REDUCE-IT USA Article Swipe
YOU?
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· 2019
· Open Access
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· DOI: https://doi.org/10.1161/circulationaha.119.044440
Background: Some trials have found that patients from the United States derive less benefit than patients enrolled outside the United States. This prespecified REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl - Intervention Trial) subgroup analysis was conducted to determine the degree of benefit of icosapent ethyl in the United States. Methods: REDUCE-IT randomized 8179 statin-treated patients with qualifying triglycerides ≥135 and 40 and ≤100 mg/dL and a history of atherosclerosis or diabetes mellitus to icosapent ethyl 4 g/d or placebo. The primary composite end point was cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina. The key secondary composite end point was cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. A hierarchy was prespecified for examination of individual and composite end points. Results: A total of 3146 US patients (38.5% of the trial) were randomized and followed for a median of 4.9 years; 32.3% were women and 9.7% were Hispanic. The primary composite end point occurred in 24.7% of placebo-treated patients versus 18.2% of icosapent ethyl-treated patients (hazard ratio [HR], 0.69 [95% CI, 0.59–0.80]; P =0.000001); the key secondary composite end point occurred in 16.6% versus 12.1% (HR, 0.69 [95% CI, 0.57–0.83]; P =0.00008). All prespecified hierarchical end points were meaningfully and significantly reduced, including cardiovascular death (6.7% to 4.7%; HR, 0.66 [95% CI, 0.49–0.90]; P =0.007), myocardial infarction (8.8% to 6.7%; HR, 0.72 [95% CI, 0.56–0.93]; P =0.01), stroke (4.1% to 2.6%; HR, 0.63 [95% CI, 0.43–0.93]; P =0.02), and all-cause mortality (9.8% to 7.2%; HR, 0.70 [95% CI, 0.55–0.90]; P =0.004); for all-cause mortality in the US versus non-US patients, P interaction =0.02. Safety and tolerability findings were consistent with the full study cohort. Conclusions: Whereas the non-US subgroup showed significant reductions in the primary and key secondary end points, the US subgroup demonstrated particularly robust risk reductions across a variety of individual and composite end points, including all-cause mortality. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01492361.
Related Topics
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1161/circulationaha.119.044440
- https://www.ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.119.044440
- OA Status
- bronze
- Cited By
- 132
- References
- 32
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W2985476501
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W2985476501Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1161/circulationaha.119.044440Digital Object Identifier
- Title
-
REDUCE-IT USAWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2019Year of publication
- Publication date
-
2019-11-11Full publication date if available
- Authors
-
Deepak L. Bhatt, Michael Miller, Eliot A. Brinton, Terry A. Jacobson, Philippe Gabríel Steg, Steven B. Ketchum, Ralph T. Doyle, Rebecca A. Juliano, Lixia Jiao, Craig Granowitz, Jean‐Claude Tardif, Brian Olshansky, Mina K. Chung, C. Michael Gibson, Robert P. Giugliano, Matthew J. Budoff, Christie M. BallantyneList of authors in order
- Landing page
-
https://doi.org/10.1161/circulationaha.119.044440Publisher landing page
- PDF URL
-
https://www.ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.119.044440Direct link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
bronzeOpen access status per OpenAlex
- OA URL
-
https://www.ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.119.044440Direct OA link when available
- Concepts
-
Medicine, Hazard ratio, Myocardial infarction, Internal medicine, Placebo, Unstable angina, Stroke (engine), Diabetes mellitus, Clinical endpoint, Cardiology, Randomized controlled trial, Confidence interval, Endocrinology, Alternative medicine, Mechanical engineering, Engineering, PathologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
132Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 11, 2024: 16, 2023: 17, 2022: 23, 2021: 25Per-year citation counts (last 5 years)
- References (count)
-
32Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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