) (submittedVersion)
- Kyoto University Research Information Repository (Kyoto University) (submittedVersion, cc-by-nc-nd)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
- Keywords
- alirocumab, acute coronary syndrome, ODYSSEY OUTCOMES trial, PCSK9 inhibitors, all-cause mortality, shared frailty model, high-intensity statin therapy, myocardial infarction, stroke, coronary revascularization, unstable angina, heart failure
- MeSH terms
- Aged, Antibodies, Monoclonal, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Middle Aged, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Acute Coronary Syndrome, Antibodies, Monoclonal, Humanized
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